This is the last major segment of the population that is not eligible. Pfizer has launched the process to seek emergency authorization for its Covid-19 vaccine for children aged six months to 4 years in the United States, the pharmaceutical giant announced on Tuesday. If approved by the US Medicines Agency (FDA), 19 million children, or 6% of the population, will be eligible.
The request initially concerns a series of two doses, but this will eventually have to include three, the Pfizer-BioNTech alliance said in a press release. 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. But with this reduced dose, the immune response elicited in 2- to 4-year-olds turned out to be less strong than expected, Pfizer announced in December. The company had thus said that it wanted to test a third dose of vaccine for this age group, and had amended the protocol of its clinical trials accordingly.
Only two out of three Americans vaccinated
“We believe that three doses of vaccine will be necessary for children aged 6 months to 4 years in order to achieve a high level of protection against current and future variants,” Pfizer boss Albert Bourla said in a statement. But “if two doses are authorized, parents will have the opportunity to start the series of vaccination against Covid-19 for their child, pending potential authorization of a third dose”, he added.
Pfizer specified that the filing of this request had been initiated “after a request” from the FDA, obviously desirous of not wasting time and of speeding up the process. The request should be fully finalized “in the coming days”, the company said.
The vaccine could thus be available for this age group in the coming weeks. Shortly after the announcement, the FDA announced that its panel of experts to review the data would meet on February 15. After leading the race, the United States is now lagging behind on vaccination: less than two out of three Americans are fully immunized, and only 41.7% received a booster dose.