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FDA Panel Recommends COVID-19 Vaccine For Emergency Use

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 FDAreleased its analysisalong 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 advisersare 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 todiscuss 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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Scott Hensley edits stories about health, biomedical research and pharmaceuticals for NPR's Science desk. During the COVID-19 pandemic, he has led the desk's reporting on the development of vaccines against the coronavirus.
Award-winning journalist Richard Harris has reported on a wide range of topics in science, medicine and the environment since he joined NPR in 1986. In early 2014, his focus shifted from an emphasis on climate change and the environment to biomedical research.
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