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Pfizer/BioNTech today reported 80% efficacy with three doses of its COVID-19 vaccination for toddlers and children up to 5 years old
The study of 1678 younger children was done when Omicron was the predominant variant.
Pfizer plans to submit this new data to the US Food and Drug Administration (FDA) as part of their application for emergency use authorization.
An FDA advisory board is scheduled to meet June 15 to determine their recommendations for the Pfizer and Moderna mRNA COVID-19 vaccines in children under 6 years old.
Safety findings for the Pfizer vaccine were similar to placebo, the company said.
As of the end of April, 10 children developed symptomatic COVID-19 at least 7 days after the third dose. The company initially expected to wait until 21 children developed symptoms, so these are interim findings and the study remains ongoing.
The dosage for children 6 months up to 5 years was 3 micrograms, one-tenth the vaccine dose authorized for adults.
Pfizer had asked the FDA to authorize its vaccine for the youngest children earlier this year, but delayed its application in February after trial results for just two doses didn’t generate a strong enough immune response, according to the company.
Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology, and critical care. Follow Damian on Twitter: @MedReporter.