The U.S. Food and Drug Administration (FDA) is planning to authorize booster doses of Pfizer-BioNTech’s COVID-19 vaccine for all adults as early as Thursday, according to a report from The New York Times.
This means that all fully vaccinated adults aged 18 and older will be able to receive the extra dose six months after their final dose.
An advisory committee to the Centers for Disease Control and Prevention (CDC) is planning to meet on Friday to discuss data on the booster shot.
However, if both the FDA and CDC greenlight boosters, it will be much more quickly than the original vaccines were authorized, with Pfizer submitting data just a week ago.
If authorization is given, the Pfizer booster will be the second to receive authorization for all American adults behind Johnson & Johnson‘s booster.
The FDA is planning to authorize Pfizer-BioNTech’s COVID-19 vaccine booster shot for all U.S. adults as early as Thursday. Pictured: Pharmacist Ryan Le (left), gives Jim Canales, 78, of Fullerton a booster shot of Pfizer-BioNTech vaccine at McDonald’s, September 2021
The companies applied for emergency use authorization of their booster just one week ago. Pictured: The sign outside the Food and Drug Administration (FDA) headquarters
In late August, the White House announced plans to make the additional shots available on September 20, though the plan ran into a few speedbumps.
At the time, Pfizer said its early data suggested people who received booster doses between six and 12 months after their final dose had high levels of protection.
The documents suggest that protection from two doses of the Pfizer vaccine declines from 96.2 percent at seven days after dose 2 to 90.1 percent two months later to 83.7 percent up to six months later.
What’s more, Pfizer cited data from Israel showing people fully vaccinated in January 2021 had a 2.26-fold increased risk for breakthrough infections compared to those fully vaccinated in April 2021.
The team also released data from a clinical trial involving 23 participants who participated in Pfizer’s early-stage trials last year.
Each had received two doses of the vaccine and were given a booster dose at least six months later.
Of the participants, 11 were in the younger adults group of those aged 18 to 55 and 12 were aged 65 to 85.
After the third dose, neutralizing antibodies against the original strain of the virus rose five-fold in the 18-to-55 age group and seven-fold in the 65-to-85 group.
However, on September 17, the FDA’s independent panel of experts, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted 16-2 against the shots’ authorization.
The main concern cited by the experts was that the vaccines were still shown to be highly effective against severe disease and illness.
Pfizer said data suggested efficacy of two doses declines from 96.2% to 83.7% after six months but that a third dose boosts antibody levels (above)
The committee was also concerned about the risk of rare heart inflammation cases for people under the age of 30 who receive the jab.
Members did not believe the risk of the condition was worth it for age groups who had little risk of complications from the virus anyways.
Some of the experts also expressed concerns about lowering the eligible age to 40 or 50.
Many critics of the White House’s booster shot plan also believe that the nation should instead focus on donating vaccine doses overseas, as preventing virus spread in low income nations can prevent new variants from forming.
A variant that develops in a nation with a low vaccination rate can quickly become a problem for Americans, and cause outbreaks stateside, like the Indian-born Delta variant did over summer.
The committee did unanimously vote to recommend Pfizer booster shots for all Americans 65 and older, though, and later extended the recommendation to include all people with serious comorbidities or with a job that puts them at risk of Covid exposure as well.
The FDA is expected to decide on boosters without consulting VRBPAC, however.
Dr Arnold Monto, the chairman of VRBPAC and an epidemiologist at the University of Michigan, told CNN that the process of holding the meeting for every approval could be cumbersome.
‘In a dynamic situation, it’s very cumbersome to be convened – we have to be screened every time for conflicts of interest and everything else that’s needed to have a meeting – all the legal niceties,’ Monto said.
‘Our role is to advise on overall policy and to leave the details to the FDA because one, we are advisory, and two, we cannot, the way we are set up, respond quickly to changing circumstances.’
While VRBPAC’s recommendations are not binding, the FDA will rarely make a decision that disagrees with the committee.
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