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An advisory panel from the US Food and Drug Administration recommended emergency approval of a Covid-19 vaccine developed by Pfizer and BioNTech.
The recommendation is expected to indicate that the first approval of a Covid-19 vaccine for use in the US is imminent. That would mark a major milestone in a pandemic that has killed more than 285,000 Americans and 1.5 million people worldwide.
If the FDA grants emergency approval, the US would be the third country in the world to have licensed the use of the Pfizer / BioNTech vaccine to a wider audience behind the UK and Canada, and will be the most populous country to do so. .
In more data on the vaccine published in the New England Journal of Medicine on Thursday, Pfizer and BioNTech said the vaccine was 95% effective in a randomized controlled trial of more than 43,000 people. An accompanying editorial in the magazine described the development of the vaccine as a “triumph” for science.
“Most vaccines have taken decades to develop, but it is likely that this will go from conception to full-scale implementation within a year,” wrote Dr. Eric J. Rubin, editor-in-chief of the journal, co-author of the editorial. .
The vaccine uses messenger RNA technology to introduce the spike protein found on the outside of the coronavirus into the body to elicit an immune response. It requires two doses, given three weeks apart.
Scientists are still studying how long the vaccine will protect people, the safety and efficacy of the vaccine in children and pregnant women, and the rate of asymptomatic disease in vaccine recipients.
In a post-vote statement, Joe Biden called the move “a bright light in an unnecessarily dark time.”
However, the president-elect also pointed out that “vaccines are not the same as vaccines.”
“Our challenge now is to expand manufacturing and distribution to deliver 100 million injections in the first 100 days of my administration,” he said. “Before taking office, we need the Trump Administration to buy the doses it has negotiated with Pfizer and Moderna and work quickly to scale manufacturing for the American population and the world. And we will need Congress to fund our distribution efforts. “
The vote was not free of late dissent. Four of the 22 members of the panel voted against issuing an emergency authorization, after a late debate on whether to remove 16- and 17-year-olds from the authorization.
Some experts argued that the data on this subgroup was “sparse” and that the panel should recommend further study. But others said the safety and efficacy data to date were sufficient for emergency use, especially since this group is unlikely to receive the vaccine for months due to supply limitations.
“We have clear evidence of benefit and everything we have on the other side is a theoretical risk,” said Dr. Paul Offit, a vaccine expert at Philadelphia Children’s Hospital.
Another major concern for the panel was how to proceed with blinded, placebo-controlled trials if the FDA issues an emergency clearance, as expected. This is because once an emergency authorization is issued, it would be unethical to prevent trial participants from finding out if they received a placebo and ultimately receiving the vaccine.
The FDA could approve the vaccine for emergency use at any time after the advisory committee meeting, and the Trump administration is pushing for it to be approved quickly. But the FDA should note that it is giving due consideration to safety and efficacy concerns. Vaccines generally have a higher approval bar than many drugs, because they are given to healthy adults.
Approving a vaccine too quickly could stoke public skepticism and lead to higher levels of vacillation. Too slow approval puts more lives at risk. More than 2,000 Americans per day and 80 Americans per hour die from the virus. The FDA takes the actions recommended by its advisory panels about 78% of the time, according to a recent study by the Milbank Quarterly.
The panel’s recommendation comes as the pandemic is pushing the US healthcare system to the brink. More than 192,000 Americans a day are diagnosed with Covid-19, hospitals in several states are full, and healthcare workers are exhausted. This week, for the first time in the pandemic, more than 3,000 people died from Covid-19 in one day.
But the U.S. Centers for Disease Control and Prevention (CDC) consider a terrible figure, which said at the advisory committee meeting Thursday that reported infections, hospitalizations and deaths are likely to be. two to seven times lower than the actual number of the virus.
“The underreporting of deaths, for example, has changed over time,” said Dr. Aron Hall, chief of the CDC’s respiratory viruses branch. But he added: “The reported number of deaths is probably an underestimate of the actual number of deaths.”
The CDC estimates that Covid-19 has caused 2.4 million hospitalizations, 44.8 illnesses, and 52.9 million infections. Infection rates are expected to rise as people infected over the Thanksgiving holiday get sick and people gather for Christmas despite warnings from health experts not to.
But even if the approval of any vaccine would be a landmark achievement, set a record for vaccine development, and bring new technology to the public, it will not be a silver bullet to end the pandemic.
Extremely limited supplies of the Pfizer vaccine mean that only about 20 million people will be vaccinated at first. A CDC advisory committee has recommended that states allocate these limited supplies to health care workers and the elderly living in long-term care facilities, a combined roughly 23 million people.
That means Americans will have to maintain social distance, wear masks, wash their hands and avoid crowds, even as the vaccine brings containment of the virus a surprising distance.
Additionally, Pfizer’s vaccine presents extreme logistical challenges, because it must be stored at -94 ° F (-70 ° C), transported on dry ice in specialized containers, staff must be trained in how to handle these containers, and the vaccine can be shipped in amounts not required. less than 975 doses.
With this in mind, experts hope that a second vaccine, just a week late in the approval process, will also be recommended for approval soon. The second vaccine is developed by the National Institute of Allergy and Infectious Diseases and Modern. A hearing for that vaccine candidate is scheduled for December 17.
