HPV vaccination cuts incidence of juvenile respiratory papillomatosis

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Introduction of a national human papillomavirus vaccination program in Australia has been associated with declines in the incidence of juvenile-onset recurrent respiratory papillomatosis, according to a nationwide study.

Juvenile-onset recurrent respiratory papillomatosis (JORRP) is a rare condition characterized by recurring growths in the larynx that often require multiple operations to remove. The disease typically emerges around age 3-4 years and most cases are thought to be caused by human papillomavirus (HPV) subtypes 6 and 11, which are acquired from the mother during birth.

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In this prospective study using data from the Australian Paediatric Surveillance Unit, researchers examined the incidence of juvenile-onset recurrent respiratory papillomatosis from October 2011 to December 2015, set against the background of the introduction of Australia’s national HPV vaccination program between 2007 and 2009 (J Infect Dis. 2017 Nov 9. doi: 10.1093/infdis/jix498).

Overall, just 15 cases were reported during the course of the study; 7 in the 1st year, 3 in the 2nd year, 2 each in the 3rd and 4th years, and 1 case in the last year. The annual rates declined from 0.16 per 100,000 children aged 0-14 years in 2012 to 0.02 per 100,000 in 2016.

Of the cases identified, none of the mothers had been vaccinated against HPV before pregnancy and 20% had a history of genital warts. Seven cases were genotyped; 4 were HPV-6 and 3 were HPV-11, and 13 of the 15 cases were born vaginally.

“Our data strongly suggest that the previously documented impact of quadrivalent HPV vaccination in dramatically reducing the prevalence of HPV-6 and HPV-11 genital infection in the Australian population is translating to a reduction in the risk of transmission to infants intrapartum and subsequent development in some of these children of JORRP,” wrote Daniel Novakovic, MD, of the University of Sydney Medical School, and his coinvestigators.

The authors noted that their initial estimate of infection rates was lower than that seen in other studies, such as the 0.5 per 100,000 rate seen in private health insurance data, and the 1.0 per 100,000 seen with Medicaid data in the United States.

Given that the study period started nearly 5 years after the vaccination program began, they suggested that this lower prevalence may reflect the early impact of the vaccine, particularly given that the prevalence of genital warts had already dramatically declined by that point.

However they also stressed that their study relied on clinicians actively reporting cases, and that given surveillance only began after the introduction of the vaccination program, no data were available on the incidence before that point.

The study was supported by a research grant from Merck and by the Australian Paediatric Surveillance Unit, which is supported by the Australian Government Department of Health. Three authors declared research funding from Merck/Seqirus for HPV studies. Two authors declared funding, speaking fees, and other support from a range of pharmaceutical companies. No other conflicts of interest were declared.

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Introduction of a national human papillomavirus vaccination program in Australia has been associated with declines in the incidence of juvenile-onset recurrent respiratory papillomatosis, according to a nationwide study.

Juvenile-onset recurrent respiratory papillomatosis (JORRP) is a rare condition characterized by recurring growths in the larynx that often require multiple operations to remove. The disease typically emerges around age 3-4 years and most cases are thought to be caused by human papillomavirus (HPV) subtypes 6 and 11, which are acquired from the mother during birth.

vaccine
jarun011/Thinkstock
In this prospective study using data from the Australian Paediatric Surveillance Unit, researchers examined the incidence of juvenile-onset recurrent respiratory papillomatosis from October 2011 to December 2015, set against the background of the introduction of Australia’s national HPV vaccination program between 2007 and 2009 (J Infect Dis. 2017 Nov 9. doi: 10.1093/infdis/jix498).

Overall, just 15 cases were reported during the course of the study; 7 in the 1st year, 3 in the 2nd year, 2 each in the 3rd and 4th years, and 1 case in the last year. The annual rates declined from 0.16 per 100,000 children aged 0-14 years in 2012 to 0.02 per 100,000 in 2016.

Of the cases identified, none of the mothers had been vaccinated against HPV before pregnancy and 20% had a history of genital warts. Seven cases were genotyped; 4 were HPV-6 and 3 were HPV-11, and 13 of the 15 cases were born vaginally.

“Our data strongly suggest that the previously documented impact of quadrivalent HPV vaccination in dramatically reducing the prevalence of HPV-6 and HPV-11 genital infection in the Australian population is translating to a reduction in the risk of transmission to infants intrapartum and subsequent development in some of these children of JORRP,” wrote Daniel Novakovic, MD, of the University of Sydney Medical School, and his coinvestigators.

The authors noted that their initial estimate of infection rates was lower than that seen in other studies, such as the 0.5 per 100,000 rate seen in private health insurance data, and the 1.0 per 100,000 seen with Medicaid data in the United States.

Given that the study period started nearly 5 years after the vaccination program began, they suggested that this lower prevalence may reflect the early impact of the vaccine, particularly given that the prevalence of genital warts had already dramatically declined by that point.

However they also stressed that their study relied on clinicians actively reporting cases, and that given surveillance only began after the introduction of the vaccination program, no data were available on the incidence before that point.

The study was supported by a research grant from Merck and by the Australian Paediatric Surveillance Unit, which is supported by the Australian Government Department of Health. Three authors declared research funding from Merck/Seqirus for HPV studies. Two authors declared funding, speaking fees, and other support from a range of pharmaceutical companies. No other conflicts of interest were declared.

Introduction of a national human papillomavirus vaccination program in Australia has been associated with declines in the incidence of juvenile-onset recurrent respiratory papillomatosis, according to a nationwide study.

Juvenile-onset recurrent respiratory papillomatosis (JORRP) is a rare condition characterized by recurring growths in the larynx that often require multiple operations to remove. The disease typically emerges around age 3-4 years and most cases are thought to be caused by human papillomavirus (HPV) subtypes 6 and 11, which are acquired from the mother during birth.

vaccine
jarun011/Thinkstock
In this prospective study using data from the Australian Paediatric Surveillance Unit, researchers examined the incidence of juvenile-onset recurrent respiratory papillomatosis from October 2011 to December 2015, set against the background of the introduction of Australia’s national HPV vaccination program between 2007 and 2009 (J Infect Dis. 2017 Nov 9. doi: 10.1093/infdis/jix498).

Overall, just 15 cases were reported during the course of the study; 7 in the 1st year, 3 in the 2nd year, 2 each in the 3rd and 4th years, and 1 case in the last year. The annual rates declined from 0.16 per 100,000 children aged 0-14 years in 2012 to 0.02 per 100,000 in 2016.

Of the cases identified, none of the mothers had been vaccinated against HPV before pregnancy and 20% had a history of genital warts. Seven cases were genotyped; 4 were HPV-6 and 3 were HPV-11, and 13 of the 15 cases were born vaginally.

“Our data strongly suggest that the previously documented impact of quadrivalent HPV vaccination in dramatically reducing the prevalence of HPV-6 and HPV-11 genital infection in the Australian population is translating to a reduction in the risk of transmission to infants intrapartum and subsequent development in some of these children of JORRP,” wrote Daniel Novakovic, MD, of the University of Sydney Medical School, and his coinvestigators.

The authors noted that their initial estimate of infection rates was lower than that seen in other studies, such as the 0.5 per 100,000 rate seen in private health insurance data, and the 1.0 per 100,000 seen with Medicaid data in the United States.

Given that the study period started nearly 5 years after the vaccination program began, they suggested that this lower prevalence may reflect the early impact of the vaccine, particularly given that the prevalence of genital warts had already dramatically declined by that point.

However they also stressed that their study relied on clinicians actively reporting cases, and that given surveillance only began after the introduction of the vaccination program, no data were available on the incidence before that point.

The study was supported by a research grant from Merck and by the Australian Paediatric Surveillance Unit, which is supported by the Australian Government Department of Health. Three authors declared research funding from Merck/Seqirus for HPV studies. Two authors declared funding, speaking fees, and other support from a range of pharmaceutical companies. No other conflicts of interest were declared.

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Key clinical point: The introduction of a human papillomavirus vaccination program in Australia has seen a decline in the incidence of juvenile-onset recurrent respiratory papillomatosis.

Major finding: The incidence of juvenile recurrent respiratory papillomatosis decreased from 0.16 per 100,000 children aged 0-14 years to 0.02 per 100,000 over 5 years shortly after the national HPV vaccination program was introduced.

Data source: Prospective study using data from the Australian Paediatric Surveillance Unit.

Disclosures: The study was supported by a research grant from Merck and by the Australian Paediatric Surveillance Unit, which is supported by the Australian Government Department of Health. Three authors declared research funding from Merck/Seqirus for HPV studies. Two authors declared funding, speaking fees, and other support from a range of pharmaceutical companies. No other conflicts of interest were declared.

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FDA approves first two-dose HBV vaccine

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When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.

Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.



“Heplisav-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization,” according to Eddie Gray, chief executive officer of Dynavax. “We expect that it will become an essential tool in the public health community’s fight to prevent hepatitis B [infection], and we look forward to making Heplisav-B available to clinicians and their adult patients.”

Incidence of HBV has increased sharply from 2012 to 2015 in the United States, with reported cases rising from 2,895 to 3,370, according to the Centers for Disease Control and Prevention.

From 2014 to 2015, acute HBV infection increased 20.7%, according to the CDC report.

The new vaccine’s approval came after review of safety and efficacy data from three phase 3 trials comparing Heplisav-B with Engerix-B, another HBV vaccine currently available, that is given in a three-dose regimen.

In one study of 2,032 patients between the ages of 18 and 55 years, seroprotection rate in the Heplisav-B group (1,511) was 95%, compared with 81.5% in the Engerix-B group (521).

Heplisav-B patients were given a two-dose regimen of the drug at 0 and 1 months, followed by a placebo at 6 months, while investigators administered Engerix-B at all three intervals in the comparator subjects.

The FDA’s decision to green-light the new vaccine follows a recommendation for approval from the FDA’s Vaccines and Related Biological Products Advisory Committee, held at the end of July this year.

During the advisory committee meeting, members were concerned about an increased relative risk for acute myocardial infarction of 6.97 in Heplisav-B patients (14), compared with Engerix-B patients (1).

The recommendation for approval came with the caveat of conducting postmarketing analysis for the risk of AMI in Heplisav-B patients, which Dynavax is conducting through the Kaiser Permanente system in California.

“To evaluate the risk of AMIs, the study will enroll 25,000 Heplisav-B patients and 25,000 Engerix-B patients over approximately 10 months and follow them for 1 year after vaccination,” according to a statement from Dynavax. “In addition we will evaluate the rate of immune-mediated diseases in these patients in an additional 5,000 Heplisav-B recipients and 5,000 Engerix-B recipients.”

Dynavax is currently set to introduce Heplisav-B commercially in the United States in 2018, with the cost of the drug set to be released soon.

“Dynavax is in the process of finalizing the price of a two-dose series of Heplisav-B, and they plan to disclose it shortly after approval,” according to the company. “Their pricing and access strategy will be aimed at ensuring that populations at risk of infection are able to access this new vaccine, while recognizing the value it brings to the health care system with a two-dose regimen and higher rates of protection compared to Engerix-B.”

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When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.

Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.



“Heplisav-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization,” according to Eddie Gray, chief executive officer of Dynavax. “We expect that it will become an essential tool in the public health community’s fight to prevent hepatitis B [infection], and we look forward to making Heplisav-B available to clinicians and their adult patients.”

Incidence of HBV has increased sharply from 2012 to 2015 in the United States, with reported cases rising from 2,895 to 3,370, according to the Centers for Disease Control and Prevention.

From 2014 to 2015, acute HBV infection increased 20.7%, according to the CDC report.

The new vaccine’s approval came after review of safety and efficacy data from three phase 3 trials comparing Heplisav-B with Engerix-B, another HBV vaccine currently available, that is given in a three-dose regimen.

In one study of 2,032 patients between the ages of 18 and 55 years, seroprotection rate in the Heplisav-B group (1,511) was 95%, compared with 81.5% in the Engerix-B group (521).

Heplisav-B patients were given a two-dose regimen of the drug at 0 and 1 months, followed by a placebo at 6 months, while investigators administered Engerix-B at all three intervals in the comparator subjects.

The FDA’s decision to green-light the new vaccine follows a recommendation for approval from the FDA’s Vaccines and Related Biological Products Advisory Committee, held at the end of July this year.

During the advisory committee meeting, members were concerned about an increased relative risk for acute myocardial infarction of 6.97 in Heplisav-B patients (14), compared with Engerix-B patients (1).

The recommendation for approval came with the caveat of conducting postmarketing analysis for the risk of AMI in Heplisav-B patients, which Dynavax is conducting through the Kaiser Permanente system in California.

“To evaluate the risk of AMIs, the study will enroll 25,000 Heplisav-B patients and 25,000 Engerix-B patients over approximately 10 months and follow them for 1 year after vaccination,” according to a statement from Dynavax. “In addition we will evaluate the rate of immune-mediated diseases in these patients in an additional 5,000 Heplisav-B recipients and 5,000 Engerix-B recipients.”

Dynavax is currently set to introduce Heplisav-B commercially in the United States in 2018, with the cost of the drug set to be released soon.

“Dynavax is in the process of finalizing the price of a two-dose series of Heplisav-B, and they plan to disclose it shortly after approval,” according to the company. “Their pricing and access strategy will be aimed at ensuring that populations at risk of infection are able to access this new vaccine, while recognizing the value it brings to the health care system with a two-dose regimen and higher rates of protection compared to Engerix-B.”

 

When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.

Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.



“Heplisav-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization,” according to Eddie Gray, chief executive officer of Dynavax. “We expect that it will become an essential tool in the public health community’s fight to prevent hepatitis B [infection], and we look forward to making Heplisav-B available to clinicians and their adult patients.”

Incidence of HBV has increased sharply from 2012 to 2015 in the United States, with reported cases rising from 2,895 to 3,370, according to the Centers for Disease Control and Prevention.

From 2014 to 2015, acute HBV infection increased 20.7%, according to the CDC report.

The new vaccine’s approval came after review of safety and efficacy data from three phase 3 trials comparing Heplisav-B with Engerix-B, another HBV vaccine currently available, that is given in a three-dose regimen.

In one study of 2,032 patients between the ages of 18 and 55 years, seroprotection rate in the Heplisav-B group (1,511) was 95%, compared with 81.5% in the Engerix-B group (521).

Heplisav-B patients were given a two-dose regimen of the drug at 0 and 1 months, followed by a placebo at 6 months, while investigators administered Engerix-B at all three intervals in the comparator subjects.

The FDA’s decision to green-light the new vaccine follows a recommendation for approval from the FDA’s Vaccines and Related Biological Products Advisory Committee, held at the end of July this year.

During the advisory committee meeting, members were concerned about an increased relative risk for acute myocardial infarction of 6.97 in Heplisav-B patients (14), compared with Engerix-B patients (1).

The recommendation for approval came with the caveat of conducting postmarketing analysis for the risk of AMI in Heplisav-B patients, which Dynavax is conducting through the Kaiser Permanente system in California.

“To evaluate the risk of AMIs, the study will enroll 25,000 Heplisav-B patients and 25,000 Engerix-B patients over approximately 10 months and follow them for 1 year after vaccination,” according to a statement from Dynavax. “In addition we will evaluate the rate of immune-mediated diseases in these patients in an additional 5,000 Heplisav-B recipients and 5,000 Engerix-B recipients.”

Dynavax is currently set to introduce Heplisav-B commercially in the United States in 2018, with the cost of the drug set to be released soon.

“Dynavax is in the process of finalizing the price of a two-dose series of Heplisav-B, and they plan to disclose it shortly after approval,” according to the company. “Their pricing and access strategy will be aimed at ensuring that populations at risk of infection are able to access this new vaccine, while recognizing the value it brings to the health care system with a two-dose regimen and higher rates of protection compared to Engerix-B.”

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Pregnant women’s access to vaccination website, social media improved infants’ up-to-date immunizations

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Pregnant women who were offered access to a website with vaccine information and interactive social media were more likely to vaccinate their infants on time than were those receiving usual care, said Jason M. Glanz, PhD, of the Institute for Health Research, Kaiser Permanente Colorado, Denver, and his associates.

“These results suggest that interactive, informational interventions administered outside of the physician’s office can improve vaccine acceptance,” the investigators said. “The information appears to be effective when presented to parents before their children are born.”

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Pregnant women who were members of Kaiser Permanente Colorado, Denver, were recruited between September 2013 and October 2015, and randomized 3:2:1 – a total of 442 women to a website with vaccine information and interactive social media components (VSM); 297 to a website with vaccine information (VI); and 149 to usual care (UC).

The women in the VSM group had access to vaccine content, social media technologies that included a blog, discussion forum, chat rooms with experts, and “Ask a Question” portal through which the women could directly ask experts questions about vaccination. The experts were a pediatrician, a vaccine safety researcher, and a risk communication specialist.

Monthly, one to two blog posts were created on topics such as new vaccine safety research, vaccine-preventable disease outbreaks, changes in immunization policy, and the importance of adhering to the recommended immunization schedule, the researchers said. The women also could submit questions privately through e-mail, and receive personalized responses within 2 business days.

At the end of 200 days of follow-up, the proportion of infants up to date with their vaccinations were 93% for the VSM group, 91% for the VI group, and 87% for the UC arms. Infants in the VSM group were more likely to be up to date at age 200 days, compared with infants in the UC group (odds ratio, 1.92; 95% confidence interval, 1.07-3.47).

“Up-to-date status did not differ significantly between the VI and UC arms or the VSM and VI arms,” Dr. Glanz and his associates wrote.

Of 739 women in the VSM and VI groups, 35% visited the website at least once, with a mean of 1.8 visits (range, 1-15 visits). Of 75 vaccine-hesitant women, 44% visited the website, compared with 34% of 664 nonhesitant women. Median vaccine hesitancy scores were 13 for the VSM group, 17 for the VI group, and 15 for the UC group.

The study authors had no relevant disclosures.

Read more in Pediatrics (2017 Nov. doi: 10.1542/peds.2017-1117).

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Pregnant women who were offered access to a website with vaccine information and interactive social media were more likely to vaccinate their infants on time than were those receiving usual care, said Jason M. Glanz, PhD, of the Institute for Health Research, Kaiser Permanente Colorado, Denver, and his associates.

“These results suggest that interactive, informational interventions administered outside of the physician’s office can improve vaccine acceptance,” the investigators said. “The information appears to be effective when presented to parents before their children are born.”

GEOLEE/Thinkstock
Pregnant women who were members of Kaiser Permanente Colorado, Denver, were recruited between September 2013 and October 2015, and randomized 3:2:1 – a total of 442 women to a website with vaccine information and interactive social media components (VSM); 297 to a website with vaccine information (VI); and 149 to usual care (UC).

The women in the VSM group had access to vaccine content, social media technologies that included a blog, discussion forum, chat rooms with experts, and “Ask a Question” portal through which the women could directly ask experts questions about vaccination. The experts were a pediatrician, a vaccine safety researcher, and a risk communication specialist.

Monthly, one to two blog posts were created on topics such as new vaccine safety research, vaccine-preventable disease outbreaks, changes in immunization policy, and the importance of adhering to the recommended immunization schedule, the researchers said. The women also could submit questions privately through e-mail, and receive personalized responses within 2 business days.

At the end of 200 days of follow-up, the proportion of infants up to date with their vaccinations were 93% for the VSM group, 91% for the VI group, and 87% for the UC arms. Infants in the VSM group were more likely to be up to date at age 200 days, compared with infants in the UC group (odds ratio, 1.92; 95% confidence interval, 1.07-3.47).

“Up-to-date status did not differ significantly between the VI and UC arms or the VSM and VI arms,” Dr. Glanz and his associates wrote.

Of 739 women in the VSM and VI groups, 35% visited the website at least once, with a mean of 1.8 visits (range, 1-15 visits). Of 75 vaccine-hesitant women, 44% visited the website, compared with 34% of 664 nonhesitant women. Median vaccine hesitancy scores were 13 for the VSM group, 17 for the VI group, and 15 for the UC group.

The study authors had no relevant disclosures.

Read more in Pediatrics (2017 Nov. doi: 10.1542/peds.2017-1117).

 

Pregnant women who were offered access to a website with vaccine information and interactive social media were more likely to vaccinate their infants on time than were those receiving usual care, said Jason M. Glanz, PhD, of the Institute for Health Research, Kaiser Permanente Colorado, Denver, and his associates.

“These results suggest that interactive, informational interventions administered outside of the physician’s office can improve vaccine acceptance,” the investigators said. “The information appears to be effective when presented to parents before their children are born.”

GEOLEE/Thinkstock
Pregnant women who were members of Kaiser Permanente Colorado, Denver, were recruited between September 2013 and October 2015, and randomized 3:2:1 – a total of 442 women to a website with vaccine information and interactive social media components (VSM); 297 to a website with vaccine information (VI); and 149 to usual care (UC).

The women in the VSM group had access to vaccine content, social media technologies that included a blog, discussion forum, chat rooms with experts, and “Ask a Question” portal through which the women could directly ask experts questions about vaccination. The experts were a pediatrician, a vaccine safety researcher, and a risk communication specialist.

Monthly, one to two blog posts were created on topics such as new vaccine safety research, vaccine-preventable disease outbreaks, changes in immunization policy, and the importance of adhering to the recommended immunization schedule, the researchers said. The women also could submit questions privately through e-mail, and receive personalized responses within 2 business days.

At the end of 200 days of follow-up, the proportion of infants up to date with their vaccinations were 93% for the VSM group, 91% for the VI group, and 87% for the UC arms. Infants in the VSM group were more likely to be up to date at age 200 days, compared with infants in the UC group (odds ratio, 1.92; 95% confidence interval, 1.07-3.47).

“Up-to-date status did not differ significantly between the VI and UC arms or the VSM and VI arms,” Dr. Glanz and his associates wrote.

Of 739 women in the VSM and VI groups, 35% visited the website at least once, with a mean of 1.8 visits (range, 1-15 visits). Of 75 vaccine-hesitant women, 44% visited the website, compared with 34% of 664 nonhesitant women. Median vaccine hesitancy scores were 13 for the VSM group, 17 for the VI group, and 15 for the UC group.

The study authors had no relevant disclosures.

Read more in Pediatrics (2017 Nov. doi: 10.1542/peds.2017-1117).

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Immunization information systems show progress over recent years

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From 2013 to 2016, all U.S. immunization information systems showed progress in bidirectional information exchange with EHRs, said Neil Murthy, MD, and his associates at the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta.

Across all 55 jurisdictions in 49 states and six cities in the United States using immunization information systems (IIS), 106% of U.S. births were registered in IIS in 2016, which is an increase from 102% in 2013; percentages may exceed 100%, because a child who is born in one state but who lives in a different state might be recorded in both IISs.

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Of the 55 jurisdictions, 33 (60%) reported that 95% or more of children aged 4 months to 5 years living in their geographic area were registered in their IIS in 2016, compared with 24 (44%) in 2013. Participation by providers in 2016 was 85% of the Vaccines for Children (VFC) sites enrolled in an IIS. The number of VFC provider sites participating in an IIS increased from 33,266 in 2013 to 34,662 in 2016.

Bidirectional exchange of data with EHRs is an important part of an IIS. In 2016, 91% of jurisdictions had an IIS that used a platform-independent messaging system that received vaccination histories from providers and returned acknowledgment messages, compared with 87% in 2013, the investigators said.

“Clinical Decision Support (CDS) functionalities enable providers to evaluate the validity of vaccine doses administered to patients and forecast future vaccines that will be needed, based on recommendations developed by the Advisory Committee on Immunization Practices,” Dr. Murthy and his associates said. In 2016, 58% of the 55 jurisdictions sent a vaccine forecast to another system, compared with 31% in 2013.

In 2016, 89% of 55 IIS jurisdictions gave a “predefined, automatic report on immunization coverage by geography,” compared with 80% in 2013. In 2016, 95% of the 55 jurisdictions gave a “predefined, automatic report on immunization coverage by provider site,” compared with 89% of jurisdictions in 2013.

“IISs are integral components of routine clinical practice and public health surveillance for immunization,” Dr. Murthy and his associates said. “Availability of more complete IIS data also offers many benefits to health care providers and public health practitioners, including consolidating patients’ vaccination histories, identifying undervaccinated subgroups, and forecasting the needs of individual patients for recommended vaccines.”

Read more in Morbidity and Mortality Weekly Report (2017 Nov 3;66[43]:1178-81).

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From 2013 to 2016, all U.S. immunization information systems showed progress in bidirectional information exchange with EHRs, said Neil Murthy, MD, and his associates at the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta.

Across all 55 jurisdictions in 49 states and six cities in the United States using immunization information systems (IIS), 106% of U.S. births were registered in IIS in 2016, which is an increase from 102% in 2013; percentages may exceed 100%, because a child who is born in one state but who lives in a different state might be recorded in both IISs.

FotoMaximum/Thinkstock
Of the 55 jurisdictions, 33 (60%) reported that 95% or more of children aged 4 months to 5 years living in their geographic area were registered in their IIS in 2016, compared with 24 (44%) in 2013. Participation by providers in 2016 was 85% of the Vaccines for Children (VFC) sites enrolled in an IIS. The number of VFC provider sites participating in an IIS increased from 33,266 in 2013 to 34,662 in 2016.

Bidirectional exchange of data with EHRs is an important part of an IIS. In 2016, 91% of jurisdictions had an IIS that used a platform-independent messaging system that received vaccination histories from providers and returned acknowledgment messages, compared with 87% in 2013, the investigators said.

“Clinical Decision Support (CDS) functionalities enable providers to evaluate the validity of vaccine doses administered to patients and forecast future vaccines that will be needed, based on recommendations developed by the Advisory Committee on Immunization Practices,” Dr. Murthy and his associates said. In 2016, 58% of the 55 jurisdictions sent a vaccine forecast to another system, compared with 31% in 2013.

In 2016, 89% of 55 IIS jurisdictions gave a “predefined, automatic report on immunization coverage by geography,” compared with 80% in 2013. In 2016, 95% of the 55 jurisdictions gave a “predefined, automatic report on immunization coverage by provider site,” compared with 89% of jurisdictions in 2013.

“IISs are integral components of routine clinical practice and public health surveillance for immunization,” Dr. Murthy and his associates said. “Availability of more complete IIS data also offers many benefits to health care providers and public health practitioners, including consolidating patients’ vaccination histories, identifying undervaccinated subgroups, and forecasting the needs of individual patients for recommended vaccines.”

Read more in Morbidity and Mortality Weekly Report (2017 Nov 3;66[43]:1178-81).

 

From 2013 to 2016, all U.S. immunization information systems showed progress in bidirectional information exchange with EHRs, said Neil Murthy, MD, and his associates at the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta.

Across all 55 jurisdictions in 49 states and six cities in the United States using immunization information systems (IIS), 106% of U.S. births were registered in IIS in 2016, which is an increase from 102% in 2013; percentages may exceed 100%, because a child who is born in one state but who lives in a different state might be recorded in both IISs.

FotoMaximum/Thinkstock
Of the 55 jurisdictions, 33 (60%) reported that 95% or more of children aged 4 months to 5 years living in their geographic area were registered in their IIS in 2016, compared with 24 (44%) in 2013. Participation by providers in 2016 was 85% of the Vaccines for Children (VFC) sites enrolled in an IIS. The number of VFC provider sites participating in an IIS increased from 33,266 in 2013 to 34,662 in 2016.

Bidirectional exchange of data with EHRs is an important part of an IIS. In 2016, 91% of jurisdictions had an IIS that used a platform-independent messaging system that received vaccination histories from providers and returned acknowledgment messages, compared with 87% in 2013, the investigators said.

“Clinical Decision Support (CDS) functionalities enable providers to evaluate the validity of vaccine doses administered to patients and forecast future vaccines that will be needed, based on recommendations developed by the Advisory Committee on Immunization Practices,” Dr. Murthy and his associates said. In 2016, 58% of the 55 jurisdictions sent a vaccine forecast to another system, compared with 31% in 2013.

In 2016, 89% of 55 IIS jurisdictions gave a “predefined, automatic report on immunization coverage by geography,” compared with 80% in 2013. In 2016, 95% of the 55 jurisdictions gave a “predefined, automatic report on immunization coverage by provider site,” compared with 89% of jurisdictions in 2013.

“IISs are integral components of routine clinical practice and public health surveillance for immunization,” Dr. Murthy and his associates said. “Availability of more complete IIS data also offers many benefits to health care providers and public health practitioners, including consolidating patients’ vaccination histories, identifying undervaccinated subgroups, and forecasting the needs of individual patients for recommended vaccines.”

Read more in Morbidity and Mortality Weekly Report (2017 Nov 3;66[43]:1178-81).

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Methotrexate holiday linked to better flu vaccine immunogenicity

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– Patients with well-controlled rheumatoid arthritis (RA) fared well during a 2-week holiday from methotrexate after flu vaccination and later showed signs of boosted immunity against the flu in comparison with patients who had not stopped the drug, according to results from a randomized controlled trial.

The research doesn’t confirm that vaccinated patients who take a break from methotrexate actually have lower rates of flu. Still, the findings suggest that brief holidays from methotrexate could be feasible in a variety of situations, such as after vaccinations and prior to surgery, said Jin Kyun Park, MD, of Seoul (South Korea) National University Hospital, lead author of the study presented at the annual meeting of the American College of Rheumatology.

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For now, Dr. Park said that he has advice for well-controlled RA patients who seek a flu vaccine: “I tell them to skip the next two doses of methotrexate, giving them a total of 2 weeks off. It doesn’t increase the risk of a flare, so you don’t risk anything by doing that.”

The study notes that RA patients are especially prone to infections for two reasons: dysfunctional immune systems and immunity-weakening treatments. According to Dr. Park, methotrexate reduces the effectiveness of flu vaccines by 15%-20%.

In a previous study, Dr. Park and his colleagues found no statistically significant sign of increased flares in patients who went without methotrexate for 2 weeks before and 2 weeks after vaccination, 4 weeks after vaccination, and 4 weeks before vaccination (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).

The earlier findings also suggested that flu vaccine uptake is highest in those who stop methotrexate after vaccination.

For the new study, a randomized controlled trial, researchers recruited patients with well-controlled RA. They assigned 159 to continue weekly doses of methotrexate after flu vaccination and 161 to stop it for 2 weeks.

The groups in the final analysis (156 and 160 subjects, respectively) were similar – about 85% women, average age of 52-53 years, and about half took glucocorticoids. Their methotrexate dose per week was about 13 mg.

At 4 weeks, just over three-quarters of the patients who had briefly stopped methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains. Of those who continued the medication, just 54.5% showed this level of response, which the researchers considered to be satisfactory.

The researchers reported that there was no appreciable increase in RA disease activity.

Dr. Park cautioned that vaccine titers don’t directly reflect immunoprotection levels. Patients who took a break from methotrexate were less likely to develop a flulike illness, but the difference wasn’t statistically significant.

The research raises questions about whether methotrexate could be stopped a week or two before surgery to lower the risk of infections, Dr. Park said.

Dr. Park said that future research should focus on whether stopping methotrexate briefly affects whether patients go on to develop the flu. He would also like to look at whether a break from the medication will boost the immune response in RA patients who get herpes zoster (shingles) vaccines.

Paul Sufka, MD, of HealthPartners and Regions Hospital in St. Paul, Minn., praised the research. The 2-week break from methotrexate is “a fairly pragmatic approach,” said Dr. Sufka, who moderated a press conference where Dr. Park presented his research.

“You can actually pull this off,” he said, versus telling patients to stop the medication for the 2 weeks before they get vaccinated. He cautioned, however, that “these people have a fairly low disease activity. You may not be able to pull this off with those who have high disease activity.”

Dr. Park and Dr. Sufka reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross Corp. and Hanmi Pharmaceutical. The study was funded by Green Cross.

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– Patients with well-controlled rheumatoid arthritis (RA) fared well during a 2-week holiday from methotrexate after flu vaccination and later showed signs of boosted immunity against the flu in comparison with patients who had not stopped the drug, according to results from a randomized controlled trial.

The research doesn’t confirm that vaccinated patients who take a break from methotrexate actually have lower rates of flu. Still, the findings suggest that brief holidays from methotrexate could be feasible in a variety of situations, such as after vaccinations and prior to surgery, said Jin Kyun Park, MD, of Seoul (South Korea) National University Hospital, lead author of the study presented at the annual meeting of the American College of Rheumatology.

copyright DesignPics/Thinkstock
For now, Dr. Park said that he has advice for well-controlled RA patients who seek a flu vaccine: “I tell them to skip the next two doses of methotrexate, giving them a total of 2 weeks off. It doesn’t increase the risk of a flare, so you don’t risk anything by doing that.”

The study notes that RA patients are especially prone to infections for two reasons: dysfunctional immune systems and immunity-weakening treatments. According to Dr. Park, methotrexate reduces the effectiveness of flu vaccines by 15%-20%.

In a previous study, Dr. Park and his colleagues found no statistically significant sign of increased flares in patients who went without methotrexate for 2 weeks before and 2 weeks after vaccination, 4 weeks after vaccination, and 4 weeks before vaccination (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).

The earlier findings also suggested that flu vaccine uptake is highest in those who stop methotrexate after vaccination.

For the new study, a randomized controlled trial, researchers recruited patients with well-controlled RA. They assigned 159 to continue weekly doses of methotrexate after flu vaccination and 161 to stop it for 2 weeks.

The groups in the final analysis (156 and 160 subjects, respectively) were similar – about 85% women, average age of 52-53 years, and about half took glucocorticoids. Their methotrexate dose per week was about 13 mg.

At 4 weeks, just over three-quarters of the patients who had briefly stopped methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains. Of those who continued the medication, just 54.5% showed this level of response, which the researchers considered to be satisfactory.

The researchers reported that there was no appreciable increase in RA disease activity.

Dr. Park cautioned that vaccine titers don’t directly reflect immunoprotection levels. Patients who took a break from methotrexate were less likely to develop a flulike illness, but the difference wasn’t statistically significant.

The research raises questions about whether methotrexate could be stopped a week or two before surgery to lower the risk of infections, Dr. Park said.

Dr. Park said that future research should focus on whether stopping methotrexate briefly affects whether patients go on to develop the flu. He would also like to look at whether a break from the medication will boost the immune response in RA patients who get herpes zoster (shingles) vaccines.

Paul Sufka, MD, of HealthPartners and Regions Hospital in St. Paul, Minn., praised the research. The 2-week break from methotrexate is “a fairly pragmatic approach,” said Dr. Sufka, who moderated a press conference where Dr. Park presented his research.

“You can actually pull this off,” he said, versus telling patients to stop the medication for the 2 weeks before they get vaccinated. He cautioned, however, that “these people have a fairly low disease activity. You may not be able to pull this off with those who have high disease activity.”

Dr. Park and Dr. Sufka reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross Corp. and Hanmi Pharmaceutical. The study was funded by Green Cross.

 

– Patients with well-controlled rheumatoid arthritis (RA) fared well during a 2-week holiday from methotrexate after flu vaccination and later showed signs of boosted immunity against the flu in comparison with patients who had not stopped the drug, according to results from a randomized controlled trial.

The research doesn’t confirm that vaccinated patients who take a break from methotrexate actually have lower rates of flu. Still, the findings suggest that brief holidays from methotrexate could be feasible in a variety of situations, such as after vaccinations and prior to surgery, said Jin Kyun Park, MD, of Seoul (South Korea) National University Hospital, lead author of the study presented at the annual meeting of the American College of Rheumatology.

copyright DesignPics/Thinkstock
For now, Dr. Park said that he has advice for well-controlled RA patients who seek a flu vaccine: “I tell them to skip the next two doses of methotrexate, giving them a total of 2 weeks off. It doesn’t increase the risk of a flare, so you don’t risk anything by doing that.”

The study notes that RA patients are especially prone to infections for two reasons: dysfunctional immune systems and immunity-weakening treatments. According to Dr. Park, methotrexate reduces the effectiveness of flu vaccines by 15%-20%.

In a previous study, Dr. Park and his colleagues found no statistically significant sign of increased flares in patients who went without methotrexate for 2 weeks before and 2 weeks after vaccination, 4 weeks after vaccination, and 4 weeks before vaccination (Ann Rheum Dis. 2017 Sep;76[9]:1559-65).

The earlier findings also suggested that flu vaccine uptake is highest in those who stop methotrexate after vaccination.

For the new study, a randomized controlled trial, researchers recruited patients with well-controlled RA. They assigned 159 to continue weekly doses of methotrexate after flu vaccination and 161 to stop it for 2 weeks.

The groups in the final analysis (156 and 160 subjects, respectively) were similar – about 85% women, average age of 52-53 years, and about half took glucocorticoids. Their methotrexate dose per week was about 13 mg.

At 4 weeks, just over three-quarters of the patients who had briefly stopped methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains. Of those who continued the medication, just 54.5% showed this level of response, which the researchers considered to be satisfactory.

The researchers reported that there was no appreciable increase in RA disease activity.

Dr. Park cautioned that vaccine titers don’t directly reflect immunoprotection levels. Patients who took a break from methotrexate were less likely to develop a flulike illness, but the difference wasn’t statistically significant.

The research raises questions about whether methotrexate could be stopped a week or two before surgery to lower the risk of infections, Dr. Park said.

Dr. Park said that future research should focus on whether stopping methotrexate briefly affects whether patients go on to develop the flu. He would also like to look at whether a break from the medication will boost the immune response in RA patients who get herpes zoster (shingles) vaccines.

Paul Sufka, MD, of HealthPartners and Regions Hospital in St. Paul, Minn., praised the research. The 2-week break from methotrexate is “a fairly pragmatic approach,” said Dr. Sufka, who moderated a press conference where Dr. Park presented his research.

“You can actually pull this off,” he said, versus telling patients to stop the medication for the 2 weeks before they get vaccinated. He cautioned, however, that “these people have a fairly low disease activity. You may not be able to pull this off with those who have high disease activity.”

Dr. Park and Dr. Sufka reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross Corp. and Hanmi Pharmaceutical. The study was funded by Green Cross.

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Key clinical point: Stopping methotrexate for 2 weeks after getting a flu vaccination might improve flu vaccine immunogenicity.

Major finding: More than three-quarters of patients who had briefly stopped methotrexate and 54.5% of patients who kept using methotrexate showed at least a fourfold increase in hemagglutination inhibition antibody titer against two or more vaccine strains at 4 weeks.

Data source: A randomized controlled trial of 320 patients with RA who were taking methotrexate.

Disclosures: The study was funded by Green Cross Corp. The presenter reported no relevant disclosures. A study author reported consulting for Pfizer and receiving research grants from Green Cross and Hanmi Pharmaceutical.

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VIDEO: New herpes zoster vaccine may boost vaccination rate

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Thu, 06/13/2019 - 13:56

LAS VEGAS– One of the benefits of the recently approved inactivated herpes zoster is its efficacy in older adults, Kenneth J. Tomecki, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

In addition, the vaccine will be recommended not only for healthy adults, but for ill adults aged 50 years and older, said Dr. Tomecki of the department of dermatology at the Cleveland Clinic. “Efficacy is greater than 90% for zoster and postherpetic neuralgia” with the new vaccine, he added.

Vaccination rates among eligible adults with the current vaccine, which is highly effective, are low, but ideally, the advent of the new vaccine will boost vaccination rates, especially in older adults, he noted.

The new vaccine, which will be marketed as Shingrix, was approved in October by the Food and Drug Administration for preventing herpes zoster in adults aged 50 years and older. The currently available herpes zoster vaccine, Zostavax, a live attenuated virus vaccine, was approved by the FDA in 2006.

Dr. Tomecki had no financial conflicts to disclose.

SDEF and this news organization are owned by the same parent company.
 

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LAS VEGAS– One of the benefits of the recently approved inactivated herpes zoster is its efficacy in older adults, Kenneth J. Tomecki, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

In addition, the vaccine will be recommended not only for healthy adults, but for ill adults aged 50 years and older, said Dr. Tomecki of the department of dermatology at the Cleveland Clinic. “Efficacy is greater than 90% for zoster and postherpetic neuralgia” with the new vaccine, he added.

Vaccination rates among eligible adults with the current vaccine, which is highly effective, are low, but ideally, the advent of the new vaccine will boost vaccination rates, especially in older adults, he noted.

The new vaccine, which will be marketed as Shingrix, was approved in October by the Food and Drug Administration for preventing herpes zoster in adults aged 50 years and older. The currently available herpes zoster vaccine, Zostavax, a live attenuated virus vaccine, was approved by the FDA in 2006.

Dr. Tomecki had no financial conflicts to disclose.

SDEF and this news organization are owned by the same parent company.
 

LAS VEGAS– One of the benefits of the recently approved inactivated herpes zoster is its efficacy in older adults, Kenneth J. Tomecki, MD, said in a video interview at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

In addition, the vaccine will be recommended not only for healthy adults, but for ill adults aged 50 years and older, said Dr. Tomecki of the department of dermatology at the Cleveland Clinic. “Efficacy is greater than 90% for zoster and postherpetic neuralgia” with the new vaccine, he added.

Vaccination rates among eligible adults with the current vaccine, which is highly effective, are low, but ideally, the advent of the new vaccine will boost vaccination rates, especially in older adults, he noted.

The new vaccine, which will be marketed as Shingrix, was approved in October by the Food and Drug Administration for preventing herpes zoster in adults aged 50 years and older. The currently available herpes zoster vaccine, Zostavax, a live attenuated virus vaccine, was approved by the FDA in 2006.

Dr. Tomecki had no financial conflicts to disclose.

SDEF and this news organization are owned by the same parent company.
 

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Use of MenACWY-CRM vaccine in 2- to 10-year-olds raised no safety concerns

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Use of the MenACWY-CRM vaccine as part of routine clinical care of children aged 2-10 years does not appear to raise any safety concerns, reported Sara Yee Tartof, PhD, of Kaiser Permanente Southern California, Pasadena, and her associates.

CDC/Amanda Mills
Quadrivalent meningococcal conjugate vaccines prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135, and the U.S. Advisory Committee on Immunization Practices recommends vaccination for children aged 2-10 years of age who are at increased risk of meningococcal disease. MenACWY-CRM (Menveo) was approved by the U.S. Food and Drug Administration in January 2011 for use in that age group.

The study was undertaken to evaluate the safety of the MenACWY-CRM vaccine in the care of children aged 2-10 years in the real world. The other quadrivalent meningococcal conjugate vaccine, MenACWY-D (Menactra), was not used in this study.

In a retrospective, observational study of 327 children aged 2-10 years when they received the MenACWY-CRM vaccine as part of routine clinical care, there was only one event of interest, which was a child who developed asthma during the 1-year observation period, and that occurred 237 days after vaccination with both the MenACWY-CRM and a typhoid vaccine. “A causal link between the two events is unlikely,” Dr. Tartof and her associates wrote.

Most of the serious medically attended events were considered to be unrelated to MenACWY-CRM vaccination, or symptom onset occurred a long time after vaccination. “The remaining events were pneumonia, bronchitis, cough, febrile convulsion, and vomiting identified within 30 days of vaccination among four children,” the investigators reported. “Pneumonia, bronchitis, and cough were diagnosed in the same child; cough, febrile convulsion, and vomiting were diagnosed separately in the other 3 children.

“It appears that many MenACWY-CRM recipients in our study population received the vaccine because of travel to high-risk areas, possible exposure to meningitis, or as routine vaccinations received early as part of the ACIP-recommended routine vaccination for those 11-12 years old,” Dr. Tartof and her associates wrote.

Read more in the Pediatric Infectious Diseases Journal (2017 Nov 1. doi: 10.1097/INF.0000000000001696).

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Use of the MenACWY-CRM vaccine as part of routine clinical care of children aged 2-10 years does not appear to raise any safety concerns, reported Sara Yee Tartof, PhD, of Kaiser Permanente Southern California, Pasadena, and her associates.

CDC/Amanda Mills
Quadrivalent meningococcal conjugate vaccines prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135, and the U.S. Advisory Committee on Immunization Practices recommends vaccination for children aged 2-10 years of age who are at increased risk of meningococcal disease. MenACWY-CRM (Menveo) was approved by the U.S. Food and Drug Administration in January 2011 for use in that age group.

The study was undertaken to evaluate the safety of the MenACWY-CRM vaccine in the care of children aged 2-10 years in the real world. The other quadrivalent meningococcal conjugate vaccine, MenACWY-D (Menactra), was not used in this study.

In a retrospective, observational study of 327 children aged 2-10 years when they received the MenACWY-CRM vaccine as part of routine clinical care, there was only one event of interest, which was a child who developed asthma during the 1-year observation period, and that occurred 237 days after vaccination with both the MenACWY-CRM and a typhoid vaccine. “A causal link between the two events is unlikely,” Dr. Tartof and her associates wrote.

Most of the serious medically attended events were considered to be unrelated to MenACWY-CRM vaccination, or symptom onset occurred a long time after vaccination. “The remaining events were pneumonia, bronchitis, cough, febrile convulsion, and vomiting identified within 30 days of vaccination among four children,” the investigators reported. “Pneumonia, bronchitis, and cough were diagnosed in the same child; cough, febrile convulsion, and vomiting were diagnosed separately in the other 3 children.

“It appears that many MenACWY-CRM recipients in our study population received the vaccine because of travel to high-risk areas, possible exposure to meningitis, or as routine vaccinations received early as part of the ACIP-recommended routine vaccination for those 11-12 years old,” Dr. Tartof and her associates wrote.

Read more in the Pediatric Infectious Diseases Journal (2017 Nov 1. doi: 10.1097/INF.0000000000001696).

 

Use of the MenACWY-CRM vaccine as part of routine clinical care of children aged 2-10 years does not appear to raise any safety concerns, reported Sara Yee Tartof, PhD, of Kaiser Permanente Southern California, Pasadena, and her associates.

CDC/Amanda Mills
Quadrivalent meningococcal conjugate vaccines prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135, and the U.S. Advisory Committee on Immunization Practices recommends vaccination for children aged 2-10 years of age who are at increased risk of meningococcal disease. MenACWY-CRM (Menveo) was approved by the U.S. Food and Drug Administration in January 2011 for use in that age group.

The study was undertaken to evaluate the safety of the MenACWY-CRM vaccine in the care of children aged 2-10 years in the real world. The other quadrivalent meningococcal conjugate vaccine, MenACWY-D (Menactra), was not used in this study.

In a retrospective, observational study of 327 children aged 2-10 years when they received the MenACWY-CRM vaccine as part of routine clinical care, there was only one event of interest, which was a child who developed asthma during the 1-year observation period, and that occurred 237 days after vaccination with both the MenACWY-CRM and a typhoid vaccine. “A causal link between the two events is unlikely,” Dr. Tartof and her associates wrote.

Most of the serious medically attended events were considered to be unrelated to MenACWY-CRM vaccination, or symptom onset occurred a long time after vaccination. “The remaining events were pneumonia, bronchitis, cough, febrile convulsion, and vomiting identified within 30 days of vaccination among four children,” the investigators reported. “Pneumonia, bronchitis, and cough were diagnosed in the same child; cough, febrile convulsion, and vomiting were diagnosed separately in the other 3 children.

“It appears that many MenACWY-CRM recipients in our study population received the vaccine because of travel to high-risk areas, possible exposure to meningitis, or as routine vaccinations received early as part of the ACIP-recommended routine vaccination for those 11-12 years old,” Dr. Tartof and her associates wrote.

Read more in the Pediatric Infectious Diseases Journal (2017 Nov 1. doi: 10.1097/INF.0000000000001696).

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PCV13 vaccination safe, effective in 6- to 17-year-olds

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Positive immunogenicity results and lack of adverse events with receipt of the 13-valent pneumococcal conjugate vaccine by 200 children and adolescents in India supports extension of the indication to that population, reported Sharad Agarkhedkar, MD, of the Padmashree Dr. D. Y. Patil Medical College in Pune, India, and associates.

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In an open-label study of 200 children and adolescents who received PCV13, 113 were 6 years to less than 10 years of age and 87 were aged 10-17 years; 54% were female. Antibody-mediated opsonophagocytic activity geometric mean titers were significantly higher for all vaccine serotypes 1 month after vaccination with PCV13, and there was no significant difference in psonophagocytic activity geometric mean titers between the two age groups. Immune responses after PCV13 vaccination were similar for the majority of serotypes in the study and in a U.S. study, the investigators said.

There were no acute reactions within 20 minutes of immunization. No adverse effects or severe adverse effects were recalled by caregivers who were questioned by the investigators 28-42 days following vaccination.

Read more in the Pediatric Infectious Diseases Journal (2017 Nov 1;36[11]:e282-5. doi: 10.1097/INF.0000000000001695).
 

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Positive immunogenicity results and lack of adverse events with receipt of the 13-valent pneumococcal conjugate vaccine by 200 children and adolescents in India supports extension of the indication to that population, reported Sharad Agarkhedkar, MD, of the Padmashree Dr. D. Y. Patil Medical College in Pune, India, and associates.

DesignPics/Thinkstock


In an open-label study of 200 children and adolescents who received PCV13, 113 were 6 years to less than 10 years of age and 87 were aged 10-17 years; 54% were female. Antibody-mediated opsonophagocytic activity geometric mean titers were significantly higher for all vaccine serotypes 1 month after vaccination with PCV13, and there was no significant difference in psonophagocytic activity geometric mean titers between the two age groups. Immune responses after PCV13 vaccination were similar for the majority of serotypes in the study and in a U.S. study, the investigators said.

There were no acute reactions within 20 minutes of immunization. No adverse effects or severe adverse effects were recalled by caregivers who were questioned by the investigators 28-42 days following vaccination.

Read more in the Pediatric Infectious Diseases Journal (2017 Nov 1;36[11]:e282-5. doi: 10.1097/INF.0000000000001695).
 

 

Positive immunogenicity results and lack of adverse events with receipt of the 13-valent pneumococcal conjugate vaccine by 200 children and adolescents in India supports extension of the indication to that population, reported Sharad Agarkhedkar, MD, of the Padmashree Dr. D. Y. Patil Medical College in Pune, India, and associates.

DesignPics/Thinkstock


In an open-label study of 200 children and adolescents who received PCV13, 113 were 6 years to less than 10 years of age and 87 were aged 10-17 years; 54% were female. Antibody-mediated opsonophagocytic activity geometric mean titers were significantly higher for all vaccine serotypes 1 month after vaccination with PCV13, and there was no significant difference in psonophagocytic activity geometric mean titers between the two age groups. Immune responses after PCV13 vaccination were similar for the majority of serotypes in the study and in a U.S. study, the investigators said.

There were no acute reactions within 20 minutes of immunization. No adverse effects or severe adverse effects were recalled by caregivers who were questioned by the investigators 28-42 days following vaccination.

Read more in the Pediatric Infectious Diseases Journal (2017 Nov 1;36[11]:e282-5. doi: 10.1097/INF.0000000000001695).
 

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Up-to-date vaccination status varies by mother’s country of origin

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Fri, 01/18/2019 - 17:08

 

Whether children in Minnesota were up to date on vaccinations from 2 months of age to 36 months depended on if their parents were born in the United States or outside the United States, and, more particularly, on the country of origin of their mother, reported Maureen Leeds and Miriam Halstead Muscoplat of the Minnesota Department of Health, St. Paul.

In a study of 97,885 Minnesota children born during 2011-2012, fewer than half were up to date with their vaccinations by age 18 months and only 70% were up to date by age 36 months.

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If children had at least one parent born outside the United States, they were 25% less likely to be up to date with their vaccinations by age 36 months than if both their parents were born in the United States. However, children whose mothers were from Africa (excluding Somalia), the Caribbean, Central and South America, or Mexico were significantly more likely to be up to date at all ages, compared with children whose mothers were born in the United States.

Children whose mothers were born in Asia, Canada, Eastern Europe, Somalia, or Western Europe were significantly less likely to be up to date at all ages than were children whose mothers were born in the United States. At 18 months, fewer than 10% of children whose mothers were born in Somalia were up to date; by 36 months, 44% were.

“Inadequate parental understanding of vaccination and weaker public health education programs in some regions might account for some of these findings, as well as economic and social factors influencing emigration, including fleeing war, religious persecution, or poverty,” Ms. Leeds and Ms. Muscoplat said. “Somali parents in Minnesota have been reported to be more likely than non-Somali parents to have concerns about the safety of measles-mumps-rubella (MMR) vaccine, which has led to a decline in coverage with MMR and possibly other childhood vaccines. From April to August 2017, Minnesota experienced a measles outbreak, ending with 79 confirmed cases, including 65 in children of Somali descent,” they wrote.

“Encouraging medical providers to use interpreters, take time to build trust, and assess vaccination status at every visit might improve vaccination coverage” in immigrant, migrant, and refugee populations, they said.

Read more in Morbidity and Mortality Weekly Report (2017 Oct 27;66[42]:1125-9).

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Whether children in Minnesota were up to date on vaccinations from 2 months of age to 36 months depended on if their parents were born in the United States or outside the United States, and, more particularly, on the country of origin of their mother, reported Maureen Leeds and Miriam Halstead Muscoplat of the Minnesota Department of Health, St. Paul.

In a study of 97,885 Minnesota children born during 2011-2012, fewer than half were up to date with their vaccinations by age 18 months and only 70% were up to date by age 36 months.

luiscar/Thinkstock


If children had at least one parent born outside the United States, they were 25% less likely to be up to date with their vaccinations by age 36 months than if both their parents were born in the United States. However, children whose mothers were from Africa (excluding Somalia), the Caribbean, Central and South America, or Mexico were significantly more likely to be up to date at all ages, compared with children whose mothers were born in the United States.

Children whose mothers were born in Asia, Canada, Eastern Europe, Somalia, or Western Europe were significantly less likely to be up to date at all ages than were children whose mothers were born in the United States. At 18 months, fewer than 10% of children whose mothers were born in Somalia were up to date; by 36 months, 44% were.

“Inadequate parental understanding of vaccination and weaker public health education programs in some regions might account for some of these findings, as well as economic and social factors influencing emigration, including fleeing war, religious persecution, or poverty,” Ms. Leeds and Ms. Muscoplat said. “Somali parents in Minnesota have been reported to be more likely than non-Somali parents to have concerns about the safety of measles-mumps-rubella (MMR) vaccine, which has led to a decline in coverage with MMR and possibly other childhood vaccines. From April to August 2017, Minnesota experienced a measles outbreak, ending with 79 confirmed cases, including 65 in children of Somali descent,” they wrote.

“Encouraging medical providers to use interpreters, take time to build trust, and assess vaccination status at every visit might improve vaccination coverage” in immigrant, migrant, and refugee populations, they said.

Read more in Morbidity and Mortality Weekly Report (2017 Oct 27;66[42]:1125-9).

 

Whether children in Minnesota were up to date on vaccinations from 2 months of age to 36 months depended on if their parents were born in the United States or outside the United States, and, more particularly, on the country of origin of their mother, reported Maureen Leeds and Miriam Halstead Muscoplat of the Minnesota Department of Health, St. Paul.

In a study of 97,885 Minnesota children born during 2011-2012, fewer than half were up to date with their vaccinations by age 18 months and only 70% were up to date by age 36 months.

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If children had at least one parent born outside the United States, they were 25% less likely to be up to date with their vaccinations by age 36 months than if both their parents were born in the United States. However, children whose mothers were from Africa (excluding Somalia), the Caribbean, Central and South America, or Mexico were significantly more likely to be up to date at all ages, compared with children whose mothers were born in the United States.

Children whose mothers were born in Asia, Canada, Eastern Europe, Somalia, or Western Europe were significantly less likely to be up to date at all ages than were children whose mothers were born in the United States. At 18 months, fewer than 10% of children whose mothers were born in Somalia were up to date; by 36 months, 44% were.

“Inadequate parental understanding of vaccination and weaker public health education programs in some regions might account for some of these findings, as well as economic and social factors influencing emigration, including fleeing war, religious persecution, or poverty,” Ms. Leeds and Ms. Muscoplat said. “Somali parents in Minnesota have been reported to be more likely than non-Somali parents to have concerns about the safety of measles-mumps-rubella (MMR) vaccine, which has led to a decline in coverage with MMR and possibly other childhood vaccines. From April to August 2017, Minnesota experienced a measles outbreak, ending with 79 confirmed cases, including 65 in children of Somali descent,” they wrote.

“Encouraging medical providers to use interpreters, take time to build trust, and assess vaccination status at every visit might improve vaccination coverage” in immigrant, migrant, and refugee populations, they said.

Read more in Morbidity and Mortality Weekly Report (2017 Oct 27;66[42]:1125-9).

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The race is on for a Zika vaccine

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Fri, 01/18/2019 - 17:08

 

– A DNA vaccine developed at the National Institute of Allergy and Infectious Diseases Vaccine Research Center – one of five National Institutes of Health Zika vaccine candidates – has entered phase 2 testing in a trial underway in Brazil, Peru, Ecuador, Mexico, and Texas.

“The DNA vaccine is a simple 21st century way of developing vaccines that I think will become one of the major [methods of the future] for emerging infections, as opposed to growing a virus and inactivating or attenuating it,” Anthony S. Fauci, MD, said at the biennial meeting of the Diabetes in Pregnancy Study Group of North America. With Zika “this is the vaccine that is ahead of all the others.”

Dr. Anthony S. Fauci
The method involves the insertion into a plasmid of a gene that encodes the virus’s surface protein(s) against which an immune response is sought. When the DNA containing the virus’s gene is injected into an individual, the body’s cells produce viruslike particles and a subsequent immune response. Since the method was employed during the SARS epidemic of 2003, the time from sequence selection to a phase 1 trial has gone from 20 months to 3.25 months (for the Zika DNA vaccine).

Will it be possible to test efficacy, given the declining prevalence of Zika across the Americas, and will it be too late to prevent more disease? Dr. Fauci, director of NIAID, said that’s a concern, and that an accelerated approval based on a bridging of animal efficacy data with human safety and immunogenicity data might be possible.

The Southern hemisphere is “entering their summer, so it’s conceivable there will be an uptick in Zika. … We’ll just need to wait and see,” he said.
 

Sexual transmission

The Zika virus is part of a “long line of arboviruses that have threatened us in the Americas,” but infection with the organism is “the first – and may be the only – arthropod-borne or mosquito-borne infection that is also sexually transmitted,” Dr. Fauci said.

Sexual contact as an important mode of viral transmission “has been documented very clearly through a number of studies in which individuals clearly had no exposure to mosquitoes but were in fact a sexual partner of someone who got infected,” he said. And recent research suggests that the “female reproductive tract is a preferentially permissive site for Zika replication, which adds to the concern about sexual transmission.”

He cited a study published in July 2017 in PLOS Pathogens in which the Zika virus was found to preferentially replicate in the reproductive tract of female rhesus macaques who received vaginal inoculations of the virus.

Zika virus was “detected in the reproductive tract before it was detected in plasma, and replication levels in the reproductive tract did not reflect viral levels in other parts of the body,” according to the author summary. The kinetics of virus replication and dissemination after intravaginal inoculation were markedly different from what was previously seen in macaques infected with the Zika virus by subcutaneous infection, the report noted (PLOS Pathogens 13[7]:e1006537).

Dr. Fauci briefly described this and several other studies and findings that he said exemplify growing knowledge of the infection. He pointed to a prospective observational study that documents episodes of oligospermia in 15 men who presented with infection in 2016 in the French Caribbean (Lancet Infect Dis. 2017;17:1200-08).

Sperm counts fell in some of the study participants by about 50% between days 7 and 60 post infection, and the counts “recovered somewhat” by day 120. “We’re still following patients in prospective studies to determine if there’s a long-term effect in men,” he said.

In the meantime, he said, research in mice has shown that “without a doubt, Zika infection damages the testes,” Dr. Fauci said, noting that the mouse model is proving to be a good model for studying Zika’s effects. “They become oligospermic and have testicular atrophy.”
 

Maternal-fetal transmission

Regarding maternal-fetal transmission, there’s evidence that placental trophoblasts “are exquisitely permissive for Zika virus replication,” he said.

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– A DNA vaccine developed at the National Institute of Allergy and Infectious Diseases Vaccine Research Center – one of five National Institutes of Health Zika vaccine candidates – has entered phase 2 testing in a trial underway in Brazil, Peru, Ecuador, Mexico, and Texas.

“The DNA vaccine is a simple 21st century way of developing vaccines that I think will become one of the major [methods of the future] for emerging infections, as opposed to growing a virus and inactivating or attenuating it,” Anthony S. Fauci, MD, said at the biennial meeting of the Diabetes in Pregnancy Study Group of North America. With Zika “this is the vaccine that is ahead of all the others.”

Dr. Anthony S. Fauci
The method involves the insertion into a plasmid of a gene that encodes the virus’s surface protein(s) against which an immune response is sought. When the DNA containing the virus’s gene is injected into an individual, the body’s cells produce viruslike particles and a subsequent immune response. Since the method was employed during the SARS epidemic of 2003, the time from sequence selection to a phase 1 trial has gone from 20 months to 3.25 months (for the Zika DNA vaccine).

Will it be possible to test efficacy, given the declining prevalence of Zika across the Americas, and will it be too late to prevent more disease? Dr. Fauci, director of NIAID, said that’s a concern, and that an accelerated approval based on a bridging of animal efficacy data with human safety and immunogenicity data might be possible.

The Southern hemisphere is “entering their summer, so it’s conceivable there will be an uptick in Zika. … We’ll just need to wait and see,” he said.
 

Sexual transmission

The Zika virus is part of a “long line of arboviruses that have threatened us in the Americas,” but infection with the organism is “the first – and may be the only – arthropod-borne or mosquito-borne infection that is also sexually transmitted,” Dr. Fauci said.

Sexual contact as an important mode of viral transmission “has been documented very clearly through a number of studies in which individuals clearly had no exposure to mosquitoes but were in fact a sexual partner of someone who got infected,” he said. And recent research suggests that the “female reproductive tract is a preferentially permissive site for Zika replication, which adds to the concern about sexual transmission.”

He cited a study published in July 2017 in PLOS Pathogens in which the Zika virus was found to preferentially replicate in the reproductive tract of female rhesus macaques who received vaginal inoculations of the virus.

Zika virus was “detected in the reproductive tract before it was detected in plasma, and replication levels in the reproductive tract did not reflect viral levels in other parts of the body,” according to the author summary. The kinetics of virus replication and dissemination after intravaginal inoculation were markedly different from what was previously seen in macaques infected with the Zika virus by subcutaneous infection, the report noted (PLOS Pathogens 13[7]:e1006537).

Dr. Fauci briefly described this and several other studies and findings that he said exemplify growing knowledge of the infection. He pointed to a prospective observational study that documents episodes of oligospermia in 15 men who presented with infection in 2016 in the French Caribbean (Lancet Infect Dis. 2017;17:1200-08).

Sperm counts fell in some of the study participants by about 50% between days 7 and 60 post infection, and the counts “recovered somewhat” by day 120. “We’re still following patients in prospective studies to determine if there’s a long-term effect in men,” he said.

In the meantime, he said, research in mice has shown that “without a doubt, Zika infection damages the testes,” Dr. Fauci said, noting that the mouse model is proving to be a good model for studying Zika’s effects. “They become oligospermic and have testicular atrophy.”
 

Maternal-fetal transmission

Regarding maternal-fetal transmission, there’s evidence that placental trophoblasts “are exquisitely permissive for Zika virus replication,” he said.

 

– A DNA vaccine developed at the National Institute of Allergy and Infectious Diseases Vaccine Research Center – one of five National Institutes of Health Zika vaccine candidates – has entered phase 2 testing in a trial underway in Brazil, Peru, Ecuador, Mexico, and Texas.

“The DNA vaccine is a simple 21st century way of developing vaccines that I think will become one of the major [methods of the future] for emerging infections, as opposed to growing a virus and inactivating or attenuating it,” Anthony S. Fauci, MD, said at the biennial meeting of the Diabetes in Pregnancy Study Group of North America. With Zika “this is the vaccine that is ahead of all the others.”

Dr. Anthony S. Fauci
The method involves the insertion into a plasmid of a gene that encodes the virus’s surface protein(s) against which an immune response is sought. When the DNA containing the virus’s gene is injected into an individual, the body’s cells produce viruslike particles and a subsequent immune response. Since the method was employed during the SARS epidemic of 2003, the time from sequence selection to a phase 1 trial has gone from 20 months to 3.25 months (for the Zika DNA vaccine).

Will it be possible to test efficacy, given the declining prevalence of Zika across the Americas, and will it be too late to prevent more disease? Dr. Fauci, director of NIAID, said that’s a concern, and that an accelerated approval based on a bridging of animal efficacy data with human safety and immunogenicity data might be possible.

The Southern hemisphere is “entering their summer, so it’s conceivable there will be an uptick in Zika. … We’ll just need to wait and see,” he said.
 

Sexual transmission

The Zika virus is part of a “long line of arboviruses that have threatened us in the Americas,” but infection with the organism is “the first – and may be the only – arthropod-borne or mosquito-borne infection that is also sexually transmitted,” Dr. Fauci said.

Sexual contact as an important mode of viral transmission “has been documented very clearly through a number of studies in which individuals clearly had no exposure to mosquitoes but were in fact a sexual partner of someone who got infected,” he said. And recent research suggests that the “female reproductive tract is a preferentially permissive site for Zika replication, which adds to the concern about sexual transmission.”

He cited a study published in July 2017 in PLOS Pathogens in which the Zika virus was found to preferentially replicate in the reproductive tract of female rhesus macaques who received vaginal inoculations of the virus.

Zika virus was “detected in the reproductive tract before it was detected in plasma, and replication levels in the reproductive tract did not reflect viral levels in other parts of the body,” according to the author summary. The kinetics of virus replication and dissemination after intravaginal inoculation were markedly different from what was previously seen in macaques infected with the Zika virus by subcutaneous infection, the report noted (PLOS Pathogens 13[7]:e1006537).

Dr. Fauci briefly described this and several other studies and findings that he said exemplify growing knowledge of the infection. He pointed to a prospective observational study that documents episodes of oligospermia in 15 men who presented with infection in 2016 in the French Caribbean (Lancet Infect Dis. 2017;17:1200-08).

Sperm counts fell in some of the study participants by about 50% between days 7 and 60 post infection, and the counts “recovered somewhat” by day 120. “We’re still following patients in prospective studies to determine if there’s a long-term effect in men,” he said.

In the meantime, he said, research in mice has shown that “without a doubt, Zika infection damages the testes,” Dr. Fauci said, noting that the mouse model is proving to be a good model for studying Zika’s effects. “They become oligospermic and have testicular atrophy.”
 

Maternal-fetal transmission

Regarding maternal-fetal transmission, there’s evidence that placental trophoblasts “are exquisitely permissive for Zika virus replication,” he said.

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