FDA Advisory Board Unanimously Votes to Approve Pfizer COVID Vaccine for Kids under 5

On June 15, the FDA advisory board unilaterally voted to approve Pfizer’s COVID vaccine for children under 5. Until now, there has been a gap in COVID-related care for children under 5 as they have not been eligible for any COVID vaccines.  

In late 2020, the Pfizer COVID vaccine was first approved by the FDA for emergency use. Since then, the vaccine emergency usage has been expanded from adults over 18 to anyone over 5.  In the early stages of vaccine rollout, the Pfizer vaccine was only approved for adults over 18, with priority given to those at an increased risk of contracting COVID-19. 

It wasn’t until several months later, in October of 2021, that the FDA released an Emergency Use Authorization (EUA) for Pfizer vaccines to be administered to kids as young as 5. Since then, the FDA has also updated EUAs to approve boosters for this age range. 

According to the American Academy of Pediatrics (AAP), the Omicron variant caused a surge in pediatric COVID cases this year. “For the week ending June 9th, almost 88,000 child COVID-19 cases were reported,” their website states.  

At the FDA advisory board meeting, Pfizer presented data from their clinical trials of the COVID vaccine on kids aged between 6 months and 4 years. The agency data was divided into two groups, a 6–23 month age range and a 2–4 year age range. Their data displayed a lower rate of COVID incidence after receiving just one dose of the Pfizer vaccine.  

Pfizer also sites an 80.3% efficacy rate of their COVID vaccine in kids six months to 5 years.  

Preventing COVID in children will also avoid its long-term potential side effects. In January, the CDC Morbidity and Mortality Report found that children who have had COVID-19 were 31% more likely to develop Type 1 Diabetes 30 or more days after infection. 

 A study published in January of 2022 validates this and highlights higher incidences of diabetic ketoacidosis in children during the COVID pandemic.  

Currently, the CDC, AMA, and AAP encourage vaccinations for children above the age of 5. Many sources anticipate that with this recent advisory panel vote, these organizations will promote vaccination for children from six months to 5 years.  

Despite two other vaccines (Moderna and J&J) being available, the Pfizer vaccine is currently the only one foreseen to be distributed within the next couple of weeks for this age range. Currently, Moderna is also working on receiving FDA EUA approval. 

With vaccine rollout on the horizon, pediatricians and parents will have to weigh adolescent COVID risk with potential concerns regarding vaccination.