FDA sets new dates to review pediatric COVID-19 vaccines
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The FDA this week revised the dates for several upcoming meetings of its vaccine advisory board to discuss pediatric COVID-19 vaccines.
The announcement came the same day that Pfizer and BioNTech announced promising data on a third dose of their pediatric vaccine and said they will submit the results to the FDA this week as part of the rolling emergency use application they began in February.
The FDA postponed its review of the vaccine for children aged 6 months to 4 years in January, citing a need for more data.
Pfizer and BioNTech announced 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 4 years, although protection among participants aged 6 to 24 months matched that seen in adolescents and young adults.
In the new data, companies reported that a third 3 ug dose of the vaccine given 2 months after a second dose was well tolerated among 1,678 children aged younger than 5 years of age, with a vaccine efficacy of 80.3%.
“The study suggests that a low 3 ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” BioNTech CEO Ugur Sahin, MD said in a press release. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to [the European Medicines Agency] and other regulatory agencies to follow within the coming weeks.”
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will tentatively meet June 14 to discuss Moderna’s EUA request for children aged 6 to 17 years, then again on June 15 to discuss Moderna’s EUA request for children aged 6 months to 5 years and Pfizer-BioNTech’s EUA request for children aged 6 months to 4 years.
The FDA said the dates are tentative because none of the EUA submissions are complete.
A Pfizer-BioNTech vaccine has been available under an EUA for children aged 5 to 11 since December. Last week, the FDA endorsed a booster shot this age group.
References:
Coronavirus (COVID-19) update: FDA announces tentative advisory committee meeting schedule regarding COVID-19 vaccines. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-tentative-advisory-committee-meeting-schedule-regarding. Updated May 23, 2022. Accessed May 23, 2022.
Pfizer-BioNTech COVID-19 vaccine demonstrates strong immune response, high efficacy and favorable safety in children 6 months to under 5 years of age following third dose. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-demonstrates-strong-immune. Published May 23, 2022. Accessed May 24, 2022.