Pfizer Inc (PFE.N) and BioNTech SE on Tuesday said they have begun submitting data to U.S. regulators seeking emergency use authorization (EUA) of their COVID-19 vaccine for children under age 5, despite weaker than expected immune responses in their clinical trial of 2- to 4-year-olds.
The companies said they started the rolling submission of the data following a request from the U.S. Food and Drug Administration in order to address an urgent public health need in the age group.
The FDA said an outside committee of expert advisers would meet on Feb. 15 to discuss the authorization.
The drug companies are asking the FDA to clear the shot as a two-dose regimen. However, Pfizer Chief Executive Albert Bourla said in a statement that 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," Bourla said.
The companies expect to complete submitting data for the EUA for a two-dose regime in the coming days, with data on a third dose to follow.
Pfizer and BioNTech are testing a 3-microgram dose of the vaccine in the age group, compared with a 10-microgram dose in 5- to 11-year-olds and 30 micrograms for people aged 12 and older.
Authorization of a vaccine for younger children could help harried parents who have had to contend with quarantines and closures of pre-schools and daycare centers.
In December, Pfizer said it was amending its clinical trial to test a three-dose version of the vaccine because the lower-dose generated an immune response in 2- to 4-year-olds that was inferior to the response measured in those aged 16 to 25. In 6- month- to 24-month-old children, the vaccine generated an immune response in line with 16- to 25-year-olds.
Last month, Pfizer said it expected to have those results by April.
Reuters
