FDA convenes meeting of its advisers to discuss Covid vaccine recalls

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That’s three days before the target date of September 20 to start offering booster doses announced by the White House last month.

The administration recently announced a plan to prepare for additional COVID-19 vaccine doses, or ‘boosters’, this fall, and a key part of that plan is for the FDA to complete an independent assessment and determination of the safety and effectiveness of these additional doses of vaccine, ”said Dr. Peter Marks, who heads the vaccines division of the FDA, in a statement.

Pfizer / BioNTech asked the FDA to approve booster doses for its vaccine last month. Moderna applied on Wednesday.

“The process of authorizing or approving the use of a booster dose of a COVID-19 vaccine involves each vaccine manufacturer submitting safety and efficacy data to the agency for support this use, ”added Marks, who heads the Center for Biologics Evaluation and the FDA. Research (CBER).

“The FDA is evaluating the data submitted by Pfizer-BioNTech in an additional biologic license application for its COVID-19 vaccine and will discuss it with the agency’s advisory committee to inform our decision-making,” Marks added. “If the data received from other manufacturers raises unique questions that would benefit from the committee’s input, the agency intends to consider additional public discussions.”

The FDA fully approved Pfizer’s vaccine last month.

Moments before the FDA released the announcement, vaccine maker Moderna said it had submitted a request to offer booster doses.

“We are delighted to initiate the process of submitting our 50 microgram booster candidate to the FDA. Our submission is supported by data generated with the 50 microgram dose of our COVID-19 vaccine, which shows robust antibody responses against the Delta variant, “Moderna CEO Stéphane Bancel said in a statement.
Two senior FDA vaccine officials step down as agency faces recall decision

This is half a dose – Moderna’s vaccine provides 100 micrograms in each dose for initial vaccinations.

The company used data from a Phase 2 study that boostered 344 interested participants six months after their second dose.

“The titers of the neutralizing antibodies had significantly decreased before being increased to about six months,” the company said. The recall brought antibody levels above what they had set as a baseline for emergency use clearance.

“After a third dose, a similar level of neutralizing titers was achieved in all age groups, especially in the elderly (65 years and older),” the company said.

“The safety profile after Dose 3 was similar to that observed previously for Dose 2 of mRNA-1273. These data will be subject to a peer-reviewed publication.”

Just half a dose of the Moderna vaccine produced abundant antibodies against the variants of concern, including Beta (B.1.351) Gamma (P.1) and Delta (B.1.617.2), the company said.

The effectiveness of the Covid-19 vaccine against serious illness has not declined significantly, CDC says
Whether most Americans still need boosters has been controversial. On Tuesday, the FDA announced that two senior CBER officials were stepping down, and some former FDA staff speculated it was because they were fed up with White House messages that often seemed to anticipate the decisions of the agency.

Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and senior White House adviser, denied this.

“There is no pressure on them to do anything other than the job they do so well,” Fauci told CNN’s Wolf Blitzer Wednesday.

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The Pfizer and Moderna vaccines are given in two doses, so a booster would be a third dose.

“A transparent, thorough and objective review of data by the FDA is essential for the medical community and the public to continue to have confidence in the safety and efficacy of COVID-19 vaccines. The FDA will review the additional request as quickly as possible. , while doing it in a thorough and scientific manner, ”Marks said in the FDA release.

The FDA’s Vaccines and Related Biologics Advisory Committee, or VRBPAC, meets to advise the agency, which typically follows the panel’s recommendations.

“In general, advisory committees include a chair, members with scientific, medical and public health expertise, as well as a consumer and industry representative. Additional members with specific expertise may be added for meetings. individual if necessary, ”the FDA said.

The meeting will be broadcast live.

Earlier this week, the U.S. Centers for Disease Control and Prevention’s Immunization Practices Advisory Committee met to discuss recalls and heard that so far there aren’t many evidence that most people need reminders. The FDA and CDC have approved boosters for some immunocompromised people, but not for the general public.

But several recent studies have indicated that people benefit from a great deal of protection against booster shots. A UC San Diego Health team reported on Wednesday that they were seeing more infections among fully vaccinated health workers.

It certainly means people should start wearing masks and taking other precautions again, they said, even if they are vaccinated. And that could be an argument for boosters, they wrote in a letter to the New England Journal of Medicine.

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