Pfizer seeks authorization of a coronavirus shot for children under 5

Pfizer and its German partner, BioNTech, on Wednesday finished submitting an application for regulatory authorization of a coronavirus vaccine for children younger than 5, according to two people familiar with the matter.

The development marked another important step toward providing vaccine for the last segment of the U.S. population that does not have access to shots.

The news comes a week after Pfizer-BioNTech announced that three shots of its low-dose pediatric vaccine triggered a robust immune response in young children and was safe. The partners began sending data to the Food and Drug Administration in February.

The advance toward a vaccine for infants, toddlers and preschoolers has been an achingly slow and incremental process, with pediatricians and families waiting for an opportunity to vaccinate young children.

“We recognize parents are anxious to have their young children vaccinated against COVID-19,” FDA spokeswoman Abigail Capobianco wrote in an email. She said the agency would move “as quickly as possible using a science-based approach.”

FDA advisers are scheduled to meet June 15 to discuss the three-shot PfizerBioNTech pediatric vaccine and a two-shot regimen from the biotechnology company Moderna. The agency is expected to act quickly, meaning young children could get their first shots this month.

Data on both vaccines has been available only in news releases so far. The FDA review of the details and the all-day session on June 15 with outside experts digging into the data will be critical in showing what is known about how well the vaccines work and any differences between the two regimens.