Covid-19 vaccine for children under 5 could come as early as June, FDA’s latest

CNN
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Covid-19 vaccines could be authorized for the United States’ youngest children as early as June, according to the US Food and Drug Administration’s latest meeting schedule.

The agency announced Friday it is reserving dates in June for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to meet to discuss updates to vaccine makers Moderna and Pfizer/BioNTech’s emergency use authorizations that would include making younger ages eligible for Covid-19 vaccination.

Tentative meeting dates for VRBPAC are June 8, 21 and 22.

Following the advisory committee’s deliberations, FDA officials could consider authorizing vaccines for younger children — with that decision also hinging on the agency’s reviews of the vaccine data.

“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 FDA’s Center for Biologics Evaluation and Research, said in Friday’s announcement.

“We are providing a tentative schedule for discussion of these submissions, as these meetings will cover a number of topics that are of great interest to the general public,” Marks said. “The agency is committed to a thorough and transparent process that considers the input of our independent advisors 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.”

It has been more than a year since adults first became eligible to receive Covid-19 vaccines in the United States, and currently, children 5 and older are eligible to get vaccinated. But no Covid-19 vaccines have been authorized yet for children younger than 5 in the US – about 18 million people – and, even though FDA advisers plan to meet in June, an exact timeline for potential authorization is still not clear.

Moderna officials have said the FDA is expected to move fast, and a Pfizer official suggested its vaccine for younger children could be available in June, if it’s authorized.

The timeline for making Covid-19 vaccines available for children under 5 hit somewhat of a delay earlier this year when a VRBPAC meeting to discuss the Pfizer/BioNTech vaccine in February was postponed so that additional data on vaccines for this age group could be reviewed.

At the time, the FDA was waiting for Pfizer and BioNTech to submit data from an ongoing trial on a three-dose regimen in these younger children before moving forward with consideration of an emergency use authorization, allowing the FDA to review all data available on the efficacy of each regimen option: two doses or three doses.

If the original meeting had occurred in February, the committee would not have seen all available data to have an informed discussion. The latest clinical trial data from Pfizer/BioNTech suggests that…