Pfizer and BioNTech are set to test a third dose of their COVID-19 vaccine in an ongoing trial of children under 5 years. This comes after the companies discovered that the two-dose regimen didn’t offer a strong enough immune response in some children.
In a news release on Friday, the companies said that “The study will now include evaluating a third dose of 3 µg at least two months after the second dose of the two-dose series to provide high levels of protection in this young age group.
“Compared to the 16- to 25-year-old population in which high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population but not for the 2- to under 5-year-old population in this analysis.”
According to the release, the decision to evaluate a third dose of 3 µg for children 6 months to under 5 years of age “reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile.”
If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to under 5 years of age in the first half of 2022.
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