Pfizer and BioNTech on Monday said they will ask the Food and Drug Administration to authorize a three-shot regimen of their Covid-19 vaccine for children under five citing promising clinical trial results, offering hope for parents wanting to vaccinate their young children after months of delays following disappointing trial results for two doses.
Three doses of Pfizer and BioNTech’s Covid-19 vaccine produced a “strong immune response” in children under five, according to results from a clinical trial, the companies announced Monday.
The trial, which has not yet been peer reviewed or published and was conducted at a time when omicron was the predominant variant, assessed a third dose in 1,678 children after trial results found two doses insufficient and regulators requested more information.
The shots—each a low dose of 3 μg (micrograms), one-tenth the strength given to adults—generated an immune response in line with adults ages 18 to 25 after their second dose and had a “favorable safety profile,” the companies said.
Pfizer chief executive Albert Bourla said the data are “encouraging” and hopes the shots will be made available to younger children as “quickly as possible.”
BioNTech co-founder and chief executive Dr. Ugur Sahin echoed Bourla and said the data are “very encouraging,” adding that the companies plan to finalize submissions with the Food and Drug Administration “this week.”
Submissions to the European Medicines Agency and other regulators around the world will “follow within the coming weeks,” Sahin added.
The results of Pfizer’s trial come after months of setbacks to the company’s effort to authorize a vaccine for infants and very young children. In February, the FDA asked Pfizer to submit data on the first two doses of the three-dose regimen, which Bourla said was with a possible view to kickstarting the vaccination process while awaiting authorization on the final dose. This evaluation was then delayed to give the company time to collect data on a third dose. The delay has potentially cost Pfizer its frontrunner status, as Moderna asked for emergency approval in children as young as six months in late April.
18 million. That’s roughly how many children there are in the U.S. aged between 6 months through 4 years that would be covered by an expanded emergency use authorization for Pfizer’s shot. It’s the only age group left in the U.S. that is ineligible to receive a Covid-19 vaccine. While children are less likely to get seriously ill from Covid-19, they can and do die from the disease, as well as pass the virus on to more vulnerable people.