FDA Announces Dates for COVID-19 Vaccine AdComs Though No Full Applications Are In Yet

May 2, 2022

The FDA has announced tentative dates for its vaccine-related advisory committee to meet to discuss the much-anticipated full applications for Emergency Use Authorization (EUA) that it expects any day from COVID-19 vaccine manufacturers for children under age six.

Moderna announced late last week that it had filed for an EUA of its two-dose COVID-19 vaccine in children less than six years old, though its application won’t be complete until later this week. And Pfizer and BioNTech are expected to file for an EUA next month for a three-dose vaccine in children under five years old. In addition, Novavax’s protein-based COVID-19 vaccine is likely to be considered. The company requested an EUA in January and is working on a rolling submission, a company spokesperson told FDAnews.

The tentative schedule for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings is as follows:

  • June 7: VRBPAC plans to discuss an EUA request for the COVID-19 vaccine manufactured by Novavax to prevent COVID-19 in individuals 18 years of age and older.
  • June 8, 21 and 22: The FDA is holding dates for the VRBPAC to discuss updates to the Moderna and Pfizer-BioNTech EUAs for their COVID-19 vaccines to include younger populations. Added the FDA: as the sponsors complete their submissions and the FDA reviews the data and submissions, it will provide additional details on scheduling of the VRBPAC meetings to discuss each EUA request.
  • June 28: The FDA plans to convene the VRBPAC to discuss whether the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified and if so, which strain(s) should be selected for fall 2022.

The June 28 meeting, said the FDA, is a follow-up to the April 6 VRBPAC meeting that discussed general considerations for future COVID-19 vaccine booster doses and the strain composition of COVID-19 vaccines. The committee intends to confront the issue of whether the population at large will need annual COVID-19 vaccine boosters.

“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,” said Peter Marks, director of the Center for Biologics Evaluation and Research (CBER).

“We intend to move quickly with any authorizations that are appropriate once our work is completed,” he added.

The FDA has been under intense pressure from many sides to expeditiously authorize a COVID-19 vaccine for children aged five and under. Rep. James Clyburn (D-S.C.), chairman of the House Select Subcommittee on the Coronavirus Crisis, wrote to FDA Commissioner Robert Califf last week, requesting a briefing on the status of COVID-19 vaccine candidates for young children. At a subsequent hearing last week, Marks said the FDA would publish a list of vaccine advisory committee dates within days.

New infection numbers released by the Centers for Disease Control and Prevention (CDC) estimate that 75 percent of children and adolescents were infected with COVID-19 from September 2021 to February 2022, a peak period for the Omicron variant.

The agency wrote in its announcement of the upcoming meetings that it understands the urgency to authorize a vaccine for age groups who are not currently eligible for vaccination and said it will “work diligently to complete our evaluation of the data.” — Suz Redfearn