FDA Panel Recommends COVID-19 Vaccine For Emergency Use
Updated 5:58 p.m.:In a 17-4 vote, with one abstention, a panel of advisers to the Food and Drug Administration recommended that the COVID-19 vaccine being developed by Pfizer and BioNTech be authorized for emergency use during the pandemic.
The vote in favor of the vaccine was taken to answer the agency's question: Do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in people 16 years of age and older.
The agency typically follows the advice of its expert advisers.
A quick FDA decision is expected given the state of the pandemic, 95% effectiveness of the Pfizer-BioNTech in preventing COVID-19 and a determination by the FDA that there are no specific safety concerns that would stand in the way of emergency use.
A previous version of this story continues.
The stunning toll of the COVID-19 pandemic is why there's so much attention focused Thursday on a meeting of advisers to the Food and Drug Administration who will be considering the vaccine developed by Pfizer and BioNTech.
These experts will weigh the benefits and risks of clearing the companies' COVID-19 vaccine for emergency use in the U.S., which would make it the first available for immunization against the disease.
The key question: Is the vaccine safe and effective enough to give to millions of Americans?
On Tuesday, the FDA released its analysis along with an information packet from Pfizer. Those documents and testimony from agency and company officials will be at the heart of this daylong discussion.
The FDA analysis builds a case that this vaccine should be authorized for emergency use, a quicker approach than the one for a full-blown marketing approval.
One goal for the public meeting is to provide transparency about the evidence for the vaccine. Another is to build confidence in the process. The advisers are likely to endorse the vaccine.
At another public meeting last Friday, the acting chair of this advisory committee, Dr. Arnold Monto, said, "Unless there are surprises ... there will not be an issue in terms of efficacy." The FDA analysis found the Pfizer-BioNTech vaccine 95% effective.
As for safety, there will no doubt be questions about side effects, but the FDA found "no specific safety concerns identified that would preclude issuance of an EUA," or emergency use authorization.
In-depth panel discussion is scheduled to start a little after 3 p.m. ET and will culminate in votes on questions posed by the FDA. The meeting is set to adjourn by 5:15 p.m.
The agency is asking the panel to discuss Pfizer's plan to continue study of the vaccine if an EUA goes into effect, and if there are any gaps in the plan.
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