Pfizer on Tuesday requested the FDA approve an emergency use authorization for a booster shot for kids between the ages of five and 11.
Pfizer announced that it filed an application with the FDA, citing the results of clinical trial data that showed the additional shot increased protection against COVID-19 in children of the specific age group, BizPacReview reports.
“Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12),” the company said in a statement.
“The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10-µg two-dose primary series, which was authorized under EUA for this age group in October 2021. Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine with no new safety signals,” the statement continues.
The clinical trial included 4,500 children in the U.S, Finland, Poland, and Spain in efforts to “evaluate the safety, tolerability, and immunogenicity” of the vaccine.
Pfizer said that it would also seek similar approval from other global regulatory agencies in the next few weeks.
