FDA postpones review of Pfizer vaccine for kids under 5, citing new data

Citing the emergence of new data, the FDA on Friday announced that it has postponed a meeting scheduled for next week in which an advisory panel would have discussed Pfizer and BioNTech’s COVID-19 vaccine for kids aged younger than 5 years.

Pfizer and BioNTech announced last week that they had begun submitting data to the FDA on the safety and efficacy of the first two doses of what is expected to be a three-dose vaccine for children aged 6 months to 4 years.

But Pfizer said Friday that the companies want to extend the rolling submission to contend with an influx of new data. They expect to have data on three-dose protection “in early April.”

“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,” Pfizer said. “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 Vaccines and Related Biological Products Advisory Committee was scheduled to discuss the two-dose data at a meeting on Feb. 15. That meeting will no longer take place, according to a joint statement issued Friday by acting FDA Commissioner Janet Woodcock, MD, and Peter Marks, MD, PhD, who leads the agency’s Center for Biologics Evaluation and Research.

“The [FDA] has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request,” they said. “As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. Based on the agency’s preliminary assessment and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.”

They will provide a new date for the meeting “once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity to complete an updated evaluation.”

Pfizer and BioNTech are seeking to amend the EUA for their vaccine to include the younger age group.

The companies said in December that they were evaluating the addition of a third 3 µg dose — one-tenth the size of an adult dose — of the vaccine after a two-dose series failed to produce the expected level of protection among study participants aged 2 to 5 years, although protection among participants aged 6 to 24 months matched that seen in adolescents and young adults.

The vaccine has been available under an EUA for kids aged 5 to 11 years since October and for adolescents aged 12 to 15 since last May. It is fully approved for anyone aged 16 years or older.

References:

Coronavirus (COVID-19) update: FDA postpones advisory committee meeting to discuss request for authorization of Pfizer-BioNTech COVID-19 vaccine for children 6 months through 4 years of age. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-postpones-advisory-committee-meeting-discuss-request-authorization. Published Feb. 11, 2022. Accessed Feb. 11, 2022.

Pfizer and BioNTech provide update on rolling submission for emergency use authorization of their COVID-19 vaccine in children 6 months through 4 years of age. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-rolling-submission. Published Feb. 11, 2022. Accessed Feb. 11, 2022.