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FDA experts to evaluate Pfizer-BioNTech COVID-19 booster

As Moderna announces it has submitted COVID-19 vaccine booster data, the FDA advisory committee of outside experts will convene in two weeks’ time

The race to approve a third booster shot of Pfizer-BioNTech vaccine may well be a photo finish, as the FDA announces that its expert panel will convene just three days before the Biden Administration said the booster programme is to begin.

On 25 August, Pfizer/BioNTech announced the initiation of a supplemental biologics licence application to the US Food and Drug Administration (FDA) for a booster dose of Comirnaty, stating they expected the complete the submission by the end of this week.

The hastily arranged advisory committee follows the announcement that both the director of the FDA’s Office of Vaccines Research & Review, Marion Gruber, and the deputy director, Philip Krause, will leave office within weeks.

“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 FDA completing an independent evaluation and determination of the safety and effectiveness of these additional vaccine doses,” said Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation.

Marks stressed that a “transparent, thorough and objective review” was critical to give both the medical community and the public confidence in the COVID-19 vaccines, and that the FDA review will be done “as expeditiously as possible”.

The panel’s primary purpose is to review the data submitted by Pfizer-BioNTech but “should the data received from other manufacturers raise unique questions”, the FDA will “consider additional public discussions”, said Marks.

The expert panel session will also be public, livestreamed on the FDA’s YouTube channel, offering what the Washington Post calls “much-needed clarity and transparency to a decision-making process that some people have criticized as confusing”.

Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia and a member of the panel, has questioned whether boosters are needed at this time, when current data suggests the initial doses of the vaccines remain effective against severe COVID-19.

Given the heated political environment around the issue, it has been suggested that the panel’s discussions will touch on wider issues than just the data, including ethical considerations of a booster programme when billions in poorer countries remain unvaccinated.

In announcing its submission of data to the FDA, Moderna CEO, Stéphane Bancel, said the 50 µg dose of its COVID-19 vaccine showed “robust antibody responses against the Delta variant” and the company remained “committed to staying ahead of the virus”.

Article by
Hugh Gosling

3rd September 2021

From: Research, Regulatory



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