By Lauran Neergaard and Matthew Perrone - The Associated Press
The Food and Drug Administration (FDA, for its acronym in English) is holding an open meeting to the public with independent experts this Friday to evaluate whether it approves a third dose of the COVID-19 vaccine from the Pfizer-BioNTech laboratory .
The FDA released much of the evidence Wednesday that its advisory group will examine.
The agency took a decidedly neutral tone on the rationale for booster shots, an unusual and prudent approach made even more surprising after President Joe Biden and his top health advisers announced a booster campaign they hoped for. start next week.
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Pfizer's argument: While protection against severe disease remains strong in the United States, immunity against the mildest infection wanes six to eight months after the second dose.
The company administered an additional dose to 306 people and recorded levels of antibodies that fight the virus three times higher than after the first injections.
Most importantly, according to Pfizer, those antibodies appear to be strong enough to deal with the extra-contagious delta variant that is emerging across the country.
To bolster its case, Pfizer pointed to the data from Israel to the FDA, which began offering reinforcements over the summer.
That study followed about a million people aged 60 and over and found that those who got vaccinated were much less likely to become infected soon after.
Pfizer said that translates to "about 95% efficacy" when the delta was spreading, comparable to the protection seen shortly after the vaccine was launched earlier in the year.
Israeli data, also published Wednesday in the New England Journal of Medicine, cannot say how long the enhanced protection lasts.
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However, FDA reviewers suggested that they focus primarily on research on how vaccines work among Americans, saying it "may more accurately represent the efficacy of the vaccine in the American population."
The data shows that Pfizer and other US-licensed COVID-19 vaccines "continue to offer protection against severe COVID-19 disease and death in the United States," the agency said.
Pfizer-BioNTech COVID-19 vaccine at a Reading Area Community College clinic in Reading, Pennsylvania, Tuesday, Sept. 14, 2021.AP Photo / Matt Rourke
The FDA is not required to follow the advice of its independent advisory panel.
But if the agency ignores its own experts, that could add to public opinion confusion.
Earlier this week, two of the FDA's top vaccine regulators joined a group of international scientists in rejecting booster vaccines now for otherwise healthy people, citing continued strong protection against serious disease.
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Dr. Anna Durbin of the Johns Hopkins School of Public Health said it's important to understand that the FDA's decision is simply whether an extra dose is safe and does what it promises: boost immunity levels.
If the FDA decides that the extra shot does both of those things, then the Centers for Disease Control and Prevention (CDC) will have to decide who should get another dose.
The CDC has scheduled a meeting with its own advisers for next week and said they are considering boosting certain individuals - such as older adults, nursing home residents, and frontline healthcare workers - rather than to the general population.
The question is broader: "What is really going to control the delta variant is the vaccination in the unvaccinated people, not the boosters," Durbin said.
According to CDC data, more than a third of Americans who qualify for vaccines are not yet fully vaccinated.
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The United States already offers an extra dose of Pfizer or Moderna vaccines to people with severely weakened immune systems.
For the average citizen, what is the evidence that immunity is waning?
The CDC says the data reveals that protection against serious illness, hospitalizations and deaths remains strong.
However, in a recent study, protection against infection was lowered as the delta variant became present: it was 91% in spring, but 78% in June and July.
The CDC has also seen an indication that, for people 75 and older, protection against hospitalizations decreased slightly in the summer.
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Moderna has also asked the FDA to allow a booster dose of its vaccine, and on Wednesday published its own study on lowering immunity.
The researchers compared about 14,000 people in Moderna's 2020 vaccine study who had received a first dose about a year ago with another 11,000 vaccinated last winter, about eight months ago.
When the delta variant soared in July and August, Moderna concluded that the more recently vaccinated group had a 36% lower rate of infections compared to those vaccinated longer ago.
It is unclear when the FDA will consider a Moderna booster dose or for people who received the Johnson & Johnson single dose.