Pfizer COVID-19 vaccine gets FDA panel recommendation for young kids

Brittany A. Roston - Oct 26, 2021, 4:20pm CDT
Pfizer COVID-19 vaccine gets FDA panel recommendation for young kids

The US is one step closer to the anticipated authorization of a COVID-19 vaccine for young kids ages five to 11 years. An independent panel of advisers has recommended the US Food and Drug Administration (FDA) authorize the use of Pfizer’s COVID-19 vaccine in children who fall in this age group, bringing the US closer than ever to a vaccine option that covers the majority of the population.

Pfizer submitted the initial data on its COVID-19 vaccine in children ages five to 11 to the FDA in late September, paving the way for analysis and, as we’ve reached today, a recommendation or lack thereof from the FDA’s independent panel of advisers. The company revealed at the time that its key trial had involved 2,268 kids in the aforementioned age group, ultimately demonstrating “robust neutralizing antibody responses” alongside a “favorable safety profile.”

Today kicked off an all-day meeting for the FDA’s Vaccines and Related Biological Products Advisory Committee to discuss whether Pfizer’s COVID-19 vaccine should be recommended for use in young kids. The meeting started at 8:30 AM ET on October 26 and wrapped up just a bit ahead of schedule, with the committee ultimately recommending the vaccine for this age group shortly ahead of 5 PM local time.

The vote was nearly unanimous with only one holdout. This doesn’t mean the Pfizer vaccine is available for kids in this age group now; rather, it is a stepping stone that paves the way for the FDA to make its own decision about whether to update the emergency use authorization. Assuming an update is made, the CDC will then step in to determine which kids are eligible to get the vaccination protocol.

The expert panel took multiple factors into consideration when making their recommendation, including the small risk of heart inflammation, current COVID-19 cases in the US, the risk young kids face from SARS-CoV-2, and how many children have likely already developed some natural immunity against the virus. The experts also considered whether it would be better to give kids a one-dose regimen of the vaccine and whether their recommendation may lead to mandates later on.


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