FDA panel endorses Pfizer coronavirus vaccine for emergency use
The FDA is expected to make its final decision on whether to approve the vaccine later this week.
A U.S. Food and Drug Administration advisory panel voted Thursday to endorse the Pfizer-BioNTech coronavirus vaccine, clearing the way for FDA leaders to authorize emergency mass distribution amid an ongoing surge of COVID-19 cases across the country.
Vaccine shipments would begin within hours of the FDA’s decision, which could come by as early as Friday, with the first vaccinations to follow soon afterward. Pfizer’s vaccine will be available in limited quantities, with initial doses earmarked for frontline health care workers and high-risk patients.
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In November, Pfizer announced that its coronavirus vaccine was 95 percent effective and has not displayed any major side effects.
The advisory panel, comprised of outside experts, based its decision on data from clinical trials. Members were asked to vote on "whether the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older" based on the totality of available evidence.
Some committee members raised concerns about the wording of the question and whether trials have provided enough information regarding the vaccine's effects on people aged 16 and 17 years old. The committee opted to vote on the question as it was originally worded.
Of the committee's 23 members, 17 voted to recommend the vaccine and four voted against the recommendation. One member abstained.
The FDA is not required to follow the panel’s recommendation, but the agency is expected to act on its endorsement.
PFIZER'S COVID-19 VACCINE DATA GETS POSITIVE FDA REVIEW
| Ticker | Security | Last | Change | Change % |
|---|---|---|---|---|
| PFE | PFIZER INC. | 28.05 | +0.35 | +1.26% |
Pfizer is one of several companies in the final stages of development. The FDA is expected to decide whether to approve a vaccine developed by Moderna for mass use later this month. Johnson & Johnson and AstraZeneca also have vaccines in the works.
More than 290,000 Americans have died from COVID-19 since the pandemic began. More than 15.4 million cases have been reported.
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The Associated Press contributed to this report.