Pfizer begins application to FDA for vaccine for kids under 5

Pfizer said Tuesday that it has begun applying for authorization for its COVID-19 vaccine for children ages 6 months to 4 years from the Food and Drug Administration (FDA). 

The announcement marks a step forward in the process for the only age group for whom COVID-19 vaccines are not yet authorized.  

In a wrinkle, the application is for two doses, though the company said it realized three doses will eventually be needed. Pfizer said it is applying now at the request of the FDA so the process on authorizing two doses can begin, and then the authorization could later be expanded to three doses once the data becomes available. 

“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Pfizer CEO Albert Bourla said. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”

The third dose would come at least eight weeks after the second dose, and the data on the third dose will come “in the coming months,” the company said. 

Pfizer said in December that the vaccine application for children under 5 could take as long as the middle of 2022, given that the immune response from two doses was not sufficient and a third dose needed to be tested. It said there were no safety concerns. 

The latest move could significantly move up the timeline to begin the process with the first two shots, with a third following later.

The Washington Post reported Monday that authorization for the first two shots could come by the end of February.

The doses in question for children under 5 are much smaller than the doses used for adults. 

While the virus is generally milder in younger age groups, Pfizer noted that 3.2 percent of COVID-19 hospitalizations in the week ending Jan. 22 were children under 4.

There is also a question of willingness to get the vaccine. A Kaiser Family Foundation poll released Tuesday found that 3 in 10 parents of children under 5 said they would get the vaccine for their child right away. 

The FDA announced Tuesday that its vaccine advisory committee would meet on Feb. 15, indicating that a final decision could come fairly soon after that. 

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge,” acting FDA Commissioner Janet Woodcock said in a statement. “Furthermore, children are not small adults. Because they’re still growing and developing, it’s critical that these vaccines are evaluated in well-designed and well-conducted clinical trials.”

Updated at 4:59 p.m.