The Food and Drug Administration could authorize COVID-19 vaccine shots for children under 6 years old as early as June following key meetings of its outside advisers now tentatively scheduled for that month. It could also greenlight a new COVID vaccine from Novavax in June.
Meetings of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) are now planned as many as four times in June to weigh a myriad of COVID-19 vaccine requests pending before the agency, the FDA said Friday.
“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, the FDA’s top vaccines official, said in a statement.
Meetings of the VRBPAC mark the final step before the FDA grants requests for emergency use authorization.
While the agency is not required to follow the committee’s votes, and has occasionally skipped consulting the panel for some previous authorizations, a green light from the advisers generally paves the way for the FDA to clear the shots within days after the meeting.
“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,” added Marks.
After the FDA grants any new emergency use authorizations, the Centers for Disease Control and Prevention must also weigh in before shots can be rolled out. A spokesperson for the CDC has said the agency plans to ask its advisers to weigh in as well before issuing new recommendations for these vaccines.
Vaccine for children 5 and under
As early as June 8, the FDA says the committee could meet to discuss emergency use authorization requests for COVID-19 vaccines in the youngest children. The agency is also holding open dates on June 21 and 22 to potentially weigh the requests.
Moderna says it plans to complete submitting data on its lower-dose shots for children by the end of next week. Pfizer and BioNTech say they could have results from their trial of three doses in kids by June.
The FDA is likely already scrutinizing data around Moderna’s vaccine manufacturing, which must be submitted a month ahead of the company’s request.
However, FDA officials have hinted that vetting Moderna’s formal submission — which spans everything from safety and efficacy data to the details of how vials will be labeled and supplied — could take longer than Pfizer and BioNTech because its submission spans a larger age group.
The population in Moderna’s request — children under 6 years old — is also larger than Pfizer and BioNTech’s, which is already authorized for children 5 and older. Moderna has also been submitting new safety data to the agency from older age groups and has said it plans to renew its push for authorizing its vaccine in adolescents, after concerns of rare but serious heart inflammation side effects stalled its application last year.
“As the sponsors complete their submissions and the FDA reviews that data and information, it will provide additional details on scheduling of the VRBPAC meetings to discuss each EUA request,” the agency said.
Novavax vaccine
On June 7, the panel could meet to discuss a request from Novavax for emergency use authorization of its COVID-19 vaccine in adults. The Novavax vaccine is already authorized in more than three dozen countries, the company says, including across Europe.
If greenlighted by the FDA, federal officials have said they hoped the protein-based vaccine could pave the way to vaccinating a handful of holdouts still hesitant to take the mRNA vaccines from Moderna or Pfizer and BioNTech.
Novavax’s shots are also being studied in a variety of government-backed booster shot trials, including for adolescents, as well as in the National Institutes of Health’s mix-and-match boosting research.
