The Food and Drug Administration (FDA) just authorized the Pfizer/BioNTech COVID-19 vaccine for use in kids under the age of 12.
Kids between the ages of five and 11 are now eligible to get the two-dose mRNA COVID-19 vaccine, according to the FDA’s emergency use authorization (EUA). As with adults, the vaccine is administered in two separate doses given three weeks apart. But the dose for kids in this age group is smaller than the dose used in adults and those age 12 and up.
The FDA’s decision to expand Pfizer’s original authorization to include younger children is based in part on a clinical trial that included more than 3,100 kids between the ages of five and 11 who received the vaccine and another 1,500 children who received a placebo. In this study, the most common side effects after the shot were generally temporary and similar to those seen in older age groups, such as pain and redness at the injection site, headaches, and muscle pain. In clinical trials including children in this age group, the vaccine was 90.7% effective at preventing COVID-19 illness.
And there are surveillance programs in place (from both government agencies and Pfizer) to monitor for rarer and more severe potential side effects that tend to show up more frequently in younger people. In particular, those systems will be on the lookout for cases of myocarditis and pericarditis, forms of heart inflammation, which have so far most frequently developed in young adult and adolescent males, according to the Centers for Disease Control and Prevention (CDC).
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Janet Woodcock, M.D., acting FDA commissioner, said in a press release. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”
The EUA comes after the FDA’s advisory panel unanimously voted (with one abstention) that the potential benefits of using the vaccine in this age group outweigh the potential harms. Previously, the Pfizer vaccine, also called Comirnaty, received authorization for use in kids ages 12 to 15 back in May of this year. It was originally authorized for use in people ages 16 and older in December 2020 and received full FDA approval in August 2021.
Vaccinating this younger age group will be a huge milestone in our battle to better contain the COVID-19 pandemic, as Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, said earlier this year. And although some dynamics of the pandemic in the U.S. have changed since then (including the rise of the highly transmissible delta variant), authorizing a COVID-19 vaccine for kids will undoubtedly help protect them and the rest of their community.
Children are less likely than adults to develop severe complications from the coronavirus, but they can definitely still get the virus. And at this stage of the pandemic, with about 57% of the population fully vaccinated and the delta variant responsible for the majority of cases, kids too young to get the shots now account for an increasing chunk of new COVID-19 cases in the U.S.
Next up, the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet next week to discuss the guidelines for implementing the FDA’s authorization and may fine-tune the exact recommendations for who should receive the vaccine. But, for now, the FDA’s authorization will be welcome news to many parents of (currently) unvaccinated kids—especially those whose children have returned to in-person learning this school year.
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