(Washington) Pfizer announced Tuesday to seek emergency authorization in the United States of its vaccine against COVID-19 for children aged six months to 4 years, which would then become the first available for this age group.
Posted at 8:21 a.m.
Updated at 5:10 p.m.
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.
“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 COVID-19 vaccination series for their child, pending potential authorization of a third dose,” he added.
Pfizer specified that the filing of the data had been initiated “after a request” from the FDA, obviously eager not to waste time and to speed up the process.
Some experts have already spoken out to criticize this unusual approach.
Acting FDA chief Janet Woodcock defended the need to move quickly on Tuesday: “Having a safe and effective vaccine available for children in this age group is a priority for the agency,” said she said in a statement.
Reduced dose
Pfizer’s application is expected to 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, two weeks from now. Its opinion is not binding, but generally followed by the agency.
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 was 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 in this direction.
As part of these trials, the third dose must be injected at least two months after the second, the first two remaining injected 3 weeks apart from each other.
Data on the third dose are expected “in the coming months,” Pfizer said on Tuesday.
23 million children
The United States has approximately 23 million children under the age of 5.
Many parents are impatiently awaiting the possibility of vaccinating their very young children, the last age category that cannot be vaccinated at the moment.
But health authorities will also face great skepticism from other parents.
Vaccination rates are much lower among minors. The vaccine has been available for three months in the United States for 5-11 year olds, but to date only 30% of them have received at least one dose, and about 22% are fully vaccinated, according to data from the Centers for Disease Prevention and Control (CDC).
Young children are less likely to become seriously ill from COVID-19, but some still end up hospitalized.
Due to the very large number of contaminations, the epidemic wave linked to the Omicron variant thus sent a record number of children to the hospital.
Young children can also develop severe cases of pediatric multisystem inflammatory syndrome (MIS-C).
Some 400 children between the ages of 0 and 4 have died of COVID-19 in the United States since the start of the pandemic, according to CDC figures.