A committee of independent experts is scheduled to be convened by the American Medicines Agency (FDA) in June to review extending Pfizer and Moderna’s anti-Covid vaccine to babies as young as six months old.
Moderna submitted Thursday to the FDA for approval of its vaccine for children ages 6 months to 5 years, and Pfizer is expected to do the same for children ages 6 months to 4 years in June. This age group is the last to remain unvaccinated in the United States, as well as many other countries. However, the timetable for a possible approval has so far been unclear.
For these vaccines to be approved, the clinical trial data provided by the companies must first be reviewed by a panel of experts before the FDA makes its decision.
On Friday, the American agency announced that it is planning several meetings of this committee on June 8, 21 and 22 to “discuss approvals for the emergency use of vaccines against Covid-19 from Pfizer and Moderna, including the younger ones Populations,” it said in a statement.
conversations
These dates “are preliminary” and could be revised, the agency said, knowing that the application files are not yet complete.
Since Moderna’s vaccine is not currently approved for children under the age of 18 in the United States, one of these meetings could also be dedicated to its expansion to adolescents.
The FDA has also indicated that the committee will meet on June 7 to review an application for approval of the Novavax vaccine for people ages 18 and older. This would add a fourth vaccine approved in the US after those from Pfizer, Moderna and Johnson & Johnson.
Finally, the same committee was scheduled to meet on June 28 to decide on the strain of virus that will be used to develop the current vaccines and whether it “needs to be modified, and if so, which strain(s) should (in ) )t fall 2022”.
Vaccines “harmonize”?
Vaccines are currently based on the parent strain of the virus and have therefore proven less effective against the variants that have emerged over time.
During a meeting of this committee in early April on the same topic of updating vaccines, the American experts said they wanted to decide for themselves which strain to use if modified. In their opinion, this practice would make it possible to harmonize the products marketed by the different companies. This is done every year with the flu shots.
However, experts had also raised many questions about the feasibility of such a strategy, including the difficulty of predicting in advance the variant that will be in circulation next fall.