Regulatory Focus™ > News Articles > 2021 > 9 > FDA convenes adcomm for Pfizer COVID booster

FDA convenes adcomm for Pfizer COVID booster

Posted 01 September 2021 | By Kari Oakes 

FDA convenes adcomm for Pfizer COVID booster

The US Food and Drug Administration (FDA) announced late Wednesday afternoon that it plans to hold an advisory committee meeting on 17 September to discuss a third booster shot of the Pfizer-BioNTech COVID-19 vaccine for individuals aged 16 years and up.
 
"The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its COVID-19 vaccine and will discuss it with the agency's advisory committee to inform our decision-making,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in the FDA in Brief announcement.
 
Pfizer and its German partner, BioNTech, announced last week that they had initiated a rolling submission to FDA for a booster dose of their fully approved vaccine, now known as Comirnaty, for individuals aged 16 years and up.
 
The agenda and roster for the virtual meeting of the Vaccines and Related Biological Products Advisory Committee will be posted no later than 2 business days before the all-day 17 September meeting.
 
President Joe Biden had previously announced a plan to make boosters available beginning in September to individuals otherwise fully vaccinated with the Pfizer or Moderna mRNA COVID-19 vaccines. Earlier this week, the vaccines advisory committee of the US Centers for Disease Control and Prevention (CDC) discussed the issue of boosters, but made no formal recommendations.
 
FDA issued an emergency use authorization for mRNA boosters for certain immunocompromised individuals earlier this month.
 
"The administration recently announced a plan to prepare for additional COVID-19 vaccine doses, or 'boosters,' this fall, and a key part of that plan is FDA completing an independent evaluation and determination of the safety and effectiveness of these additional vaccine doses,” added Marks.
 
"Should the data received from other manufacturers raise unique questions that would benefit from the committee's input, the agency intends to consider additional public discussions. The FDA will review the supplemental application as expeditiously as possible, while still doing so in a thorough and science-based manner."
 

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe