Pfizer Inc and its German partner BioNTech SE said they would include and evaluate a third dose of their COVID-19 vaccine in an ongoing trial in children six months to less than five years of age.
The decision was made after an analysis showed that the two-dose vaccine elicited an immune response in the population aged two to less than five years, which was lower than previously seen in children aged 16 to 25 years.
The study will now include a third 3-microgram dose given at least two months after the second dose of cycle two to provide high levels of protection, the companies said.
If the three-dose study is successful, Pfizer and BioNTech hope to present the data to regulators to support an emergency use authorization for children six months to less than five years of age in the first half of 2022.
The vaccine received full authorization for ages 16 and older in the United States in August. It also has an emergency use authorization for children ages 5 to 15.
On Thursday, the companies applied for full approval of their COVID-19 vaccine from the U.S. Food and Drug Administration (FDA) to include teens ages 12-15.
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