The Food and Drug Administration could approve COVID-19 shots for children under 6 as early as June after key meetings of its outside advisers, now tentatively scheduled for this month. It could also get the green light for a new COVID vaccine from Novavax in June.
Meetings of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) are now scheduled up to four times in June to consider a variety of COVID-19 vaccine applications pending at the agency, the FDA announced 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,” said Dr. Peter Marks, the FDA’s chief vaccine official, in a statement.
VRBPAC meetings mark the final step before the FDA approves emergency use authorization requests.
While the agency is not required to follow committee votes and has on occasion skipped panel consultation for some prior approvals, a green light from advisors generally paves the way for the FDA to open recordings within days of the meeting Clear.
“The agency is committed to a thorough and transparent process that takes into account input from our independent consultants and provides insight into our review of COVID-19 vaccines. We intend to move quickly with all appropriate permits once our work is complete.” Mark added.
Now that the FDA has issued new emergency use authorizations, the Centers for Disease Control and Prevention are also having to weigh up before shots can be introduced. A spokesman for the CDC said the agency plans to ask its advisers to also weigh before issuing new recommendations for these vaccines.
Vaccine for children under 5 years old
The FDA says the committee could meet as early as June 8 to discuss requests for emergency use of 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 plans to complete filing data on its lower-dose childhood vaccines by the end of next week. Pfizer and BioNTech say they could have results from their three-dose study in children by June.
The FDA is likely already reviewing data on Moderna’s vaccine manufacturing to be submitted a month before the company’s request.
However, FDA officials have indicated that reviewing Moderna’s formal filing — which includes everything from safety and efficacy data to the details of vial labeling and delivery — could take longer than that of Pfizer and BioNTech because the filing is a larger age group.
The population in Moderna’s application – children under the age of 6 – is also larger than those of Pfizer and BioNTech, which are already approved for children as young as 5 years of age. Moderna has also provided the agency with new safety data from older age groups and said it would renew its push for approval of its vaccine in adolescents after concerns about rare but serious heart inflammation side effects delayed its use last year.
“As sponsors complete their submissions and the FDA reviews this data and information, it will provide additional details for scheduling VRBPAC meetings to discuss each EUA application,” the agency said.
Novavax vaccine
On June 7, the panel could meet to consider Novavax’s application for emergency use authorization of its COVID-19 vaccine in adults. The Novavax vaccine is already approved in more than three dozen countries, including across Europe, the company says.
If the FDA gives the green light, federal officials have hoped the protein-based vaccine could pave the way to vaccination for a handful of holdouts who are still reluctant to take Moderna’s or Pfizer’s and BioNTech’s mRNA vaccines.
Novavax injections are also being studied in a variety of federally sponsored booster shot studies, including for adolescents, as well as the National Institutes of Health mix-and-match boosting research.
Novavax’s filing for approval of its “protein subunit” vaccine was filed months ago, at the end of January. FDA officials have acknowledged the request for the recordings and dismissed allegations that the regulator was slow to review the company’s filing.
“This is an incredibly complex review process, reviewing not only clinical data but also manufacturing data needed to make an emergency approval decision,” said Dr. The FDA’s Doran Fink addressed the CDC’s outside vaccine advisors earlier this month.
Alignment with future tribes
Later in the month, on June 28, the FDA says it will ask the panel to meet again to discuss the possibility of selecting a new strain as a target for the COVID-19 vaccines before a deadly new wave will arrive, experts are warning of this fall or winter.
The committee met on April 6 to discuss the issue.
Both Moderna, Pfizer and BioNTech have been investigating a range of new COVID-19 vaccines adapted to different or multiple variants, including Omicron, which could serve as a fourth dose for the general population.
A panel of experts convened by the World Health Organization is also considering recommendations, similar to the process countries around the world already rely on to coordinate annual flu shots.
However, it’s unclear if the group will release their decision in time for the fall. The conversion of factories making new COVID-19 vaccines could take months, experts warned the committee, demanding a decision by early summer.
Among the risks of reformulating the vaccines, moving to an Omicron-adapted vaccine could also reveal susceptibility to other future variants that could carry very different mutations from the current Omicron BA.1 and BA.2 strains found in the spread to the United States, experts warned the committee.
Gathering data on the new vaccines will also pose a challenge for regulators, given the uncertainties in measuring the immune protection that current vaccines provide and the rapidly changing landscape of new variants.
“At the end of our process, our goal here is really to stay ahead of future variants and outbreaks and make sure we’re doing our best to reduce the number of illnesses and deaths from COVID-19 in our population,” he said Marks concludes the April meeting.
More Alexander Tin