FDA postpones evaluation of Pfizer vaccine for teenagers below 5, citing new knowledge

February 11, 2022

2 min learn

Citing the emergence of latest knowledge, the FDA on Friday introduced that it has postponed a gathering scheduled for subsequent week during which an advisory panel would have mentioned Pfizer and BioNTech’s COVID-19 vaccine for teenagers aged youthful than 5 years.

Pfizer and BioNTech introduced final week that they’d begun submitting data to the FDA on the security and efficacy of the primary two doses of what’s anticipated to be a three-dose vaccine for kids aged 6 months to 4 years.

Pfizer vial on tray
Pfizer and BioNTech are gathering extra knowledge on their pediatric COVID-19 vaccine. Supply: Adobe Inventory

However Pfizer stated Friday that the businesses wish to lengthen the rolling submission to take care of an inflow of latest knowledge. They anticipate to have knowledge on three-dose safety “in early April.”

“Instances proceed to build up in accordance with the research protocol and extra knowledge are being generated as a result of charges of an infection and sickness stay excessive in kids of this age, particularly because of the latest omicron surge,” Pfizer stated. “On condition that the research is advancing at a fast tempo, the businesses will look forward to the three-dose knowledge as Pfizer and BioNTech proceed to consider it could present a better stage of safety on this age group.”

The Vaccines and Associated Organic Merchandise Advisory Committee was scheduled to debate the two-dose knowledge at a gathering on Feb. 15. That assembly will now not happen, in accordance with a joint assertion issued Friday by performing FDA Commissioner Janet Woodcock, MD, and Peter Marks, MD, PhD, who leads the company’s Middle for Biologics Analysis and Analysis.

“The [FDA] has been notified by Pfizer that new knowledge have lately emerged relating to its emergency use authorization request,” they stated. “As a part of its rolling submission, the corporate lately notified the company of extra findings from its ongoing scientific trial. Based mostly on the company’s preliminary evaluation and to permit extra time to guage extra knowledge, we consider extra info relating to the continued analysis of a 3rd dose ought to be thought of as a part of our decision-making for potential authorization.”

They’ll present a brand new date for the assembly “as soon as we obtain extra knowledge on a 3rd dose on this age group from the corporate’s ongoing scientific trial and have a possibility to finish an up to date analysis.”

Pfizer and BioNTech are looking for to amend the EUA for his or her vaccine to incorporate the youthful age group.

The businesses stated in December that they had been evaluating the addition of a third 3 µg dose — one-tenth the scale of an grownup dose — of the vaccine after a two-dose collection failed to provide the anticipated stage of safety amongst research contributors aged 2 to five years, though safety amongst contributors aged 6 to 24 months matched that seen in adolescents and younger adults.

The vaccine has been obtainable below an EUA for kids aged 5 to 11 years since October and for adolescents aged 12 to 15 since final Might. It’s fully approved for anybody aged 16 years or older.

References:

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

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

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