US panel endorses Pfizer vaccine
OK for widespread use, awaits final decision by FDA
WASHINGTON— AU.S. government advisory panel endorsed widespread use of Pfizer’s coronavirus vaccine Thursday, putting the country one step away from launching an epic vaccination campaign against the outbreak that has killed more than 292,000 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 17-4 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 received the vaccine earlier this week when Britain became the first country to begin dispensing thePfizer-BioNTech shot.
Despite all the remaining unknowns, inanemergency, “thequestion iswhetheryou 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 non-government 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 viruswas identified.
The decision came as COVID-19 cases surge to ever-higher levels across theU.S., with deaths hitting an all-time, one-day high of more than 3,100 Wednesday.
Pfizer has said it will have about 25 million doses of thetwo-shot vaccine for the U.S. by the end of December. But initial supplies will be limited and reserved primarily for health care workers and nursing home residents, withother vulnerable groupsnext inline until the shots become widely available on demand, some
thing that will probably not happen until the spring.
Experts estimate at least 70% of the U.S. population will have to be vaccinated to achieve herd immunity, the point at which the virus can beheldin check. Thatmeans it could be several months before things start get back to normal and Americans can put away their masks.
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. Behind that is a candidate from AstraZeneca and OxfordUniversity
All eyes now turn to the FDA staff scientists who will make the final decision on whether to greenlight use of the Pfizer-BioNTech vaccine. Regulators not only in Britain but inCanadahave already approved it for use in their countries, and President Donald Trump and White House officials have complained for weeks about the pace of FDA’s careful review.
The FDA’s vaccine director, Dr. Peter Marks, said ahead of the expertmeeting that a decision would come within “days to aweek.”
“Americans want us to do a scientific review, but I think they also want us to make sure we’re not wasting time on paperwork as opposed to going forward with the decision,” FDA
Commissioner Stephen Hahn said before the meeting
positive vote for the vaccine was virtually assured after FDA scientists issued a glowing review of the vaccine earlier in the week. Agency staffers said data from Pfizer’s ongoing study of 44,000 people showed strong protection across different age groups, races and health conditions with no major, unexpected safety problems.
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 symptomsofCOVID-19, the FDA’s advisers stressed it is not yet clear if it can stopthe silent, symptomless spread that accounts for up to half of cases.
“Eventhoughthe individual efficacy of this vaccine is very, very, very high, you really as of right nowdo not have any evidence” that it will lower transmission, said Dr. Patrick Moore of theUniversity of Pittsburgh. He urgedPfizerto take additional steps to answer that question.
And the advisers are worried that Pfizerwill lose its opportunity to answer critical questions as it begins offering the real vaccine to study participants who had been gettingdummy shots.
Pfizer must still show whether the vaccine works in children younger than 16 and in pregnantwomen.
On the safety front, as widespread vaccinations begin, the first recipients will be closely tracked by government health authorities since studies in tens of thousands of people can’t detect rare risks that strike 1 in a million patients.
Hanging over the meetingwere the British allergic reactions observed in two recipients and a warning from authorities there that peoplewitha history of serious reactions shouldn’t get the vaccine for now.
Pfizer representatives said they have seen no signs of allergic reactions in their trial. But some of the FDA advisers fear the British warning will deter millions of Americans with allergies who might benefit from the COVID-19 vaccine from giving it a try, and urged additional studies to try to settle the issue.