Pfizer asks the US to authorize vaccine for children under 5 years
Pfizer asked the U.S. government on Tuesday to authorize the use of its very low-dose COVID-19 vaccine for children under 5, paving the way for younger Americans to start receiving the vaccine as soon as possible. of March.
In an extraordinary move, the Food and Drug Administration (FDA) had asked Pfizer and its partner BioNTech to apply for authorization earlier than the companies had planned.
The 19 million children under the age of 5 in the United States are the only group not yet eligible to receive the COVID-19 vaccine. Many parents have been pushing for the vaccination campaign to be expanded to include infants and preschool-age children, particularly as the wave of the omicron variant leaves record numbers of hospitalizations among minors.
If the FDA gives its approval, injections of Pfizer’s vaccine at one-tenth the dose given to adults could begin in children as young as 6 months of age. Pfizer said Tuesday that it had begun submitting its information to the FDA and expects to complete the process within days.
However, one remaining question is how many doses the little ones will need. Pfizer is testing a three-injection schedule after the two low-dose applications were strong enough for infants, but not for preschoolers, and final data is not expected to be ready until end of March.
That means the FDA could consider authorizing both doses for now, with the possibility of a third being approved if the study supports it.
The FDA said Tuesday that it will convene a panel of independent researchers and clinicians in mid-February to review the data submitted by Pfizer. The agency is not required to follow the panel’s recommendations, but its input is a key step in public review of the safety and effectiveness of vaccines.
The FDA’s final decision could be issued within a month, but that’s not the only hurdle. The Centers for Disease Control and Prevention (CDC) also have to give the go-ahead.
The administration of President Joe Biden has tried to speed up the authorization process for COVID-19 vaccines for children, saying the vaccine is essential to get schools and daycares reopening and operating, and to free up parents. of childcare duties so that they can return to work.