16-05-2022 by Mirai
The US Food and Drug Administration (FDA) should convene a committee of independent experts in June to examine the extension of Pfizer and Moderna's anti-Covid vaccine to babies from six months of age.
Moderna filed Thursday, April 28, with the FDA for approval of its vaccine for children between 6 months and 5 years, and Pfizer is expected to do the same in June for children between 6 months and 4 years. This age group is the last not to be vaccinated in the United States, as well as in many countries.
Decision process
But the timetable for a possible authorization was not clear at this time. For these vaccines to be licensed, 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, April 29, the US 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 vaccines against Covid-19 of Pfizer and Moderna, to include the youngest". 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.
Novavax Vaccine Authorization
Since Moderna's vaccine is not currently licensed in the United States for those under 18 years of age, one of these meetings may also be dedicated 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 over 18 years of age. This would add a fourth authorized vaccine in the United States, after those of Pfizer, Moderna and Johnson & Johnson.
Towards a vaccine update?
Finally, on June 28, this same committee should meet to consider whether the virus strain used to develop current vaccines "needs to be modified, and if so, which strains should be selected by fall 2022."
Currently, the vaccines are based on the initial strain of the virus and, therefore, have been shown to be less effective against the variants that have been appearing. During a meeting of this committee in early April on the same topic of updating vaccines, US experts had said that they wanted to decide for themselves whether the strain used in the future should be modified, in order to harmonize the products distributed by the different companies. This is what is done every year with flu shots.
vaccine, covid, babies, children, minors, 6 months, 4 years, coronavirus, infections, vaccination, expert committee, virus, update, efficacy