A committee of independent experts should be convened in June by the American Medicines Agency (FDA) to examine the extension of the anti-Covid vaccine from Pfizer and Moderna to babies from six months old.
Moderna filed Thursday with the FDA for approval of its vaccine for children between 6 months and 5 years old, and Pfizer is expected to do the same in June for children between 6 months and 4 years old. This age group is the last to not be vaccinated in the United States, as well as in many countries. But the timetable for a possible authorization had remained unclear so far.
For these vaccines to be authorized, the clinical trial data provided by the companies must first be reviewed by a committee of experts, before the FDA makes its decision.
On Friday, the American agency announced that it was planning several meetings of this committee, on June 8, 21 and 22, in order to discuss “authorizations for the emergency use of vaccines against Covid-19 from Pfizer and Moderna, to include the younger populations,” according to a statement.
talks
These dates “are provisional” and could be revised, the agency said, knowing that the application files are not yet complete to date.
Since Moderna’s vaccine is not currently authorized in the United States for children under 18, one of these meetings may also be devoted to its extension to adolescents.
The FDA has also specified that the committee will meet on June 7 to study an application for authorization of the Novavax vaccine for people 18 years of age and older. This would add a fourth vaccine authorized in the United States, after those of Pfizer, Moderna and Johnson & Johnson.
Finally, on June 28, this same committee should meet to decide on the strain of the virus used to develop the current vaccines, and decide if it “needs to be modified, and if so, which strain (s) should (in )t be selected for fall 2022”.
“Harmonize” vaccines?
Vaccines are currently based on the initial strain of the virus and have thus proved less effective against the variants which have gradually appeared.
During a meeting of this committee in early April on the same subject of updating vaccines, the American experts said they wanted to decide for themselves the strain used, if it should be modified. According to them, this practice would make it possible to harmonize the products distributed by the various companies. This is what is done every year with the flu shots.
But experts had also raised many questions about the feasibility of such a strategy, including the difficulty of predicting in advance the variant in circulation next fall.