"Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that following a request from the US Food and Drug Administration (FDA) the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population," the release said on Tuesday.
Pfizer and BioNTech said they expect to complete the EUA submission in the coming days, the release also said.
BioNTech CEO Ugur Sahin said in the release that the vaccine has demonstrated favorable safety, tolerability and efficacy profiles in multiple clinical trials starting from five-years old.
The requested EUA would authorize the first two doses of a planned three-dose primary series in the age demographic, the release said.
A third vaccine dose will be needed in the future to achieve high levels of protection against current and potential future coronavirus variants, but that the EUA will give parents an opportunity to begin the vaccination series while awaiting an authorization for the third dose, Pfizer CEO Alber Bourla said.