Pfizer and BioNTech completed an application to the Food and Drug Administration on Wednesday for authorization of a COVID-19 vaccine for children younger than 5, Barron’s reported.
Pfizer’s submission includes safety, immunogenicity and efficacy data from a trial conducted on children under 5 who received a third dose of the COVID vaccine two months after the second dose, according to the company.
A press release from last month also confirmed Pfizer’s three-dose trial proved more than 80% effective at eliciting a robust immune response in the young subjects.
In the same release, Pfizer said it would submit data from the trials to the European Medicines Agency and other regulatory agencies worldwide.
The news comes after Moderna submitted a request to the FDA in late April seeking authorization for its COVID-19 vaccine in children from 6 months to under 6 years old, Axios reported.
Results from the trial used to justify the submission showed the vaccine was 43.7% effective for children ages 6 months to 2 years and 37.5% effective for children ages 2 to 6.
“We now have clinical data on the performance of our vaccine from infants 6 months of age through older adults,” Moderna CEO Stéphane Bancel wrote in a March statement. “Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible.”