Pfizer Laboratories announced Tuesday that it is asking the U.S. drug regulator to authorize its vaccine against Covid-19 for use in children between the ages of six months and four years. Ultimately, three doses should be required.
Pfizer announced on TuesdayUh In February, it requested the U.S. to urgently authorize its Covid-19 vaccine for children 6 months to 4 years old. If approved, it will be the first available for that age group.
The Pfizer-BioNTech alliance said in a release that the application to the U.S. Drug Administration (FDA) initially involved a series of two doses, but must eventually include three doses.
“We believe that children between the ages of six months and four years will need three doses of the vaccine to achieve a high level of protection against current and future variants,” Pfizer boss Albert Burra said in a statement.
However, “if two doses are authorized, parents will have the opportunity to start a Covid-19 vaccine series for their children, pending the potential authorization of a third dose,” he added.
Pfizer made it clear that the submission of the data began “after receiving a request from the FDA,” apparently in order not to waste time and to expedite the process. Some experts have publicly criticized the unusual approach.
Acting FDA Commissioner Janet Woodcock on Tuesday defended the need for swift action: “Providing safe and effective vaccines for children of this age is the agency’s top priority,” she said in a statement.
The company said Pfizer’s application should be fully finalized “within the next few days.” Therefore, the vaccine could be used in 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. Its opinions are not binding, but are generally followed by the agency.
For these very young children, the pharma giant opted for a dose of just 3 micrograms per mouthful (compared to 30 micrograms for adults and 10 micrograms for children aged 5-11) to limit side effects.
But Pfizer announced in December that with the dose reduction, the immune response in children aged 2 to 4 was not as strong as expected. As a result, the company has said it wants to test a third dose of the vaccine for this age group and has modified its clinical trial protocol in that direction.
As part of these trials, the third dose must be given at least two months after the second, with the first two doses given three weeks apart.
Pfizer said Tuesday that it expects to provide data on the third dose “in the coming months.”
Many parents questioned
There are approximately 23 million children under the age of 5 in the United States.
Many parents are anxiously awaiting the possibility of vaccinating their young children, the last age group currently unavailable.
But health authorities will also face great skepticism from other parents. Vaccination rates for minors are much lower. According to the Centers for Disease Control, the vaccine has been given to children ages 5-11 for three months in the U.S., but so far, only 30% have received at least one dose of the vaccine, and about 22% have been fully vaccinated for prophylaxis. and control (CDC).
Young children are less likely to become seriously ill from Covid-19, but some still end up in hospital. Due to so much contamination, a wave of epidemics linked to the Omicron variant sent a record number of children to the hospital.
Young children can also develop severe pediatric multisystem inflammatory syndrome (MIS-C).
About 400 children ages 0 to 4 have died from Covid-19 in the United States since the pandemic began, according to the CDC.