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FDA Approves EUA for Pfizer-BioNTech COVID-19 Vaccine for 5 to 11 Year Olds

The emergency use authorization (EUA) is based on the vaccine data and the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommendation.

The FDA has approved an EUA for Pfizer-BioNTech COVID-19 vaccine for 5 to 11 year olds in a primary 2-dose series.

The decision comes a few days after the FDA VRBPAC panel met on Tuesday to discuss the existing data and debated the benefits vs the risks of the vaccine in this 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 Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will be meeting on Tuesday to discuss COVID-19 vaccines specifically, and if recent history is any indication, an endorsement from the CDC on the Pfizer-BioNTech vaccine for 5 to 11 year olds will likely follow. If the CDC officially signs-off, the expectation is vaccines will be available to this population shortly thereafter.

The Data

Data presented to the FDA prior to VRBPAC 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.