Pfizer and BioNTech on Tuesday officially announced they have begun submitting data to US regulators seeking emergency use authorization (EUA) of their COVID-19 vaccine for children under age 5.
The Washington Post reported late on Monday that Pfizer and BioNTech would submit the request to the US Food and Drug Administration (FDA) as soon as Tuesday. If approved, the vaccine would be the only one approved for use in infants.
In a statement quoted by Reuters, the companies said they started the rolling submission of the data following a request from the FDA 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 February 15 to discuss the authorization.
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.
On Monday, the FDA granted full approval to the Moderna coronavirus vaccine for use on adults.
Later in the day, Novavax filed for emergency use authorization of its COVID-19 vaccine for US adults.
The filing is based on data provided to the US Food and Drug Administration last month and results of two late-stage trials in the United States, Mexico and the UK that showed the protein-based vaccine had an overall efficacy of about 90%, the company said.
Novavax's vaccine uses a different technology than the mRNA vaccines from Pfizer/BioNTech and Moderna, or the Johnson & Johnson one-dose shot.