May 23, 2022, 06:55am
Pfizer and BioNTech said on Monday that they will ask the FDA to approve a three-shot regimen of their Covid-19 vaccine for children under five due to promising clinical trial results.
Pfizer and BioNTech reported promising results for their vaccine regimen.
The vaccine produced a strong immune response in children under five, according to the companies.
The trial, which has not yet been peer reviewed or published, was conducted at a time when omicron was the most common variant, and regulators requested more information.
The immune response of adults ages 18 to 25 after their second dose of the vaccine was the same as it was after the first dose.
Albert Bourla, Pfizer's chief executive, hopes the shots will be made available to younger children quickly.
The data are very encouraging, and the companies plan to finalize submissions with the FDA this week, according to Dr. Ugur Sahin.
Within the coming weeks, submissions to the European Medicines Agency and other regulators around the world will follow.
The results of Pfizer's trial came after months of setbacks to the company's effort to authorize a vaccine for infants and young children. Bourla said that the FDA asked Pfizer to submit data on the first two doses of the three-dose regimen in order to start the vaccine process while awaiting authorization on the final dose. The company was given time to collect data on a third dose. Moderna asked for emergency approval for children as young as six months in late April, which may have cost Pfizer its top spot.
18 million dollars. The number of children in the US that would be covered by an expanded emergency use authorization for Pfizer's shot is roughly how many there are. The only age group left in the US that isn't eligible for a Covid-19 vaccine is young adults. Children are less likely to get seriously ill from Covid-19, but they can and do die from the disease, as well as pass it on to more vulnerable people.
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