Pfizer seeks US approval for vaccine for 5-11 year olds

The American laboratory Pfizer announced Thursday that it had formally filed a file asking the United States Medicines Agency, the FDA, for its green light for the vaccine developed with BioNTech against COVID-19 in children aged 5 to 11.

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The group, which explained on Twitter that it had made a request for an emergency use authorization, had already submitted to the agency at the end of September the results of the trials of its vaccine for children of this age group.

The FDA has warned that once Pfizer’s request is made, the process could still take “a few weeks” until the first shots can actually be taken.

The agency said last week it had scheduled a meeting of its advisory committee to review the data on October 26. The latter will have to give his opinion before the authorization is then officially granted.

Pfizer / BioNTech has conducted clinical trials on more than 2,000 children aged 5 to 11. The companies indicated by presenting these results that the vaccine was well tolerated in these children, and elicited a “robust” immune response, “comparable” to that observed in 16 to 25 year olds.

The dosage has been adjusted to 10 micrograms per injection, compared to 30 micrograms for the older groups.

Many parents have been eagerly awaiting vaccine clearance for their young children, especially since the start of the school year and the return of face-to-face classes.

For the time being in the United States, Pfizer’s remedy is fully licensed for ages 16 and over, and emergency licensed for ages 12-15.

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