FDA may authorize COVID vaccine for children 5 and under and Novavax vaccine in June
The Food and Drug Administration could authorize COVID-19 vaccine injections for children under 6 as early as June following key meetings of its outside advisers now tentatively scheduled for that month. He could also give the green light to a newin June.
Meetings of the FDA’s Vaccines and Related Biologicals Advisory Committee (VRBPAC) are now scheduled up to four times in June to weigh a myriad of COVID-19 vaccine applications pending before the agency, the agency announced Friday. the FDA.
“As we continue to fight the ongoing COVID-19 pandemic, there are a number of anticipated scientific submissions and questions that will benefit from discussions with our advisory board members,” said Dr Peter Marks, the FDA’s top vaccine official, in a statement. .
VRBPAC meetings mark the final step before the FDA grants emergency use authorization requests.
Although the agency is not required to track committee votes and has sometimes failed to consult the panel for some previous approvals, a green light from advisers usually clears the way for the FDA to clear the shots within days of the meeting. .
“The agency is committed to following a thorough and transparent process that considers input from our independent advisors and provides insight into our review of COVID-19 vaccines. We intend to act quickly with all appropriate permissions once our work is complete”, Marks added.
Once the FDA grants new emergency use authorizations, the Centers for Disease Control and Prevention must also step in before injections can be rolled out. A CDC spokesperson said the agency plans to ask its advisers to step in as well before issuing new recommendations for those vaccines.
Vaccine for children 5 years and under
As early as June 8, the FDA says the committee could meet to discuss requests for emergency use authorization for COVID-19 vaccines in younger children. The agency is also holding open dates on June 21 and 22 to possibly weigh applications.
Moderna says it plans to complete data submission on itsby the end of next week. Pfizer and BioNTech say they could have the results of their three-dose trial in children by June.
The FDA is likely already reviewing Moderna’s vaccine manufacturing data, which must be submitted a month before the company’s application.
However, FDA officials have hinted that vetting Moderna’s official submission — which covers everything from safety and efficacy data to details of how the vials will be labeled and supplied — may take longer. than Pfizer and BioNTech because its submission covers a broader age group.
Moderna’s on-demand population – children under 6 – is also larger than that of Pfizer and BioNTech, which is already licensed for children 5 and older. Moderna also submitted new safety data on older age groups to the agency and said it plans to renew efforts to license its vaccine in adolescents, after concerns about rare but serious side effects from heart inflammation blocked its application last year.
“As sponsors complete their submissions and FDA reviews this data and information, it will provide additional details on scheduling VRBPAC meetings to discuss each EUA request,” the agency said.
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 licensed in more than three dozen countries, the company says, including across Europe.
If given the green light by the FDA, federal officials said they hope the protein-based vaccine could pave the way for vaccinating a handful of resistants still hesitant to take Moderna’s mRNA vaccines. or Pfizer and BioNTech.
Novavax’s vaccines are also being studied in a variety of government-supported booster trials, including for adolescents, as well as in the National Institutes of Health’s mixed stimulation research.
Novavax’s application to license its “protein subunit” vaccine was filed months ago,. FDA officials acknowledged the vaccine request, dismissing accusations that the regulator was slow to verify the company’s submission.
“This is an incredibly complex review process that involves reviewing not only clinical data, but also manufacturing data that will be needed to make a decision on emergency use authorization,” FDA’s Dr. Doran Fink told the CDC’s outside vaccine advisers earlier this month.
Target future strains
Later that month, on June 28, the FDA announced that it would ask the panel to reconvene to discuss the possibility of selecting a new strain to target for COVID-19 vaccines ahead of a new deadly wave that, according to experts, is likely to happen. this fall or winter.
The committee previously met on April 6 to discuss the matter.
Moderna along with Pfizer and BioNTech have studied a range of new COVID-19 vaccines suitable for different or multiple variants, including Omicron, which could serve as a fourth dose for the general population.
An expert committee convened by the World Health Organization is also developing recommendations, similar to the process countries around the world already rely on to coordinate the annual flu shot.
However, it’s unclear whether the group will make its decision in time for the fall. Switching over factories making new COVID-19 vaccines could take months, committee experts have warned, requiring a decision by early summer.
Among the risks of vaccine reformulation, switching to a vaccine suitable for Omicron could also expose vulnerability to other future variants that could have mutations very different from the current Omicron BA.1 and BA.2 strains spreading in the United States. United, experts have warned. .
Collecting data on new vaccines will also pose a challenge for regulators, given the uncertainties surrounding the extent of immune protection offered by current vaccines 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 to make sure that we’re doing our best to reduce the number of illnesses and deaths from COVID-19. on our population,” Marks said in closing. the April meeting.
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