Pfizer stalls COVID-19 vaccine app as it awaits data on 3rd dose in young kids

Parents may have to wait several weeks longer before they can get their youngest children vaccinated with Pfizer and BioNTech’s mRNA-based COVID-19 vaccine.

Pfizer on Friday said it would extend its rolling FDA submission in anticipation of data on a third dose of its COVID-19 vaccine in children younger than 5. Just earlier this month, on Feb. 1, the company filed its emergency use authorization application at the agency's request. That request covered the two-dose regimen, and the company said at the time that data for the planned three-dose series would be expected in the coming months.

Today, however, Pfizer is announcing that it will instead wait to share more data with the FDA through its rolling submission. The company’s pediatric study, which covers children ages 6 months to 4 years old, will carry on. Pfizer continues to share data on an initial two-dose regimen with the FDA “on an ongoing basis,” the company said in the release. “Cases continue to accumulate according to the study protocol, and more data are being generated because rates of infection and illness remain high in children of this age especially due to the recent Omicron surge,” the company continued.

Back in December, Pfizer and BioNTech said their trial in young kids would evaluate a third 3-microgram dose of their mRNA-based shot that would be given two months after the subjects received their second doses. Pfizer says it expects to have data on the three-dose regimen by early April. 

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“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,” the company said. 

The move has the support of the independent data monitoring committee for the vaccine’s pediatric study. The group has backed “the continuation of the trial according to the protocol” and believe the data so far suggest the vaccine is well-tolerated and worthy of a potential three-dose regimen, Pfizer said.

“The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion,” the company said.

Also on Friday, the FDA said it was postponing an advisory committee meeting on Pfizer-BioNTech’s pediatric vaccine approval originally scheduled for Feb. 15. The move gives the regulator time to consider additional data on a third dose, the FDA said in its announcement. 

The agency said it would update the timing for the advisory panel meeting once it has received additional data on dose no. 3 in kids 6 months to 4 years old.

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Pfizer’s COVID-19 vaccine has proven a tremendous boon for the company—and the pandemic is likely to continue filling its coffers for years to come. Pfizer’s scientists think it’s “unlikely that [SARS-CoV-2] will be fully eradicated in the foreseeable future,” Pfizer CEO Albert Bourla said on a call with investors this week.

All told, Pfizer’s full-year revenues for 2021 clocked in at a whopping $81.3 billion. Nearly $37 million of that came from sales of the company’s COVID-19 vaccine, Comirnaty.

For 2022, Pfizer expects Comirnaty and its new COVID-19 pill, Paxlovid, to generate sales of $54 billion.