BioNTech and Pfizer has formally appealed to the US Food and Drug Administration (FDA) to authorize their COVID-19 vaccine for young children and infants between the age of 6 months to 5 years.
If approved, this would be the only COVID-19 vaccine for this age group in the United States.
In rare move, regulators push for application
The companies said they began submitting the data for their formal application "following a request" from the FDA, even though they did not meet a key target in the clinical trials of 2-to 4-year-olds.
Soon after the announcement, the FDA said an outside committee of expert advisers will consider the request at a meeting in two weeks, on February 15.
"Having a safe and effective vaccine available for children in this age group is a priority for the agency," said acting FDA Commissioner Janet Woodcock.
The agency also confirmed that they asked the vaccine makers to submit the application "in light of the recent omicron surge."
If the FDA authorizes the emergency use of the vaccine, the US Centers for Disease Control and Prevention (CDC) will also have to sign off on its use following a meeting with the body's own advisers.
How many shots will young children need?
The companies are currently seeking authorization for only two doses of a planned three-dose regimen.
Pfizer CEO Albert Bourla said the company believes three doses of the vaccine will be needed "to achieve high levels of protection against current and potential future variants."
"If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose," he said in a statement.
Extra-low dose
BioNTech and Pfizer said they had chosen to significantly decrease the dosage of its vaccine to limit the side effects for this age group.
The youngest Americans will receive a 3-microgram dose of the vaccine as compared to 30 micrograms for people aged 12 and older and a 10-microgram dose in 5- to 11-year-olds.
The two companies said that children under 5 are currently getting two doses three weeks apart, followed by a third dose two months later.
According to early study results, the extra low doses of the vaccine generated an immune response in children up to 2 years.
However, the antibody results for kids aged 2 to 4 were lower than those for older children and teens. By administering a third dose in testing, the firms hope to further improve protection.
There are about 23 million children under 5 years of age in the US. The approval of a vaccine for them would help many parents struggling with closures of preschools and daycare centers.
