Key panel OKs vaccine for America
WASHINGTON — A U.S. 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.
In a 17-to-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 older.
That endorsement came despite questions about allergic reactions in two people who recceived the vaccine this week when Britain became the first country to begin dispensing the Pfizer-BioNTech shot.
Despite all the remaining unknowns, in an emergency, “the question is whether you know enough,” said panel member Dr. Paul Offit of Children’s Hospital of Philadelphia, who concluded that the shot’s potential benefits outweigh its risks.
The independent review by nongovernment experts in vaccine development, infectious diseases and medical statistics was considered critical to boosting Americans’ confidence in the safety of the shot, which was developed at breakneck speed less than a year after the virus was identified.
The decision came as COVID-19 cases surge to ever-higher levels across the U.S., with deaths hitting an all-time, one-day high of more than 3,100 oon Wednesday.
Pfizer has said it will have about 25 million doses of the two-shot vaccine for the U.S. by the end of December. But the initial supplies will be reserved primarily 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 on demand — something that will probably not happen until the spring.
The FDA next week 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.