Pfizer and BioNTech are requesting emergency use authorization for their two-dose Covid-19 vaccine for children age 6 months up to 5 years, the companies said Tuesday.
Pfizer and BioNTech said they have initiated a rolling submission of data to the US Food and Drug Administration after a request from the agency. They expect to complete the EUA submission in the coming days and say they will also submit clinical trial data to the European Medicines Agency and other agencies around the world.
The FDA’s vaccine advisory committee will meet on February 15th to discuss the submission. Safety and effectiveness are key, said Dr. Paul Offit, a member of the committee and director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” said Pfizer CEO Albert Bourla in a statement.
Bourla said kids under 5 will ultimately need a third dose to have the best protection against omicron and future Covid variants. By getting the first two-doses FDA authorized, parents can start getting their kids vaccinated while they wait for the third dose, Bourla said. Pfizer and BioNTech expect to complete their application for emergency approval of the first two doses in the coming days.
Toddlers and kids under 5 years old are the last age group left that is not eligible for vaccination. The FDA is expected to fast-track the approval process for 6-month to 4-year-olds like it has for other age groups. Once approved, pediatricians will be able to administer shots within a matter of days.