CDC says child vaccination exemptions hit all-time high

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Wed, 11/15/2023 - 10:39

The Centers for Disease Control and Prevention said 3% of children starting kindergarten in the 2022-2023 school year received an exemption from one of the four key vaccines – the highest exemption rate ever reported in the United States.

Of the 3% of children who got exemptions, 0.2% were for medical reasons and 2.8% for nonmedical reasons, the CDC report said. The overall exemption rate was 2.6% for the previous school year. 

Though more children received exemptions, the overall national vaccination rate remained steady at 93% for children entering kindergarten for the 2022-2023 school year. Before the COVID-19 pandemic, the overall rate was 95%, the CDC said.

“The bad news is that it’s gone down since the pandemic and still hasn’t rebounded,” Sean O’Leary, MD, a University of Colorado pediatric infectious diseases specialist, told The Associated Press. “The good news is that the vast majority of parents are still vaccinating their kids according to the recommended schedule.”

The CDC report did not offer a specific reason for higher vaccine exemptions. But it did note that the increase could be caused by the COVID-19 pandemic and COVID vaccine hesitancy. 

“There is a rising distrust in the health care system,” Amna Husain, MD, a pediatrician in private practice in North Carolina and a spokesperson for the American Academy of Pediatrics, told NBC News. Vaccine exemptions “have unfortunately trended upward with it.”

Exemption rates varied across the nation. The CDC said 40 states reported a rise in exemptions and that the exemption rate went over 5% in 10 states: Alaska, Arizona, Hawaii, Idaho, Michigan, Nevada, North Dakota, Oregon, Utah, and Wisconsin. Idaho had the highest exemption rate in 2022 with 12%.

While requirements vary from state to state, most states require students entering kindergarten to receive four vaccines: MMR, DTaP, polio, and chickenpox.

A version of this article first appeared on WebMD.com.

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The Centers for Disease Control and Prevention said 3% of children starting kindergarten in the 2022-2023 school year received an exemption from one of the four key vaccines – the highest exemption rate ever reported in the United States.

Of the 3% of children who got exemptions, 0.2% were for medical reasons and 2.8% for nonmedical reasons, the CDC report said. The overall exemption rate was 2.6% for the previous school year. 

Though more children received exemptions, the overall national vaccination rate remained steady at 93% for children entering kindergarten for the 2022-2023 school year. Before the COVID-19 pandemic, the overall rate was 95%, the CDC said.

“The bad news is that it’s gone down since the pandemic and still hasn’t rebounded,” Sean O’Leary, MD, a University of Colorado pediatric infectious diseases specialist, told The Associated Press. “The good news is that the vast majority of parents are still vaccinating their kids according to the recommended schedule.”

The CDC report did not offer a specific reason for higher vaccine exemptions. But it did note that the increase could be caused by the COVID-19 pandemic and COVID vaccine hesitancy. 

“There is a rising distrust in the health care system,” Amna Husain, MD, a pediatrician in private practice in North Carolina and a spokesperson for the American Academy of Pediatrics, told NBC News. Vaccine exemptions “have unfortunately trended upward with it.”

Exemption rates varied across the nation. The CDC said 40 states reported a rise in exemptions and that the exemption rate went over 5% in 10 states: Alaska, Arizona, Hawaii, Idaho, Michigan, Nevada, North Dakota, Oregon, Utah, and Wisconsin. Idaho had the highest exemption rate in 2022 with 12%.

While requirements vary from state to state, most states require students entering kindergarten to receive four vaccines: MMR, DTaP, polio, and chickenpox.

A version of this article first appeared on WebMD.com.

The Centers for Disease Control and Prevention said 3% of children starting kindergarten in the 2022-2023 school year received an exemption from one of the four key vaccines – the highest exemption rate ever reported in the United States.

Of the 3% of children who got exemptions, 0.2% were for medical reasons and 2.8% for nonmedical reasons, the CDC report said. The overall exemption rate was 2.6% for the previous school year. 

Though more children received exemptions, the overall national vaccination rate remained steady at 93% for children entering kindergarten for the 2022-2023 school year. Before the COVID-19 pandemic, the overall rate was 95%, the CDC said.

“The bad news is that it’s gone down since the pandemic and still hasn’t rebounded,” Sean O’Leary, MD, a University of Colorado pediatric infectious diseases specialist, told The Associated Press. “The good news is that the vast majority of parents are still vaccinating their kids according to the recommended schedule.”

The CDC report did not offer a specific reason for higher vaccine exemptions. But it did note that the increase could be caused by the COVID-19 pandemic and COVID vaccine hesitancy. 

“There is a rising distrust in the health care system,” Amna Husain, MD, a pediatrician in private practice in North Carolina and a spokesperson for the American Academy of Pediatrics, told NBC News. Vaccine exemptions “have unfortunately trended upward with it.”

Exemption rates varied across the nation. The CDC said 40 states reported a rise in exemptions and that the exemption rate went over 5% in 10 states: Alaska, Arizona, Hawaii, Idaho, Michigan, Nevada, North Dakota, Oregon, Utah, and Wisconsin. Idaho had the highest exemption rate in 2022 with 12%.

While requirements vary from state to state, most states require students entering kindergarten to receive four vaccines: MMR, DTaP, polio, and chickenpox.

A version of this article first appeared on WebMD.com.

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Preventing RSV in children and adults: A vaccine update

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Wed, 12/06/2023 - 08:11
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Preventing RSV in children and adults: A vaccine update

In the past year, there has been significant progress in the availability of interventions to prevent respiratory syncytial virus (RSV) and its complications. Four products have been approved by the US Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). They include 2 vaccines for adults ages 60 years and older, a monoclonal antibody for infants and high-risk children, and a maternal vaccine to prevent RSV infection in newborns.

Who’s at increased risk for severe RSV disease?

RSV in adults

While there is some uncertainty about the total burden of RSV in adults in the United States, the CDC estimates that each year it causes 0.9 to 1.4 million medical encounters, 60,000 to 160,000 hospitalizations, and 6000 to 10,000 deaths.1 The rate of RSV-caused hospitalization increases with age,2 and the infection is more severe in those with certain chronic medical conditions (TABLE 11). The FIGURE2 demonstrates the outcomes of adults who are hospitalized for RSV. Adults older than 65 years have a 5% mortality rate if hospitalized for RSV infection.2

Outcomes among adults hospitalized for RSV, 2017-2018 to 2019-2020

Vaccine options for adults

Two vaccines were recently approved for the prevention of RSV-associated lower respiratory tract disease (LRTD) in those ages 60 years and older: RSVPreF3 (Arexvy, GSK), which is an adjuvanted recombinant F protein vaccine, and RSVpreF (Abrysvo, Pfizer), which is a recombinant stabilized vaccine. Both require only a single dose (0.5 mL IM), which provides protection for 2 years.

The efficacy of the GSK vaccine in preventing laboratory-confirmed, RSV-­associated LRTD was 82.6% during the first RSV season and 56.1% during the second season. The efficacy of the Pfizer vaccine in preventing symptomatic, laboratory-confirmed LRTD was 88.9% during the first RSV season and 78.6% during the second season.1 However, the trials leading to licensure of both vaccines were underpowered to show efficacy in the oldest adults and those who are frail or to show efficacy against RSV-caused hospitalization.

Safety of the adult RSV vaccines. The safety trials for both vaccines had a total of 38,177 participants. There were a total of 6 neurologic inflammatory conditions that developed within 42 days of vaccination, including 2 cases of suspected Guillain-Barré syndrome (GBS), 2 cases of possible acute disseminated encephalomyelitis, and 1 case each of chronic inflammatory demyelinating polyneuropathy and undifferentiated motor-­sensory axonal polyneuropathy.1 That is a rate of 1 case of a neurologic inflammatory condition for every 6363 people vaccinated. Since the trials were not powered to determine whether the small number of cases were due to chance, postmarketing surveillance will be needed to clarify the true risk for GBS or other neurologic inflammatory events from RSV vaccination.

The lack of efficacy data for the most vulnerable older adults and the lingering questions about safety prompted the ACIP to recommend that adults ages 60 years and older may receive a single dose of RSV vaccine, using shared clinical decision-­making—which is different from a routine or risk-based vaccine recommendation. For RSV vaccination, the decision to vaccinate should be based on a risk/benefit discussion between the clinician and the patient. Those most likely to benefit from the vaccine are listed in ­TABLE 1.1

While data on coadministration of RSV vaccines with other adult vaccines are sparse, the ACIP states that co-administration with other vaccines is acceptable.1 It is not known yet whether boosters will be needed after 2 years.

Continue to: RSV in infants and children

 

 

RSV in infants and children

RSV is the most common cause of hospitalization among infants and children in the United States. The CDC estimates that each year in children younger than 5 years, RSV is responsible for 1.5 million outpatient clinic visits, 520,000 emergency department visits, 58,000 to 80,000 hospitalizations, and 100 to 200 deaths.3 The risk for hospitalization from RSV is highest in the second and third months of life and decreases with increasing age.3

There are racial disparities in RSV severity: Intensive care unit admission rates are 1.2 to 1.6 times higher among non-Hispanic Black infants younger than 6 months than among non-Hispanic White infants, and hospitalization rates are up to 5 times higher in American Indian and Alaska Native populations.3

The months of highest RSV transmission in most locations are December through February, but this can vary. For practical purposes, RSV season runs from October through March.

Prevention in infants and children

The monoclonal antibody nirsevimab is now available for use in infants younger than 8 months born during or entering their first RSV season and children ages 8 to 19 months who are at increased risk for severe RSV disease and entering their second RSV season. Details regarding the use of this product were described in a recent Practice Alert Brief.4

Early studies on nirsevimab demonstrated 79% effectiveness in preventing ­medical-attended LRTD, 80.6% effectiveness in preventing hospitalization, and 90% effectiveness in preventing ICU admission. The number needed to immunize with nirsevimab to prevent an outpatient visit is estimated to be 17; to prevent an ED visit, 48; and to prevent an inpatient admission, 128. Due to the low RSV death rate, the studies were not able to demonstrate reduced mortality.5

Continue to: RSV vaccine in pregnancy

 

 

RSV vaccine in pregnancy

In August, the FDA approved Pfizer’s RSVpreF vaccine for use during pregnancy—as a single dose given at 32 to 36 weeks’ ­gestation—for the prevention of RSV LRTD in infants in the first 6 months of life. In the clinical trials, the vaccine was given at 24 to 36 weeks’ gestation. However, there was a statistically nonsignificant increase in preterm births in the RSVpreF group compared to the placebo group.6 While there were insufficient data to prove or rule out a causal relationship, the FDA advisory committee was more comfortable approving the vaccine for use only later in pregnancy, to avoid the possibility of very early preterm births after vaccination. The ACIP agreed.

From time of maternal vaccination, at least 14 days are needed to develop and transfer maternal antibodies across the placenta to protect the infant. Therefore, infants born less than 14 days after maternal vaccination should be considered unprotected.

Both maternal vaccination with RSVpreF and infant injection with nirsevimab are now options to protect newborns and infants from RSV. However, use of both products is not needed, since combined they do not offer significant added protection compared to either product alone (exceptions to be discussed shortly).6 When the estimated due date will occur in the RSV season, maternity clinicians should provide information on both products and assist the mother in deciding whether to be vaccinated or rely on administration of nirsevimab to the infant after birth. The benefits and risks of these 2 options are listed in TABLE 2.6

Relative risks and benefits of maternal vaccination and nirsevimab

There are some rare situations in which use of both products is recommended, and they include6:

  • When the baby is born less than 14 days from the time of maternal ­vaccination
  • When the mother has a condition that could produce an inadequate response to the vaccine
  • When the infant has had cardiopulmonary bypass, which would lead to loss of maternal antibodies
  • When the infant has severe disease placing them at increased risk for ­severe RSV.

Conclusion

All of these new RSV preventive products should soon be widely available and covered with no out-of-pocket expense by commercial and government payers. The exception might be nirsevimab—because of the time needed to produce it, it might not be universally available in the 2023-2024 season.

References

1. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccine in older adults: recommendation of the Advisory Committee on Immunization Practices—United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72:793-801.

2. Melgar M. Evidence to recommendation framework. RSV in adults. Presented to the ACIP on February 23, 2023. Accessed November 7, 2023. www.cdc.gov/vaccines/acip/meetings/­downloads/slides-2023-02/slides-02-23/RSV-Adults-04-­Melgar-508.pdf

3. Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendation of the Advisory Committee on Immunization Practices—United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72:90-925.

4. Campos-Outcalt D. Are you ready for RSV season? There’s a new preventive option. J Fam Pract. 2023;72. doi: 10.12788/jfp.0663

5. Jones J. Evidence to recommendation framework: nirsevimab updates. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. https://stacks.cdc.gov/view/cdc/131586

6. Jones J. Clinical considerations for maternal RSVPreF vaccine and nirsevimab. Presented to the ACIP on September 25, 2023. Accessed November 8, 2023. www2.cdc.gov/vaccines/ed/­ciinc/archives/23/09/ciiw_RSV2/CIIW%20RSV%20maternal%20­vaccine%20mAb%209.27.23.pdf

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In the past year, there has been significant progress in the availability of interventions to prevent respiratory syncytial virus (RSV) and its complications. Four products have been approved by the US Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). They include 2 vaccines for adults ages 60 years and older, a monoclonal antibody for infants and high-risk children, and a maternal vaccine to prevent RSV infection in newborns.

Who’s at increased risk for severe RSV disease?

RSV in adults

While there is some uncertainty about the total burden of RSV in adults in the United States, the CDC estimates that each year it causes 0.9 to 1.4 million medical encounters, 60,000 to 160,000 hospitalizations, and 6000 to 10,000 deaths.1 The rate of RSV-caused hospitalization increases with age,2 and the infection is more severe in those with certain chronic medical conditions (TABLE 11). The FIGURE2 demonstrates the outcomes of adults who are hospitalized for RSV. Adults older than 65 years have a 5% mortality rate if hospitalized for RSV infection.2

Outcomes among adults hospitalized for RSV, 2017-2018 to 2019-2020

Vaccine options for adults

Two vaccines were recently approved for the prevention of RSV-associated lower respiratory tract disease (LRTD) in those ages 60 years and older: RSVPreF3 (Arexvy, GSK), which is an adjuvanted recombinant F protein vaccine, and RSVpreF (Abrysvo, Pfizer), which is a recombinant stabilized vaccine. Both require only a single dose (0.5 mL IM), which provides protection for 2 years.

The efficacy of the GSK vaccine in preventing laboratory-confirmed, RSV-­associated LRTD was 82.6% during the first RSV season and 56.1% during the second season. The efficacy of the Pfizer vaccine in preventing symptomatic, laboratory-confirmed LRTD was 88.9% during the first RSV season and 78.6% during the second season.1 However, the trials leading to licensure of both vaccines were underpowered to show efficacy in the oldest adults and those who are frail or to show efficacy against RSV-caused hospitalization.

Safety of the adult RSV vaccines. The safety trials for both vaccines had a total of 38,177 participants. There were a total of 6 neurologic inflammatory conditions that developed within 42 days of vaccination, including 2 cases of suspected Guillain-Barré syndrome (GBS), 2 cases of possible acute disseminated encephalomyelitis, and 1 case each of chronic inflammatory demyelinating polyneuropathy and undifferentiated motor-­sensory axonal polyneuropathy.1 That is a rate of 1 case of a neurologic inflammatory condition for every 6363 people vaccinated. Since the trials were not powered to determine whether the small number of cases were due to chance, postmarketing surveillance will be needed to clarify the true risk for GBS or other neurologic inflammatory events from RSV vaccination.

The lack of efficacy data for the most vulnerable older adults and the lingering questions about safety prompted the ACIP to recommend that adults ages 60 years and older may receive a single dose of RSV vaccine, using shared clinical decision-­making—which is different from a routine or risk-based vaccine recommendation. For RSV vaccination, the decision to vaccinate should be based on a risk/benefit discussion between the clinician and the patient. Those most likely to benefit from the vaccine are listed in ­TABLE 1.1

While data on coadministration of RSV vaccines with other adult vaccines are sparse, the ACIP states that co-administration with other vaccines is acceptable.1 It is not known yet whether boosters will be needed after 2 years.

Continue to: RSV in infants and children

 

 

RSV in infants and children

RSV is the most common cause of hospitalization among infants and children in the United States. The CDC estimates that each year in children younger than 5 years, RSV is responsible for 1.5 million outpatient clinic visits, 520,000 emergency department visits, 58,000 to 80,000 hospitalizations, and 100 to 200 deaths.3 The risk for hospitalization from RSV is highest in the second and third months of life and decreases with increasing age.3

There are racial disparities in RSV severity: Intensive care unit admission rates are 1.2 to 1.6 times higher among non-Hispanic Black infants younger than 6 months than among non-Hispanic White infants, and hospitalization rates are up to 5 times higher in American Indian and Alaska Native populations.3

The months of highest RSV transmission in most locations are December through February, but this can vary. For practical purposes, RSV season runs from October through March.

Prevention in infants and children

The monoclonal antibody nirsevimab is now available for use in infants younger than 8 months born during or entering their first RSV season and children ages 8 to 19 months who are at increased risk for severe RSV disease and entering their second RSV season. Details regarding the use of this product were described in a recent Practice Alert Brief.4

Early studies on nirsevimab demonstrated 79% effectiveness in preventing ­medical-attended LRTD, 80.6% effectiveness in preventing hospitalization, and 90% effectiveness in preventing ICU admission. The number needed to immunize with nirsevimab to prevent an outpatient visit is estimated to be 17; to prevent an ED visit, 48; and to prevent an inpatient admission, 128. Due to the low RSV death rate, the studies were not able to demonstrate reduced mortality.5

Continue to: RSV vaccine in pregnancy

 

 

RSV vaccine in pregnancy

In August, the FDA approved Pfizer’s RSVpreF vaccine for use during pregnancy—as a single dose given at 32 to 36 weeks’ ­gestation—for the prevention of RSV LRTD in infants in the first 6 months of life. In the clinical trials, the vaccine was given at 24 to 36 weeks’ gestation. However, there was a statistically nonsignificant increase in preterm births in the RSVpreF group compared to the placebo group.6 While there were insufficient data to prove or rule out a causal relationship, the FDA advisory committee was more comfortable approving the vaccine for use only later in pregnancy, to avoid the possibility of very early preterm births after vaccination. The ACIP agreed.

From time of maternal vaccination, at least 14 days are needed to develop and transfer maternal antibodies across the placenta to protect the infant. Therefore, infants born less than 14 days after maternal vaccination should be considered unprotected.

Both maternal vaccination with RSVpreF and infant injection with nirsevimab are now options to protect newborns and infants from RSV. However, use of both products is not needed, since combined they do not offer significant added protection compared to either product alone (exceptions to be discussed shortly).6 When the estimated due date will occur in the RSV season, maternity clinicians should provide information on both products and assist the mother in deciding whether to be vaccinated or rely on administration of nirsevimab to the infant after birth. The benefits and risks of these 2 options are listed in TABLE 2.6

Relative risks and benefits of maternal vaccination and nirsevimab

There are some rare situations in which use of both products is recommended, and they include6:

  • When the baby is born less than 14 days from the time of maternal ­vaccination
  • When the mother has a condition that could produce an inadequate response to the vaccine
  • When the infant has had cardiopulmonary bypass, which would lead to loss of maternal antibodies
  • When the infant has severe disease placing them at increased risk for ­severe RSV.

Conclusion

All of these new RSV preventive products should soon be widely available and covered with no out-of-pocket expense by commercial and government payers. The exception might be nirsevimab—because of the time needed to produce it, it might not be universally available in the 2023-2024 season.

In the past year, there has been significant progress in the availability of interventions to prevent respiratory syncytial virus (RSV) and its complications. Four products have been approved by the US Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). They include 2 vaccines for adults ages 60 years and older, a monoclonal antibody for infants and high-risk children, and a maternal vaccine to prevent RSV infection in newborns.

Who’s at increased risk for severe RSV disease?

RSV in adults

While there is some uncertainty about the total burden of RSV in adults in the United States, the CDC estimates that each year it causes 0.9 to 1.4 million medical encounters, 60,000 to 160,000 hospitalizations, and 6000 to 10,000 deaths.1 The rate of RSV-caused hospitalization increases with age,2 and the infection is more severe in those with certain chronic medical conditions (TABLE 11). The FIGURE2 demonstrates the outcomes of adults who are hospitalized for RSV. Adults older than 65 years have a 5% mortality rate if hospitalized for RSV infection.2

Outcomes among adults hospitalized for RSV, 2017-2018 to 2019-2020

Vaccine options for adults

Two vaccines were recently approved for the prevention of RSV-associated lower respiratory tract disease (LRTD) in those ages 60 years and older: RSVPreF3 (Arexvy, GSK), which is an adjuvanted recombinant F protein vaccine, and RSVpreF (Abrysvo, Pfizer), which is a recombinant stabilized vaccine. Both require only a single dose (0.5 mL IM), which provides protection for 2 years.

The efficacy of the GSK vaccine in preventing laboratory-confirmed, RSV-­associated LRTD was 82.6% during the first RSV season and 56.1% during the second season. The efficacy of the Pfizer vaccine in preventing symptomatic, laboratory-confirmed LRTD was 88.9% during the first RSV season and 78.6% during the second season.1 However, the trials leading to licensure of both vaccines were underpowered to show efficacy in the oldest adults and those who are frail or to show efficacy against RSV-caused hospitalization.

Safety of the adult RSV vaccines. The safety trials for both vaccines had a total of 38,177 participants. There were a total of 6 neurologic inflammatory conditions that developed within 42 days of vaccination, including 2 cases of suspected Guillain-Barré syndrome (GBS), 2 cases of possible acute disseminated encephalomyelitis, and 1 case each of chronic inflammatory demyelinating polyneuropathy and undifferentiated motor-­sensory axonal polyneuropathy.1 That is a rate of 1 case of a neurologic inflammatory condition for every 6363 people vaccinated. Since the trials were not powered to determine whether the small number of cases were due to chance, postmarketing surveillance will be needed to clarify the true risk for GBS or other neurologic inflammatory events from RSV vaccination.

The lack of efficacy data for the most vulnerable older adults and the lingering questions about safety prompted the ACIP to recommend that adults ages 60 years and older may receive a single dose of RSV vaccine, using shared clinical decision-­making—which is different from a routine or risk-based vaccine recommendation. For RSV vaccination, the decision to vaccinate should be based on a risk/benefit discussion between the clinician and the patient. Those most likely to benefit from the vaccine are listed in ­TABLE 1.1

While data on coadministration of RSV vaccines with other adult vaccines are sparse, the ACIP states that co-administration with other vaccines is acceptable.1 It is not known yet whether boosters will be needed after 2 years.

Continue to: RSV in infants and children

 

 

RSV in infants and children

RSV is the most common cause of hospitalization among infants and children in the United States. The CDC estimates that each year in children younger than 5 years, RSV is responsible for 1.5 million outpatient clinic visits, 520,000 emergency department visits, 58,000 to 80,000 hospitalizations, and 100 to 200 deaths.3 The risk for hospitalization from RSV is highest in the second and third months of life and decreases with increasing age.3

There are racial disparities in RSV severity: Intensive care unit admission rates are 1.2 to 1.6 times higher among non-Hispanic Black infants younger than 6 months than among non-Hispanic White infants, and hospitalization rates are up to 5 times higher in American Indian and Alaska Native populations.3

The months of highest RSV transmission in most locations are December through February, but this can vary. For practical purposes, RSV season runs from October through March.

Prevention in infants and children

The monoclonal antibody nirsevimab is now available for use in infants younger than 8 months born during or entering their first RSV season and children ages 8 to 19 months who are at increased risk for severe RSV disease and entering their second RSV season. Details regarding the use of this product were described in a recent Practice Alert Brief.4

Early studies on nirsevimab demonstrated 79% effectiveness in preventing ­medical-attended LRTD, 80.6% effectiveness in preventing hospitalization, and 90% effectiveness in preventing ICU admission. The number needed to immunize with nirsevimab to prevent an outpatient visit is estimated to be 17; to prevent an ED visit, 48; and to prevent an inpatient admission, 128. Due to the low RSV death rate, the studies were not able to demonstrate reduced mortality.5

Continue to: RSV vaccine in pregnancy

 

 

RSV vaccine in pregnancy

In August, the FDA approved Pfizer’s RSVpreF vaccine for use during pregnancy—as a single dose given at 32 to 36 weeks’ ­gestation—for the prevention of RSV LRTD in infants in the first 6 months of life. In the clinical trials, the vaccine was given at 24 to 36 weeks’ gestation. However, there was a statistically nonsignificant increase in preterm births in the RSVpreF group compared to the placebo group.6 While there were insufficient data to prove or rule out a causal relationship, the FDA advisory committee was more comfortable approving the vaccine for use only later in pregnancy, to avoid the possibility of very early preterm births after vaccination. The ACIP agreed.

From time of maternal vaccination, at least 14 days are needed to develop and transfer maternal antibodies across the placenta to protect the infant. Therefore, infants born less than 14 days after maternal vaccination should be considered unprotected.

Both maternal vaccination with RSVpreF and infant injection with nirsevimab are now options to protect newborns and infants from RSV. However, use of both products is not needed, since combined they do not offer significant added protection compared to either product alone (exceptions to be discussed shortly).6 When the estimated due date will occur in the RSV season, maternity clinicians should provide information on both products and assist the mother in deciding whether to be vaccinated or rely on administration of nirsevimab to the infant after birth. The benefits and risks of these 2 options are listed in TABLE 2.6

Relative risks and benefits of maternal vaccination and nirsevimab

There are some rare situations in which use of both products is recommended, and they include6:

  • When the baby is born less than 14 days from the time of maternal ­vaccination
  • When the mother has a condition that could produce an inadequate response to the vaccine
  • When the infant has had cardiopulmonary bypass, which would lead to loss of maternal antibodies
  • When the infant has severe disease placing them at increased risk for ­severe RSV.

Conclusion

All of these new RSV preventive products should soon be widely available and covered with no out-of-pocket expense by commercial and government payers. The exception might be nirsevimab—because of the time needed to produce it, it might not be universally available in the 2023-2024 season.

References

1. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccine in older adults: recommendation of the Advisory Committee on Immunization Practices—United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72:793-801.

2. Melgar M. Evidence to recommendation framework. RSV in adults. Presented to the ACIP on February 23, 2023. Accessed November 7, 2023. www.cdc.gov/vaccines/acip/meetings/­downloads/slides-2023-02/slides-02-23/RSV-Adults-04-­Melgar-508.pdf

3. Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendation of the Advisory Committee on Immunization Practices—United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72:90-925.

4. Campos-Outcalt D. Are you ready for RSV season? There’s a new preventive option. J Fam Pract. 2023;72. doi: 10.12788/jfp.0663

5. Jones J. Evidence to recommendation framework: nirsevimab updates. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. https://stacks.cdc.gov/view/cdc/131586

6. Jones J. Clinical considerations for maternal RSVPreF vaccine and nirsevimab. Presented to the ACIP on September 25, 2023. Accessed November 8, 2023. www2.cdc.gov/vaccines/ed/­ciinc/archives/23/09/ciiw_RSV2/CIIW%20RSV%20maternal%20­vaccine%20mAb%209.27.23.pdf

References

1. Melgar M, Britton A, Roper LE, et al. Use of respiratory syncytial virus vaccine in older adults: recommendation of the Advisory Committee on Immunization Practices—United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72:793-801.

2. Melgar M. Evidence to recommendation framework. RSV in adults. Presented to the ACIP on February 23, 2023. Accessed November 7, 2023. www.cdc.gov/vaccines/acip/meetings/­downloads/slides-2023-02/slides-02-23/RSV-Adults-04-­Melgar-508.pdf

3. Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendation of the Advisory Committee on Immunization Practices—United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72:90-925.

4. Campos-Outcalt D. Are you ready for RSV season? There’s a new preventive option. J Fam Pract. 2023;72. doi: 10.12788/jfp.0663

5. Jones J. Evidence to recommendation framework: nirsevimab updates. Presented to the ACIP on August 3, 2023. Accessed August 23, 2023. https://stacks.cdc.gov/view/cdc/131586

6. Jones J. Clinical considerations for maternal RSVPreF vaccine and nirsevimab. Presented to the ACIP on September 25, 2023. Accessed November 8, 2023. www2.cdc.gov/vaccines/ed/­ciinc/archives/23/09/ciiw_RSV2/CIIW%20RSV%20maternal%20­vaccine%20mAb%209.27.23.pdf

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Keep COVID-19 vaccination on your patients’ radar

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The Advisory Committee on Immunization Practices (ACIP) recently issued updated recommendations on the use of vaccines to protect against COVID-19.1 In addition, 3 new COVID-19 vaccine products have been approved for use in the United States since September. Before we discuss both of these items, it’s important to understand why we’re still talking about COVID-19 vaccines.

The impact of vaccination can’t be understated. Vaccines to protect against COVID-19 have been hugely successful in preventing mortality and morbidity from illness caused by SARS-CoV-2. It is estimated that in the first year alone, after vaccines became widely available, they saved more than 14 million lives globally.2 By the end of 2022, they had prevented 18.5 million hospitalizations and 3.2 million deaths in the United States.3 However, waning levels of vaccine-induced immunity and the continuous mutation of the virus have prompted the need for booster doses of vaccine and development of new vaccines.

Enter this year’s vaccines. The new products include updated (2023-2024 formula) COVID-19 mRNA vaccines from Moderna and Pfizer-BioNTech, for use in those ages 6 months and older, and Novavax COVID-19 vaccine for use in those ages 12 years and older. All 3 provide protection against the currently circulating XBB variants, which by September 2023 accounted for > 99% of circulating SARS-CoV-2 strains in the United States.1

Novavax is an option for those who are hesitant to use an mRNA-based vaccine, although the exact recommendations for its use are still pending. Of note, the previously approved bivalent vaccines and the previous Novavax monovalent vaccine are no longer approved for use in the United States.

Current recommendations. For those ages 5 years and older, the recommendation is for a single dose of the 2023-2024 COVID-19 vaccine regardless of previous vaccination history—except for those who were previously unvaccinated and choose Novavax. (Those individuals should receive 2 doses, 3 to 8 weeks apart.) For those ages 6 months through 4 years, the recommended number of doses varies by vaccine and previous vaccination history1; a table can be found at www.cdc.gov/mmwr/volumes/72/wr/mm7242e1.htm.

Those who are moderately to severely immunocompromised should receive a 3-dose series with one of the 2023-2024 COVID-19 vaccines and may receive 1 or more additional updated doses.1 These recommendations are more nuanced, and a full description of them can be found at www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.

Major changes in this year’s recommendations,4 compared to those previously made on the use of the bivalent vaccines, include:

  • Eliminating complex recommendations for 5-year-olds, who are now included in the standard recommendation
  • Reducing the number of COVID-19 vaccine products in use by standardizing the dose (25 mcg) for those ages 6 months to 11 years
  • Choosing to monitor epidemiology and vaccine effectiveness data to determine whether an additional dose of this year’s vaccine will be needed for those ages 65 years and older, rather than making a recommendation now.

Who’s paying? Another change is how COVID-19 vaccines are paid for. The United States is moving from a system of federal procurement and distribution to the commercial marketplace. This may lead to some disruption and confusion.

All commercial health plans, as well as Medicare and Medicaid, must cover vaccines recommend by the ACIP with no out-of-pocket cost. The Vaccines for Children program provides free vaccine for uninsured and underinsured children up to age 19 years.

However, that leaves no payer for uninsured adults. In response, the CDC has announced the establishment of the Bridge Access Program, which is a private/government partnership to provide the vaccine to this age group. Details about where an adult can obtain a free COVID-19 vaccine through this program can be found by visiting www.cdc.gov/vaccines/programs/bridge/index.html or by calling 800-CDC-INFO.

A dynamic situation. COVID-19 vaccines and associated recommendations are likely to change with time, as we learn how best to formulate them to adjust to virus mutations and determine the optimal intervals to adjust and administer these vaccines. The result may (or may not) eventually resemble the approach recommended for influenza vaccines, which is annual assessment and adjustment of the targeted antigens, when needed, and annual universal vaccination.

References

1. Regan JJ, Moulia DL, Link-Guelles R, et al. Use of updated COVID-19 vaccines 2023-2024 formula for persons aged > 6 months: recommendations of the Advisory Committee on Immunization Practices—United States, September 2023. MMWR Morb Mortal Wkly Rep. 2023;72:1140-1146. doi: 10.15585/mmwr.mm7242e1

2. Watson OJ, Barnsley G, Toor J, et al. Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Lancet Infect Dis. 2022;22:1293-302. doi: 10.1016/S1473-3099(22)00320-6

3. Fitzpatrick M, Moghadas S, Pandey A, et al. Two years of US COVID-19 vaccines have prevented millions of hospitalizations and deaths. The Commonwealth Fund; 2022. Published December 13, 2022. Accessed November 2, 2023. www.commonwealthfund.org/blog/2022/two-years-covid-vaccines-prevented-millions-deaths-hospitalizations https://doi.org/10.26099/whsf-fp90

4. Wallace M. Evidence to recommendations framework: 2023-2024 (monovalent, XBB containing) COVID-19 vaccine. Presented to the Advisory Committee on Immunization Practices, September 12, 2023. Accessed November 2, 2023. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-12/11-COVID-Wallace-508.pdf

Author and Disclosure Information

Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author is a paid consultant to the Advisory Committee on Immunization Practices.

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Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author is a paid consultant to the Advisory Committee on Immunization Practices.

Author and Disclosure Information

Doug Campos-Outcalt, MD, MPA, is a clinical professor at the University of Arizona College of Medicine and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The author is a paid consultant to the Advisory Committee on Immunization Practices.

The Advisory Committee on Immunization Practices (ACIP) recently issued updated recommendations on the use of vaccines to protect against COVID-19.1 In addition, 3 new COVID-19 vaccine products have been approved for use in the United States since September. Before we discuss both of these items, it’s important to understand why we’re still talking about COVID-19 vaccines.

The impact of vaccination can’t be understated. Vaccines to protect against COVID-19 have been hugely successful in preventing mortality and morbidity from illness caused by SARS-CoV-2. It is estimated that in the first year alone, after vaccines became widely available, they saved more than 14 million lives globally.2 By the end of 2022, they had prevented 18.5 million hospitalizations and 3.2 million deaths in the United States.3 However, waning levels of vaccine-induced immunity and the continuous mutation of the virus have prompted the need for booster doses of vaccine and development of new vaccines.

Enter this year’s vaccines. The new products include updated (2023-2024 formula) COVID-19 mRNA vaccines from Moderna and Pfizer-BioNTech, for use in those ages 6 months and older, and Novavax COVID-19 vaccine for use in those ages 12 years and older. All 3 provide protection against the currently circulating XBB variants, which by September 2023 accounted for > 99% of circulating SARS-CoV-2 strains in the United States.1

Novavax is an option for those who are hesitant to use an mRNA-based vaccine, although the exact recommendations for its use are still pending. Of note, the previously approved bivalent vaccines and the previous Novavax monovalent vaccine are no longer approved for use in the United States.

Current recommendations. For those ages 5 years and older, the recommendation is for a single dose of the 2023-2024 COVID-19 vaccine regardless of previous vaccination history—except for those who were previously unvaccinated and choose Novavax. (Those individuals should receive 2 doses, 3 to 8 weeks apart.) For those ages 6 months through 4 years, the recommended number of doses varies by vaccine and previous vaccination history1; a table can be found at www.cdc.gov/mmwr/volumes/72/wr/mm7242e1.htm.

Those who are moderately to severely immunocompromised should receive a 3-dose series with one of the 2023-2024 COVID-19 vaccines and may receive 1 or more additional updated doses.1 These recommendations are more nuanced, and a full description of them can be found at www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.

Major changes in this year’s recommendations,4 compared to those previously made on the use of the bivalent vaccines, include:

  • Eliminating complex recommendations for 5-year-olds, who are now included in the standard recommendation
  • Reducing the number of COVID-19 vaccine products in use by standardizing the dose (25 mcg) for those ages 6 months to 11 years
  • Choosing to monitor epidemiology and vaccine effectiveness data to determine whether an additional dose of this year’s vaccine will be needed for those ages 65 years and older, rather than making a recommendation now.

Who’s paying? Another change is how COVID-19 vaccines are paid for. The United States is moving from a system of federal procurement and distribution to the commercial marketplace. This may lead to some disruption and confusion.

All commercial health plans, as well as Medicare and Medicaid, must cover vaccines recommend by the ACIP with no out-of-pocket cost. The Vaccines for Children program provides free vaccine for uninsured and underinsured children up to age 19 years.

However, that leaves no payer for uninsured adults. In response, the CDC has announced the establishment of the Bridge Access Program, which is a private/government partnership to provide the vaccine to this age group. Details about where an adult can obtain a free COVID-19 vaccine through this program can be found by visiting www.cdc.gov/vaccines/programs/bridge/index.html or by calling 800-CDC-INFO.

A dynamic situation. COVID-19 vaccines and associated recommendations are likely to change with time, as we learn how best to formulate them to adjust to virus mutations and determine the optimal intervals to adjust and administer these vaccines. The result may (or may not) eventually resemble the approach recommended for influenza vaccines, which is annual assessment and adjustment of the targeted antigens, when needed, and annual universal vaccination.

The Advisory Committee on Immunization Practices (ACIP) recently issued updated recommendations on the use of vaccines to protect against COVID-19.1 In addition, 3 new COVID-19 vaccine products have been approved for use in the United States since September. Before we discuss both of these items, it’s important to understand why we’re still talking about COVID-19 vaccines.

The impact of vaccination can’t be understated. Vaccines to protect against COVID-19 have been hugely successful in preventing mortality and morbidity from illness caused by SARS-CoV-2. It is estimated that in the first year alone, after vaccines became widely available, they saved more than 14 million lives globally.2 By the end of 2022, they had prevented 18.5 million hospitalizations and 3.2 million deaths in the United States.3 However, waning levels of vaccine-induced immunity and the continuous mutation of the virus have prompted the need for booster doses of vaccine and development of new vaccines.

Enter this year’s vaccines. The new products include updated (2023-2024 formula) COVID-19 mRNA vaccines from Moderna and Pfizer-BioNTech, for use in those ages 6 months and older, and Novavax COVID-19 vaccine for use in those ages 12 years and older. All 3 provide protection against the currently circulating XBB variants, which by September 2023 accounted for > 99% of circulating SARS-CoV-2 strains in the United States.1

Novavax is an option for those who are hesitant to use an mRNA-based vaccine, although the exact recommendations for its use are still pending. Of note, the previously approved bivalent vaccines and the previous Novavax monovalent vaccine are no longer approved for use in the United States.

Current recommendations. For those ages 5 years and older, the recommendation is for a single dose of the 2023-2024 COVID-19 vaccine regardless of previous vaccination history—except for those who were previously unvaccinated and choose Novavax. (Those individuals should receive 2 doses, 3 to 8 weeks apart.) For those ages 6 months through 4 years, the recommended number of doses varies by vaccine and previous vaccination history1; a table can be found at www.cdc.gov/mmwr/volumes/72/wr/mm7242e1.htm.

Those who are moderately to severely immunocompromised should receive a 3-dose series with one of the 2023-2024 COVID-19 vaccines and may receive 1 or more additional updated doses.1 These recommendations are more nuanced, and a full description of them can be found at www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.

Major changes in this year’s recommendations,4 compared to those previously made on the use of the bivalent vaccines, include:

  • Eliminating complex recommendations for 5-year-olds, who are now included in the standard recommendation
  • Reducing the number of COVID-19 vaccine products in use by standardizing the dose (25 mcg) for those ages 6 months to 11 years
  • Choosing to monitor epidemiology and vaccine effectiveness data to determine whether an additional dose of this year’s vaccine will be needed for those ages 65 years and older, rather than making a recommendation now.

Who’s paying? Another change is how COVID-19 vaccines are paid for. The United States is moving from a system of federal procurement and distribution to the commercial marketplace. This may lead to some disruption and confusion.

All commercial health plans, as well as Medicare and Medicaid, must cover vaccines recommend by the ACIP with no out-of-pocket cost. The Vaccines for Children program provides free vaccine for uninsured and underinsured children up to age 19 years.

However, that leaves no payer for uninsured adults. In response, the CDC has announced the establishment of the Bridge Access Program, which is a private/government partnership to provide the vaccine to this age group. Details about where an adult can obtain a free COVID-19 vaccine through this program can be found by visiting www.cdc.gov/vaccines/programs/bridge/index.html or by calling 800-CDC-INFO.

A dynamic situation. COVID-19 vaccines and associated recommendations are likely to change with time, as we learn how best to formulate them to adjust to virus mutations and determine the optimal intervals to adjust and administer these vaccines. The result may (or may not) eventually resemble the approach recommended for influenza vaccines, which is annual assessment and adjustment of the targeted antigens, when needed, and annual universal vaccination.

References

1. Regan JJ, Moulia DL, Link-Guelles R, et al. Use of updated COVID-19 vaccines 2023-2024 formula for persons aged > 6 months: recommendations of the Advisory Committee on Immunization Practices—United States, September 2023. MMWR Morb Mortal Wkly Rep. 2023;72:1140-1146. doi: 10.15585/mmwr.mm7242e1

2. Watson OJ, Barnsley G, Toor J, et al. Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Lancet Infect Dis. 2022;22:1293-302. doi: 10.1016/S1473-3099(22)00320-6

3. Fitzpatrick M, Moghadas S, Pandey A, et al. Two years of US COVID-19 vaccines have prevented millions of hospitalizations and deaths. The Commonwealth Fund; 2022. Published December 13, 2022. Accessed November 2, 2023. www.commonwealthfund.org/blog/2022/two-years-covid-vaccines-prevented-millions-deaths-hospitalizations https://doi.org/10.26099/whsf-fp90

4. Wallace M. Evidence to recommendations framework: 2023-2024 (monovalent, XBB containing) COVID-19 vaccine. Presented to the Advisory Committee on Immunization Practices, September 12, 2023. Accessed November 2, 2023. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-12/11-COVID-Wallace-508.pdf

References

1. Regan JJ, Moulia DL, Link-Guelles R, et al. Use of updated COVID-19 vaccines 2023-2024 formula for persons aged > 6 months: recommendations of the Advisory Committee on Immunization Practices—United States, September 2023. MMWR Morb Mortal Wkly Rep. 2023;72:1140-1146. doi: 10.15585/mmwr.mm7242e1

2. Watson OJ, Barnsley G, Toor J, et al. Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Lancet Infect Dis. 2022;22:1293-302. doi: 10.1016/S1473-3099(22)00320-6

3. Fitzpatrick M, Moghadas S, Pandey A, et al. Two years of US COVID-19 vaccines have prevented millions of hospitalizations and deaths. The Commonwealth Fund; 2022. Published December 13, 2022. Accessed November 2, 2023. www.commonwealthfund.org/blog/2022/two-years-covid-vaccines-prevented-millions-deaths-hospitalizations https://doi.org/10.26099/whsf-fp90

4. Wallace M. Evidence to recommendations framework: 2023-2024 (monovalent, XBB containing) COVID-19 vaccine. Presented to the Advisory Committee on Immunization Practices, September 12, 2023. Accessed November 2, 2023. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-12/11-COVID-Wallace-508.pdf

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FDA to health care providers: Double-check COVID vaccine dose for children

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Health care providers who give this year’s Moderna COVID-19 vaccine to children aged 6 months to 11 years should be sure they withdraw the correct volume of the vaccine from the vial to ensure a proper dose, the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.

That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”

The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.

“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.

Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.

“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.

A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
 

No safety risks identified

“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.

“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
 

One parent’s experience

Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.

A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
 

Perhaps more reactions, no danger

“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”

If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”

Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”

The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”

A version of this article appeared on Medscape.com.

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Health care providers who give this year’s Moderna COVID-19 vaccine to children aged 6 months to 11 years should be sure they withdraw the correct volume of the vaccine from the vial to ensure a proper dose, the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.

That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”

The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.

“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.

Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.

“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.

A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
 

No safety risks identified

“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.

“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
 

One parent’s experience

Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.

A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
 

Perhaps more reactions, no danger

“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”

If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”

Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”

The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”

A version of this article appeared on Medscape.com.

Health care providers who give this year’s Moderna COVID-19 vaccine to children aged 6 months to 11 years should be sure they withdraw the correct volume of the vaccine from the vial to ensure a proper dose, the Food and Drug Administration said in a MedWatch issued Nov. 1, 2023.

That dose is 0.25 mL for children 6 months through 11 years. In the MedWatch, the FDA said that it “has become aware” that the single-dose vial for use in this age group “contains notably more than 0.25 mL of the vaccine.” It added: “Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual.”

The FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine to clarify that the 0.25 mL should be withdrawn from the vial and that the vial and any excess then should be discarded. It is in a single-dose vial with a blue cap and a green label.

“It is common [for vaccine makers] to put in a little bit of extra vaccine just to make sure everyone gets enough,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center, Nashville, Tenn. “The provider is supposed to be looking at the syringe when they withdraw it to make sure they get the right amount,” Dr. Schaffner said.

Recently, parents on social media had expressed concerns that their children may have gotten more than the recommended dose, with some parents noticing more reactions such as soreness and fever with the 2023-2024 vaccine dose than they did with their children’s previous COVID vaccinations.

“Since the beginning of the rollout, parents were telling us of cases where pharmacies accidentally gave their children a double dose, while doctors in our group were pointing out that their vials for children contained twice the amount than what was needed,” said Fatima Khan, a parent and cofounder of the group Protect Their Future, an organization that advocates for pediatric vaccine access. Members contacted the FDA and other officials. “We appreciate that the FDA took our concerns seriously and issued this safety update,” Ms. Khan said.

A spokesperson for Moderna is researching how much more vaccine the single-dose vials might contain.
 

No safety risks identified

“The FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age and no serious adverse events were identified related to a dosing error for the vaccine,” Cherie Duvall-Jones, an FDA spokesperson, said in an email response.

“The FDA received questions from stakeholders about the dosing issue on Oct. 29, and contacted Moderna to discuss and better understand the issue,” Ms. Duvall-Jones said. The agency then alerted health care providers via the safety communication and other means to be sure the correct dosage is given to the children aged 12 years or younger.
 

One parent’s experience

Jane Jih, MD, an internist in San Francisco, took her 7-year-old daughter to a pharmacy to get the vaccine, and it was the first time the pharmacist had given a pediatric dose. “We both had to double check the dose,” Dr. Jih said. She observed that the vial had about 0.40 mL, which is 0.15 mL above the recommended dose.

A few weeks later, Dr. Jih could access the vaccine for her nearly-3-year-old son. The nurse practitioner who administered it had been giving many pediatric Moderna shots, she said, “so I felt more confident in the second scenario.”
 

Perhaps more reactions, no danger

“If you get a little bit more [than the recommended 0.25 mL], that certainly is not going to harm the child,” Dr. Schaffner said. “There may be a little bit more local reaction. In terms of the child’s immune system, there really isn’t any harm.”

If an entire adult dose is mistakenly given, he said, “I think the reaction locally in some children may be more evident, they may get more sore arms, redness, maybe a little bit more swelling and tenderness. Fever is also a possibility, but “these vaccines have not been associated with too much fever.”

Could a double dose do more harm than that? “It is unknown,” said Aaron Glatt, MD, chief of infectious diseases and hospital epidemiologist for Mount Sinai South Nassau, Oceanside, N.Y. “But there is the theoretical potential for some more complications. I do not know whether this [excess vaccine] would cause an increased likelihood of cardiac inflammatory problems like myocarditis or other rare complications to occur more frequently.”

The message for health care providers giving the vaccine, Dr. Schaffner said, is: “Look at your syringe to make sure the dose is appropriate.”

A version of this article appeared on Medscape.com.

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Serious mental illness tied to 50% higher all-cause mortality risk after COVID

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Thu, 11/02/2023 - 13:38

 

TOPLINE:

Severe mental illness (SMI) has been linked to a 50% increased risk for all-cause mortality risk after COVID-19, a large population-based study suggests.

METHODOLOGY:

  • Investigators analyzed data from the Clinical Practice Research Datalink database, which contains health information on 13.5 million patients receiving care from family practices in England and Northern Ireland.
  • The study included participants with SMI, including schizophrenia, schizoaffective disorder, and bipolar disorder.
  • Participants were aged 5 years or older with a SARS-CoV-2 infection recorded between Feb. 1, 2020, and March 31, 2021, spanning two waves of the pandemic.
  • Death rates among participants with SMI and COVID-19 (n = 7,150; 56% female) were compared with those in a control group of participants without SMI who had been diagnosed with COVID-19 (n = 650,000; 55% female).

TAKEAWAY:

  • Participants with SMI and COVID-19 had a 53% higher risk for death than those in the non-SMI control group (adjusted hazard ratio, 1.53; 95% confidence interval, 1.39-1.68).
  • Black Caribbean/Black African participants were more likely than White participants to die of COVID-19 (aHR, 1.22; 95% CI, 1.12-1.34), although ethnicity was not recorded in 30% of participants.
  • After SARS-CoV-2 infection, for every additional multimorbid condition, the aHR for death increased by 6% in the SMI group and 16% in the non-SMI group (P = .001). Some of these conditions included hypertension, heart disease, diabetes, kidney disease, depression, and anxiety.

IN PRACTICE:

“From a public health perspective, our study has emphasized the need for early and timely preventative interventions (e.g. vaccination) for the SMI population. Future studies are needed to disentangle the complex biological and psychosocial factors, and health care pathways, that have led to the greater mortality rates in the SMI population,” the authors write.

SOURCE:

Jayati Das-Munshi, MD, of Kings College London, led the study, which was published online in the British Journal of Psychiatry. The study was funded by the Health Foundation.

LIMITATIONS:

COVID-19 may have been underdiagnosed or underreported in the records studied. Also, investigators did not have information about cause of death.

DISCLOSURES:

One author received funding from Janssen, GSK, and Takeda. All other authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Severe mental illness (SMI) has been linked to a 50% increased risk for all-cause mortality risk after COVID-19, a large population-based study suggests.

METHODOLOGY:

  • Investigators analyzed data from the Clinical Practice Research Datalink database, which contains health information on 13.5 million patients receiving care from family practices in England and Northern Ireland.
  • The study included participants with SMI, including schizophrenia, schizoaffective disorder, and bipolar disorder.
  • Participants were aged 5 years or older with a SARS-CoV-2 infection recorded between Feb. 1, 2020, and March 31, 2021, spanning two waves of the pandemic.
  • Death rates among participants with SMI and COVID-19 (n = 7,150; 56% female) were compared with those in a control group of participants without SMI who had been diagnosed with COVID-19 (n = 650,000; 55% female).

TAKEAWAY:

  • Participants with SMI and COVID-19 had a 53% higher risk for death than those in the non-SMI control group (adjusted hazard ratio, 1.53; 95% confidence interval, 1.39-1.68).
  • Black Caribbean/Black African participants were more likely than White participants to die of COVID-19 (aHR, 1.22; 95% CI, 1.12-1.34), although ethnicity was not recorded in 30% of participants.
  • After SARS-CoV-2 infection, for every additional multimorbid condition, the aHR for death increased by 6% in the SMI group and 16% in the non-SMI group (P = .001). Some of these conditions included hypertension, heart disease, diabetes, kidney disease, depression, and anxiety.

IN PRACTICE:

“From a public health perspective, our study has emphasized the need for early and timely preventative interventions (e.g. vaccination) for the SMI population. Future studies are needed to disentangle the complex biological and psychosocial factors, and health care pathways, that have led to the greater mortality rates in the SMI population,” the authors write.

SOURCE:

Jayati Das-Munshi, MD, of Kings College London, led the study, which was published online in the British Journal of Psychiatry. The study was funded by the Health Foundation.

LIMITATIONS:

COVID-19 may have been underdiagnosed or underreported in the records studied. Also, investigators did not have information about cause of death.

DISCLOSURES:

One author received funding from Janssen, GSK, and Takeda. All other authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Severe mental illness (SMI) has been linked to a 50% increased risk for all-cause mortality risk after COVID-19, a large population-based study suggests.

METHODOLOGY:

  • Investigators analyzed data from the Clinical Practice Research Datalink database, which contains health information on 13.5 million patients receiving care from family practices in England and Northern Ireland.
  • The study included participants with SMI, including schizophrenia, schizoaffective disorder, and bipolar disorder.
  • Participants were aged 5 years or older with a SARS-CoV-2 infection recorded between Feb. 1, 2020, and March 31, 2021, spanning two waves of the pandemic.
  • Death rates among participants with SMI and COVID-19 (n = 7,150; 56% female) were compared with those in a control group of participants without SMI who had been diagnosed with COVID-19 (n = 650,000; 55% female).

TAKEAWAY:

  • Participants with SMI and COVID-19 had a 53% higher risk for death than those in the non-SMI control group (adjusted hazard ratio, 1.53; 95% confidence interval, 1.39-1.68).
  • Black Caribbean/Black African participants were more likely than White participants to die of COVID-19 (aHR, 1.22; 95% CI, 1.12-1.34), although ethnicity was not recorded in 30% of participants.
  • After SARS-CoV-2 infection, for every additional multimorbid condition, the aHR for death increased by 6% in the SMI group and 16% in the non-SMI group (P = .001). Some of these conditions included hypertension, heart disease, diabetes, kidney disease, depression, and anxiety.

IN PRACTICE:

“From a public health perspective, our study has emphasized the need for early and timely preventative interventions (e.g. vaccination) for the SMI population. Future studies are needed to disentangle the complex biological and psychosocial factors, and health care pathways, that have led to the greater mortality rates in the SMI population,” the authors write.

SOURCE:

Jayati Das-Munshi, MD, of Kings College London, led the study, which was published online in the British Journal of Psychiatry. The study was funded by the Health Foundation.

LIMITATIONS:

COVID-19 may have been underdiagnosed or underreported in the records studied. Also, investigators did not have information about cause of death.

DISCLOSURES:

One author received funding from Janssen, GSK, and Takeda. All other authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

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mRNA vaccine cuts COVID-related Guillain-Barré risk

Article Type
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Thu, 11/02/2023 - 13:39

 

TOPLINE:

The risk for Guillain-Barré syndrome (GBS) is six times higher in people with COVID-19 in the 6 weeks following infection, according to a new study that also showed receipt of the Pfizer-BioNTech mRNA vaccine reduced GSB risk by 59%.

METHODOLOGY:

  • The nested-case control study analyzed data from the largest healthcare provider in Israel for 3.2 million patients aged 16 years and older, with no history of GBS.
  • GBS cases (n = 76) were identified based on hospital discharge data from January 2021 to June 2022.
  • For every GBS case, investigators chose 10 controls at random, matched for age, gender, and follow-up duration (n = 760).
  • Investigators examined the association between GBS and SARS-CoV-2 infection, established through documentation of prior positive SARS-CoV-2 test (PCR or antigen), and any COVID-19 vaccine administration.

TAKEAWAY:

  • Among those diagnosed with GBS, 8 were exposed to SARS-CoV-2 infection only, 7 were exposed to COVID-19 vaccination only, and 1 patient was exposed to both SARS-CoV-2 infection and COVID-19 vaccination in the prior 6 weeks, leaving 60 GBS patients without exposure to either infection or vaccination.
  • All COVID-19 vaccine doses administered in GBS cases within 6 weeks of the index date, and all but two doses administered in controls in the same timeframe, were Pfizer-BioNTech vaccines.
  • Compared with people without GBS, those with the condition were more than six times as likely to have had SARS-CoV-2 infection within 6 weeks of GBS diagnosis (adjusted odds ratio, 6.30; 95% confidence interval, 2.55-15.56).
  • People who received the COVID-19 vaccine were 59% less likely to develop GBS than those who did not get the vaccine (aOR, 0.41; 95% CI, 0.17-0.96).

IN PRACTICE:

“While Guillain-Barré is extremely rare, people should be aware that having a COVID infection can increase their risk of developing the disorder, and receiving an mRNA vaccine can decrease their risk,” study author Anat Arbel, MD, of Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel, said in a press release.

SOURCE:

In addition to Dr. Arbel, the other lead author is Haya Bishara, MD, of Lady Davis Carmel Medical Center. The research was published online  in the journal Neurology.

LIMITATIONS:

There is a possibility of misclassification of SARS-CoV-2 infection, which could lead to an overestimation of the magnitude of association between infection and GBS. The diagnosis of GBS relied solely on ICD-9 coding, which has been shown in prior studies to contain errors.

DISCLOSURES:

The study was unfunded. Dr. Bishara and Dr. Arbel report no relevant financial relationships. One co-author, Eitan Auriel, MD, has received lecturer fees from Novo Nordisk, Pfizer, Boehringer Ingelheim, and Medison.

A version of this article first appeared on Medscape.com.

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TOPLINE:

The risk for Guillain-Barré syndrome (GBS) is six times higher in people with COVID-19 in the 6 weeks following infection, according to a new study that also showed receipt of the Pfizer-BioNTech mRNA vaccine reduced GSB risk by 59%.

METHODOLOGY:

  • The nested-case control study analyzed data from the largest healthcare provider in Israel for 3.2 million patients aged 16 years and older, with no history of GBS.
  • GBS cases (n = 76) were identified based on hospital discharge data from January 2021 to June 2022.
  • For every GBS case, investigators chose 10 controls at random, matched for age, gender, and follow-up duration (n = 760).
  • Investigators examined the association between GBS and SARS-CoV-2 infection, established through documentation of prior positive SARS-CoV-2 test (PCR or antigen), and any COVID-19 vaccine administration.

TAKEAWAY:

  • Among those diagnosed with GBS, 8 were exposed to SARS-CoV-2 infection only, 7 were exposed to COVID-19 vaccination only, and 1 patient was exposed to both SARS-CoV-2 infection and COVID-19 vaccination in the prior 6 weeks, leaving 60 GBS patients without exposure to either infection or vaccination.
  • All COVID-19 vaccine doses administered in GBS cases within 6 weeks of the index date, and all but two doses administered in controls in the same timeframe, were Pfizer-BioNTech vaccines.
  • Compared with people without GBS, those with the condition were more than six times as likely to have had SARS-CoV-2 infection within 6 weeks of GBS diagnosis (adjusted odds ratio, 6.30; 95% confidence interval, 2.55-15.56).
  • People who received the COVID-19 vaccine were 59% less likely to develop GBS than those who did not get the vaccine (aOR, 0.41; 95% CI, 0.17-0.96).

IN PRACTICE:

“While Guillain-Barré is extremely rare, people should be aware that having a COVID infection can increase their risk of developing the disorder, and receiving an mRNA vaccine can decrease their risk,” study author Anat Arbel, MD, of Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel, said in a press release.

SOURCE:

In addition to Dr. Arbel, the other lead author is Haya Bishara, MD, of Lady Davis Carmel Medical Center. The research was published online  in the journal Neurology.

LIMITATIONS:

There is a possibility of misclassification of SARS-CoV-2 infection, which could lead to an overestimation of the magnitude of association between infection and GBS. The diagnosis of GBS relied solely on ICD-9 coding, which has been shown in prior studies to contain errors.

DISCLOSURES:

The study was unfunded. Dr. Bishara and Dr. Arbel report no relevant financial relationships. One co-author, Eitan Auriel, MD, has received lecturer fees from Novo Nordisk, Pfizer, Boehringer Ingelheim, and Medison.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

The risk for Guillain-Barré syndrome (GBS) is six times higher in people with COVID-19 in the 6 weeks following infection, according to a new study that also showed receipt of the Pfizer-BioNTech mRNA vaccine reduced GSB risk by 59%.

METHODOLOGY:

  • The nested-case control study analyzed data from the largest healthcare provider in Israel for 3.2 million patients aged 16 years and older, with no history of GBS.
  • GBS cases (n = 76) were identified based on hospital discharge data from January 2021 to June 2022.
  • For every GBS case, investigators chose 10 controls at random, matched for age, gender, and follow-up duration (n = 760).
  • Investigators examined the association between GBS and SARS-CoV-2 infection, established through documentation of prior positive SARS-CoV-2 test (PCR or antigen), and any COVID-19 vaccine administration.

TAKEAWAY:

  • Among those diagnosed with GBS, 8 were exposed to SARS-CoV-2 infection only, 7 were exposed to COVID-19 vaccination only, and 1 patient was exposed to both SARS-CoV-2 infection and COVID-19 vaccination in the prior 6 weeks, leaving 60 GBS patients without exposure to either infection or vaccination.
  • All COVID-19 vaccine doses administered in GBS cases within 6 weeks of the index date, and all but two doses administered in controls in the same timeframe, were Pfizer-BioNTech vaccines.
  • Compared with people without GBS, those with the condition were more than six times as likely to have had SARS-CoV-2 infection within 6 weeks of GBS diagnosis (adjusted odds ratio, 6.30; 95% confidence interval, 2.55-15.56).
  • People who received the COVID-19 vaccine were 59% less likely to develop GBS than those who did not get the vaccine (aOR, 0.41; 95% CI, 0.17-0.96).

IN PRACTICE:

“While Guillain-Barré is extremely rare, people should be aware that having a COVID infection can increase their risk of developing the disorder, and receiving an mRNA vaccine can decrease their risk,” study author Anat Arbel, MD, of Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel, said in a press release.

SOURCE:

In addition to Dr. Arbel, the other lead author is Haya Bishara, MD, of Lady Davis Carmel Medical Center. The research was published online  in the journal Neurology.

LIMITATIONS:

There is a possibility of misclassification of SARS-CoV-2 infection, which could lead to an overestimation of the magnitude of association between infection and GBS. The diagnosis of GBS relied solely on ICD-9 coding, which has been shown in prior studies to contain errors.

DISCLOSURES:

The study was unfunded. Dr. Bishara and Dr. Arbel report no relevant financial relationships. One co-author, Eitan Auriel, MD, has received lecturer fees from Novo Nordisk, Pfizer, Boehringer Ingelheim, and Medison.

A version of this article first appeared on Medscape.com.

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Right under our noses

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Changed
Tue, 11/07/2023 - 14:03

Until a couple of weeks ago I considered myself a COVID virgin. I had navigated a full 36 months without a positive test, despite cohabiting with my wife in a 2,500-square-foot house during her bout with the SARS-CoV-2 virus last year. I have been reasonably careful, a situational mask wearer, and good about avoiding poorly ventilated crowded spaces. Of course I was fully vaccinated but was waiting until we had gotten closer to a December trip before getting the newest booster.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

I had always been quietly smug about my good luck. And, I was pretty sure that luck had been the major contributor to my run of good health. Nonetheless, in my private moments I often wondered if I somehow had inherited or acquired an unusual defense against the virus that had been getting the best of my peers. One rather far-fetched explanation that kept popping out of my subconscious involved my profuse and persistent runny nose.

Like a fair number in my demographic, I have what I have self-diagnosed as vasomotor rhinitis. In the cooler months and particularly when I am active outdoors, my nose runs like a faucet. I half-jokingly told my wife after a particularly drippy bike ride on a frigid November afternoon that even the most robust virus couldn’t possibly have survived the swim upstream against torrent of mucus splashing onto the handlebars of my bike.

A recent study published in the journal Cell suggests that my off-the-wall explanation for my COVID resistance wasn’t quite so hair-brained. The investigators haven’t found that septuagenarian adults with high-volume runny noses are drowning the SARS-Co- 2 virus before it can do any damage. However, the researchers did discover that, in general, young children seem to be having fewer and milder COVID infections because “infants mount a robust mucosal response” in their noses. This first line of defense seems to be more effective than in adults, where the virus can more easily slip through into the bloodstream, sometimes with a dramatic release of circulating cytokines, which occasionally create problems of their own. Children also release cytokines, but this is predominantly in their nose, where it appears to be less damaging. Interestingly, in children this initial response persists for around 300 days while in adults the immune response experiences a much more rapid decline. I guess this means we have to chalk one more up for snotty nose kids.

However, the results of this study also suggest that we should be giving more attention to the development of nasal vaccines. I recall that nearly 3 years ago, at the beginning of the pandemic, scientists using a ferret model had developed an effective nasal vaccine. I’m not sure why this faded out of the picture, but it feels like it’s time to turn the spotlight on this line of research again.

I suspect that in addition to being more effective, a nasal vaccine may gain more support among the antivaxxer population, many of whom I suspect are really needle phobics hiding behind a smoke screen of anti-science double talk.

At any rate, I will continue to search for articles that support my contention that my high-flow rhinorrhea is protecting me. I have always been told that a cold nose was the sign of a healthy dog. I’m just trying to prove that the same is true for us old guys with clear runny noses.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

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Until a couple of weeks ago I considered myself a COVID virgin. I had navigated a full 36 months without a positive test, despite cohabiting with my wife in a 2,500-square-foot house during her bout with the SARS-CoV-2 virus last year. I have been reasonably careful, a situational mask wearer, and good about avoiding poorly ventilated crowded spaces. Of course I was fully vaccinated but was waiting until we had gotten closer to a December trip before getting the newest booster.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

I had always been quietly smug about my good luck. And, I was pretty sure that luck had been the major contributor to my run of good health. Nonetheless, in my private moments I often wondered if I somehow had inherited or acquired an unusual defense against the virus that had been getting the best of my peers. One rather far-fetched explanation that kept popping out of my subconscious involved my profuse and persistent runny nose.

Like a fair number in my demographic, I have what I have self-diagnosed as vasomotor rhinitis. In the cooler months and particularly when I am active outdoors, my nose runs like a faucet. I half-jokingly told my wife after a particularly drippy bike ride on a frigid November afternoon that even the most robust virus couldn’t possibly have survived the swim upstream against torrent of mucus splashing onto the handlebars of my bike.

A recent study published in the journal Cell suggests that my off-the-wall explanation for my COVID resistance wasn’t quite so hair-brained. The investigators haven’t found that septuagenarian adults with high-volume runny noses are drowning the SARS-Co- 2 virus before it can do any damage. However, the researchers did discover that, in general, young children seem to be having fewer and milder COVID infections because “infants mount a robust mucosal response” in their noses. This first line of defense seems to be more effective than in adults, where the virus can more easily slip through into the bloodstream, sometimes with a dramatic release of circulating cytokines, which occasionally create problems of their own. Children also release cytokines, but this is predominantly in their nose, where it appears to be less damaging. Interestingly, in children this initial response persists for around 300 days while in adults the immune response experiences a much more rapid decline. I guess this means we have to chalk one more up for snotty nose kids.

However, the results of this study also suggest that we should be giving more attention to the development of nasal vaccines. I recall that nearly 3 years ago, at the beginning of the pandemic, scientists using a ferret model had developed an effective nasal vaccine. I’m not sure why this faded out of the picture, but it feels like it’s time to turn the spotlight on this line of research again.

I suspect that in addition to being more effective, a nasal vaccine may gain more support among the antivaxxer population, many of whom I suspect are really needle phobics hiding behind a smoke screen of anti-science double talk.

At any rate, I will continue to search for articles that support my contention that my high-flow rhinorrhea is protecting me. I have always been told that a cold nose was the sign of a healthy dog. I’m just trying to prove that the same is true for us old guys with clear runny noses.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

Until a couple of weeks ago I considered myself a COVID virgin. I had navigated a full 36 months without a positive test, despite cohabiting with my wife in a 2,500-square-foot house during her bout with the SARS-CoV-2 virus last year. I have been reasonably careful, a situational mask wearer, and good about avoiding poorly ventilated crowded spaces. Of course I was fully vaccinated but was waiting until we had gotten closer to a December trip before getting the newest booster.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

I had always been quietly smug about my good luck. And, I was pretty sure that luck had been the major contributor to my run of good health. Nonetheless, in my private moments I often wondered if I somehow had inherited or acquired an unusual defense against the virus that had been getting the best of my peers. One rather far-fetched explanation that kept popping out of my subconscious involved my profuse and persistent runny nose.

Like a fair number in my demographic, I have what I have self-diagnosed as vasomotor rhinitis. In the cooler months and particularly when I am active outdoors, my nose runs like a faucet. I half-jokingly told my wife after a particularly drippy bike ride on a frigid November afternoon that even the most robust virus couldn’t possibly have survived the swim upstream against torrent of mucus splashing onto the handlebars of my bike.

A recent study published in the journal Cell suggests that my off-the-wall explanation for my COVID resistance wasn’t quite so hair-brained. The investigators haven’t found that septuagenarian adults with high-volume runny noses are drowning the SARS-Co- 2 virus before it can do any damage. However, the researchers did discover that, in general, young children seem to be having fewer and milder COVID infections because “infants mount a robust mucosal response” in their noses. This first line of defense seems to be more effective than in adults, where the virus can more easily slip through into the bloodstream, sometimes with a dramatic release of circulating cytokines, which occasionally create problems of their own. Children also release cytokines, but this is predominantly in their nose, where it appears to be less damaging. Interestingly, in children this initial response persists for around 300 days while in adults the immune response experiences a much more rapid decline. I guess this means we have to chalk one more up for snotty nose kids.

However, the results of this study also suggest that we should be giving more attention to the development of nasal vaccines. I recall that nearly 3 years ago, at the beginning of the pandemic, scientists using a ferret model had developed an effective nasal vaccine. I’m not sure why this faded out of the picture, but it feels like it’s time to turn the spotlight on this line of research again.

I suspect that in addition to being more effective, a nasal vaccine may gain more support among the antivaxxer population, many of whom I suspect are really needle phobics hiding behind a smoke screen of anti-science double talk.

At any rate, I will continue to search for articles that support my contention that my high-flow rhinorrhea is protecting me. I have always been told that a cold nose was the sign of a healthy dog. I’m just trying to prove that the same is true for us old guys with clear runny noses.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

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How clinicians can prepare for and defend against social media attacks

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Wed, 11/01/2023 - 11:16

WASHINGTON – The entire video clip is just 15 seconds — 15 seconds that went viral and temporarily upended the entire life and disrupted the medical practice of Nicole Baldwin, MD, a pediatrician in Cincinnati, Ohio, in January 2020. At the annual meeting of the American Academy of Pediatrics, Dr. Baldwin told attendees how her pro-vaccine TikTok video led a horde of anti-vaccine activists to swarm her social media profiles across multiple platforms, leave one-star reviews with false stories about her medical practice on various doctor review sites, and personally threaten her.

The initial response to the video was positive, with 50,000 views in the first 24 hours after the video was posted and more than 1.5 million views the next day. But 2 days after the video was posted, an organized attack that originated on Facebook required Dr. Baldwin to enlist the help of 16 volunteers, working 24/7 for a week, to help ban and block more than 6,000 users on Facebook, Instagram, and TikTok. Just 4 days after she’d posted the video, Dr. Baldwin was reporting personal threats to the police and had begun contacting sites such as Yelp, Google, Healthgrades, Vitals, RateMDs, and WebMD so they could start removing false reviews about her practice.

Dr. Nicole Baldwin

Today, years after those 2 exhausting, intense weeks of attacks, Dr. Baldwin has found two silver linings in the experience: More people have found her profiles, allowing her to share evidence-based information with an even wider audience, and she can now help other physicians protect themselves and reduce the risk of similar attacks, or at least know how to respond to them if they occur. Dr. Baldwin shared a wealth of tips and resources during her lecture to help pediatricians prepare ahead for the possibility that they will be targeted next, whether the issue is vaccines or another topic.
 

Online risks and benefits

A Pew survey of U.S. adults in September 2020 found that 41% have personally experienced online harassment, including a quarter of Americans who have experienced severe harassment. More than half of respondents said online harassment and bullying is a major problem – and that was a poll of the entire population, not even just physicians and scientists.

“Now, these numbers would be higher,” Dr. Baldwin said. “A lot has changed in the past 3 years, and the landscape is very different.”

The pandemic contributed to those changes to the landscape, including an increase in harassment of doctors and researchers. A June 2023 study revealed that two-thirds of 359 respondents in an online survey reported harassment on social media, a substantial number even after accounting for selection bias in the individuals who chose to respond to the survey. Although most of the attacks (88%) resulted from the respondent’s advocacy online, nearly half the attacks (45%) were gender based, 27% were based on race/ethnicity, and 13% were based on sexual orientation.

While hateful comments are likely the most common type of online harassment, other types can involve sharing or tagging your profile, creating fake profiles to misrepresent you, fake reviews of your practice, harassing phone calls and hate mail at your office, and doxxing, in which someone online widely shares your personal address, phone number, email, or other contact information.

Despite the risks of all these forms of harassment, Dr. Baldwin emphasized the value of doctors having a social media presence given how much misinformation thrives online. For example, a recent report from the Kaiser Family Foundation revealed how many people weren’t sure whether certain health misinformation claims were true or false. Barely a third of people were sure that COVID-19 vaccines had not caused thousands of deaths in healthy people, and only 22% of people were sure that ivermectin is not an effective treatment for COVID.

“There is so much that we need to be doing and working in these spaces to put evidence-based content out there so that people are not finding all of this crap from everybody else,” Dr. Baldwin said. Having an online presence is particularly important given that the public still has high levels of trust in their doctors, she added.

“They trust their physician, and you may not be their physician online, but I will tell you from experience, when you build a community of followers, you become that trusted source of information for them, and it is so important,” Dr. Baldwin said. “There is room for everybody in this space, and we need all of you.”
 

 

 

Proactive steps for protection

Dr. Baldwin then went through the details of what people should do now to make things easier in the event of an attack later. “The best defense is a good offense,” Dr. Baldwin said, “so make sure all of your accounts are secure.”

She recommended the following steps:

For doctors who are attacked specifically because of pro-vaccine advocacy, Dr. Baldwin recommended contacting Shots Heard Round The World, a site that was created by a physician whose practice was attacked by anti-vaccine activists. The site also has a toolkit that anyone can download for tips on preparing ahead for possible attacks and what to do if you are attacked.

Dr. Baldwin then reviewed how to set up different social media profiles to automatically hide certain comments, including comments with words commonly used by online harassers and trolls:

  • Sheep
  • Sheeple
  • Pharma
  • Shill
  • Die
  • Psychopath
  • Clown
  • Various curse words
  • The clown emoji

In Instagram, go to “Settings and privacy —> Hidden Words” for options on hiding offensive comments and messages and for managing custom words and phrases that should be automatically hidden.

On Facebook, go to “Professional dashboard —> Moderation Assist,” where you can add or edit criteria to automatically hide comments on your Facebook page. In addition to hiding comments with certain keywords, you can hide comments from new accounts, accounts without profile photos, or accounts with no friends or followers.

On TikTok, click the three-line menu icon in the upper right, and choose “Privacy —> Comments —> Filter keywords.”

On the platform formerly known as Twitter, go to “Settings and privacy —> Privacy and safety —> Mute and block —> Muted words.”

On YouTube, under “Manage your community & comments,” select “Learn about comment settings.”

Dr. Baldwin did not discourage doctors from posting about controversial topics, but she said it’s important to know what they are so that you can be prepared for the possibility that a post about one of these topics could lead to online harassment. These hot button topics include vaccines, firearm safety, gender-affirming care, reproductive choice, safe sleep/bedsharing, breastfeeding, and COVID masks.

If you do post on one of these and suspect it could result in harassment, Dr. Baldwin recommends turning on your notifications so you know when attacks begin, alerting your office and call center staff if you think they might receive calls, and, when possible, post your content at a time when you’re more likely to be able to monitor the post. She acknowledged that this last tip isn’t always relevant since attacks can take a few days to start or gain steam.
 

 

 

Defending yourself in an attack

Even after taking all these precautions, it’s not possible to altogether prevent an attack from happening, so Dr. Baldwin provided suggestions on what to do if one occurs, starting with taking a deep breath.

“If you are attacked, first of all, please remain calm, which is a lot easier said than done,” she said. “But know that this too shall pass. These things do come to an end.”

She advises you to get help if you need it, enlisting friends or colleagues to help with moderation and banning/blocking. If necessary, alert your employer to the attack, as attackers may contact your employer. Some people may opt to turn off comments on their post, but doing so “is a really personal decision,” she said. It’s okay to turn off comments if you don’t have the bandwidth or help to deal with them.

However, Dr. Baldwin said she never turns off comments because she wants to be able to ban and block people to reduce the likelihood of a future attack from them, and each comment brings the post higher in the algorithm so that more people are able to see the original content. “So sometimes these things are actually a blessing in disguise,” she said.

If you do have comments turned on, take screenshots of the most egregious or threatening ones and then report them and ban/block them. The screenshots are evidence since blocking will remove the comment.

“Take breaks when you need to,” she said. “Don’t stay up all night” since there are only going to be more in the morning, and if you’re using keywords to help hide many of these comments, that will hide them from your followers while you’re away. She also advised monitoring your online reviews at doctor/practice review sites so you know whether you’re receiving spurious reviews that need to be removed.

Dr. Baldwin also addressed how to handle trolls, the people online who intentionally antagonize others with inflammatory, irrelevant, offensive, or otherwise disruptive comments or content. The No. 1 rule is not to engage – “Don’t feed the trolls” – but Dr. Baldwin acknowledged that she can find that difficult sometimes. So she uses kindness or humor to defuse them or calls them out on their inaccurate information and then thanks them for their engagement. Don’t forget that you are in charge of your own page, so any complaints about “censorship” or infringing “free speech” aren’t relevant.

If the comments are growing out of control and you’re unable to manage them, multiple social media platforms have options for limited interactions or who can comment on your page.

On Instagram under “Settings and privacy,” check out “Limited interactions,” “Comments —> Allow comments from,” and “Tags and mentions” to see ways you can limit who is able to comment, tag or mention your account. If you need a complete break, you can turn off commenting by clicking the three dots in the upper right corner of the post, or make your account temporarily private under “Settings and privacy —> Account privacy.”

On Facebook, click the three dots in the upper right corner of posts to select “Who can comment on your post?” Also, under “Settings —> Privacy —> Your Activity,” you can adjust who sees your future posts. Again, if things are out of control, you can temporarily deactivate your page under “Settings —> Privacy —> Facebook Page information.”

On TikTok, click the three lines in the upper right corner of your profile and select “Privacy —> Comments” to adjust who can comment and to filter comments. Again, you can make your account private under “Settings and privacy —> Privacy —> Private account.”

On the platform formerly known as Twitter, click the three dots in the upper right corner of the tweet to change who can reply to the tweet. If you select “Only people you mentioned,” then no one can reply if you did not mention anyone. You can control tagging under “Settings and privacy —> Privacy and safety —> Audience and tagging.”

If you or your practice receive false reviews on review sites, report the reviews and alert the rating site when you can. In the meantime, lock down your private social media accounts and ensure that no photos of your family are publicly available.
 

 

 

Social media self-care

Dr. Baldwin acknowledged that experiencing a social media attack can be intense and even frightening, but it’s rare and outweighed by the “hundreds and hundreds and hundreds of positive comments all the time.” She also reminded attendees that being on social media doesn’t mean being there all the time.

“Over time, my use of social media has certainly changed. It ebbs and flows,” she said. “There are times when I have a lot of bandwidth and I’m posting a lot, and then I actually have had some struggles with my own mental health, with some anxiety and mild depression, so I took a break from social media for a while. When I came back, I posted about my mental health struggles, and you wouldn’t believe how many people were so appreciative of that.”
 

Accurate information from a trusted source

Ultimately, Dr. Baldwin sees her work online as an extension of her work educating patients.

“This is where our patients are. They are in your office for maybe 10-15 minutes maybe once a year, but they are on these platforms every single day for hours,” she said. “They need to see this information from medical professionals because there are random people out there that are telling them [misinformation].”

Elizabeth Murray, DO, MBA, an emergency medicine pediatrician at Golisano Children’s Hospital at the University of Rochester, agreed that there’s substantial value in doctors sharing accurate information online.

“Disinformation and misinformation is rampant, and at the end of the day, we know the facts,” Dr. Murray said. “We know what parents want to hear and what they want to learn about, so we need to share that information and get the facts out there.”

Dr. Murray found the session very helpful because there’s so much to learn across different social media platforms and it can feel overwhelming if you aren’t familiar with the tools.

“Social media is always going to be here. We need to learn to live with all of these platforms,” Dr. Murray said. “That’s a skill set. We need to learn the skills and teach our kids the skill set. You never really know what you might put out there that, in your mind is innocent or very science-based, that for whatever reason somebody might take issue with. You might as well be ready because we’re all about prevention in pediatrics.”

There were no funders for the presentation. Dr. Baldwin and Dr. Murray had no disclosures.

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WASHINGTON – The entire video clip is just 15 seconds — 15 seconds that went viral and temporarily upended the entire life and disrupted the medical practice of Nicole Baldwin, MD, a pediatrician in Cincinnati, Ohio, in January 2020. At the annual meeting of the American Academy of Pediatrics, Dr. Baldwin told attendees how her pro-vaccine TikTok video led a horde of anti-vaccine activists to swarm her social media profiles across multiple platforms, leave one-star reviews with false stories about her medical practice on various doctor review sites, and personally threaten her.

The initial response to the video was positive, with 50,000 views in the first 24 hours after the video was posted and more than 1.5 million views the next day. But 2 days after the video was posted, an organized attack that originated on Facebook required Dr. Baldwin to enlist the help of 16 volunteers, working 24/7 for a week, to help ban and block more than 6,000 users on Facebook, Instagram, and TikTok. Just 4 days after she’d posted the video, Dr. Baldwin was reporting personal threats to the police and had begun contacting sites such as Yelp, Google, Healthgrades, Vitals, RateMDs, and WebMD so they could start removing false reviews about her practice.

Dr. Nicole Baldwin

Today, years after those 2 exhausting, intense weeks of attacks, Dr. Baldwin has found two silver linings in the experience: More people have found her profiles, allowing her to share evidence-based information with an even wider audience, and she can now help other physicians protect themselves and reduce the risk of similar attacks, or at least know how to respond to them if they occur. Dr. Baldwin shared a wealth of tips and resources during her lecture to help pediatricians prepare ahead for the possibility that they will be targeted next, whether the issue is vaccines or another topic.
 

Online risks and benefits

A Pew survey of U.S. adults in September 2020 found that 41% have personally experienced online harassment, including a quarter of Americans who have experienced severe harassment. More than half of respondents said online harassment and bullying is a major problem – and that was a poll of the entire population, not even just physicians and scientists.

“Now, these numbers would be higher,” Dr. Baldwin said. “A lot has changed in the past 3 years, and the landscape is very different.”

The pandemic contributed to those changes to the landscape, including an increase in harassment of doctors and researchers. A June 2023 study revealed that two-thirds of 359 respondents in an online survey reported harassment on social media, a substantial number even after accounting for selection bias in the individuals who chose to respond to the survey. Although most of the attacks (88%) resulted from the respondent’s advocacy online, nearly half the attacks (45%) were gender based, 27% were based on race/ethnicity, and 13% were based on sexual orientation.

While hateful comments are likely the most common type of online harassment, other types can involve sharing or tagging your profile, creating fake profiles to misrepresent you, fake reviews of your practice, harassing phone calls and hate mail at your office, and doxxing, in which someone online widely shares your personal address, phone number, email, or other contact information.

Despite the risks of all these forms of harassment, Dr. Baldwin emphasized the value of doctors having a social media presence given how much misinformation thrives online. For example, a recent report from the Kaiser Family Foundation revealed how many people weren’t sure whether certain health misinformation claims were true or false. Barely a third of people were sure that COVID-19 vaccines had not caused thousands of deaths in healthy people, and only 22% of people were sure that ivermectin is not an effective treatment for COVID.

“There is so much that we need to be doing and working in these spaces to put evidence-based content out there so that people are not finding all of this crap from everybody else,” Dr. Baldwin said. Having an online presence is particularly important given that the public still has high levels of trust in their doctors, she added.

“They trust their physician, and you may not be their physician online, but I will tell you from experience, when you build a community of followers, you become that trusted source of information for them, and it is so important,” Dr. Baldwin said. “There is room for everybody in this space, and we need all of you.”
 

 

 

Proactive steps for protection

Dr. Baldwin then went through the details of what people should do now to make things easier in the event of an attack later. “The best defense is a good offense,” Dr. Baldwin said, “so make sure all of your accounts are secure.”

She recommended the following steps:

For doctors who are attacked specifically because of pro-vaccine advocacy, Dr. Baldwin recommended contacting Shots Heard Round The World, a site that was created by a physician whose practice was attacked by anti-vaccine activists. The site also has a toolkit that anyone can download for tips on preparing ahead for possible attacks and what to do if you are attacked.

Dr. Baldwin then reviewed how to set up different social media profiles to automatically hide certain comments, including comments with words commonly used by online harassers and trolls:

  • Sheep
  • Sheeple
  • Pharma
  • Shill
  • Die
  • Psychopath
  • Clown
  • Various curse words
  • The clown emoji

In Instagram, go to “Settings and privacy —> Hidden Words” for options on hiding offensive comments and messages and for managing custom words and phrases that should be automatically hidden.

On Facebook, go to “Professional dashboard —> Moderation Assist,” where you can add or edit criteria to automatically hide comments on your Facebook page. In addition to hiding comments with certain keywords, you can hide comments from new accounts, accounts without profile photos, or accounts with no friends or followers.

On TikTok, click the three-line menu icon in the upper right, and choose “Privacy —> Comments —> Filter keywords.”

On the platform formerly known as Twitter, go to “Settings and privacy —> Privacy and safety —> Mute and block —> Muted words.”

On YouTube, under “Manage your community & comments,” select “Learn about comment settings.”

Dr. Baldwin did not discourage doctors from posting about controversial topics, but she said it’s important to know what they are so that you can be prepared for the possibility that a post about one of these topics could lead to online harassment. These hot button topics include vaccines, firearm safety, gender-affirming care, reproductive choice, safe sleep/bedsharing, breastfeeding, and COVID masks.

If you do post on one of these and suspect it could result in harassment, Dr. Baldwin recommends turning on your notifications so you know when attacks begin, alerting your office and call center staff if you think they might receive calls, and, when possible, post your content at a time when you’re more likely to be able to monitor the post. She acknowledged that this last tip isn’t always relevant since attacks can take a few days to start or gain steam.
 

 

 

Defending yourself in an attack

Even after taking all these precautions, it’s not possible to altogether prevent an attack from happening, so Dr. Baldwin provided suggestions on what to do if one occurs, starting with taking a deep breath.

“If you are attacked, first of all, please remain calm, which is a lot easier said than done,” she said. “But know that this too shall pass. These things do come to an end.”

She advises you to get help if you need it, enlisting friends or colleagues to help with moderation and banning/blocking. If necessary, alert your employer to the attack, as attackers may contact your employer. Some people may opt to turn off comments on their post, but doing so “is a really personal decision,” she said. It’s okay to turn off comments if you don’t have the bandwidth or help to deal with them.

However, Dr. Baldwin said she never turns off comments because she wants to be able to ban and block people to reduce the likelihood of a future attack from them, and each comment brings the post higher in the algorithm so that more people are able to see the original content. “So sometimes these things are actually a blessing in disguise,” she said.

If you do have comments turned on, take screenshots of the most egregious or threatening ones and then report them and ban/block them. The screenshots are evidence since blocking will remove the comment.

“Take breaks when you need to,” she said. “Don’t stay up all night” since there are only going to be more in the morning, and if you’re using keywords to help hide many of these comments, that will hide them from your followers while you’re away. She also advised monitoring your online reviews at doctor/practice review sites so you know whether you’re receiving spurious reviews that need to be removed.

Dr. Baldwin also addressed how to handle trolls, the people online who intentionally antagonize others with inflammatory, irrelevant, offensive, or otherwise disruptive comments or content. The No. 1 rule is not to engage – “Don’t feed the trolls” – but Dr. Baldwin acknowledged that she can find that difficult sometimes. So she uses kindness or humor to defuse them or calls them out on their inaccurate information and then thanks them for their engagement. Don’t forget that you are in charge of your own page, so any complaints about “censorship” or infringing “free speech” aren’t relevant.

If the comments are growing out of control and you’re unable to manage them, multiple social media platforms have options for limited interactions or who can comment on your page.

On Instagram under “Settings and privacy,” check out “Limited interactions,” “Comments —> Allow comments from,” and “Tags and mentions” to see ways you can limit who is able to comment, tag or mention your account. If you need a complete break, you can turn off commenting by clicking the three dots in the upper right corner of the post, or make your account temporarily private under “Settings and privacy —> Account privacy.”

On Facebook, click the three dots in the upper right corner of posts to select “Who can comment on your post?” Also, under “Settings —> Privacy —> Your Activity,” you can adjust who sees your future posts. Again, if things are out of control, you can temporarily deactivate your page under “Settings —> Privacy —> Facebook Page information.”

On TikTok, click the three lines in the upper right corner of your profile and select “Privacy —> Comments” to adjust who can comment and to filter comments. Again, you can make your account private under “Settings and privacy —> Privacy —> Private account.”

On the platform formerly known as Twitter, click the three dots in the upper right corner of the tweet to change who can reply to the tweet. If you select “Only people you mentioned,” then no one can reply if you did not mention anyone. You can control tagging under “Settings and privacy —> Privacy and safety —> Audience and tagging.”

If you or your practice receive false reviews on review sites, report the reviews and alert the rating site when you can. In the meantime, lock down your private social media accounts and ensure that no photos of your family are publicly available.
 

 

 

Social media self-care

Dr. Baldwin acknowledged that experiencing a social media attack can be intense and even frightening, but it’s rare and outweighed by the “hundreds and hundreds and hundreds of positive comments all the time.” She also reminded attendees that being on social media doesn’t mean being there all the time.

“Over time, my use of social media has certainly changed. It ebbs and flows,” she said. “There are times when I have a lot of bandwidth and I’m posting a lot, and then I actually have had some struggles with my own mental health, with some anxiety and mild depression, so I took a break from social media for a while. When I came back, I posted about my mental health struggles, and you wouldn’t believe how many people were so appreciative of that.”
 

Accurate information from a trusted source

Ultimately, Dr. Baldwin sees her work online as an extension of her work educating patients.

“This is where our patients are. They are in your office for maybe 10-15 minutes maybe once a year, but they are on these platforms every single day for hours,” she said. “They need to see this information from medical professionals because there are random people out there that are telling them [misinformation].”

Elizabeth Murray, DO, MBA, an emergency medicine pediatrician at Golisano Children’s Hospital at the University of Rochester, agreed that there’s substantial value in doctors sharing accurate information online.

“Disinformation and misinformation is rampant, and at the end of the day, we know the facts,” Dr. Murray said. “We know what parents want to hear and what they want to learn about, so we need to share that information and get the facts out there.”

Dr. Murray found the session very helpful because there’s so much to learn across different social media platforms and it can feel overwhelming if you aren’t familiar with the tools.

“Social media is always going to be here. We need to learn to live with all of these platforms,” Dr. Murray said. “That’s a skill set. We need to learn the skills and teach our kids the skill set. You never really know what you might put out there that, in your mind is innocent or very science-based, that for whatever reason somebody might take issue with. You might as well be ready because we’re all about prevention in pediatrics.”

There were no funders for the presentation. Dr. Baldwin and Dr. Murray had no disclosures.

WASHINGTON – The entire video clip is just 15 seconds — 15 seconds that went viral and temporarily upended the entire life and disrupted the medical practice of Nicole Baldwin, MD, a pediatrician in Cincinnati, Ohio, in January 2020. At the annual meeting of the American Academy of Pediatrics, Dr. Baldwin told attendees how her pro-vaccine TikTok video led a horde of anti-vaccine activists to swarm her social media profiles across multiple platforms, leave one-star reviews with false stories about her medical practice on various doctor review sites, and personally threaten her.

The initial response to the video was positive, with 50,000 views in the first 24 hours after the video was posted and more than 1.5 million views the next day. But 2 days after the video was posted, an organized attack that originated on Facebook required Dr. Baldwin to enlist the help of 16 volunteers, working 24/7 for a week, to help ban and block more than 6,000 users on Facebook, Instagram, and TikTok. Just 4 days after she’d posted the video, Dr. Baldwin was reporting personal threats to the police and had begun contacting sites such as Yelp, Google, Healthgrades, Vitals, RateMDs, and WebMD so they could start removing false reviews about her practice.

Dr. Nicole Baldwin

Today, years after those 2 exhausting, intense weeks of attacks, Dr. Baldwin has found two silver linings in the experience: More people have found her profiles, allowing her to share evidence-based information with an even wider audience, and she can now help other physicians protect themselves and reduce the risk of similar attacks, or at least know how to respond to them if they occur. Dr. Baldwin shared a wealth of tips and resources during her lecture to help pediatricians prepare ahead for the possibility that they will be targeted next, whether the issue is vaccines or another topic.
 

Online risks and benefits

A Pew survey of U.S. adults in September 2020 found that 41% have personally experienced online harassment, including a quarter of Americans who have experienced severe harassment. More than half of respondents said online harassment and bullying is a major problem – and that was a poll of the entire population, not even just physicians and scientists.

“Now, these numbers would be higher,” Dr. Baldwin said. “A lot has changed in the past 3 years, and the landscape is very different.”

The pandemic contributed to those changes to the landscape, including an increase in harassment of doctors and researchers. A June 2023 study revealed that two-thirds of 359 respondents in an online survey reported harassment on social media, a substantial number even after accounting for selection bias in the individuals who chose to respond to the survey. Although most of the attacks (88%) resulted from the respondent’s advocacy online, nearly half the attacks (45%) were gender based, 27% were based on race/ethnicity, and 13% were based on sexual orientation.

While hateful comments are likely the most common type of online harassment, other types can involve sharing or tagging your profile, creating fake profiles to misrepresent you, fake reviews of your practice, harassing phone calls and hate mail at your office, and doxxing, in which someone online widely shares your personal address, phone number, email, or other contact information.

Despite the risks of all these forms of harassment, Dr. Baldwin emphasized the value of doctors having a social media presence given how much misinformation thrives online. For example, a recent report from the Kaiser Family Foundation revealed how many people weren’t sure whether certain health misinformation claims were true or false. Barely a third of people were sure that COVID-19 vaccines had not caused thousands of deaths in healthy people, and only 22% of people were sure that ivermectin is not an effective treatment for COVID.

“There is so much that we need to be doing and working in these spaces to put evidence-based content out there so that people are not finding all of this crap from everybody else,” Dr. Baldwin said. Having an online presence is particularly important given that the public still has high levels of trust in their doctors, she added.

“They trust their physician, and you may not be their physician online, but I will tell you from experience, when you build a community of followers, you become that trusted source of information for them, and it is so important,” Dr. Baldwin said. “There is room for everybody in this space, and we need all of you.”
 

 

 

Proactive steps for protection

Dr. Baldwin then went through the details of what people should do now to make things easier in the event of an attack later. “The best defense is a good offense,” Dr. Baldwin said, “so make sure all of your accounts are secure.”

She recommended the following steps:

For doctors who are attacked specifically because of pro-vaccine advocacy, Dr. Baldwin recommended contacting Shots Heard Round The World, a site that was created by a physician whose practice was attacked by anti-vaccine activists. The site also has a toolkit that anyone can download for tips on preparing ahead for possible attacks and what to do if you are attacked.

Dr. Baldwin then reviewed how to set up different social media profiles to automatically hide certain comments, including comments with words commonly used by online harassers and trolls:

  • Sheep
  • Sheeple
  • Pharma
  • Shill
  • Die
  • Psychopath
  • Clown
  • Various curse words
  • The clown emoji

In Instagram, go to “Settings and privacy —> Hidden Words” for options on hiding offensive comments and messages and for managing custom words and phrases that should be automatically hidden.

On Facebook, go to “Professional dashboard —> Moderation Assist,” where you can add or edit criteria to automatically hide comments on your Facebook page. In addition to hiding comments with certain keywords, you can hide comments from new accounts, accounts without profile photos, or accounts with no friends or followers.

On TikTok, click the three-line menu icon in the upper right, and choose “Privacy —> Comments —> Filter keywords.”

On the platform formerly known as Twitter, go to “Settings and privacy —> Privacy and safety —> Mute and block —> Muted words.”

On YouTube, under “Manage your community & comments,” select “Learn about comment settings.”

Dr. Baldwin did not discourage doctors from posting about controversial topics, but she said it’s important to know what they are so that you can be prepared for the possibility that a post about one of these topics could lead to online harassment. These hot button topics include vaccines, firearm safety, gender-affirming care, reproductive choice, safe sleep/bedsharing, breastfeeding, and COVID masks.

If you do post on one of these and suspect it could result in harassment, Dr. Baldwin recommends turning on your notifications so you know when attacks begin, alerting your office and call center staff if you think they might receive calls, and, when possible, post your content at a time when you’re more likely to be able to monitor the post. She acknowledged that this last tip isn’t always relevant since attacks can take a few days to start or gain steam.
 

 

 

Defending yourself in an attack

Even after taking all these precautions, it’s not possible to altogether prevent an attack from happening, so Dr. Baldwin provided suggestions on what to do if one occurs, starting with taking a deep breath.

“If you are attacked, first of all, please remain calm, which is a lot easier said than done,” she said. “But know that this too shall pass. These things do come to an end.”

She advises you to get help if you need it, enlisting friends or colleagues to help with moderation and banning/blocking. If necessary, alert your employer to the attack, as attackers may contact your employer. Some people may opt to turn off comments on their post, but doing so “is a really personal decision,” she said. It’s okay to turn off comments if you don’t have the bandwidth or help to deal with them.

However, Dr. Baldwin said she never turns off comments because she wants to be able to ban and block people to reduce the likelihood of a future attack from them, and each comment brings the post higher in the algorithm so that more people are able to see the original content. “So sometimes these things are actually a blessing in disguise,” she said.

If you do have comments turned on, take screenshots of the most egregious or threatening ones and then report them and ban/block them. The screenshots are evidence since blocking will remove the comment.

“Take breaks when you need to,” she said. “Don’t stay up all night” since there are only going to be more in the morning, and if you’re using keywords to help hide many of these comments, that will hide them from your followers while you’re away. She also advised monitoring your online reviews at doctor/practice review sites so you know whether you’re receiving spurious reviews that need to be removed.

Dr. Baldwin also addressed how to handle trolls, the people online who intentionally antagonize others with inflammatory, irrelevant, offensive, or otherwise disruptive comments or content. The No. 1 rule is not to engage – “Don’t feed the trolls” – but Dr. Baldwin acknowledged that she can find that difficult sometimes. So she uses kindness or humor to defuse them or calls them out on their inaccurate information and then thanks them for their engagement. Don’t forget that you are in charge of your own page, so any complaints about “censorship” or infringing “free speech” aren’t relevant.

If the comments are growing out of control and you’re unable to manage them, multiple social media platforms have options for limited interactions or who can comment on your page.

On Instagram under “Settings and privacy,” check out “Limited interactions,” “Comments —> Allow comments from,” and “Tags and mentions” to see ways you can limit who is able to comment, tag or mention your account. If you need a complete break, you can turn off commenting by clicking the three dots in the upper right corner of the post, or make your account temporarily private under “Settings and privacy —> Account privacy.”

On Facebook, click the three dots in the upper right corner of posts to select “Who can comment on your post?” Also, under “Settings —> Privacy —> Your Activity,” you can adjust who sees your future posts. Again, if things are out of control, you can temporarily deactivate your page under “Settings —> Privacy —> Facebook Page information.”

On TikTok, click the three lines in the upper right corner of your profile and select “Privacy —> Comments” to adjust who can comment and to filter comments. Again, you can make your account private under “Settings and privacy —> Privacy —> Private account.”

On the platform formerly known as Twitter, click the three dots in the upper right corner of the tweet to change who can reply to the tweet. If you select “Only people you mentioned,” then no one can reply if you did not mention anyone. You can control tagging under “Settings and privacy —> Privacy and safety —> Audience and tagging.”

If you or your practice receive false reviews on review sites, report the reviews and alert the rating site when you can. In the meantime, lock down your private social media accounts and ensure that no photos of your family are publicly available.
 

 

 

Social media self-care

Dr. Baldwin acknowledged that experiencing a social media attack can be intense and even frightening, but it’s rare and outweighed by the “hundreds and hundreds and hundreds of positive comments all the time.” She also reminded attendees that being on social media doesn’t mean being there all the time.

“Over time, my use of social media has certainly changed. It ebbs and flows,” she said. “There are times when I have a lot of bandwidth and I’m posting a lot, and then I actually have had some struggles with my own mental health, with some anxiety and mild depression, so I took a break from social media for a while. When I came back, I posted about my mental health struggles, and you wouldn’t believe how many people were so appreciative of that.”
 

Accurate information from a trusted source

Ultimately, Dr. Baldwin sees her work online as an extension of her work educating patients.

“This is where our patients are. They are in your office for maybe 10-15 minutes maybe once a year, but they are on these platforms every single day for hours,” she said. “They need to see this information from medical professionals because there are random people out there that are telling them [misinformation].”

Elizabeth Murray, DO, MBA, an emergency medicine pediatrician at Golisano Children’s Hospital at the University of Rochester, agreed that there’s substantial value in doctors sharing accurate information online.

“Disinformation and misinformation is rampant, and at the end of the day, we know the facts,” Dr. Murray said. “We know what parents want to hear and what they want to learn about, so we need to share that information and get the facts out there.”

Dr. Murray found the session very helpful because there’s so much to learn across different social media platforms and it can feel overwhelming if you aren’t familiar with the tools.

“Social media is always going to be here. We need to learn to live with all of these platforms,” Dr. Murray said. “That’s a skill set. We need to learn the skills and teach our kids the skill set. You never really know what you might put out there that, in your mind is innocent or very science-based, that for whatever reason somebody might take issue with. You might as well be ready because we’re all about prevention in pediatrics.”

There were no funders for the presentation. Dr. Baldwin and Dr. Murray had no disclosures.

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New meningococcal vaccine wins FDA approval

Article Type
Changed
Tue, 10/24/2023 - 16:21

The U.S. Food and Drug Administration has approved a meningococcal vaccine against the five most common serogroups causing disease in children and young adults.

The new formulation called Penbraya is manufactured by Pfizer and combines the components from two existing meningococcal vaccines, Trumenba the group B vaccine and Nimenrix groups A, C, W-135, and Y conjugate vaccine.

This is the first pentavalent vaccine for meningococcal disease and is approved for use in people aged 10-25.

“Today marks an important step forward in the prevention of meningococcal disease in the U.S.,” Annaliesa Anderson, PhD, head of vaccine research and development at Pfizer, said in a news release. “In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.”
 

One shot, five common types

“Incomplete protection against invasive meningococcal disease,” is common, added Jana Shaw, MD, MPH, a pediatric infectious diseases specialist from Upstate Golisano Children’s Hospital in Syracuse, N.Y. Reducing the number of shots is important because streamlining the vaccination process should help increase the number of young people who get fully vaccinated against meningococcal disease.

Rates are low in the United States, according to the Centers for Disease Control and Prevention, and in 2021 there were around 210 cases reported. But a statewide outbreak has been going on in Virginia since June 2022, with 29 confirmed cases and 6 deaths.

The FDA’s decision is based on the positive results from phase 2 and phase 3 trials, including a randomized, active-controlled and observer-blinded phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate, compared with currently licensed meningococcal vaccines. The phase 3 trial evaluated more than 2,400 patients from the United States and Europe.

The CDC Advisory Committee on Immunization Practices is meeting on Oct. 25 to discuss recommendations for the appropriate use of Penbraya in young people.

A version of this article first appeared on Medscape.com.

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The U.S. Food and Drug Administration has approved a meningococcal vaccine against the five most common serogroups causing disease in children and young adults.

The new formulation called Penbraya is manufactured by Pfizer and combines the components from two existing meningococcal vaccines, Trumenba the group B vaccine and Nimenrix groups A, C, W-135, and Y conjugate vaccine.

This is the first pentavalent vaccine for meningococcal disease and is approved for use in people aged 10-25.

“Today marks an important step forward in the prevention of meningococcal disease in the U.S.,” Annaliesa Anderson, PhD, head of vaccine research and development at Pfizer, said in a news release. “In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.”
 

One shot, five common types

“Incomplete protection against invasive meningococcal disease,” is common, added Jana Shaw, MD, MPH, a pediatric infectious diseases specialist from Upstate Golisano Children’s Hospital in Syracuse, N.Y. Reducing the number of shots is important because streamlining the vaccination process should help increase the number of young people who get fully vaccinated against meningococcal disease.

Rates are low in the United States, according to the Centers for Disease Control and Prevention, and in 2021 there were around 210 cases reported. But a statewide outbreak has been going on in Virginia since June 2022, with 29 confirmed cases and 6 deaths.

The FDA’s decision is based on the positive results from phase 2 and phase 3 trials, including a randomized, active-controlled and observer-blinded phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate, compared with currently licensed meningococcal vaccines. The phase 3 trial evaluated more than 2,400 patients from the United States and Europe.

The CDC Advisory Committee on Immunization Practices is meeting on Oct. 25 to discuss recommendations for the appropriate use of Penbraya in young people.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved a meningococcal vaccine against the five most common serogroups causing disease in children and young adults.

The new formulation called Penbraya is manufactured by Pfizer and combines the components from two existing meningococcal vaccines, Trumenba the group B vaccine and Nimenrix groups A, C, W-135, and Y conjugate vaccine.

This is the first pentavalent vaccine for meningococcal disease and is approved for use in people aged 10-25.

“Today marks an important step forward in the prevention of meningococcal disease in the U.S.,” Annaliesa Anderson, PhD, head of vaccine research and development at Pfizer, said in a news release. “In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.”
 

One shot, five common types

“Incomplete protection against invasive meningococcal disease,” is common, added Jana Shaw, MD, MPH, a pediatric infectious diseases specialist from Upstate Golisano Children’s Hospital in Syracuse, N.Y. Reducing the number of shots is important because streamlining the vaccination process should help increase the number of young people who get fully vaccinated against meningococcal disease.

Rates are low in the United States, according to the Centers for Disease Control and Prevention, and in 2021 there were around 210 cases reported. But a statewide outbreak has been going on in Virginia since June 2022, with 29 confirmed cases and 6 deaths.

The FDA’s decision is based on the positive results from phase 2 and phase 3 trials, including a randomized, active-controlled and observer-blinded phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate, compared with currently licensed meningococcal vaccines. The phase 3 trial evaluated more than 2,400 patients from the United States and Europe.

The CDC Advisory Committee on Immunization Practices is meeting on Oct. 25 to discuss recommendations for the appropriate use of Penbraya in young people.

A version of this article first appeared on Medscape.com.

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News & Perspectives from Ob.Gyn. News

Article Type
Changed
Wed, 10/18/2023 - 22:56

 

COMMENTARY

The safety of vaginal estrogen in breast cancer survivors

Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

LATEST NEWS

Older women who get mammograms risk overdiagnosis

TOPLINE:

Women who continue breast cancer screening after age 70 face a considerable risk for overdiagnosis.

METHODOLOGY:

  • Overdiagnosis – the risk of detecting and treating cancers that would never have caused issues in a person’s lifetime – is increasingly recognized as a harm of breast cancer screening; however, the scope of the problem among older women remains uncertain.
  • To get an idea, investigators linked Medicare claims data with Surveillance, Epidemiology, and End Results (SEER) data for 54,635 women 70 years or older to compare the incidence of breast cancer and breast cancer–specific death among women who continued screening mammography with those who did not.
  • The women all had undergone recent screening mammograms and had no history of breast cancer at study entry. Those who had a subsequent mammogram within 3 years were classified as undergoing continued screening while those who did not were classified as not undergoing continued screening.
  • Overdiagnosis was defined as the difference in cumulative incidence of breast cancer between screened and unscreened women divided by the cumulative incidence among screened women.
  • Results were adjusted for potential confounders, including age, race, and ethnicity.

Continue to: TAKEAWAY...

 

 

TAKEAWAY:

  • Over 80% of women 70-84 years old and more than 60% of women 85 years or older continued screening.
  • Among women 70-74 years old, the adjusted cumulative incidence of breast cancer was 6.1 cases per 100 screened women vs. 4.2 cases per 100 unscreened women; for women aged 75-84 years old, the cumulative incidence was 4.9 per 100 screened women vs. 2.6 per 100 unscreened women, and for women 85 years and older, the cumulative incidence was 2.8 vs. 1.3 per 100, respectively.
  • Estimates of overdiagnosis ranged from 31% of breast cancer cases among screened women in the 70-74 age group to 54% of cases in the 85 and older group.
  • The researchers found no statistically significant reduction in breast cancer–specific death associated with screening in any age or life-expectancy group. Overdiagnosis appeared to be driven by in situ and localized invasive breast cancer, not advanced breast cancer.

IN PRACTICE:

The proportion of older women who continue to receive screening mammograms and may experience breast cancer overdiagnosis is “considerable” and “increases with advancing age and with decreasing life expectancy,” the authors conclude. Given potential benefits and harms of screening in this population, “patient preferences, including risk tolerance, comfort with uncertainty, and willingness to undergo treatment, are important for informing screening decisions.”

SOURCE: https://www.acpjournals.org/doi/10.7326/M23-0133

https://www.mdedge.com/obgyn/latest-news

CONFERENCE COVERAGE

Offering HPV vaccine at age 9 linked to greater series completion

BALTIMORE—Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

https://www.mdedge.com/obgyn/conference-coverage

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COMMENTARY

The safety of vaginal estrogen in breast cancer survivors

Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

LATEST NEWS

Older women who get mammograms risk overdiagnosis

TOPLINE:

Women who continue breast cancer screening after age 70 face a considerable risk for overdiagnosis.

METHODOLOGY:

  • Overdiagnosis – the risk of detecting and treating cancers that would never have caused issues in a person’s lifetime – is increasingly recognized as a harm of breast cancer screening; however, the scope of the problem among older women remains uncertain.
  • To get an idea, investigators linked Medicare claims data with Surveillance, Epidemiology, and End Results (SEER) data for 54,635 women 70 years or older to compare the incidence of breast cancer and breast cancer–specific death among women who continued screening mammography with those who did not.
  • The women all had undergone recent screening mammograms and had no history of breast cancer at study entry. Those who had a subsequent mammogram within 3 years were classified as undergoing continued screening while those who did not were classified as not undergoing continued screening.
  • Overdiagnosis was defined as the difference in cumulative incidence of breast cancer between screened and unscreened women divided by the cumulative incidence among screened women.
  • Results were adjusted for potential confounders, including age, race, and ethnicity.

Continue to: TAKEAWAY...

 

 

TAKEAWAY:

  • Over 80% of women 70-84 years old and more than 60% of women 85 years or older continued screening.
  • Among women 70-74 years old, the adjusted cumulative incidence of breast cancer was 6.1 cases per 100 screened women vs. 4.2 cases per 100 unscreened women; for women aged 75-84 years old, the cumulative incidence was 4.9 per 100 screened women vs. 2.6 per 100 unscreened women, and for women 85 years and older, the cumulative incidence was 2.8 vs. 1.3 per 100, respectively.
  • Estimates of overdiagnosis ranged from 31% of breast cancer cases among screened women in the 70-74 age group to 54% of cases in the 85 and older group.
  • The researchers found no statistically significant reduction in breast cancer–specific death associated with screening in any age or life-expectancy group. Overdiagnosis appeared to be driven by in situ and localized invasive breast cancer, not advanced breast cancer.

IN PRACTICE:

The proportion of older women who continue to receive screening mammograms and may experience breast cancer overdiagnosis is “considerable” and “increases with advancing age and with decreasing life expectancy,” the authors conclude. Given potential benefits and harms of screening in this population, “patient preferences, including risk tolerance, comfort with uncertainty, and willingness to undergo treatment, are important for informing screening decisions.”

SOURCE: https://www.acpjournals.org/doi/10.7326/M23-0133

https://www.mdedge.com/obgyn/latest-news

CONFERENCE COVERAGE

Offering HPV vaccine at age 9 linked to greater series completion

BALTIMORE—Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

https://www.mdedge.com/obgyn/conference-coverage

 

COMMENTARY

The safety of vaginal estrogen in breast cancer survivors

Currently, more than 3.8 million breast cancer survivors reside in the United States, reflecting high prevalence as well as cure rates for this common malignancy.

When over-the-counter measures including vaginal lubricants and moisturizers are not adequate, vaginal estrogen may be a highly effective treatment for genitourinary syndrome of menopause (GSM), a common condition associated with hypoestrogenism that impairs sexual function and quality of life.

Use of vaginal formulations does not result in systemic levels of estrogen above the normal postmenopausal range. Nonetheless, the U.S. Food and Drug Administration lists a history of breast cancer as a contraindication to the use of all systemic as well as vaginal estrogens.

In premenopausal women, chemotherapy for breast cancer often results in early menopause. Aromatase inhibitors, although effective in preventing recurrent disease in menopausal women, exacerbate GSM. These factors result in a high prevalence of GSM in breast cancer survivors.

Because the safety of vaginal estrogen in the setting of breast cancer is uncertain, investigators at Johns Hopkins conducted a cohort study using claims-based data from more than 200 million U.S. patients that identified women with GSM who had previously been diagnosed with breast cancer. Among some 42,000 women diagnosed with GSM after breast cancer, 5% had three or more prescriptions and were considered vaginal estrogen users.

No significant differences were noted in recurrence-free survival between the vaginal estrogen group and the no estrogen group. At 5 and 10 years of follow-up, use of vaginal estrogen was not associated with higher all-cause mortality. Among women with estrogen receptor–positive tumors, risk for breast cancer recurrence was similar between estrogen users and nonusers.

LATEST NEWS

Older women who get mammograms risk overdiagnosis

TOPLINE:

Women who continue breast cancer screening after age 70 face a considerable risk for overdiagnosis.

METHODOLOGY:

  • Overdiagnosis – the risk of detecting and treating cancers that would never have caused issues in a person’s lifetime – is increasingly recognized as a harm of breast cancer screening; however, the scope of the problem among older women remains uncertain.
  • To get an idea, investigators linked Medicare claims data with Surveillance, Epidemiology, and End Results (SEER) data for 54,635 women 70 years or older to compare the incidence of breast cancer and breast cancer–specific death among women who continued screening mammography with those who did not.
  • The women all had undergone recent screening mammograms and had no history of breast cancer at study entry. Those who had a subsequent mammogram within 3 years were classified as undergoing continued screening while those who did not were classified as not undergoing continued screening.
  • Overdiagnosis was defined as the difference in cumulative incidence of breast cancer between screened and unscreened women divided by the cumulative incidence among screened women.
  • Results were adjusted for potential confounders, including age, race, and ethnicity.

Continue to: TAKEAWAY...

 

 

TAKEAWAY:

  • Over 80% of women 70-84 years old and more than 60% of women 85 years or older continued screening.
  • Among women 70-74 years old, the adjusted cumulative incidence of breast cancer was 6.1 cases per 100 screened women vs. 4.2 cases per 100 unscreened women; for women aged 75-84 years old, the cumulative incidence was 4.9 per 100 screened women vs. 2.6 per 100 unscreened women, and for women 85 years and older, the cumulative incidence was 2.8 vs. 1.3 per 100, respectively.
  • Estimates of overdiagnosis ranged from 31% of breast cancer cases among screened women in the 70-74 age group to 54% of cases in the 85 and older group.
  • The researchers found no statistically significant reduction in breast cancer–specific death associated with screening in any age or life-expectancy group. Overdiagnosis appeared to be driven by in situ and localized invasive breast cancer, not advanced breast cancer.

IN PRACTICE:

The proportion of older women who continue to receive screening mammograms and may experience breast cancer overdiagnosis is “considerable” and “increases with advancing age and with decreasing life expectancy,” the authors conclude. Given potential benefits and harms of screening in this population, “patient preferences, including risk tolerance, comfort with uncertainty, and willingness to undergo treatment, are important for informing screening decisions.”

SOURCE: https://www.acpjournals.org/doi/10.7326/M23-0133

https://www.mdedge.com/obgyn/latest-news

CONFERENCE COVERAGE

Offering HPV vaccine at age 9 linked to greater series completion

BALTIMORE—Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

https://www.mdedge.com/obgyn/conference-coverage

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