FDA advisers to meet to discuss COVID-19 shots for kids, vaccines for fall

(NEW YORK) — In the wake of Pfizer’s new pediatric COVID-19 vaccine data for children under the age of 5, which was released on Monday, the Food and Drug Administration has set new, tentative dates for when its advisers will meet to discuss the COVID-19 vaccine applications for children.

The FDA said it expects its independent Vaccines and Related Biological Products Advisory Committee to convene in mid-June to discuss both Pfizer and Moderna’s pediatric COVID-19 vaccines.

“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members,” Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, said in a statement on Monday.

Although children 5 years and older already have access to a COVID-19 vaccine — and now a booster shot — through Pfizer’s two-dose vaccine, on June 14, the committee will meet to discuss Moderna’s emergency use authorization request for children ages 6 to 17 years of age.

The next day, on June 15, the committee will meet to discuss both Moderna’s emergency authorization request for children ages 6 months to under 6 years of age and Pfizer and BioNTech’s authorization request for children ages 6 months to under 5 years of age.

The new dates confirm the FDA anticipates that its advisers will review both Moderna and Pfizer’s applications for young children at the same time, which would indicate that both vaccines could be authorized by the end of June.

The FDA emphasized the dates are tentative, but officials noted that should any of the submissions be completed in a “timely manner and the data support a clear path forward following our evaluation,” the agency will move forward and convene the committee at an earlier or later date.

On June 8, 21 and 22, the FDA has held dates for its advisers to meet to discuss updates to the Moderna and Pfizer-BioNTech emergency use authorization requests. As more data and information is submitted by the companies, additional scheduling details will be released, officials wrote.

“The agency is committed to a thorough and transparent process that considers the input of our independent advisers and provides insight into our review of the COVID-19 vaccines. We intend to move quickly with any authorizations that are appropriate once our work is completed,” Marks said.

Ahead of an anticipated fall and winter surge, the FDA also announced new dates for the committee to discuss a possible new generation of COVID-19 vaccines, which could address already circulating variants.

The FDA also plans to convene its advisers on June 28 to discuss whether the COVID-19 strain composition of the vaccines should be modified for the fall.

Federal regulators are expected to decide on a new COVID-19 vaccine design in early July, which would allow vaccine companies to begin production for rollout this fall and winter.

“We’ll have to make some decision by early July to make sure that the manufacturers know what we’re looking to do, so that they know what they have to start producing in large quantities,” Marks told ABC News in an interview, last week.

Additionally, the FDA’s advisers are expected to meet on June 7 to discuss an EUA request for a COVID-19 vaccine manufactured by Novavax to protect against COVID-19 in individuals 18 years of age and older.

Novavax asked for emergency authorization of its protein-based vaccine earlier this year in January.

Novavax was part of the Trump administration’s Operation Warp Speed — the multibillion-dollar program that was created at the onset of the pandemic to quickly bring safe and effective vaccines to market.

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