Pfizer on June 1 said it has completed its application for emergency use authorization from the FDA for its three-dose COVID-19 vaccine in children under 5, The Wall Street Journal reports.
In May, Pfizer and partner BioNTech said preliminary data showed the three-dose vaccine regimen was 80 percent effective at preventing symptomatic COVID-19 in children between the ages of 6 months and 5 years. The vaccine formulation is one-tenth of the dose strength for adults and was well-tolerated among children, the drugmakers said.
Pending FDA clearance and sign-off from the CDC, the vaccine would become available to an estimated 19 million U.S. children under 5. An outside panel of vaccine experts for the FDA is set to meet June 14 and June 15 to review applications from both Pfizer and Moderna, which submitted its request to the FDA for its two-dose vaccine regimen for young children at the end of April.
Pfizer initially submitted an EUA request for a two-dose vaccine regimen for children under 5 in February. Shortly after, it announced it was postponing its rolling submission as it waited for data on a three-dose regimen, as results indicated the two-dose regimen didn't generate a strong immune response in 2- to 4-year-olds.