FDA May Decide Soon If All Adults Are Eligible For Pfizer’s Covid-19 Booster Vaccine

(Trends Wide) — Key decisions about whether all adults will be eligible for a booster dose of the covid-19 vaccine could come soon.

The U.S. Food and Drug Administration (FDA) is currently considering Pfizer and BioNTech’s request to amend the emergency use authorization for their COVID-19 vaccine so that all adults are eligible for a booster dose.

Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, told Trends Wide that the application was the center’s “top priority.”

On Tuesday, the agency confirmed that its vaccine advisers, the Advisory Committee on Vaccines and Related Biologicals, will not be convened to consider the US booster decision, meaning the FDA clearance decision could come at any time. .

“While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the application as quickly as possible,” FDA spokeswoman Alison Hunt told Trends Wide.

Also Tuesday, CDC spokesman Jason McDonald said the Advisory Committee on Immunization Practices of the U.S. Centers for Disease Control and Prevention (ACIP) will meet on Friday. to discuss expanding booster eligibility for Pfizer’s covid-19 vaccine. CDC vaccine advisers generally meet only after a vaccine has received FDA clearance.

If the FDA authorizes boosters for all adults and CDC’s vaccine advisers support their recommendation, CDC Director Dr. Rochelle Walensky must approve the recommendation before they can be officially administered.

However, most adults are already eligible for boosters. The FDA has already authorized boosters for anyone 65 years of age or older who has been vaccinated at least six months ago and for certain adults at high risk of infection or serious illness.

Recent studies suggest that while vaccination still provides strong protection against serious illness and death months later, immunity may begin to wane and protection against milder, asymptomatic illnesses may wane. Studies also show that booster doses restore that immunity.

And with the increase in COVID-19 cases, some states and cities are choosing not to wait for official approval from the FDA or CDC, and have already opened boosters to all adults.

Need for transparency about vaccines

FDA vaccine advisers generally meet to discuss a request for an amendment to an EUA and make a recommendation on how the agency should proceed. This time, the FDA has concluded that the Pfizer / BioNTech application does not raise questions that require further discussion by the advisory committee, which is made up of experts who do not work for the agency.

Dr. Arnold Monto, acting chairman of the FDA advisory committee, told Trends Wide last week that there is precedent for the FDA choosing not to consult its vaccine advisory committee on certain decisions. And he noted that committee members meet “at the FDA’s discretion” and that it can be “cumbersome” to convene members, making it difficult to respond quickly to changing circumstances.

But Dr. Paul Offit, a member of the FDA’s vaccine advisory committee, told Trends Wide last week that he thought the FDA-CDC vaccine advisory meetings were “the best way to be transparent” about the boosters of the covid-19 vaccine.

“I think we need to show why a booster dose is clearly beneficial for 18-29 year olds, because if it is not clearly beneficial, we must consider the fact that myocarditis was a second dose phenomenon and it can also be a second dose phenomenon. of the third dose. Do the benefits clearly and definitely outweigh the risks for 18-29 year olds? “said Offit.

Dr. Grace Lee, a member of the CDC’s Vaccine Advisory Committee, noted that the ACIP meeting will give the public a view of the vaccine’s booster data once it has been cleared by the FDA.

“We know that Pfizer submitted an application to the FDA and anticipated that as soon as the FDA has made a decision, ACIP will discuss this in an open meeting where the public can see all available data,” said Lee, a pediatrician at the School of Medicine of Stanford University.