FDA committee recommends emergency use authorization for Pfizer coronavirus vaccine
An FDA advisory committee has voted to recommend emergency use authorization for Pfizer’s coronavirus vaccine, marking a historic breakthrough amid some of the deadliest days of the pandemic.
“We will take into consideration what we heard today when deciding on not only EUA issuance here but also how to move on in the development and licensure of this product,” said Marion Gruber, director of the office of vaccines research and review at the FDA.
“EUA” means emergency use authorization. That’s different than FDA approval, which is expected to come later, but it does allow widespread use of the vaccine and continued monitoring.
Depending on how fast the U.S. Food & Drug Administration signs off on the panel’s recommendation, which it is expected to do, shots could begin within days. Data shows the vaccine, done in a two-shot regimen, is 95% effective at preventing coronavirus, and has no major safety concerns.
Members of the independent and highly vetted Vaccines and Related Biological Products Advisory Committee voted 17-4 with one abstention in favor of the EUA on Thursday afternoon, providing the largest glimmer of hope in beating back the pandemic thus far.
The VRBPAC public meeting, which lasted all day Thursday, covered presentations from Pfizer, the FDA and the Centers for Disease Control and Prevention as well as public comment and a deep dive into safety, efficacy and ethics, which were rigorously discussed and questioned by scholars and scientists.
Following reports of allergic reactions to the vaccine in the United Kingdom, the FDA asked that Pfizer add allergic reactions to its plans to study safety. An FDA official said vaccine fact sheets will advise that people with a known history of allergic reactions to any component of the vaccine should not get the shot.
Many public commenters supported the EUA, while others expressed concerns and highlighted the need for ongoing transparency.
“It’s our opinion that at this time there are too many unanswered questions regarding the safety and efficacy to release the vaccine,” said Dru West of the USA Patient Network.
The EUA was recommended under contingencies of active follow-up and monitoring of vaccine recipients and continuation of blinded clinical trials.
Pfizer has an agreement with the United States to deliver 100 million doses, which can vaccinate 50 million people, with options to acquire more.