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Home Special Coverage Coronavirus Outbreak

FDA panel endorses widespread use of Pfizer COVID-19 vaccine

In a 17-4 vote with one abstention, government advisers conclude vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and over. American Academy of Pediatrics president hails US Food and Drug Administration endorsement as "a light at the end of the long tunnel of this pandemic."

by  Yoni Hersch , AP and ILH Staff
Published on  12-11-2020 13:12
Last modified: 12-11-2020 13:12
FDA panel endorses widespread use of Pfizer COVID-19 vaccineCourtesy

A vial of the Pfizer-BioNTech vaccine | Illustration: Courtesy

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A US government advisory panel endorsed widespread use of Pfizer's coronavirus vaccine, Thursday, putting the country just one step away from launching an epic vaccination campaign against the outbreak that has killed close to 300,000 Americans.

Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee's recommendation.

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"This is a light at the end of the long tunnel of this pandemic," declared Dr. Sally Goza, president of the American Academy of Pediatrics.

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.

That endorsement came despite questions about allergic reactions in two people who received the vaccine earlier this week when Britain became the first country to begin dispensing the Pfizer-BioNTech shot.

While there are a number of remaining unknowns about the vaccine, in an emergency, "the question is whether you know enough" to press ahead, said panel member Dr. Paul Offit of Children's Hospital of Philadelphia. He concluded that the potential benefits outweigh the risks.

The decision came as COVID-19 cases surge to ever-higher levels across the U.S., with deaths setting an all-time, one-day record of more than 3,100 on Wednesday.

Next week, the FDA will review a second vaccine, from Moderna 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. Behind that is a candidate from AstraZeneca and Oxford University.

All eyes now turn to the FDA staff scientists who will make the final decision of whether to press ahead with large-scale immunizations with Pfizer-BioNTech's vaccine. The FDA's vaccine director, Dr. Peter Marks, said a decision would come within "days to a week."

The Pfizer-BioNTech shot remains experimental because that final-stage study isn't complete. As a result, the expert panel wrestled with a list of questions that have yet to be answered.

For example, while the vaccine is more than 90% effective in blocking the symptoms of COVID-19, the FDA's advisers stressed it is not yet clear whether it can stop the silent, symptomless spread that accounts for roughly half of all cases.

Several of the dissenting panel members objected to authorizing the shot for 16- and 17-year-olds, given their small numbers in the study and the low risk they face from COVID-19.

Pfizer must still show whether the vaccine works in children younger than 16 and in pregnant women.

Israel received its first shipment of 3,000-4,000 Pfizer coronavirus vaccines on Wednesday and is set to begin inoculating citizens on Dec. 27.

Speaking in front of the DHL cargo jet that delivered the batch on the tarmac at Ben Gurion Airport, Prime Minister Benjamin Netanyahu said that "today was a day of celebration" as the end of the pandemic was "now in sight."

According to Health Ministry data published Friday morning, 1,866 of the 70,960 people who tested for the coronavirus on Thursday were found to be carrying the virus, for an infection rate of 2.7%. Israel currently has 16,298 active cases, 323 of which are serious. Of those in serious condition, 101 people are on ventilators. Since the outbreak of the pandemic, Israel has logged 352,968 cases of the virus. So far, 2,969 people have died.

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Tags: COVID-19FDApfizer

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