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CDC: More kids hospitalized with COVID since pandemic began
Hospital admissions of U.S. children younger than 5 – the only group ineligible for vaccination – have reached their peak since the start of the pandemic, according to new data from the Centers for Disease Control and Prevention.
CDC Director Rochelle Walensky, MD, said the higher numbers show the importance of vaccination for all eligible groups.
“This is the highest number of pediatric hospitalizations we’ve seen throughout the pandemic, which we said about Delta until now,” she said at a CDC briefing Friday. “This very well may be that there are just more cases out there, and our children are more vulnerable when they have more cases surrounding them.”
Despite the skyrocketing admissions, hospitalizations are still relatively low for children, she said. The hospitalization rate for children under 5 is 4 in 100,000, and it’s about 1 in 100,000 in children 5-17.
Dr. Walensky said not all children are being hospitalized for COVID-19 – some are admitted for unrelated issues and test positive but don’t have symptoms.
“We are still learning more about the severity of Omicron in children,” she said, noting that just over 50% of children 12-18 are fully vaccinated, while only 16% of those ages 5-11 are fully vaccinated.
Friday’s teleconference was the first CDC briefing in several months and comes on the heels of recent guideline updates for testing and isolation that have left the American public dumbfounded. When asked why the briefing was held, Dr. Walensky said there had been interest in hearing more from the CDC, saying, “I anticipate this will be the first of many briefings.”
She also defended the confusing guideline changes, saying, “We’re in an unprecedented time with the speed of Omicron cases rising. … This is hard, and I am committed to continuing to improve as we learn more about the science and communicate that to you.”
A version of this article first appeared on WebMD.com.
Hospital admissions of U.S. children younger than 5 – the only group ineligible for vaccination – have reached their peak since the start of the pandemic, according to new data from the Centers for Disease Control and Prevention.
CDC Director Rochelle Walensky, MD, said the higher numbers show the importance of vaccination for all eligible groups.
“This is the highest number of pediatric hospitalizations we’ve seen throughout the pandemic, which we said about Delta until now,” she said at a CDC briefing Friday. “This very well may be that there are just more cases out there, and our children are more vulnerable when they have more cases surrounding them.”
Despite the skyrocketing admissions, hospitalizations are still relatively low for children, she said. The hospitalization rate for children under 5 is 4 in 100,000, and it’s about 1 in 100,000 in children 5-17.
Dr. Walensky said not all children are being hospitalized for COVID-19 – some are admitted for unrelated issues and test positive but don’t have symptoms.
“We are still learning more about the severity of Omicron in children,” she said, noting that just over 50% of children 12-18 are fully vaccinated, while only 16% of those ages 5-11 are fully vaccinated.
Friday’s teleconference was the first CDC briefing in several months and comes on the heels of recent guideline updates for testing and isolation that have left the American public dumbfounded. When asked why the briefing was held, Dr. Walensky said there had been interest in hearing more from the CDC, saying, “I anticipate this will be the first of many briefings.”
She also defended the confusing guideline changes, saying, “We’re in an unprecedented time with the speed of Omicron cases rising. … This is hard, and I am committed to continuing to improve as we learn more about the science and communicate that to you.”
A version of this article first appeared on WebMD.com.
Hospital admissions of U.S. children younger than 5 – the only group ineligible for vaccination – have reached their peak since the start of the pandemic, according to new data from the Centers for Disease Control and Prevention.
CDC Director Rochelle Walensky, MD, said the higher numbers show the importance of vaccination for all eligible groups.
“This is the highest number of pediatric hospitalizations we’ve seen throughout the pandemic, which we said about Delta until now,” she said at a CDC briefing Friday. “This very well may be that there are just more cases out there, and our children are more vulnerable when they have more cases surrounding them.”
Despite the skyrocketing admissions, hospitalizations are still relatively low for children, she said. The hospitalization rate for children under 5 is 4 in 100,000, and it’s about 1 in 100,000 in children 5-17.
Dr. Walensky said not all children are being hospitalized for COVID-19 – some are admitted for unrelated issues and test positive but don’t have symptoms.
“We are still learning more about the severity of Omicron in children,” she said, noting that just over 50% of children 12-18 are fully vaccinated, while only 16% of those ages 5-11 are fully vaccinated.
Friday’s teleconference was the first CDC briefing in several months and comes on the heels of recent guideline updates for testing and isolation that have left the American public dumbfounded. When asked why the briefing was held, Dr. Walensky said there had been interest in hearing more from the CDC, saying, “I anticipate this will be the first of many briefings.”
She also defended the confusing guideline changes, saying, “We’re in an unprecedented time with the speed of Omicron cases rising. … This is hard, and I am committed to continuing to improve as we learn more about the science and communicate that to you.”
A version of this article first appeared on WebMD.com.
Lack of high school education vaccine hesitancy predictor
Lack of a high school education is a predictor of whether a person will be resistant to getting the COVID-19 vaccine, a new study shows.
Researchers from the University of North Carolina looked at vaccination rates in 3,142 counties in the U.S. They compared them to population characteristics based on the CDC Social Vulnerability Index.
They found that more than half of the unvaccinated adults in the U.S. with strong vaccine hesitancy had a high school education or less. Vaccine hesitancy was defined as refusal to be vaccinated even if the COVID-19 vaccine was available.
The other main predictor for vaccine hesitancy was concern about vaccine availability and distribution, the researchers said.
“Our study suggests that low education levels are a major contributor to vaccine hesitancy and ultimately vaccination levels,” the authors wrote. The study was published in the American Journal of Infection Control. “Specifically, low vaccination levels were found in communities with a less educated population and with more concern about vaccine uptake capacity, suggesting that education is an ongoing challenge.”
“Our findings suggest that policy makers and community leaders should tailor vaccine information and efforts to those with limited education and specifically address knowledge concerns that are prevalent and likely more modifiable.”
The study was based on data gathered months ago. It says that as of May 9, 2021, 34.7% of the U.S. population was fully vaccinated and that 8% reported a strong unwillingness to get vaccinated.
At press time, the Centers for Disease Control and Prevention’s COVID Data Tracker showed that 62.5% of the U.S. population was fully vaccinated.
According to the study, other consistent characteristics of people who are vaccine hesitant are that they belong to a racial minority, are 65 or older, live in a household with children 18 or younger, or are unemployed.
When asked why they were vaccine hesitant, people gave these reasons: Lack of trust in COVID-19 vaccines (55%), concerns about side effects (48%), and lack of trust in government (46%).
Lack of access to vaccines, often cited in previous studies about resistance to other vaccines, was not cited as a reason for not getting the COVID-19 vaccine.
“COVID-19 vaccine hesitancy is a public health threat,” the researchers concluded. “Since education levels are not easily modifiable, our results suggest that policymakers would be best served by closing knowledge gaps to overcome negative perceptions of the vaccine through tailored interventions.”
A version of this article first appeared on WebMD.com.
Lack of a high school education is a predictor of whether a person will be resistant to getting the COVID-19 vaccine, a new study shows.
Researchers from the University of North Carolina looked at vaccination rates in 3,142 counties in the U.S. They compared them to population characteristics based on the CDC Social Vulnerability Index.
They found that more than half of the unvaccinated adults in the U.S. with strong vaccine hesitancy had a high school education or less. Vaccine hesitancy was defined as refusal to be vaccinated even if the COVID-19 vaccine was available.
The other main predictor for vaccine hesitancy was concern about vaccine availability and distribution, the researchers said.
“Our study suggests that low education levels are a major contributor to vaccine hesitancy and ultimately vaccination levels,” the authors wrote. The study was published in the American Journal of Infection Control. “Specifically, low vaccination levels were found in communities with a less educated population and with more concern about vaccine uptake capacity, suggesting that education is an ongoing challenge.”
“Our findings suggest that policy makers and community leaders should tailor vaccine information and efforts to those with limited education and specifically address knowledge concerns that are prevalent and likely more modifiable.”
The study was based on data gathered months ago. It says that as of May 9, 2021, 34.7% of the U.S. population was fully vaccinated and that 8% reported a strong unwillingness to get vaccinated.
At press time, the Centers for Disease Control and Prevention’s COVID Data Tracker showed that 62.5% of the U.S. population was fully vaccinated.
According to the study, other consistent characteristics of people who are vaccine hesitant are that they belong to a racial minority, are 65 or older, live in a household with children 18 or younger, or are unemployed.
When asked why they were vaccine hesitant, people gave these reasons: Lack of trust in COVID-19 vaccines (55%), concerns about side effects (48%), and lack of trust in government (46%).
Lack of access to vaccines, often cited in previous studies about resistance to other vaccines, was not cited as a reason for not getting the COVID-19 vaccine.
“COVID-19 vaccine hesitancy is a public health threat,” the researchers concluded. “Since education levels are not easily modifiable, our results suggest that policymakers would be best served by closing knowledge gaps to overcome negative perceptions of the vaccine through tailored interventions.”
A version of this article first appeared on WebMD.com.
Lack of a high school education is a predictor of whether a person will be resistant to getting the COVID-19 vaccine, a new study shows.
Researchers from the University of North Carolina looked at vaccination rates in 3,142 counties in the U.S. They compared them to population characteristics based on the CDC Social Vulnerability Index.
They found that more than half of the unvaccinated adults in the U.S. with strong vaccine hesitancy had a high school education or less. Vaccine hesitancy was defined as refusal to be vaccinated even if the COVID-19 vaccine was available.
The other main predictor for vaccine hesitancy was concern about vaccine availability and distribution, the researchers said.
“Our study suggests that low education levels are a major contributor to vaccine hesitancy and ultimately vaccination levels,” the authors wrote. The study was published in the American Journal of Infection Control. “Specifically, low vaccination levels were found in communities with a less educated population and with more concern about vaccine uptake capacity, suggesting that education is an ongoing challenge.”
“Our findings suggest that policy makers and community leaders should tailor vaccine information and efforts to those with limited education and specifically address knowledge concerns that are prevalent and likely more modifiable.”
The study was based on data gathered months ago. It says that as of May 9, 2021, 34.7% of the U.S. population was fully vaccinated and that 8% reported a strong unwillingness to get vaccinated.
At press time, the Centers for Disease Control and Prevention’s COVID Data Tracker showed that 62.5% of the U.S. population was fully vaccinated.
According to the study, other consistent characteristics of people who are vaccine hesitant are that they belong to a racial minority, are 65 or older, live in a household with children 18 or younger, or are unemployed.
When asked why they were vaccine hesitant, people gave these reasons: Lack of trust in COVID-19 vaccines (55%), concerns about side effects (48%), and lack of trust in government (46%).
Lack of access to vaccines, often cited in previous studies about resistance to other vaccines, was not cited as a reason for not getting the COVID-19 vaccine.
“COVID-19 vaccine hesitancy is a public health threat,” the researchers concluded. “Since education levels are not easily modifiable, our results suggest that policymakers would be best served by closing knowledge gaps to overcome negative perceptions of the vaccine through tailored interventions.”
A version of this article first appeared on WebMD.com.
FROM THE AMERICAN JOURNAL OF INFECTION CONTROL
Mayo Clinic fires 700 employees for refusing COVID vaccine
The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.
Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.
The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.
“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.
The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.
The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.
“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”
With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”
“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”
A version of this article first appeared on WebMD.com.
The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.
Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.
The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.
“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.
The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.
The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.
“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”
With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”
“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”
A version of this article first appeared on WebMD.com.
The medical center, which is Minnesota’s largest employer, has major campuses in Arizona, Florida, and Minnesota and operates hospitals in Iowa and Wisconsin.
Employees had until Jan. 3 to get vaccinated or receive approval for an exemption. On Jan. 4, the hospital fired those who didn’t meet the requirement, according to Action News Jax, a CBS affiliate in Florida.
The 700 employees make up about 1% of Mayo Clinic’s 73,000-person workforce. So far, none of the employees at the campus in Jacksonville, Fla., have been affected, the news outlet reported.
“Florida staff who are not in compliance with our vaccination program remain employed pending the outcome of litigation related to the Centers for Medicare & Medicaid Services requirements,” a Mayo Clinic spokesperson told Action News Jax.
The federal government and Florida remain at odds over vaccine mandates, and several lawsuits are winding through the court system. Florida Gov. Ron DeSantis signed legislation in November that bans private Florida employers from requiring all employees to get vaccinated and calls for various exemption options, according to The Florida Times-Union. The state law clashes with a federal rule that requires vaccinations for all health care workers at hospitals that receive Medicare and Medicaid funding.
The Mayo Clinic mandate required employees to receive at least one COVID-19 vaccine dose and not be “overdue” for a second dose, according to the statement. Only medical and religious exemptions were allowed, and most medical and religious exemptions were approved.
“While Mayo Clinic is saddened to lose valuable employees, we need to take all steps necessary to keep our patients, workforce, visitors, and communities safe,” Mayo Clinic wrote in its statement. “If individuals released from employment choose to get vaccinated at a later date, the opportunity exists for them to apply and return to Mayo Clinic for future job openings.”
With the latest surge in COVID-19 cases from the Omicron variant, the Mayo Clinic also encouraged unvaccinated people to get a shot and those who are eligible for a booster to get one “as soon as possible.”
“Based on science and data, it’s clear that vaccination keeps people out of the hospital and saves lives,” according to the statement. “That’s true for everyone in our communities – and it’s especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day.”
A version of this article first appeared on WebMD.com.
COVID-19 vaccination has little impact on menstrual cycle
Women may rest a bit easier thanks to results from a study showing that vaccination against the SARS-CoV-2 virus has almost no impact on a woman’s menstrual cycle. The issue is significant, as regular menstruation is a sign of health and fertility, and fears of disturbances might increase vaccination hesitancy as COVID-19 cases continue to surge.
Alison Edelman, MD, MPH, a professor of obstetrics and gynecology at Oregon Health & Science University, Portland, led a group studying prospective data on almost 24,000 menstrual cycles reported by almost 4,000 U.S. women.
The investigators found that COVID-19 vaccination was associated with a less than 1-day change in cycle length for the menstrual cycles after the first and second inoculations, compared with prevaccine cycles. Vaccination had no effect on the actual number of days menstrual bleeding lasted.
The study looked at the menstrual patterns of women aged 18-45 years with normal cycle lengths of 24-38 days for the three consecutive cycles before the first vaccine dose and for three consecutive postvaccine cycles. The final sample included 2,403 vaccinated and 1,556 unvaccinated individuals.
In vaccinated women, the study initially found a slight average increase in cycle length after dose one of 71% of a day and 91% of a day after dose two. Following adjustments, those increases dropped to 64% of a day after the first dose and 79% of a day after the second dose.
In unvaccinated women, the study looked at six cycles over a similar time period and found no significant changes from baseline.
“Coronavirus disease 2019 vaccination is associated with a small change in cycle length but not menses length,” Dr. Edelman’s group concluded in Obstetrics and Gynecology.
In the rare instance that a woman received two vaccine doses within the same menstrual cycle, the change in length could increase to 2 days. These variations appear to resolve quickly, possibly as soon as the next cycle after vaccination and do not indicate any cause for long-term physical or reproductive health concern, according to the authors.
Reports by women on social media, however, have suggested that postvaccine menstrual disruptions are more common with, for example, heavier and breakthrough bleeding. But it appears such changes are temporary and resolve quickly.
“These findings are reassuring and validating,” Dr. Edelman said in an interview. On a population level, the changes indicate no cause for concern for long-term physical or reproductive health and no reason to avoid vaccination. “On a personal level, people want this information so they know what to expect when they get vaccinated, and not worry about a pregnancy scare or be disappointed if they were trying for pregnancy.”
According to the International Federation of Gynecologists and Obstetricians, variations in cycle length of fewer than 8 days are considered normal, said Christine Metz, PhD, a research biologist and a professor of molecular medicine at the Feinstein Institutes for Medical Research in Manhasset, N.Y. “Thus, the extra 17 hours added to the menstrual cycle length in the vaccination group in this study is well within the ‘normal’ range.”
In a group of about 1,600 menstruating women being studied at Dr. Metz’s center, some have anecdotally reported transient cycle changes post vaccination for COVID-19, including delays in menstruation onset and changes in bleeding patterns.
Exactly how vaccination might alter menstrual cycle length is not known and has not been studied with vaccination against other infections such as influenza and meningococcal disease.
“Many factors are known to affect menstrual cycle length including changes in diet, sleep, and exercise, as well as sickness, travel, and stress,” Dr. Metz said. The COVID-19 vaccines have affected people in different ways, with side effects ranging from injection-site pain to nausea, aches, fever, and fatigue. “Vaccination side effects, particularly if severe, could lead to changes in diet, exercise, and sleep, and feelings of sickness and/or stress.”
These stressors can alter hormone production and stability, as well as the body’s response to hormones such as estrogen, progesterone, follicle-stimulating hormone, luteinizing hormone, and other hormones associated with female reproduction. “Because these hormones regulate the menstrual cycle, variations in these hormones can either shorten or lengthen the cycle,” Dr. Metz explained.
More research needs to be done at the global level, according to the authors. “Questions remain about other possible changes in menstrual cycles, such as menstrual symptoms, unscheduled bleeding, and changes in the quality and quantity of menstrual bleeding.”
This research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health’s Office of Research on Women’s Health. Dr. Edelman reported support from the American College of Obstetrics and Gynecology, the World Health Organization, Gynuity, and the Karolinska Institute as well as royalties from UpToDate. Other study authors reported similar relationships with not-for-profit and private-sector companies. Three coauthors are employees of Natural Cycles, a fertility tracking device that was used in the study. Dr. Metz disclosed no conflicts of interest with regard to her comments.
Women may rest a bit easier thanks to results from a study showing that vaccination against the SARS-CoV-2 virus has almost no impact on a woman’s menstrual cycle. The issue is significant, as regular menstruation is a sign of health and fertility, and fears of disturbances might increase vaccination hesitancy as COVID-19 cases continue to surge.
Alison Edelman, MD, MPH, a professor of obstetrics and gynecology at Oregon Health & Science University, Portland, led a group studying prospective data on almost 24,000 menstrual cycles reported by almost 4,000 U.S. women.
The investigators found that COVID-19 vaccination was associated with a less than 1-day change in cycle length for the menstrual cycles after the first and second inoculations, compared with prevaccine cycles. Vaccination had no effect on the actual number of days menstrual bleeding lasted.
The study looked at the menstrual patterns of women aged 18-45 years with normal cycle lengths of 24-38 days for the three consecutive cycles before the first vaccine dose and for three consecutive postvaccine cycles. The final sample included 2,403 vaccinated and 1,556 unvaccinated individuals.
In vaccinated women, the study initially found a slight average increase in cycle length after dose one of 71% of a day and 91% of a day after dose two. Following adjustments, those increases dropped to 64% of a day after the first dose and 79% of a day after the second dose.
In unvaccinated women, the study looked at six cycles over a similar time period and found no significant changes from baseline.
“Coronavirus disease 2019 vaccination is associated with a small change in cycle length but not menses length,” Dr. Edelman’s group concluded in Obstetrics and Gynecology.
In the rare instance that a woman received two vaccine doses within the same menstrual cycle, the change in length could increase to 2 days. These variations appear to resolve quickly, possibly as soon as the next cycle after vaccination and do not indicate any cause for long-term physical or reproductive health concern, according to the authors.
Reports by women on social media, however, have suggested that postvaccine menstrual disruptions are more common with, for example, heavier and breakthrough bleeding. But it appears such changes are temporary and resolve quickly.
“These findings are reassuring and validating,” Dr. Edelman said in an interview. On a population level, the changes indicate no cause for concern for long-term physical or reproductive health and no reason to avoid vaccination. “On a personal level, people want this information so they know what to expect when they get vaccinated, and not worry about a pregnancy scare or be disappointed if they were trying for pregnancy.”
According to the International Federation of Gynecologists and Obstetricians, variations in cycle length of fewer than 8 days are considered normal, said Christine Metz, PhD, a research biologist and a professor of molecular medicine at the Feinstein Institutes for Medical Research in Manhasset, N.Y. “Thus, the extra 17 hours added to the menstrual cycle length in the vaccination group in this study is well within the ‘normal’ range.”
In a group of about 1,600 menstruating women being studied at Dr. Metz’s center, some have anecdotally reported transient cycle changes post vaccination for COVID-19, including delays in menstruation onset and changes in bleeding patterns.
Exactly how vaccination might alter menstrual cycle length is not known and has not been studied with vaccination against other infections such as influenza and meningococcal disease.
“Many factors are known to affect menstrual cycle length including changes in diet, sleep, and exercise, as well as sickness, travel, and stress,” Dr. Metz said. The COVID-19 vaccines have affected people in different ways, with side effects ranging from injection-site pain to nausea, aches, fever, and fatigue. “Vaccination side effects, particularly if severe, could lead to changes in diet, exercise, and sleep, and feelings of sickness and/or stress.”
These stressors can alter hormone production and stability, as well as the body’s response to hormones such as estrogen, progesterone, follicle-stimulating hormone, luteinizing hormone, and other hormones associated with female reproduction. “Because these hormones regulate the menstrual cycle, variations in these hormones can either shorten or lengthen the cycle,” Dr. Metz explained.
More research needs to be done at the global level, according to the authors. “Questions remain about other possible changes in menstrual cycles, such as menstrual symptoms, unscheduled bleeding, and changes in the quality and quantity of menstrual bleeding.”
This research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health’s Office of Research on Women’s Health. Dr. Edelman reported support from the American College of Obstetrics and Gynecology, the World Health Organization, Gynuity, and the Karolinska Institute as well as royalties from UpToDate. Other study authors reported similar relationships with not-for-profit and private-sector companies. Three coauthors are employees of Natural Cycles, a fertility tracking device that was used in the study. Dr. Metz disclosed no conflicts of interest with regard to her comments.
Women may rest a bit easier thanks to results from a study showing that vaccination against the SARS-CoV-2 virus has almost no impact on a woman’s menstrual cycle. The issue is significant, as regular menstruation is a sign of health and fertility, and fears of disturbances might increase vaccination hesitancy as COVID-19 cases continue to surge.
Alison Edelman, MD, MPH, a professor of obstetrics and gynecology at Oregon Health & Science University, Portland, led a group studying prospective data on almost 24,000 menstrual cycles reported by almost 4,000 U.S. women.
The investigators found that COVID-19 vaccination was associated with a less than 1-day change in cycle length for the menstrual cycles after the first and second inoculations, compared with prevaccine cycles. Vaccination had no effect on the actual number of days menstrual bleeding lasted.
The study looked at the menstrual patterns of women aged 18-45 years with normal cycle lengths of 24-38 days for the three consecutive cycles before the first vaccine dose and for three consecutive postvaccine cycles. The final sample included 2,403 vaccinated and 1,556 unvaccinated individuals.
In vaccinated women, the study initially found a slight average increase in cycle length after dose one of 71% of a day and 91% of a day after dose two. Following adjustments, those increases dropped to 64% of a day after the first dose and 79% of a day after the second dose.
In unvaccinated women, the study looked at six cycles over a similar time period and found no significant changes from baseline.
“Coronavirus disease 2019 vaccination is associated with a small change in cycle length but not menses length,” Dr. Edelman’s group concluded in Obstetrics and Gynecology.
In the rare instance that a woman received two vaccine doses within the same menstrual cycle, the change in length could increase to 2 days. These variations appear to resolve quickly, possibly as soon as the next cycle after vaccination and do not indicate any cause for long-term physical or reproductive health concern, according to the authors.
Reports by women on social media, however, have suggested that postvaccine menstrual disruptions are more common with, for example, heavier and breakthrough bleeding. But it appears such changes are temporary and resolve quickly.
“These findings are reassuring and validating,” Dr. Edelman said in an interview. On a population level, the changes indicate no cause for concern for long-term physical or reproductive health and no reason to avoid vaccination. “On a personal level, people want this information so they know what to expect when they get vaccinated, and not worry about a pregnancy scare or be disappointed if they were trying for pregnancy.”
According to the International Federation of Gynecologists and Obstetricians, variations in cycle length of fewer than 8 days are considered normal, said Christine Metz, PhD, a research biologist and a professor of molecular medicine at the Feinstein Institutes for Medical Research in Manhasset, N.Y. “Thus, the extra 17 hours added to the menstrual cycle length in the vaccination group in this study is well within the ‘normal’ range.”
In a group of about 1,600 menstruating women being studied at Dr. Metz’s center, some have anecdotally reported transient cycle changes post vaccination for COVID-19, including delays in menstruation onset and changes in bleeding patterns.
Exactly how vaccination might alter menstrual cycle length is not known and has not been studied with vaccination against other infections such as influenza and meningococcal disease.
“Many factors are known to affect menstrual cycle length including changes in diet, sleep, and exercise, as well as sickness, travel, and stress,” Dr. Metz said. The COVID-19 vaccines have affected people in different ways, with side effects ranging from injection-site pain to nausea, aches, fever, and fatigue. “Vaccination side effects, particularly if severe, could lead to changes in diet, exercise, and sleep, and feelings of sickness and/or stress.”
These stressors can alter hormone production and stability, as well as the body’s response to hormones such as estrogen, progesterone, follicle-stimulating hormone, luteinizing hormone, and other hormones associated with female reproduction. “Because these hormones regulate the menstrual cycle, variations in these hormones can either shorten or lengthen the cycle,” Dr. Metz explained.
More research needs to be done at the global level, according to the authors. “Questions remain about other possible changes in menstrual cycles, such as menstrual symptoms, unscheduled bleeding, and changes in the quality and quantity of menstrual bleeding.”
This research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health’s Office of Research on Women’s Health. Dr. Edelman reported support from the American College of Obstetrics and Gynecology, the World Health Organization, Gynuity, and the Karolinska Institute as well as royalties from UpToDate. Other study authors reported similar relationships with not-for-profit and private-sector companies. Three coauthors are employees of Natural Cycles, a fertility tracking device that was used in the study. Dr. Metz disclosed no conflicts of interest with regard to her comments.
FROM OBSTETRICS & GYNECOLOGY
CDC panel recommends Pfizer COVID-19 boosters for ages 12-15
The CDC had already said 16- and 17-year-olds “may” receive a Pfizer booster but the new recommendation adds the 12- to 15-year-old group and strengthens the “may” to “should” for 16- and 17-year-olds.
The committee voted 13-1 to recommend the booster for ages 12-17. CDC Director Rochelle Walensky, MD, must still approve the recommendation for it to take effect.
The vote comes after the FDA on Jan. 3 authorized the Pfizer vaccine booster dose for 12- to 15-year-olds.
The FDA action updated the authorization for the Pfizer vaccine, and the agency also shortened the recommended time between a second dose and the booster to 5 months or more (from 6 months). A third primary series dose is also now authorized for certain immunocompromised children between 5 and 11 years old. Full details are available in an FDA news release.
The CDC on Jan. 4 also backed the shortened time frame and a third primary series dose for some immunocompromised children 5-11 years old. But the CDC delayed a decision on a booster for 12- to 15-year-olds until it heard from its Advisory Committee on Immunization Practices on Jan. 5.
The decision came as school districts nationwide are wrestling with decisions of whether to keep schools open or revert to a virtual format as cases surge, and as pediatric COVID-19 cases and hospitalizations reach new highs.
The only dissenting vote came from Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, Tenn.
She said after the vote, “I am just fine with kids getting a booster. This is not me against all boosters. I just really want the U.S. to move forward with all kids.”
Dr. Talbot said earlier in the comment period, “If we divert our public health from the unvaccinated to the vaccinated, we are not going to make a big impact. Boosters are incredibly important but they won’t solve this problem of the crowded hospitals.”
She said vaccinating the unvaccinated must be the priority.
“If you are a parent out there who has not yet vaccinated your child because you have questions, please, please talk to a health care provider,” she said.
Among the 13 supporters of the recommendation was Oliver Brooks, MD, chief medical officer of Watts HealthCare Corporation in Los Angeles.
Dr. Brooks said extending the population for boosters is another tool in the toolbox.
“If it’s a hammer, we should hit that nail hard,” he said.
Sara Oliver, MD, ACIP’s lead for the COVID-19 work group, presented the case behind the recommendation.
She noted the soaring Omicron cases.
“As of Jan. 3, the 7-day average had reached an all-time high of nearly 500,000 cases,” Dr. Oliver noted.
Since this summer, she said, adolescents have had a higher rate of incidence than that of adults.
“The majority of COVID cases continue to occur among the unvaccinated,” she said, “with unvaccinated 12- to 17-year-olds having a 7-times-higher risk of testing positive for SARS-CoV-2 compared to vaccinated 12- to 17-year-olds. Unvaccinated 12- to 17-year-olds have around 11 times higher risk of hospitalization than vaccinated 12- to 17-year-olds.
“Vaccine effectiveness in adolescents 12-15 years old remains high,” Dr. Oliver said, but evidence shows there may be “some waning over time.”
Discussion of risk centered on myocarditis.
Dr. Oliver said myocarditis rates reported after the Pfizer vaccine in Israel across all populations as of Dec. 15 show that “the rates of myocarditis after a third dose are lower than what is seen after the second dose.”
A version of this article first appeared on WebMD.com.
The CDC had already said 16- and 17-year-olds “may” receive a Pfizer booster but the new recommendation adds the 12- to 15-year-old group and strengthens the “may” to “should” for 16- and 17-year-olds.
The committee voted 13-1 to recommend the booster for ages 12-17. CDC Director Rochelle Walensky, MD, must still approve the recommendation for it to take effect.
The vote comes after the FDA on Jan. 3 authorized the Pfizer vaccine booster dose for 12- to 15-year-olds.
The FDA action updated the authorization for the Pfizer vaccine, and the agency also shortened the recommended time between a second dose and the booster to 5 months or more (from 6 months). A third primary series dose is also now authorized for certain immunocompromised children between 5 and 11 years old. Full details are available in an FDA news release.
The CDC on Jan. 4 also backed the shortened time frame and a third primary series dose for some immunocompromised children 5-11 years old. But the CDC delayed a decision on a booster for 12- to 15-year-olds until it heard from its Advisory Committee on Immunization Practices on Jan. 5.
The decision came as school districts nationwide are wrestling with decisions of whether to keep schools open or revert to a virtual format as cases surge, and as pediatric COVID-19 cases and hospitalizations reach new highs.
The only dissenting vote came from Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, Tenn.
She said after the vote, “I am just fine with kids getting a booster. This is not me against all boosters. I just really want the U.S. to move forward with all kids.”
Dr. Talbot said earlier in the comment period, “If we divert our public health from the unvaccinated to the vaccinated, we are not going to make a big impact. Boosters are incredibly important but they won’t solve this problem of the crowded hospitals.”
She said vaccinating the unvaccinated must be the priority.
“If you are a parent out there who has not yet vaccinated your child because you have questions, please, please talk to a health care provider,” she said.
Among the 13 supporters of the recommendation was Oliver Brooks, MD, chief medical officer of Watts HealthCare Corporation in Los Angeles.
Dr. Brooks said extending the population for boosters is another tool in the toolbox.
“If it’s a hammer, we should hit that nail hard,” he said.
Sara Oliver, MD, ACIP’s lead for the COVID-19 work group, presented the case behind the recommendation.
She noted the soaring Omicron cases.
“As of Jan. 3, the 7-day average had reached an all-time high of nearly 500,000 cases,” Dr. Oliver noted.
Since this summer, she said, adolescents have had a higher rate of incidence than that of adults.
“The majority of COVID cases continue to occur among the unvaccinated,” she said, “with unvaccinated 12- to 17-year-olds having a 7-times-higher risk of testing positive for SARS-CoV-2 compared to vaccinated 12- to 17-year-olds. Unvaccinated 12- to 17-year-olds have around 11 times higher risk of hospitalization than vaccinated 12- to 17-year-olds.
“Vaccine effectiveness in adolescents 12-15 years old remains high,” Dr. Oliver said, but evidence shows there may be “some waning over time.”
Discussion of risk centered on myocarditis.
Dr. Oliver said myocarditis rates reported after the Pfizer vaccine in Israel across all populations as of Dec. 15 show that “the rates of myocarditis after a third dose are lower than what is seen after the second dose.”
A version of this article first appeared on WebMD.com.
The CDC had already said 16- and 17-year-olds “may” receive a Pfizer booster but the new recommendation adds the 12- to 15-year-old group and strengthens the “may” to “should” for 16- and 17-year-olds.
The committee voted 13-1 to recommend the booster for ages 12-17. CDC Director Rochelle Walensky, MD, must still approve the recommendation for it to take effect.
The vote comes after the FDA on Jan. 3 authorized the Pfizer vaccine booster dose for 12- to 15-year-olds.
The FDA action updated the authorization for the Pfizer vaccine, and the agency also shortened the recommended time between a second dose and the booster to 5 months or more (from 6 months). A third primary series dose is also now authorized for certain immunocompromised children between 5 and 11 years old. Full details are available in an FDA news release.
The CDC on Jan. 4 also backed the shortened time frame and a third primary series dose for some immunocompromised children 5-11 years old. But the CDC delayed a decision on a booster for 12- to 15-year-olds until it heard from its Advisory Committee on Immunization Practices on Jan. 5.
The decision came as school districts nationwide are wrestling with decisions of whether to keep schools open or revert to a virtual format as cases surge, and as pediatric COVID-19 cases and hospitalizations reach new highs.
The only dissenting vote came from Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, Tenn.
She said after the vote, “I am just fine with kids getting a booster. This is not me against all boosters. I just really want the U.S. to move forward with all kids.”
Dr. Talbot said earlier in the comment period, “If we divert our public health from the unvaccinated to the vaccinated, we are not going to make a big impact. Boosters are incredibly important but they won’t solve this problem of the crowded hospitals.”
She said vaccinating the unvaccinated must be the priority.
“If you are a parent out there who has not yet vaccinated your child because you have questions, please, please talk to a health care provider,” she said.
Among the 13 supporters of the recommendation was Oliver Brooks, MD, chief medical officer of Watts HealthCare Corporation in Los Angeles.
Dr. Brooks said extending the population for boosters is another tool in the toolbox.
“If it’s a hammer, we should hit that nail hard,” he said.
Sara Oliver, MD, ACIP’s lead for the COVID-19 work group, presented the case behind the recommendation.
She noted the soaring Omicron cases.
“As of Jan. 3, the 7-day average had reached an all-time high of nearly 500,000 cases,” Dr. Oliver noted.
Since this summer, she said, adolescents have had a higher rate of incidence than that of adults.
“The majority of COVID cases continue to occur among the unvaccinated,” she said, “with unvaccinated 12- to 17-year-olds having a 7-times-higher risk of testing positive for SARS-CoV-2 compared to vaccinated 12- to 17-year-olds. Unvaccinated 12- to 17-year-olds have around 11 times higher risk of hospitalization than vaccinated 12- to 17-year-olds.
“Vaccine effectiveness in adolescents 12-15 years old remains high,” Dr. Oliver said, but evidence shows there may be “some waning over time.”
Discussion of risk centered on myocarditis.
Dr. Oliver said myocarditis rates reported after the Pfizer vaccine in Israel across all populations as of Dec. 15 show that “the rates of myocarditis after a third dose are lower than what is seen after the second dose.”
A version of this article first appeared on WebMD.com.
Serious problems rare in ages 5-11 from COVID vaccine
The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.
In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.
In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.
“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.
Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.
CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.
Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.
The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.
The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”
The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.
In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.
Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.
In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.
Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.
Among all the children hospitalized with COVID-19, about 1.5% died.
“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.
A version of this article first appeared on WebMD.com.
The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.
In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.
In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.
“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.
Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.
CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.
Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.
The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.
The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”
The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.
In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.
Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.
In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.
Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.
Among all the children hospitalized with COVID-19, about 1.5% died.
“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.
A version of this article first appeared on WebMD.com.
The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.
In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.
In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.
“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.
Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.
CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.
Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.
The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.
The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”
The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.
In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.
Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.
In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.
Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.
Among all the children hospitalized with COVID-19, about 1.5% died.
“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.
A version of this article first appeared on WebMD.com.
FDA backs Pfizer booster for 12- to 15-year-olds
Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.
The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.
“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.
What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
A lower risk of myocarditis?
Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”
“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.
The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.
The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.
“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.
Dr. Marks also pointed out that most cases of myocarditis clear up quickly.
“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.
“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”
He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.
Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.
Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.
Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.
The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
Mixing and matching vaccines
Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.
“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.
Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
‘It’s not too late’
No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.
“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.
“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”
A version of this article first appeared on WebMD.com.
Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.
The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.
“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.
What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
A lower risk of myocarditis?
Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”
“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.
The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.
The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.
“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.
Dr. Marks also pointed out that most cases of myocarditis clear up quickly.
“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.
“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”
He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.
Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.
Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.
Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.
The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
Mixing and matching vaccines
Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.
“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.
Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
‘It’s not too late’
No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.
“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.
“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”
A version of this article first appeared on WebMD.com.
Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.
The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.
“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.
What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
A lower risk of myocarditis?
Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”
“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.
The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.
The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.
“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.
Dr. Marks also pointed out that most cases of myocarditis clear up quickly.
“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.
“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”
He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.
Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.
Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.
Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.
The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
Mixing and matching vaccines
Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.
“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.
Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
‘It’s not too late’
No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.
“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.
“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”
A version of this article first appeared on WebMD.com.
Why mRNA COVID vaccines are preferred (and why patients should be reassured)
On December 16, 2021, the Advisory Committee on Immunization Practices (ACIP) voted to preferentially recommend messenger RNA (mRNA) vaccines over the Johnson & Johnson/Janssen (J&J) COVID-19 (Ad.26.COV2.S) adenovirus vector vaccine for prevention of COVID-19.1 The mRNA vaccines include Pfizer-BioNTech COVID-19 (BNT162b2) and Moderna COVID-19 (mRNA-1273).
The reason for this preferential recommendation is a rare but serious adverse reaction—thrombosis with thrombocytopenia (TTS) —that has been associated with the J&J vaccine. As of December 8, 2021, more than 16.9 million doses of the J&J COVID-19 vaccine have been given in the United States. The CDC has identified 57 confirmed reports of people who received this vaccine and later developed TTS.2 The known incidence of TTS is thus 1 per ~ 300,000 doses, although the rate may actually be higher.2 All cases have been documented as having occurred after administration of the J&J primary single-dose vaccine; none have been documented (so far) after the booster—although the number of booster doses of the J&J COVID-19 vaccine has been small.
Women between the ages of 30 and 50 years have the highest risk for TTS, with rates of 1 per 94,000 in those ages 30-39 and 1 per 111,000 for those ages 40-49.2,3 All those with TTS have been hospitalized, and 9 have died.2,3 While this adverse reaction is rare, the seriousness of it led the ACIP to state a preference for the mRNA vaccines.
The significance of the recommendation:
- Unless a person has a contraindication to an mRNA vaccine, they should receive 1 of these 2 vaccines for their primary series and boosters.
- The only “Mix and Match” that should occur with boosters is to follow a J&J/Janssen COVID-19 vaccine with an mRNA booster. At this time, booster doses following a 2-dose mRNA primary series should be with an mRNA vaccine.
- The recommendation is for adults ages 18 and older; however, the J&J/Janssen COVID-19 vaccine is not yet approved for younger age-groups.
- The J&J/Janssen COVID-19 vaccine remains an option for those who cannot receive an mRNA vaccine, but it should be administered only after full informed consent.
The J&J/Janssen COVID-19 vaccine initially looked promising a year ago because of its single-dose primary series and its much less stringent storage requirements. However, things have not quite panned out for the vaccine. Its effectiveness after a single dose has proven to be significantly inferior to the 2-dose mRNA vaccines, and it has now been associated with a very serious, albeit rare, adverse reaction.
The major take-home point for physicians to pass on to their patients is that the nation’s system for monitoring vaccine safety works. It can pick up serious adverse reactions that occur at a rate as low as 1/300,000. This should be reassuring.
1. CDC. CDC Endorses ACIP’s Updated COVID-19 Vaccine Recommendations [press release]. December 16, 2021. Accessed December 22, 2021. www.cdc.gov/media/releases/2021/s1216-covid-19-vaccines.html
2. CDC. Selected Adverse Events Reported after COVID-19 Vaccination. December 20, 2021. Accessed December 22, 2021. www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
3. See I. Updates on thrombosis with thrombocytopenia syndrome (TTS). Presented to the Advisory Committee on Immunization Practices. December 16, 2021. Accessed December 22, 2021. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-12-16/02-COVID-See-508.pdf
On December 16, 2021, the Advisory Committee on Immunization Practices (ACIP) voted to preferentially recommend messenger RNA (mRNA) vaccines over the Johnson & Johnson/Janssen (J&J) COVID-19 (Ad.26.COV2.S) adenovirus vector vaccine for prevention of COVID-19.1 The mRNA vaccines include Pfizer-BioNTech COVID-19 (BNT162b2) and Moderna COVID-19 (mRNA-1273).
The reason for this preferential recommendation is a rare but serious adverse reaction—thrombosis with thrombocytopenia (TTS) —that has been associated with the J&J vaccine. As of December 8, 2021, more than 16.9 million doses of the J&J COVID-19 vaccine have been given in the United States. The CDC has identified 57 confirmed reports of people who received this vaccine and later developed TTS.2 The known incidence of TTS is thus 1 per ~ 300,000 doses, although the rate may actually be higher.2 All cases have been documented as having occurred after administration of the J&J primary single-dose vaccine; none have been documented (so far) after the booster—although the number of booster doses of the J&J COVID-19 vaccine has been small.
Women between the ages of 30 and 50 years have the highest risk for TTS, with rates of 1 per 94,000 in those ages 30-39 and 1 per 111,000 for those ages 40-49.2,3 All those with TTS have been hospitalized, and 9 have died.2,3 While this adverse reaction is rare, the seriousness of it led the ACIP to state a preference for the mRNA vaccines.
The significance of the recommendation:
- Unless a person has a contraindication to an mRNA vaccine, they should receive 1 of these 2 vaccines for their primary series and boosters.
- The only “Mix and Match” that should occur with boosters is to follow a J&J/Janssen COVID-19 vaccine with an mRNA booster. At this time, booster doses following a 2-dose mRNA primary series should be with an mRNA vaccine.
- The recommendation is for adults ages 18 and older; however, the J&J/Janssen COVID-19 vaccine is not yet approved for younger age-groups.
- The J&J/Janssen COVID-19 vaccine remains an option for those who cannot receive an mRNA vaccine, but it should be administered only after full informed consent.
The J&J/Janssen COVID-19 vaccine initially looked promising a year ago because of its single-dose primary series and its much less stringent storage requirements. However, things have not quite panned out for the vaccine. Its effectiveness after a single dose has proven to be significantly inferior to the 2-dose mRNA vaccines, and it has now been associated with a very serious, albeit rare, adverse reaction.
The major take-home point for physicians to pass on to their patients is that the nation’s system for monitoring vaccine safety works. It can pick up serious adverse reactions that occur at a rate as low as 1/300,000. This should be reassuring.
On December 16, 2021, the Advisory Committee on Immunization Practices (ACIP) voted to preferentially recommend messenger RNA (mRNA) vaccines over the Johnson & Johnson/Janssen (J&J) COVID-19 (Ad.26.COV2.S) adenovirus vector vaccine for prevention of COVID-19.1 The mRNA vaccines include Pfizer-BioNTech COVID-19 (BNT162b2) and Moderna COVID-19 (mRNA-1273).
The reason for this preferential recommendation is a rare but serious adverse reaction—thrombosis with thrombocytopenia (TTS) —that has been associated with the J&J vaccine. As of December 8, 2021, more than 16.9 million doses of the J&J COVID-19 vaccine have been given in the United States. The CDC has identified 57 confirmed reports of people who received this vaccine and later developed TTS.2 The known incidence of TTS is thus 1 per ~ 300,000 doses, although the rate may actually be higher.2 All cases have been documented as having occurred after administration of the J&J primary single-dose vaccine; none have been documented (so far) after the booster—although the number of booster doses of the J&J COVID-19 vaccine has been small.
Women between the ages of 30 and 50 years have the highest risk for TTS, with rates of 1 per 94,000 in those ages 30-39 and 1 per 111,000 for those ages 40-49.2,3 All those with TTS have been hospitalized, and 9 have died.2,3 While this adverse reaction is rare, the seriousness of it led the ACIP to state a preference for the mRNA vaccines.
The significance of the recommendation:
- Unless a person has a contraindication to an mRNA vaccine, they should receive 1 of these 2 vaccines for their primary series and boosters.
- The only “Mix and Match” that should occur with boosters is to follow a J&J/Janssen COVID-19 vaccine with an mRNA booster. At this time, booster doses following a 2-dose mRNA primary series should be with an mRNA vaccine.
- The recommendation is for adults ages 18 and older; however, the J&J/Janssen COVID-19 vaccine is not yet approved for younger age-groups.
- The J&J/Janssen COVID-19 vaccine remains an option for those who cannot receive an mRNA vaccine, but it should be administered only after full informed consent.
The J&J/Janssen COVID-19 vaccine initially looked promising a year ago because of its single-dose primary series and its much less stringent storage requirements. However, things have not quite panned out for the vaccine. Its effectiveness after a single dose has proven to be significantly inferior to the 2-dose mRNA vaccines, and it has now been associated with a very serious, albeit rare, adverse reaction.
The major take-home point for physicians to pass on to their patients is that the nation’s system for monitoring vaccine safety works. It can pick up serious adverse reactions that occur at a rate as low as 1/300,000. This should be reassuring.
1. CDC. CDC Endorses ACIP’s Updated COVID-19 Vaccine Recommendations [press release]. December 16, 2021. Accessed December 22, 2021. www.cdc.gov/media/releases/2021/s1216-covid-19-vaccines.html
2. CDC. Selected Adverse Events Reported after COVID-19 Vaccination. December 20, 2021. Accessed December 22, 2021. www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
3. See I. Updates on thrombosis with thrombocytopenia syndrome (TTS). Presented to the Advisory Committee on Immunization Practices. December 16, 2021. Accessed December 22, 2021. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-12-16/02-COVID-See-508.pdf
1. CDC. CDC Endorses ACIP’s Updated COVID-19 Vaccine Recommendations [press release]. December 16, 2021. Accessed December 22, 2021. www.cdc.gov/media/releases/2021/s1216-covid-19-vaccines.html
2. CDC. Selected Adverse Events Reported after COVID-19 Vaccination. December 20, 2021. Accessed December 22, 2021. www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
3. See I. Updates on thrombosis with thrombocytopenia syndrome (TTS). Presented to the Advisory Committee on Immunization Practices. December 16, 2021. Accessed December 22, 2021. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-12-16/02-COVID-See-508.pdf
Pfizer COVID vaccine for younger children hits snag
Pfizer’s COVID-19 vaccine for children ages 2 to 5 years old fizzled in clinical trials, the company said on Friday, signaling a further delay in getting a vaccine to preschoolers just as Omicron bears down on the U.S.
In a news release, Pfizer reported that while its 3-microgram dose – which is less than one-third of the dose given to older children – generated a protective immune response in babies and toddlers ages 6 to 24 months, it didn’t generate adequate immunity in children ages 2 to 5.
The company plans to change its clinical trial to add a third dose for younger children in hopes of improving those results. It also plans to test a third dose of its 10-microgram vaccine for children ages 5 to 12.
If the trials are successful, Pfizer said it would submit data to the FDA for an emergency use authorization (EUA) in the first half of 2022.
That pushes the timeline of getting a vaccine to younger children back by several months. In November, Anthony Fauci, MD, head of the National Institute of Allergy Infectious Diseases, predicted a vaccine would be ready for preschoolers by spring.
“On one hand, parents are understandably disappointed,” said Jill Foster, MD, a pediatric infectious disease doctor at the University of Minnesota Medical School. “On the other, it shows that the system for testing vaccines is working. Children are not little adults and have complex immune systems, so it’s not just a matter of making the dose smaller and expecting that it will work,” she said, noting that data from Moderna’s KidCOVE study in preschoolers is pending.
Until there’s a vaccine, Dr. Foster says parents should protect babies and toddlers by making sure everyone around them is vaccinated, promote the use of face masks for everyone around them and for all children over age 2, and continue to avoid crowded gatherings, particularly those that are indoors.
“Hand sanitizer is important, but this virus, especially the Omicron variant, is very easily spread through the air, so keep the air clear of virus as much as possible,” she said.
While the youngest children are still waiting for an effective vaccine, there was reassuring news Dec. 16 about the safety of Pfizer’s vaccine for school-aged kids – those ages 5 through 11.
Out of more than 7 million doses given since this vaccine was authorized for emergency use in late October, most reactions to the vaccine – including arm pain, swelling, and fatigue – have been mild and gone away quickly, without the need to miss school or see a doctor, the CDC reported to a meeting of its Advisory Committee on Immunization Practices, or ACIP.
Many experts had been waiting to see if this vaccine would cause rare cases of heart inflammation called myocarditis, as a higher dose did in teens and young adults.
The news on this front was excellent. About 6 weeks after this vaccine became available, the CDC says there have been only eight confirmed cases of myocarditis in this age group. Six more cases are under investigation.
To put this risk into context, data collected by the American Academy of Pediatrics and the Children’s Hospital Association shows that about 1% of children who test positive for COVID-19 are hospitalized for their infections, while the risk of getting a case of myocarditis after vaccination is .0002%, making it about 5,000 times more likely that a child would need to be hospitalized for COVID-19 than for myocarditis after vaccination.
John Su, MD, who is a member of the CDC’s Vaccine Safety Team, reported there had been two deaths in children after a COVID-19 vaccination. Both were girls, ages 5 and 6. Both had complicated medical histories for several medical disorders. It’s not clear their deaths were linked to the vaccine, and the causes of their deaths are still under investigation.
A version of this article first appeared on WebMD.com.
Pfizer’s COVID-19 vaccine for children ages 2 to 5 years old fizzled in clinical trials, the company said on Friday, signaling a further delay in getting a vaccine to preschoolers just as Omicron bears down on the U.S.
In a news release, Pfizer reported that while its 3-microgram dose – which is less than one-third of the dose given to older children – generated a protective immune response in babies and toddlers ages 6 to 24 months, it didn’t generate adequate immunity in children ages 2 to 5.
The company plans to change its clinical trial to add a third dose for younger children in hopes of improving those results. It also plans to test a third dose of its 10-microgram vaccine for children ages 5 to 12.
If the trials are successful, Pfizer said it would submit data to the FDA for an emergency use authorization (EUA) in the first half of 2022.
That pushes the timeline of getting a vaccine to younger children back by several months. In November, Anthony Fauci, MD, head of the National Institute of Allergy Infectious Diseases, predicted a vaccine would be ready for preschoolers by spring.
“On one hand, parents are understandably disappointed,” said Jill Foster, MD, a pediatric infectious disease doctor at the University of Minnesota Medical School. “On the other, it shows that the system for testing vaccines is working. Children are not little adults and have complex immune systems, so it’s not just a matter of making the dose smaller and expecting that it will work,” she said, noting that data from Moderna’s KidCOVE study in preschoolers is pending.
Until there’s a vaccine, Dr. Foster says parents should protect babies and toddlers by making sure everyone around them is vaccinated, promote the use of face masks for everyone around them and for all children over age 2, and continue to avoid crowded gatherings, particularly those that are indoors.
“Hand sanitizer is important, but this virus, especially the Omicron variant, is very easily spread through the air, so keep the air clear of virus as much as possible,” she said.
While the youngest children are still waiting for an effective vaccine, there was reassuring news Dec. 16 about the safety of Pfizer’s vaccine for school-aged kids – those ages 5 through 11.
Out of more than 7 million doses given since this vaccine was authorized for emergency use in late October, most reactions to the vaccine – including arm pain, swelling, and fatigue – have been mild and gone away quickly, without the need to miss school or see a doctor, the CDC reported to a meeting of its Advisory Committee on Immunization Practices, or ACIP.
Many experts had been waiting to see if this vaccine would cause rare cases of heart inflammation called myocarditis, as a higher dose did in teens and young adults.
The news on this front was excellent. About 6 weeks after this vaccine became available, the CDC says there have been only eight confirmed cases of myocarditis in this age group. Six more cases are under investigation.
To put this risk into context, data collected by the American Academy of Pediatrics and the Children’s Hospital Association shows that about 1% of children who test positive for COVID-19 are hospitalized for their infections, while the risk of getting a case of myocarditis after vaccination is .0002%, making it about 5,000 times more likely that a child would need to be hospitalized for COVID-19 than for myocarditis after vaccination.
John Su, MD, who is a member of the CDC’s Vaccine Safety Team, reported there had been two deaths in children after a COVID-19 vaccination. Both were girls, ages 5 and 6. Both had complicated medical histories for several medical disorders. It’s not clear their deaths were linked to the vaccine, and the causes of their deaths are still under investigation.
A version of this article first appeared on WebMD.com.
Pfizer’s COVID-19 vaccine for children ages 2 to 5 years old fizzled in clinical trials, the company said on Friday, signaling a further delay in getting a vaccine to preschoolers just as Omicron bears down on the U.S.
In a news release, Pfizer reported that while its 3-microgram dose – which is less than one-third of the dose given to older children – generated a protective immune response in babies and toddlers ages 6 to 24 months, it didn’t generate adequate immunity in children ages 2 to 5.
The company plans to change its clinical trial to add a third dose for younger children in hopes of improving those results. It also plans to test a third dose of its 10-microgram vaccine for children ages 5 to 12.
If the trials are successful, Pfizer said it would submit data to the FDA for an emergency use authorization (EUA) in the first half of 2022.
That pushes the timeline of getting a vaccine to younger children back by several months. In November, Anthony Fauci, MD, head of the National Institute of Allergy Infectious Diseases, predicted a vaccine would be ready for preschoolers by spring.
“On one hand, parents are understandably disappointed,” said Jill Foster, MD, a pediatric infectious disease doctor at the University of Minnesota Medical School. “On the other, it shows that the system for testing vaccines is working. Children are not little adults and have complex immune systems, so it’s not just a matter of making the dose smaller and expecting that it will work,” she said, noting that data from Moderna’s KidCOVE study in preschoolers is pending.
Until there’s a vaccine, Dr. Foster says parents should protect babies and toddlers by making sure everyone around them is vaccinated, promote the use of face masks for everyone around them and for all children over age 2, and continue to avoid crowded gatherings, particularly those that are indoors.
“Hand sanitizer is important, but this virus, especially the Omicron variant, is very easily spread through the air, so keep the air clear of virus as much as possible,” she said.
While the youngest children are still waiting for an effective vaccine, there was reassuring news Dec. 16 about the safety of Pfizer’s vaccine for school-aged kids – those ages 5 through 11.
Out of more than 7 million doses given since this vaccine was authorized for emergency use in late October, most reactions to the vaccine – including arm pain, swelling, and fatigue – have been mild and gone away quickly, without the need to miss school or see a doctor, the CDC reported to a meeting of its Advisory Committee on Immunization Practices, or ACIP.
Many experts had been waiting to see if this vaccine would cause rare cases of heart inflammation called myocarditis, as a higher dose did in teens and young adults.
The news on this front was excellent. About 6 weeks after this vaccine became available, the CDC says there have been only eight confirmed cases of myocarditis in this age group. Six more cases are under investigation.
To put this risk into context, data collected by the American Academy of Pediatrics and the Children’s Hospital Association shows that about 1% of children who test positive for COVID-19 are hospitalized for their infections, while the risk of getting a case of myocarditis after vaccination is .0002%, making it about 5,000 times more likely that a child would need to be hospitalized for COVID-19 than for myocarditis after vaccination.
John Su, MD, who is a member of the CDC’s Vaccine Safety Team, reported there had been two deaths in children after a COVID-19 vaccination. Both were girls, ages 5 and 6. Both had complicated medical histories for several medical disorders. It’s not clear their deaths were linked to the vaccine, and the causes of their deaths are still under investigation.
A version of this article first appeared on WebMD.com.
New hepatitis B vaccination recommendations praised amid low awareness
An updated recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) calling for universal hepatitis B vaccination of all adults aged 59 and younger has boosted the call to improve clinicians’ awareness of the increasing infection and low vaccination rates – and raise the issue with patients.
“This new recommendation from [the] ACIP will be instrumental [in] raising adult hepatitis B vaccination rates in the U.S. to levels that will allow us to finally eliminate hepatitis B in this country,” said Rita K. Kuwahara, MD, a primary care internal medicine physician and health policy fellow at Georgetown University, in Washington, D.C., in addressing the issue at the U.S. Conference on HIV/AIDS (USCHA) this month.
“We have the tools to prevent hepatitis B, and since we have such safe and highly effective vaccines to protect against community [spread], we should not have a single new infection in our nation,” she asserted.
The unanimously approved updated ACIP recommendation was issued in November and still requires adoption by the CDC director. The ACIP specifically recommends that adults aged 19 to 59 and those 60 years and older with risk factors for infection “should” receive the hepatitis B vaccine, and it further stipulates that those 60 years and older without known risk factors for hepatitis B “may” receive the vaccine.
The recommendation was previously only for adults at risk for hepatitis B infection due to a variety of factors, including sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, and HIV infection.
“The number of risk factors was long, and for a busy primary care provider to have to go through a lengthy risk-based protocol like that, it may not happen,” Dr. Kuwahara told this news organization.
“Now we have a really helpful new recommendation that is simply age based, and clinicians can just tell patients that if they were born before this certain period, a hepatitis B vaccination is recommended.”
The change comes amid a troubling trajectory of hepatitis B, with up to 2.4 million individuals currently having chronic hepatitis B in the U.S. and infection rates soaring by 100% to more than 400% in states with high opioid use, such as West Virginia, Kentucky, Tennessee, and Maine, Dr. Kuwahara said.
Notably, hepatitis B is the leading cause of liver disease, and one in four individuals with unmanaged chronic hepatitis B goes on to develop liver failure and/or cirrhosis or liver cancer, which has a 5-year survival rate of only 18%.
Despite the rising infection rates, only 25%-30% of adults in the U.S. are reported to be currently vaccinated for hepatitis B, even though safe and highly effective vaccines are available, notably including a new two-dose vaccine (Heplisav-B) that can be provided over just a month (vs. other hepatitis B vaccines requiring 3 doses over 6 months).
Clinician awareness of low vaccination rates lacking
Dr. Kuwahara noted that awareness among clinicians of the issues surrounding hepatitis B appears low, with one small survey that she and her colleagues conducted of 30 primary care physicians showing that not one of the respondents was aware of the low vaccination rate.
Dr. Kuwahara says a key reason for the low awareness to discuss the hepatitis B vaccination with adults is the common impression that the responsibility for the vaccination lies in the hands of pediatricians.
But that’s only half correct – universal vaccination for hepatitis B in all infants and children is indeed currently the policy in the U.S. – but that was not implemented in all states until the mid-to-late ‘90s, meaning the millions of adults over the age of about 25 to 30, born before that period, are likely not fully vaccinated against hepatitis B.
“When I was in medical school, there wasn’t a lot of discussion of how low the hepatitis B vaccination rate was because everyone knew there was universal childhood vaccination, and I think there was an assumption that it had been going on for a long time,” Dr. Kuwahara said. “So I think it’s clearly a misconception, and it’s really important to improve clinician awareness around the issue.”
Opioid use a key factor in rising infection rates
Importantly, a large proportion of opioid users are among the population of patients born before the mid-’90s – and those adults have a particularly high risk of transmission, with data indicating that 36% of new hepatitis B infections are the result of the opioid epidemic, Dr. Kuwahara noted.
“In the opioid epidemic, we have seen some of the greatest increases in acute hepatitis B presenting in adults aged 30 to 49 years old, as most adults in this age range would not have been vaccinated as children in the U.S.,” she said.
Approximately two-thirds of individuals with chronic hepatitis B are reportedly not even aware of their infection status due to ineffective prevention and vaccination programs, adding to the spread of infection, Dr. Kuwahara said.
Meanwhile, COVID-19 has only exacerbated the problem, with record-high instances of overdoses and overdose-related deaths during the pandemic, she explained.
However, the pandemic, and specifically the sweeping innovations that have been implemented in desperate efforts to bring COVID-19 vaccines to the public, could in fact represent a critical opportunity for hepatitis B prevention, Dr. Kuwahara said.
“Significant resources and federal funding have already been invested to develop a robust infrastructure for multi-dose COVID-19 vaccine administration during the pandemic, which has resulted in millions of people across the U.S. receiving the COVID-19 vaccine in easily accessible settings within their communities,” she said.
“It is essential that we expand the infrastructure development ... so that we may use this infrastructure to administer other vaccines such as the hepatitis B vaccine to adults throughout the nation and prevent additional outbreaks.”
Implementation of vaccine recommendations key
Dr. Kuwahara outlined key measures that will be important in implementing the hepatitis B vaccine recommendations:
- Awareness of the hepatitis B vaccination recommendations at the primary care level: “The first step in implementing universal [guidelines] will be to ensure that health care providers, particularly in primary care, are aware of the new ACIP guidelines so that they can speak with their patients about this and appropriately order hepatitis B testing and vaccination,” she said.
- Availability of vaccines: In addition to making sure primary care clinics are well stocked with hepatitis B vaccines, the vaccines should also be available in pharmacies and other convenient nonclinical settings through community outreach, similar to COVID-19 vaccines.
- Follow-up: Systems should be established to remind patients to receive follow-up doses.
- Public funding for vaccines: Policy changes will need to occur to allocate appropriate Section 317 funding to provide hepatitis B vaccines to adults without health insurance coverage, Dr. Kuwahara said, underscoring concerns about health equity in vaccination.
- Track vaccinations: Communication should be established between places administering vaccines and primary care providers to make sure that vaccination status can be documented in a reliable setting.
Dr. Kuwahara also noted that a federal immunization information system will be essential to track vaccines across a lifespan, providing one integrated vaccine record that can be accessed even when patients travel or move to different states.
Commenting on the issue, Frank Hood, manager of hepatitis advocacy for The AIDS Institute in Washington, D.C., added that, in addition to simplifying the process, the new age-based recommendation removes the issue of perceived judgement from the advice.
“The previous recommendations were more risk based, and patients may tend to say ‘oh, I don’t have any of those behaviors,’ and there can be some stigma,” he said. “But having something that says everyone in these age groups should be or may be vaccinated just makes it much easier and covers a greater number of individuals.”
Mr. Hood further underscored the need for continued diligence in improving measures to prevent and eradicate HBV as well as other infectious diseases.
“It is imperative that the systems being built now to respond to future infectious disease outbreaks are done so in a way to equitably support the efforts and end goal of eliminating current infectious disease epidemics like viral hepatitis and HIV,” he emphasized.“Elimination can’t be achieved if we leave people behind.”
Dr. Kuwahara and Mr. Hood had no disclosures to report.
A version of this article first appeared on Medscape.com.
An updated recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) calling for universal hepatitis B vaccination of all adults aged 59 and younger has boosted the call to improve clinicians’ awareness of the increasing infection and low vaccination rates – and raise the issue with patients.
“This new recommendation from [the] ACIP will be instrumental [in] raising adult hepatitis B vaccination rates in the U.S. to levels that will allow us to finally eliminate hepatitis B in this country,” said Rita K. Kuwahara, MD, a primary care internal medicine physician and health policy fellow at Georgetown University, in Washington, D.C., in addressing the issue at the U.S. Conference on HIV/AIDS (USCHA) this month.
“We have the tools to prevent hepatitis B, and since we have such safe and highly effective vaccines to protect against community [spread], we should not have a single new infection in our nation,” she asserted.
The unanimously approved updated ACIP recommendation was issued in November and still requires adoption by the CDC director. The ACIP specifically recommends that adults aged 19 to 59 and those 60 years and older with risk factors for infection “should” receive the hepatitis B vaccine, and it further stipulates that those 60 years and older without known risk factors for hepatitis B “may” receive the vaccine.
The recommendation was previously only for adults at risk for hepatitis B infection due to a variety of factors, including sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, and HIV infection.
“The number of risk factors was long, and for a busy primary care provider to have to go through a lengthy risk-based protocol like that, it may not happen,” Dr. Kuwahara told this news organization.
“Now we have a really helpful new recommendation that is simply age based, and clinicians can just tell patients that if they were born before this certain period, a hepatitis B vaccination is recommended.”
The change comes amid a troubling trajectory of hepatitis B, with up to 2.4 million individuals currently having chronic hepatitis B in the U.S. and infection rates soaring by 100% to more than 400% in states with high opioid use, such as West Virginia, Kentucky, Tennessee, and Maine, Dr. Kuwahara said.
Notably, hepatitis B is the leading cause of liver disease, and one in four individuals with unmanaged chronic hepatitis B goes on to develop liver failure and/or cirrhosis or liver cancer, which has a 5-year survival rate of only 18%.
Despite the rising infection rates, only 25%-30% of adults in the U.S. are reported to be currently vaccinated for hepatitis B, even though safe and highly effective vaccines are available, notably including a new two-dose vaccine (Heplisav-B) that can be provided over just a month (vs. other hepatitis B vaccines requiring 3 doses over 6 months).
Clinician awareness of low vaccination rates lacking
Dr. Kuwahara noted that awareness among clinicians of the issues surrounding hepatitis B appears low, with one small survey that she and her colleagues conducted of 30 primary care physicians showing that not one of the respondents was aware of the low vaccination rate.
Dr. Kuwahara says a key reason for the low awareness to discuss the hepatitis B vaccination with adults is the common impression that the responsibility for the vaccination lies in the hands of pediatricians.
But that’s only half correct – universal vaccination for hepatitis B in all infants and children is indeed currently the policy in the U.S. – but that was not implemented in all states until the mid-to-late ‘90s, meaning the millions of adults over the age of about 25 to 30, born before that period, are likely not fully vaccinated against hepatitis B.
“When I was in medical school, there wasn’t a lot of discussion of how low the hepatitis B vaccination rate was because everyone knew there was universal childhood vaccination, and I think there was an assumption that it had been going on for a long time,” Dr. Kuwahara said. “So I think it’s clearly a misconception, and it’s really important to improve clinician awareness around the issue.”
Opioid use a key factor in rising infection rates
Importantly, a large proportion of opioid users are among the population of patients born before the mid-’90s – and those adults have a particularly high risk of transmission, with data indicating that 36% of new hepatitis B infections are the result of the opioid epidemic, Dr. Kuwahara noted.
“In the opioid epidemic, we have seen some of the greatest increases in acute hepatitis B presenting in adults aged 30 to 49 years old, as most adults in this age range would not have been vaccinated as children in the U.S.,” she said.
Approximately two-thirds of individuals with chronic hepatitis B are reportedly not even aware of their infection status due to ineffective prevention and vaccination programs, adding to the spread of infection, Dr. Kuwahara said.
Meanwhile, COVID-19 has only exacerbated the problem, with record-high instances of overdoses and overdose-related deaths during the pandemic, she explained.
However, the pandemic, and specifically the sweeping innovations that have been implemented in desperate efforts to bring COVID-19 vaccines to the public, could in fact represent a critical opportunity for hepatitis B prevention, Dr. Kuwahara said.
“Significant resources and federal funding have already been invested to develop a robust infrastructure for multi-dose COVID-19 vaccine administration during the pandemic, which has resulted in millions of people across the U.S. receiving the COVID-19 vaccine in easily accessible settings within their communities,” she said.
“It is essential that we expand the infrastructure development ... so that we may use this infrastructure to administer other vaccines such as the hepatitis B vaccine to adults throughout the nation and prevent additional outbreaks.”
Implementation of vaccine recommendations key
Dr. Kuwahara outlined key measures that will be important in implementing the hepatitis B vaccine recommendations:
- Awareness of the hepatitis B vaccination recommendations at the primary care level: “The first step in implementing universal [guidelines] will be to ensure that health care providers, particularly in primary care, are aware of the new ACIP guidelines so that they can speak with their patients about this and appropriately order hepatitis B testing and vaccination,” she said.
- Availability of vaccines: In addition to making sure primary care clinics are well stocked with hepatitis B vaccines, the vaccines should also be available in pharmacies and other convenient nonclinical settings through community outreach, similar to COVID-19 vaccines.
- Follow-up: Systems should be established to remind patients to receive follow-up doses.
- Public funding for vaccines: Policy changes will need to occur to allocate appropriate Section 317 funding to provide hepatitis B vaccines to adults without health insurance coverage, Dr. Kuwahara said, underscoring concerns about health equity in vaccination.
- Track vaccinations: Communication should be established between places administering vaccines and primary care providers to make sure that vaccination status can be documented in a reliable setting.
Dr. Kuwahara also noted that a federal immunization information system will be essential to track vaccines across a lifespan, providing one integrated vaccine record that can be accessed even when patients travel or move to different states.
Commenting on the issue, Frank Hood, manager of hepatitis advocacy for The AIDS Institute in Washington, D.C., added that, in addition to simplifying the process, the new age-based recommendation removes the issue of perceived judgement from the advice.
“The previous recommendations were more risk based, and patients may tend to say ‘oh, I don’t have any of those behaviors,’ and there can be some stigma,” he said. “But having something that says everyone in these age groups should be or may be vaccinated just makes it much easier and covers a greater number of individuals.”
Mr. Hood further underscored the need for continued diligence in improving measures to prevent and eradicate HBV as well as other infectious diseases.
“It is imperative that the systems being built now to respond to future infectious disease outbreaks are done so in a way to equitably support the efforts and end goal of eliminating current infectious disease epidemics like viral hepatitis and HIV,” he emphasized.“Elimination can’t be achieved if we leave people behind.”
Dr. Kuwahara and Mr. Hood had no disclosures to report.
A version of this article first appeared on Medscape.com.
An updated recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) calling for universal hepatitis B vaccination of all adults aged 59 and younger has boosted the call to improve clinicians’ awareness of the increasing infection and low vaccination rates – and raise the issue with patients.
“This new recommendation from [the] ACIP will be instrumental [in] raising adult hepatitis B vaccination rates in the U.S. to levels that will allow us to finally eliminate hepatitis B in this country,” said Rita K. Kuwahara, MD, a primary care internal medicine physician and health policy fellow at Georgetown University, in Washington, D.C., in addressing the issue at the U.S. Conference on HIV/AIDS (USCHA) this month.
“We have the tools to prevent hepatitis B, and since we have such safe and highly effective vaccines to protect against community [spread], we should not have a single new infection in our nation,” she asserted.
The unanimously approved updated ACIP recommendation was issued in November and still requires adoption by the CDC director. The ACIP specifically recommends that adults aged 19 to 59 and those 60 years and older with risk factors for infection “should” receive the hepatitis B vaccine, and it further stipulates that those 60 years and older without known risk factors for hepatitis B “may” receive the vaccine.
The recommendation was previously only for adults at risk for hepatitis B infection due to a variety of factors, including sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, and HIV infection.
“The number of risk factors was long, and for a busy primary care provider to have to go through a lengthy risk-based protocol like that, it may not happen,” Dr. Kuwahara told this news organization.
“Now we have a really helpful new recommendation that is simply age based, and clinicians can just tell patients that if they were born before this certain period, a hepatitis B vaccination is recommended.”
The change comes amid a troubling trajectory of hepatitis B, with up to 2.4 million individuals currently having chronic hepatitis B in the U.S. and infection rates soaring by 100% to more than 400% in states with high opioid use, such as West Virginia, Kentucky, Tennessee, and Maine, Dr. Kuwahara said.
Notably, hepatitis B is the leading cause of liver disease, and one in four individuals with unmanaged chronic hepatitis B goes on to develop liver failure and/or cirrhosis or liver cancer, which has a 5-year survival rate of only 18%.
Despite the rising infection rates, only 25%-30% of adults in the U.S. are reported to be currently vaccinated for hepatitis B, even though safe and highly effective vaccines are available, notably including a new two-dose vaccine (Heplisav-B) that can be provided over just a month (vs. other hepatitis B vaccines requiring 3 doses over 6 months).
Clinician awareness of low vaccination rates lacking
Dr. Kuwahara noted that awareness among clinicians of the issues surrounding hepatitis B appears low, with one small survey that she and her colleagues conducted of 30 primary care physicians showing that not one of the respondents was aware of the low vaccination rate.
Dr. Kuwahara says a key reason for the low awareness to discuss the hepatitis B vaccination with adults is the common impression that the responsibility for the vaccination lies in the hands of pediatricians.
But that’s only half correct – universal vaccination for hepatitis B in all infants and children is indeed currently the policy in the U.S. – but that was not implemented in all states until the mid-to-late ‘90s, meaning the millions of adults over the age of about 25 to 30, born before that period, are likely not fully vaccinated against hepatitis B.
“When I was in medical school, there wasn’t a lot of discussion of how low the hepatitis B vaccination rate was because everyone knew there was universal childhood vaccination, and I think there was an assumption that it had been going on for a long time,” Dr. Kuwahara said. “So I think it’s clearly a misconception, and it’s really important to improve clinician awareness around the issue.”
Opioid use a key factor in rising infection rates
Importantly, a large proportion of opioid users are among the population of patients born before the mid-’90s – and those adults have a particularly high risk of transmission, with data indicating that 36% of new hepatitis B infections are the result of the opioid epidemic, Dr. Kuwahara noted.
“In the opioid epidemic, we have seen some of the greatest increases in acute hepatitis B presenting in adults aged 30 to 49 years old, as most adults in this age range would not have been vaccinated as children in the U.S.,” she said.
Approximately two-thirds of individuals with chronic hepatitis B are reportedly not even aware of their infection status due to ineffective prevention and vaccination programs, adding to the spread of infection, Dr. Kuwahara said.
Meanwhile, COVID-19 has only exacerbated the problem, with record-high instances of overdoses and overdose-related deaths during the pandemic, she explained.
However, the pandemic, and specifically the sweeping innovations that have been implemented in desperate efforts to bring COVID-19 vaccines to the public, could in fact represent a critical opportunity for hepatitis B prevention, Dr. Kuwahara said.
“Significant resources and federal funding have already been invested to develop a robust infrastructure for multi-dose COVID-19 vaccine administration during the pandemic, which has resulted in millions of people across the U.S. receiving the COVID-19 vaccine in easily accessible settings within their communities,” she said.
“It is essential that we expand the infrastructure development ... so that we may use this infrastructure to administer other vaccines such as the hepatitis B vaccine to adults throughout the nation and prevent additional outbreaks.”
Implementation of vaccine recommendations key
Dr. Kuwahara outlined key measures that will be important in implementing the hepatitis B vaccine recommendations:
- Awareness of the hepatitis B vaccination recommendations at the primary care level: “The first step in implementing universal [guidelines] will be to ensure that health care providers, particularly in primary care, are aware of the new ACIP guidelines so that they can speak with their patients about this and appropriately order hepatitis B testing and vaccination,” she said.
- Availability of vaccines: In addition to making sure primary care clinics are well stocked with hepatitis B vaccines, the vaccines should also be available in pharmacies and other convenient nonclinical settings through community outreach, similar to COVID-19 vaccines.
- Follow-up: Systems should be established to remind patients to receive follow-up doses.
- Public funding for vaccines: Policy changes will need to occur to allocate appropriate Section 317 funding to provide hepatitis B vaccines to adults without health insurance coverage, Dr. Kuwahara said, underscoring concerns about health equity in vaccination.
- Track vaccinations: Communication should be established between places administering vaccines and primary care providers to make sure that vaccination status can be documented in a reliable setting.
Dr. Kuwahara also noted that a federal immunization information system will be essential to track vaccines across a lifespan, providing one integrated vaccine record that can be accessed even when patients travel or move to different states.
Commenting on the issue, Frank Hood, manager of hepatitis advocacy for The AIDS Institute in Washington, D.C., added that, in addition to simplifying the process, the new age-based recommendation removes the issue of perceived judgement from the advice.
“The previous recommendations were more risk based, and patients may tend to say ‘oh, I don’t have any of those behaviors,’ and there can be some stigma,” he said. “But having something that says everyone in these age groups should be or may be vaccinated just makes it much easier and covers a greater number of individuals.”
Mr. Hood further underscored the need for continued diligence in improving measures to prevent and eradicate HBV as well as other infectious diseases.
“It is imperative that the systems being built now to respond to future infectious disease outbreaks are done so in a way to equitably support the efforts and end goal of eliminating current infectious disease epidemics like viral hepatitis and HIV,” he emphasized.“Elimination can’t be achieved if we leave people behind.”
Dr. Kuwahara and Mr. Hood had no disclosures to report.
A version of this article first appeared on Medscape.com.