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Pfizer submits data to FDA for clearance

The Pfizer / BioNTech alliance intends to ask the US Medicines Agency to authorize the marketing of their vaccine against Covid-19 for children between 5 and 11 years old.

The Pfizer / BioNTech alliance announced on September 28 that it had submitted the results of clinical trials for its vaccine against Covid-19 in children aged 5 to 11 to the United States Medicines Agency. The alliance plans to file a formal marketing authorization request for this age group “in the coming weeks”.

The companies said last week that the vaccine was well tolerated in these children and elicited a “robust” immune response, “comparable” to that seen in 16 to 25 year olds. The trials were conducted on nearly 2,300 participants aged 5 to 11 years. The dosage has been adjusted to 10 micrograms per injection, compared to 30 micrograms for the older groups.

“[Ces données] have been submitted to the FDA [Agence américaine des médicaments] for a preliminary analysis, ”Pfizer said in a statement. “A formal request for an emergency use authorization […] should follow in the coming weeks, ”the company said. Then the process might take a few more weeks until the first bites can actually be taken.

The FDA had, in fact, specified in a press release at the beginning of September that once the authorization request was filed, it “examines[rait] data to assess benefits and risks, and will be[it]0 * prepared to complete its analysis as quickly as possible, probably in a period of a few weeks rather than months. ”

At the moment, Pfizer’s vaccine is fully licensed for ages 16 and over, and emergency licensed for ages 12-15. The Pfizer / BioNTech alliance has also confirmed that it expects to be able to publish the results of the trials for two other age groups, 2-5 years and 6 months-2 years, “from the fourth quarter” of 2021. .



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