FDA VRBPAC Votes to Recommend Pfizer-BioNTech COVID-19 Vaccine in 5 to 11 Year Olds

The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel voted to recommend the Pfizer-BioNTech vaccine in the 5 to 11 year old pediatric population.

The panel voted on the following question:

Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine when administered as a 2-dose series (10 µg each dose, three weeks apart) outweigh its risk for use in children 5-11 years of age.

Seventeen members voted yes and 1 member voted to abstain.

The VRBPAC recommendation today was the first step in paving the way for younger children to get the first series of COVID-19 vaccines as this population has not been eligible for any vaccines yet.

Although no timetable has been set for the FDA to decide on an official EUA, recent history demonstrates a decision will happen soon.

The Data

Data presented to the FDA prior to today’s meeting showed that 2 10 µg doses of the Pfizer-BioNTech vaccine to be 90.7% effective in children older than 5 and younger than 12.

There were no cases of severe COVID-19 and no cases of MIS-C reported as of the 3-month follow-up period after the second vaccine.

The reactogenicity profile of this age group was mild to moderate; most events arose 1-2 days after vaccination and dissipated soon after. The most common side effects were injection site pain, fatigue, headache, muscle pain, and chills. The adverse event (AE) profile post-vaccination mostly reflected reactogenicity. No serious AEs related to the vaccine were reported.

Today’s VRBPAC Proceedings

The meeting today highlighted the data and safety concerns associated with myocarditis risks.

In the morning, the Centers for Disease Control and Prevention (CDC) presented on the epidemiology of COVID-19 in children, followed by the known safety signals of vaccines in adolescents and young adults.

Mathew Oster, MD, MPH, CDC COVID-19 Response CDC Center on Birth Defects and Developmental Disabilities Pediatric Cardiologist, Sibley Heart Center, Children’s Healthcare of Atlanta Emory University School of Medicine and Rollins School of Public Health, presented on the known safety signals (Myocarditis in adolescents and young adults). During his presentation, Oster said most myocarditis was seen in MIC-S cases due to COVID-19. He also pointed out that not all myocarditis cases are the same when looking at patients who presented with myocarditis during the pre-COVID-19 era, patients with MIC-S, and patients with COVID-19 vaccine-related myocarditis.

In one study looking at COVID-19 vaccination-associated myocarditis in adolescents there were 54 cases with the mean age being 15.6 years old and 92% were male. Seven of them had persistent symptoms. Electrocardiogram showed 80% were normal.

Oster pointed out that myocarditis overall is a “rare but important adverse event following COVID-19 vaccination.” He said medical providers are following-up and early follow-up results of COVID-19 vaccine-associated myocarditis is sparse.

William Gruber, MD, FAAP, FIDSA, FPIDS senior vice president, Vaccine Clinical Res. And Development, Pfizer, presented findings of their data looking at administration of their COVID-19 vaccine. Gruber said immunobridging success criteria were met. The Pfizer-BioNTech vaccine “effectively neutralized both the USA-WA12020 (reference strain) and the highly transmissible B.617.2 (Delta) variant of concern.” He went on to say in the presentation that the vaccine as a 2-dose series, “is highly protective against COVID-19 in 5 to <12 year-olds when Delta variant was prominent.”

In terms of safety, there were no cases of anaphylaxis, myocarditis/pericarditis, Bell’s palsy, or appendicitis were witnessed in the this study through the 3 months of follow-up after the second dose.

Reactogenicity was mostly mild to moderate, and short lived. The investigators observed mild to moderate local reactions (redness, swelling) captured by e-diary were more common and system reactions (including fever) less common than those 16-25 year olds.

Gruber said the observed AE profile in this study, “did not suggest any safety concerns for BNT162b2 vaccination in children 5 to <12 years of age.”

The FDA reviewed the Pfizer-BioNTech vaccine submission and presented post-authorization evaluation and a benefit-risk analysis.

There was a public comment portion of the meeting and a question and answer session for the committee in the afternoon.

In the committee discussion there was a debate about whether to modify the question to possibly look at just offering the EUA to kids within specific populations within this age group.

After this, the committee voted on whether or not to recommend the EUA.