FDA is planning to authorize Pfizer’s COVID-19 vaccine booster for all adults aged 18 and older as early as Thursday

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  • FDA plans to authorize Pfizer-BioNtech’s COVID-19 vaccine booster shot for all US adults as early as Thursday
  • The companies applied for emergency use authorization for their boosters just a week ago
  • Pfizer’s booster is currently only approved for Americans age 65 and older, those with underlying conditions or with a job that puts them at higher risk.
  • The agency is taking decisions without the advice of the advisory committee as ‘one meeting for every approval can be cumbersome’, the chairman said.

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The US Food and Drug Administration (FDA) is planning to authorize a booster dose of Pfizer-BioNtech’s COVID-19 vaccine as early as Thursday for all adults, according to a report from T.The New York Times,

This means that all fully vaccinated adults age 18 and older will be able to receive an additional dose for six months after their last dose.

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An advisory committee from the Centers for Disease Control and Prevention (CDC) plans to meet on Friday to discuss the booster shot data.

However, if both the FDA and CDC Greenlight the booster, it would be authorized much more quickly than the original vaccines, Pfizer submitted data just a week ago.

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If granted authorization, the Pfizer booster would be the second to receive authorization for all US adults, behind Johnson & Johnson’s boosters.

The FDA plans to authorize Pfizer-BioNtech’s COVID-19 vaccine booster shot for all US adults as early as Thursday. Pictured: Pharmacist Ryan Lay (left) gives Jim Canales, 78, of Fullerton, a booster shot of the Pfizer-BioNtech vaccine at McDonald’s, September 2021

The companies applied for emergency use authorization for their boosters just a week ago.  Image: Sign outside Food and Drug Administration (FDA) Headquarters

The companies applied for emergency use authorization for their boosters just a week ago. Image: Sign outside Food and Drug Administration (FDA) Headquarters

In late August, the White House announced plans to make additional shots available on September 20, although the plan ran into some speedbumps.

At the time, Pfizer said its initial data showed that those who received a booster dose between six and 12 months after their last dose had higher levels of protection.

NS documents The suggestion is that protection from two doses of the Pfizer vaccine decreases from 96.2 percent at seven days after dose 2 to 90.1 percent after two months to 83.7 percent after six months.

What’s more, Pfizer cited data from Israel showing that people who were fully vaccinated in January 2021 had a 2.26-fold increased risk for breakthrough infection compared to those who were fully vaccinated in April 2021.

The team also released data from a clinical trial involving 23 Participants who took part in Pfizer’s early-stage trials last year.

Each had received two doses of the vaccine and was given a booster dose at least six months later.

11 of the participants were in Young adult groups aged 18 to 55 and 12 were aged 65 to 85.

After the third dose, neutralizing antibodies against the original strain of the virus increased five-fold in the 18 to 55 age group and seven-fold in the 65 to 85 age group.

However, on September 17, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), an independent panel of experts from the FDA, voted 16-2 against authorization of the shots.

The main concern cited by experts was that vaccines were still shown to be highly effective against serious illness and disease.

Pfizer said the data shows the efficacy of two doses decreases from 96.2% to 83.7% after six months, but the third dose increases antibody levels (above)

Pfizer said the data shows the efficacy of two doses decreases from 96.2% to 83.7% after six months, but the third dose increases 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 didn’t believe the risk of the condition was worth it for the age groups, who had a much lower risk of complications from the virus anyway.

Some experts also expressed concern over reducing 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 new forms of the virus are prevented from forming in low-income countries. can be stopped.

One variant that develops in a country with low vaccination rates could quickly become a problem for Americans, and cause outbreaks in the states, as the Indian-origin Delta version did over the summer.

The committee voted unanimously to recommend Pfizer booster shots for all Americans 65 and older, and later extended the recommendation to include all people with severe comorbidities or those with jobs that put them at risk for COVID-19. as well as putting them at risk.

However, the FDA is expected to make a decision on the booster without consulting VRBPAC.

Dr. Arnold Monto, president of VRBPAC at the University of Michigan and an epidemiologist CNN That the process of holding a meeting for every approval can be cumbersome.

“In a dynamic situation, it’s too cumbersome to call it out – we have to check every time everything necessary for a conflict of interest and meeting – all the legal nuances,” Monto said.

‘Our role is to advise on overall policy and leave the details to the FDA because one, we are consultants, and two, as we are established, we cannot 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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