A U.S. government advisory panel endorsed the widespread use of Pfizer’s coronavirus vaccine on 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.
The injections could begin in a few days, depending on how quickly the Food and Drug Administration approves, as expected, the expert committee’s recommendation.
“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.
In a 17-4 vote and one abstention, government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and adolescents 16 years of age and older.
That support came despite questions about allergic reactions in two people who received the vaccine earlier this week, when Britain became the first country to start dispensing the Pfizer-BioNTech injection.
While there are a number of unknowns about the vaccine, in an emergency, “the question is do you know enough” to move on, said panel member Dr. Paul Offit of the Children’s Hospital of Philadelphia. It concluded that the potential benefits outweigh the risks.
The decision was made as Covid-19 cases spiked to ever-higher levels in the US, with deaths setting a one-day all-time high of more than 3,100 on Wednesday.
Pfizer has said it will have about 25 million doses of the two-shot vaccine for the United States by the end of December. But initial supplies will be reserved primarily for healthcare workers and nursing home residents, and other vulnerable groups will remain in line until increased production allows injections to be widely available on demand – something that is likely not to be. it will happen until spring.
Next week, the FDA will review a second vaccine, from Moderna and the National Institutes of Health, that appears as protective as the Pfizer-BioNTech injection. A third candidate, from Johnson & Johnson, who would require just one dose, is working his way down the pipeline. Behind that is a candidate from AstraZeneca and the University of Oxford.
US health experts hope that a combination of vaccines will allow the US to beat the outbreak.
But experts estimate that at least 70% of the US population will have to be vaccinated to achieve herd immunity, the point at which the virus can be controlled. That means it could be several months before things return to normal and Americans can remove their masks.
All eyes are now on the scientists on the FDA staff who will make the final decision to go ahead with large-scale immunizations with the Pfizer-BioNTech vaccine. The FDA’s director of vaccines, Dr. Peter Marks, said before the expert meeting that the decision would be made within “days to a week.”
Independent review by nongovernmental experts in vaccine development, infectious diseases, and medical statistics was deemed critical to increasing Americans’ confidence in the safety of the vaccine, which developed at breakneck speed less than a year after the virus identification.
Regulators not only in Britain but in Canada have already approved the vaccine for use in their countries, and President Donald Trump and White House officials have complained for weeks about the pace of the FDA’s careful review.
“The Americans want us to do a scientific review, but I think they also want us to make sure we don’t waste time on paperwork rather than follow through with the decision,” FDA Commissioner Stephen Hahn said before the meeting.
A positive vote for the vaccine was practically assured after FDA scientists released an enthusiastic review of the vaccine earlier in the week. Agency staff said data from Pfizer’s ongoing study of 44,000 people showed strong protection across different age groups, races and health conditions without major and unexpected safety concerns.
The Pfizer-BioNTech injection remains experimental because that end-stage study is not 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 symptoms of Covid-19, FDA advisers emphasized that it is not yet clear whether it can stop the silent and asymptomatic spread that accounts for up to half of all cases. .
“Even though the individual efficacy of this vaccine is very, very, very high, at this time you really don’t have any evidence” that it will decrease transmission, said Dr. Patrick Moore of the University of Pittsburgh. He urged Pfizer to take additional steps to answer that question.
Several of the dissenting panel members opposed authorizing the vaccine for 16- and 17-year-olds, given their small number in the study and the low risk they face from Covid-19.
Members were also concerned that Pfizer would miss an opportunity to answer critical questions once it begins offering the real vaccine to study participants who have so far been receiving fake injections.
The company proposed gradually moving those patients to the vaccine group, with priority based on age, health conditions and other factors. Under that plan, 70-year-old participants would cross before healthy 30-year-olds.
Pfizer has yet to show if the vaccine works in children under 16 and pregnant women.
On the safety front, as widespread vaccinations begin, government health authorities will closely follow the first recipients, as studies in tens of thousands of people fail to detect rare risks affecting 1 in one million. Above the meeting were British allergic reactions and a warning from authorities that people with a history of severe reactions should not get vaccinated for now.
Pfizer representatives said they have seen no signs of allergic reactions in their trial. But some of the FDA advisers fear that the British warning will deter millions of Americans with allergies who could benefit from the Covid-19 vaccine from trying it, and they urged additional studies to try to solve the problem.
“This problem is not going to go away until we have better data,” Offit said.
.
