A FOOD AND DRUG Administration advisory committee on Thursday gave a strong endorsement for the agency to grant emergency use authorization to the coronavirus vaccine from Pfizer and BioNTech.
The Vaccines and Related Biological Products Advisory Committee voted 17-4 with one person abstaining that the benefits of the vaccine outweigh the risks for individuals 16 years of age and older.
The FDA, which was waiting for the committee’s recommendation, could at any time issue an emergency use authorization for the vaccine. The authorization would allow the shipment and distribution of the vaccine to begin, and shots could be administered as soon as next week.
Some committee members drew issue with the age given in the recommendation, arguing that there wasn’t enough trial data to recommend the vaccine for 16-and-17-year-olds.
The FDA earlier this week released an analysis that supported the claim from Pfizer and BioNTech that their vaccine is 95% effective. The agency found “no specific safety concerns identified that would preclude issuance of an EUA.”
“Today’s meeting is an important step in the process – allowing outside scientific experts an opportunity to provide valuable advice and input for the agency to consider as part of its final review,” FDA Commissioner Stephen Hahn said in a statement on Thursday. “Importantly, final decisions about whether to authorize a vaccine for emergency use will be made by FDA’s career officials in the Center for Biologics Evaluation and Research.”
A Centers for Disease Control and Prevention advisory committee is scheduled to meet Friday and vote Sunday on whether to recommend the vaccine for public distribution and who should get it.
The FDA has noted that there isn’t enough data to determine whether the vaccine is safe for children under the age of 16, pregnant women and immunocompromised people. Additionally, U.K. regulators this week warned that those with a “significant history of allergic reactions” should not take the coronavirus vaccine from Pfizer and BioNTech following two incidents involving health care workers who received the shot.
Pfizer representatives said they are seeking further information about the incidents and that its trial did not include participants who previously had poor reactions to vaccines.
The company is in discussions with FDA about whether to offer the vaccine to its trial participants who received the placebo, although some on the committee expressed concern about how unblinding the trial could affect its results. Participants will be followed for two years after their first shot.
Steven Goodman, associate dean of clinical and translational research at the Stanford University School of Medicine, offered a possible compromise to the dilemma. To keep the trial blinded, participants could report normally when it is their turn to get a vaccine in their area, and they would be given either the vaccine or a placebo without knowledge of which one they are getting.
The coronavirus vaccine candidate from Moderna, which is the only other candidate that has applied for emergency use authorization with the FDA, will get its turn in front of the advisory committee next week.