Pfizer Pauses FDA Request To OK Covid-19 Vaccine For Kids Under 5 Pfizer Pauses FDA Vax Approval Request for Kids Under 5

by Lauren Levy

This pause on Pfizer’s FDA request means that kids under 5 won’t be getting vaccinated as soon as we hoped

Despite optimistic buzz earlier this month, it looks like parents of young kids will have to wait longer than previously hoped for the Food and Drug Administration to approve the Pfizer-BioNTech COVID-19 vaccine for children under 5. Excitement first grew about the possibility of being able to finally vaccinate the youngest members for many families after it was reported on Jan. 31 that Pfizer was preparing to ask the FDA to authorize emergency use of their COVID vaccine for little ones 6 months to 5 years old. However, Pfizer has now stalled that plan, according to reports.

According to NBC News, Pfizer is postponing its rolling application that would make kids in this age group eligible for the first two doses of the vaccine. Although this setback is understandably disappointing for parents hoping to finally be able to help protect their littles in the coming weeks, Pfizer said in a statement that the setback is based on the need for more information. According to the company, it is waiting for additional data on how three doses of the vaccine perform before the approval for the first two because the three-dose series “may provide a higher level of protection in this age group.”

Although the potential of increased protection for kids is good news, the timeline isn’t necessarily. Pfizer shared that it does not expect to have this data until early April. The original plan that Pfizer sought approval for was to expand the use of it’s two-dose vaccine for young children (despite trial results that found two doses in kids 2-4 years old didn’t generate the desired immune response), and then submit additional findings on the third dose in the coming months.

This would allow children to start receiving the first two doses out of what was expected to be a three-dose series. But now that Pfizer has pulled its request, it gives the company more time to confirm that the third dose is enough to provide adequate protection since it was already established that first two didn’t work.

This comes just days after Pfizer’s CEO Albert Bourla told CNBC on Tuesday that he felt confident the FDA would approve the request to fast-track authorization for the first two doses. “I think the chances are very high for FDA to approve it,” he said. “I think that they will be pleased with the data and they will approve.”

But just because it could be approved doesn’t mean that the company now believes that it should be at this time, based on evolving data. “Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” Pfizer added in its statement. The company also explained the need for more time and data “because rates of infection and illness remain high in children of this age” as the omicron variant continues to spread.

Although these may seem like two conflicting messages, Dr. Peter Marks hopes that instead of letting down eager parents, the pause helps to reassure anxious ones. “Rather than having any issue of of causing anyone to question the process, I hope this reassures people that the process has a standard that the process is one that we follow, and we follow the science in making sure that anything that we authorize has the safety and efficacy that people have come to expect from our regulatory review of medical products,” Marks, who oversees the FDA’s vaccine safety department , said during a press call, according to ABC News.

Although in the short term this delay undoubtedly is a massive blow for many moms and dads, hopefully in the long run it was the right call in helping to meet this common hope: ensuring the vaccine is both as safe and effective as possible for little ones who deserve the best protection we can offer them from this pandemic.