An advisory panel from the US government approved the widespread use of Pfizer’s coronavirus vaccine on Thursday, which put the country just one step away from launching an epic vaccination campaign against the outbreak that has killed nearly 300,000 Americans.
Shots can start within a few days, depending on how quickly the Food and Drug Administration signs, as expected, on the expert committee’s recommendation.
In a 17-4 vote with one abstention, government advisers concluded that the vaccine from Pfizer and its German partner BioNTech works safely and effectively for emergency use in adults and adolescents 16 years and older.
This approval came despite questions about allergic reactions in two people who received the vaccine earlier this week when the UK became the first country to start dispensing the Pfizer-BioNTech shot.
Despite all the remaining unknowns, in an emergency, “the question is whether you know enough,” says panelist Dr. Paul Offit of the Children’s Hospital of Philadelphia, who concluded that the potential benefits of the shot outweigh its risks.
The independent review by non-governmental experts in vaccine development, infectious diseases, and medical statistics was considered crucial in increasing Americans’ confidence in the safety of the shot, which developed at breakneck speed less than a year after the virus was identified.
The decision came as COVID-19 cases rose to ever-higher levels across the United States, with deaths affecting a full-time, one-day high of more than 3,100 on Wednesday.
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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 the original deliveries will be reserved mainly for nursing staff and nursing home residents, with other vulnerable groups next in line until rampant production allows shots to be widely available on request – something that will probably not happen until spring.
The FDA next week will review a second vaccine, from the Modern and National Institutes of Health, which is about as protective as Pfizer-BioNTech’s shots. A third candidate from Johnson & Johnson, who would need only one dose, is working his way through the pipeline. Behind it is a candidate from AstraZeneca and Oxford University.
US health experts hope that a combination of vaccines will ultimately enable the United States to conquer the outbreak.
However, experts estimate that at least 70% of the US population will need to be vaccinated to achieve herd immunity, the point at which the virus can be kept in check. This means that it can take several months before things start to return to normal and Americans can put on their masks.
All eyes are now on the FDA’s HR researchers who will make the final decision on whether to proceed with widespread use of the Pfizer-BioNTech vaccine. FDA Vaccine Director Dr. Peter Marks told the expert meeting that a decision would be made within “days to a week.”
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Regulators not only in the UK but also in Canada have already approved the vaccine for use in their countries, and President Donald Trump and White House officials have been complaining for weeks about the pace of FDA scrutiny.
“Americans want us to do a scientific review, but I think they also want us to make sure we do not waste paperwork as opposed to moving forward with the decision,” FDA Commissioner Stephen Hahn said before the meeting.
A positive vote for the vaccine was virtually ensured after FDA researchers issued a brilliant review of the vaccine earlier this 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, unexpected safety issues.
The Pfizer-BioNTech shot is still experimental as the final study is not complete. As a result, the panel of experts struggled with a list of questions that have not yet been answered.
While the vaccine, for example, is more than 90% effective in blocking the symptoms of COVID-19, FDA advisers stressed that it is not yet clear whether it can stop the silent, asymptomatic spread that accounts for up to half of all cases.
“Although the individual effect of this vaccine is very, very, very high, you currently have no evidence” that it will slow down transmission, “said Dr. Patrick Moore of the University of Pittsburgh. He urged Pfizer to take further steps to answer that question.
The advisers also worried that Pfizer will lose its chance to answer critical questions when it starts offering the real vaccine to study participants who have so far received dummy shots.
The company suggested that patients be gradually transferred to the vaccine group, with priority based on age, health status and other factors. According to that plan, 70-year-old participants would go over before healthy 30-year-olds.
Pfizer still needs to show if the vaccine works in children under 16 and in pregnant women.
On the security front, when widespread vaccinations begin, the first recipients will be closely monitored by state health authorities as studies on tens of thousands of people cannot detect rare risks that hit 1 in a million. Hanging over the meeting were the British allergic reactions and a warning from the authorities there that people with a history of serious reactions would not receive the vaccine at the moment.
Britain warns people with serious allergies to avoid Pfizer vaccine after two side effects
Pfizer’s representatives said they had not seen any signs of allergic reactions in their trial. But some FDA advisers fear that the British warning will deter millions of Americans with allergies who may benefit from the COVID-19 vaccine from giving it a try and called for further studies to try to solve the problem.
“This issue will not die until we have better data,” Offit said.
(AP)
