UPDATE Feb. 15, 2022: The FDA’s plan to fast-track the vaccine for kids under five has been sidetracked for now, as the number of COVID cases in Pfizer’s clinical trial was too low to produce meaningful data. The FDA plans to wait until more data has emerged on the three-dose vaccine regimen which may take until April.
On February 1, Pfizer and BioNTech reached out to the Food and Drug Administration to request authorization for a two-dose COVID-19 vaccine for children under five years old. If approved, the move would give access to over 19 million children who have not yet been able to get vaccinated.
An emergency meeting of FDA officials is scheduled for February 15 to discuss Pfizer’s request. If the FDA approves the request and issues an emergency authorization, it would make children from six months old to five years old eligible for the two-dose vaccine as soon as the end of February.
The move by Pfizer is coming sooner than expected as parents have been organizing and petitioning for an expedited approval process for the pediatric vaccine. Vaccine researchers have been testing a three-dose regimen for the under-five age group which is believed to be more effective than the two-dose vaccine which is nearing approval—but they won’t have definitive results for those tests until late March at the earliest.
Once enough data has been collected on the three-dose pediatric vaccine for kids under five, the FDA is expected to update their guidance to include a third dose of the Pfizer COVID-19 vaccine—with the first two doses spaced three weeks apart, followed by a third dose two months after the second.
If children are able to get their initial injections as soon as this month, then they will be ready for their third dose around the same time it gets approved by the FDA and becomes available to the public. In the meantime, the two-dose vaccine has been proven to be safe, and to offer vital protection to kids under five against severe COVID-19 infection.