FDA advisory panel set to review COVID-19 booster doses

The FDA announced that an advisory committee will meet on September 17 to discuss the issue of booster doses of COVID-19 vaccines. The Vaccines and Related Biological Products Advisory Committee will specifically look at Pfizer/BioNTech's recent submission seeking approval of a third dose of their vaccine Comirnaty to prevent COVID-19 in people 16 years and older.

Peter Marks, director of the FDA's Center for Biologics Research and Evaluation, said "the administration recently announced a plan to prepare for additional COVID-19 vaccine doses…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." The broad rollout of booster vaccines is slated to get under way as of September 20.

Moderna starts filing

The announcement of the advisory committee meeting came the same day that Moderna said it initiated a submission to the FDA for a booster dose of its COVID-19 vaccine mRNA-1273. Marks noted that "should the data received from other manufacturers raise unique questions that would benefit from the committee's input, the agency intends to consider additional public discussions."

The issue of booster doses, along with when and to whom they should be given, has proven to be a contentious one in the US, with the FDA, Centers for Disease Control and Prevention and government all weighing in on the matter. Earlier this week, the FDA confirmed that two top officials overseeing the review of vaccine applications are set to leave over the next several months, with people close to the matter citing the furore over the booster issue as part of the reason for their departure.

EU sees no "urgent" need for boosters

Meanwhile, on the same day as the FDA meeting was disclosed, the European Centre for Disease Prevention and Control said that there is no "urgent need" to give boosters to people who are fully vaccinated. Despite this, the agency suggested that boosters should be considered for those "who may experience a limited response to the primary series of COVID-19 vaccination, such as some categories of immunocompromised individuals."

For related analysis on the views of doctors to COVID-19 booster doses, read here for the viewpoint of US physicians and here for those in Europe.

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