May 23, 2022 – The U.S. could be one step closer to FDA authorization of COVID-19 vaccination for toddlers and children up to 5 years old – based on new data from Pfizer that found its vaccine delivers a strong immune response.

The company reported 80% efficacy with three doses based on a study of 1,678 younger children. The study was done when Omicron was the predominant variant.

Pfizer plans to submit this new data to the FDA as part of its application for emergency use authorization (EUA). An FDA advisory board is expected to announce its recommendations for the Pfizer and Moderna COVID-19 vaccines in children under 5 in June.

Moderna submitted its application for authorization of a COVID-19 vaccine for younger children in April. While FDA officials have said they are not waiting to decide on that application until Pfizer also files, advocacy groups are urging the agency to move more quickly.

“With the country in the midst of a surge, every day counts,” the group Protect Their Future said in a statement on Monday. “Each EUA application for children under 5 should be considered on its own merits and accorded the urgency of prior EUA submissions for every other age cohort.”

Safety findings for the vaccine were similar to those for a placebo, the company said. As of the end of April, 10 children got COVID-19 with symptoms at least 7 days after the third dose. The company at first expected to wait until 21 children got 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.

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Pfizer: “Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years of Age Following Third Dose.”

Protect Their Future: “Statement on FDA Delay for Moderna Data Review.”

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