Soon a vaccine against Covid-19 for children over 6 months? This is the meaning of Moderna’s request, which should be followed by that of Pfizer, to the FDA, the American Medicines Agency. The age group under 6 years old is indeed the last to not be able to be vaccinated in the United States and in many countries. But the timetable for a possible authorization had remained unclear so far.
On Friday, the American agency announced that it is planning several meetings of this committee, on June 8, 21 and 22, in order to discuss the “emergency use authorizations for the vaccines against Covid-19 from Pfizer and Moderna, to include the younger populations,” according to a statement. These dates “are provisional” and could be revised, the agency said, knowing that the application files are not yet complete to date.
A vaccine created from a variant?
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. 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 consider whether the strain of the virus used to develop the current vaccines “needs to be modified, and if so, which strain (s) should (s) t be selected (s) for fall 2022”. Vaccines are currently based on the initial strain of the virus and have thus proved less effective against the variants which have gradually appeared.