CDC Committee Recommends Pfizer-BioNTech COVID-19 Vaccine for Children 5-11 Years Old

5 PM EST Update: The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has voted 14-0 to recommend the use of Pfizer-BioNTech COVID-19 vaccine BNT162b2 for children aged 5-11 years old, under the US Food and Drug Administration's (FDA) emergency use authorization.

The vote of support, punctuating a days' worth of deliberation and review of clinical research and pediatric vaccination strategy, sets into motion the anticipated rollout of the first COVID-19 vaccine doses available to children younger than 12 years old.

As discussed by the CDC during the ACIP meeting, enough BNT162b2 10mcg doses are available to vaccinate the entire US population aged 5-11 years old. Last week, the FDA granted EUA to Pfizer-BioNTech for the vaccine in the specified pediatric age group.

At the conclusion of the expert committee vote, CDC advisors stressed the proven benefit and safety of the 2-dose mRNA vaccine relative to the risk of pediatric COVID-19—some noting that they themselves are parents who will be making the choice to vaccinate their children against the pandemic virus. Analyses shared during the ACIP meeting noted that approximately half of all American parents are interested in having their child vaccinated for COVID-19.

3:30 Update: After a lengthy discussion on vaccine-associated myocarditis risk which concluded with an expert confirming that the benefits of pediatric COVID-19 vaccination with Pfizer-BioNTech’s BNT162b2 outweighs any risk of the thrombotic event, the ACIP committee reviewed a pair of presentations on strategies set to rollout, administer, and monitor the first COVID-19 vaccine made available for children aged 5-11 years old.

Rollout

As stressed in the presentation on vaccine implementation, the CDC has 4 emphasized goals:

• Reach the most eligible children possible
• Address hard-to-reach and high-risk populations
• Minimize delays of distribution and administration
• Disseminate timely clinical guidance

Targeted facilities for pediatric COVID-19 vaccine doses include primary care offices, pharmacies, and school-located vaccination clinics. The CDC is currently working to provide guidance and support to school districts that are partnering with local/regional pharmacies to create such vaccination clinics.

The federal authority anticipates more than 100 US children’s hospitals will establish their own vaccination sites, while temporary pediatric vaccination community clinics may be simplistically established on the basis of previously-set adolescent and adult clinics.

What’s more, the CDC has made available on their website a pair of planning resources informed by jurisdictional readiness surveys: an operational planning guide and preliminary information on the Pfizer-BioNTech COVID-19 vaccine dose granted emergency use authorization (EUA) by the US Food and Drug Administration (FDA).

From such readiness surveys, the CDC interpreted that most jurisdictions in the US believe children’s doctor’s offices and clinics will be their primary site for pediatric COVID-19 vaccination, followed by federal-qualified health centers (FQHCs) and health care centers.

Monitoring

In what he called the “most intensive vaccine safety monitoring effort in US history,” Tom Shimabukuro, MD, MPH, MBA, of the CDC COVID-19 Vaccine Task Force, detailed the multitude of COVID-19 vaccine monitoring systems adapting to include children aged 5-11 years old.

Among those systems include:

• V-safe
• Vaccine Adverse Events Reporting System (VAERS)
• Vaccine Safety Datalink (VSD)
• Clinical Immunization Safety Assessment (CISA) Project

First, the mobile app v-safe program will begin to aggregate data from health surveys conducted in the first 7 days after vaccination in children, comparing the reactogenicity profile of younger children to that observed in children aged 12-17 years old. Outcomes initially reported in v-safe will be verified by a telephone follow-up before being included in VAERS analysis.

Adult parents and guardians may add a dependent to the v-safe program on their mobile devices without creating an account. Program check-ins will broaden to once-weekly in weeks 2-6 post-pediatric vaccination, then once at months 3, 6, and 9.

Next, the joint CDC-FDA VAERS database will provide a particular focus on the aforementioned rare adverse event myocarditis. Potential reports identified by the Medical Dictionary for Regulator Activities (MedDRA) standardized codes will seek out potential myocarditis or pericarditis cases. The CDC intends to conduct periodic analyses of case counts and reporting rates of such cases.

The VSD will include an age-stratified statistical analysis of outcomes observed in children aged 5-11 years old—seeking a primary analysis of risk interval for myocarditis/pericarditis and seizures at 0-7 days post-vaccination, then other outcomes up to 21 days after vaccination, to compare to expected rates set by a populated adjusted for age, sex, race/ethnicity, VSD site, and calendar date of vaccination.

Lastly, CISA includes 7 participating medical research centers across the US, and will provide clinical case reviews, as well as consultation on complex vaccine adverse events and technical consultation on clinical guidance informed by vaccine outcomes.

2:00 PM Update: A CDC review of SARS-CoV-2 infection and COVID-19 disease severity risk in children showed those aged 5 to 11 years old are as likely as adults to test positive for the pandemic virus, and face their own risk of severe illness.

The presentation of data from cohorts including the CDC’s COVID-NET showed that weekly COVID-19 associated hospitalizations per 100,000 children aged 5 to 11 years old has generally been lower than that observed in younger (0-4 years old) and older children (12-17 years old). However, like these age groups, it has been on the rise; weekly hospitalizations per 100,000 in this age group reached its highest mark since March 2020 in the week ending October 2 of this year.

Like adults, severe COVID-19 risk has been discriminate among children’s race; Black/Non-Hispanic, Hispanic, and American Indian/Alaska native children have had significantly greater rates of hospitalization than Non-Hispanic White children in the US, per the CDC.

A comparison of cumulative influenza and COVID-19 associated hospitalizations among children ages 5-11 years showed with COVID-19 generally stay in the hospital longer, and are more likely to be admitted to the ICU and receive invasive mechanical ventilation. The mortality rate among hospitalized COVID and flu children was consistent at about 0.6%.

The CDC’s analysis of FluSurv-NET data considered the 2017-18, 2018-19, and 2019-20 flu seasons—given that last year’s flu season was significantly mitigated among children due to masking and social distancing measures in place due to COVID-19.

An additional assessment of COVID-NET data from March 2020 to August 2021 show two-thirds (68%) of all children aged 5-11 years old to have been hospitalized with COVID-19 were either Black/Non-Hispanic or Hispanic. Another one-third (32%) had no underlying condition prior to their hospitalization, and median age was 8 years old.

As of October 16, children aged 5-11 years old have only constituted at least 94 of the US population’s cumulative COVID-19 deaths. However, this equates to approximately 1.7% of all deaths in this age group during the pandemic.

This pediatric age group is also at specific risk of multi-inflammatory syndrome in children (MIS-C), a hyperinflammatory condition occurring 2-6 weeks following acute SARS-CoV-2 infection. Through September 23, more than 5200 MIS-C cases have been observed in the US; the median patient age is 9 years old, and 44% of all patients range from 5-11 years old.

Though post-infection symptoms have been observed less frequently in children than adults with COVID-19, younger patients are nonetheless at risk of experiencing symptoms including fatigue, headache, insomnia, trouble concentrating, muscle and joint pain, and cough.

What’s more, infected children are frequently flying under the radar: despite there being approximately 2 million reported cases in children aged 5-11 years old, seroprevalence data has suggested that children with COVID-19 are less likely to be reported than adults with infection.

1:00 PM Update: In today’s ACIP deliberation on the potentially recommended use of Pfizer-BioNTech’s COVID-19 vaccine BNT162b2 in children aged 5 to 11 years old, Pfizer representatives presented “clear and compelling data” supporting the CDC panel’s would-be recommendation.

Chief among the data presented at the beginning of the daylong ACIP meeting was supporting clinical trial data showing the 2-dose, 10 mcg mRNA vaccine was associated with a 90.7% efficacy in preventing symptomatic COVID-19 in vaccinated children. Additionally, Pfizer representatives shared data showing the vaccine met immunobridging criteria in a comparative analysis of vaccinated 5 to 11-year-olds to 12 to 16-year-olds and 25-year-olds.

What’s more, phase 2/3 clinical trial data including children aged 5 to 11 years old showed that no fully vaccinated pediatric participants experienced a vaccine-related serious adverse event. Investigators reported no significant differences in mild-to-moderate adverse events and local site reactions among children naïve to and previously infected with SARS-CoV-2.

Prior to the data presentation, CDC Director Rochelle Wallensky, MD, MPH, spoke on the benefit of pediatric vaccination contrasted to the risk of SARS-CoV-2 infection in children—an effect that could impact their overall health, mortality, and as observed during pre-vaccination COVID-19 outbreaks, their ability to attend school and gatherings.

11:00 AM Update: The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is meeting today, November 2, to discuss the regulated use of Pfizer-BioNTech COVID-19 vaccine BNT162b2 in children aged 5-11 years old.

The expert committee will be holding a daylong public meeting to review relevant data for the emergency-authorized dosage of BNT162b2 in this pediatric population, as well as the impact of SARS-CoV-2 and COVID-19 on children. They will vote on the recommended use of the vaccine in the age group prior to adjourning this late afternoon.

Follow along here, and follow Contagion on Twitter, for live updates and expert perspective on the ACIP meeting.