Pharmaceutical giant Pfizer and its partner BioNTech are preparing to ask US health authorities to authorize their COVID-19 vaccine for children under the age of 5, several media reported on Monday in the United States.
If approved, the vaccine from the two companies would become the first available in the country for this age group.
The request for authorization from the American Medicines Agency (Food and Drug Administration, FDA) could be filed as early as Tuesday, says the washington post, citing sources familiar with the matter. The daily specifies, as the New York Times or public radio NPR, that the request is only for a two-dose regimen, not three.
Pfizer announced in December that it wanted to test a third dose of the anti-COVID vaccine in children under the age of 5, suggesting that the company would file an application for authorization for three doses immediately for this age group.
Two doses to start
As part of clinical trials, the American pharmaceutical giant had selected a dosage of 3 micrograms per injection for children between 6 months and 4 years old. That is ten times less than the dosage administered to adults (30 micrograms), and also less than that of 5 to 11 year olds (10 micrograms).
In children aged 2 to 4 years, a dosage of 10 micrograms indeed caused more fever than in older groups, prompting the firm to select a lower dosage.
But with two injections of 3 micrograms, their immune response was found to be worse than that conferred on adolescents and young adults by the vaccine.
“We know that two doses are not enough, and we understand that,” said the washington post a source close to the file, before specifying: “the idea is to say, let’s go, let’s start the examination [des données] of the two doses. If the data holds up in the licensing application, you could start vaccinating children with their first two doses sooner than if you do nothing while waiting for the third dose data to arrive. »
Faced with disappointing data for two doses, Pfizer had decided to modify the protocol of its clinical trials to include a third dose, injected “at least two months after the second”, the first two remaining administered 3 weeks apart from each other. the other.
A booster dose has in fact brought about a demonstrated increase in the protection conferred in the older categories of the population.