A pharmaceutical giant wants to immunize younger children against the COVID-19 disease.
Pfizer recently requested emergency use authorization from the U.S. Food and Drug Administration (FDA) to vaccinate children aged between six months and 5 years old.
The drug maker claims the Pfizer-BioNTech COVID-19 shot is urgently needed across the United States due to more than 1.6 million hospitalized children aged under 5 since the beginning of the pandemic.
The New York City-headquartered company proposes administering two 3-microgram doses of a planned “three-dose primary series” in this age group.
“Three doses of the vaccine will be needed for children 6 months through [to] 4 years of age to achieve high levels of protection against current and potential future variants,” Pfizer chairman and CEO Albert Bourla said in a statement.
“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,” he added.
The FDA and its independent advisers will consider Pfizer’s preliminary vaccination data before potentially authorizing the vaccine. For now, a public hearing has been scheduled for Feb. 15, 2022.
The company is optimistic about its chances of securing FDA approval to vaccinate children aged under 5.
“Our vaccine has already demonstrated a favorable safety, tolerability and efficacy profile in multiple clinical trials and real-world studies for all age groups, starting from 5 years old,” BioNTech co-founding CEO Ugur Sahin said in the statement.
“If authorized, we are very excited about the prospect of offering parents the opportunity to help protect their children 6 months through 4 years of age from COVID-19, and the potentially severe consequences of infection,” he added.