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FDA Panel Approves Pfizer Coronavirus Vaccine, Paving Way for Full Approval in US

A United States government advisory panel endorsed widespread use of Pfizer’s coronavirus vaccine […]

A United States government advisory panel endorsed widespread use of Pfizer’s coronavirus vaccine on Thursday evening, putting the country just one step away from the official launch of a vaccination campaign against the virus that has killed close to 300,000 Americans. Experts estimate that doctors could start administering shots within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the committee’s recommendation.

In a 17-4 vote with one abstention, the government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and over. “This is a light at the end of the long tunnel of this pandemic,” said Dr. Sally Goza, president of the American Academy of Pediatrics.

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The endorsement came despite questions about allergic reactions in two people who received the vaccine earlier this week in Britain, which became the first country to dispense the Pfizer-BioNTech shot. Dr. Paul Offit of the Children’s Hospital of Philadelphia told the Associated Press that “the question is whether you know enough” to press ahead in an emergency. He concluded that the potential benefits outweigh the risks.

The vaccine decision couldn’t have come a minute too soon, as COVID-19 cases surge to record-breaking levels across the entire country, with deaths setting an all-time one-day record of more than 13,000 on Wednesday. Pfizer will have about 25 million doses of the two-shot vaccine for the U.S. by the end of December.

The initial shipment of 6.4 million doses will leave warehouses within 24 hours of being cleared by the F.D.A., according to federal officials. About half of those doses will be sent across the country, and the other half will be reserved for the initial recipients to receive their second dose about three weeks later.

Initial supplies will be reserved for health care workers and nursing home residents, with other vulnerable groups next in line until ramped-up production enables shots to become widely available in the spring.

Next up for the FDA is a second vaccine, from Modern and the National Institutes of Health, that appears about as protective as Pfizer-BioNTech’s shot. A third candidate, from Johnson & Johnson, which would require just one dose, is working its way through the pipeline as well. Behind that is a candidate from AstraZeneca and Oxford University.