The application, filed with the US Medicines Agency, initially concerns a series of two doses of vaccine.
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Authorization should be fast. Pfizer announced Tuesday, February 2 to request emergency authorization in the United States of its vaccine against Covid-19 for children aged six months to 4 years. He would then become the first available for this age group. For these very young children, a dose of only 3 micrograms per bite has been chosen by the pharmaceutical giant (compared to 30 for adults, and 10 for 5-11 year olds), in order to limit side effects.
The application, filed with the US Medicines Agency (FDA), initially concerns a series of two doses, but it will eventually have to include three, the Pfizer-BioNTech alliance said in a press release. Pfizer clarified that the deposit of the data had been initiated “after request” from the FDA, obviously eager to waste no time and speed up the process.
Pfizer’s application should be fully finalized “in the next few days”, the company said. Shortly after the announcement, the FDA announced that its panel of experts to review the data would meet on February 15, two weeks from now. Its opinion is not binding, but generally followed by the agency. The vaccine could thus be available for this age group in the coming weeks.