Low-Dose Pfizer-BioNTech Vaccine Fails in Trial in Children 2 to 5 Years of Age
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A low dose of Pfizer-BioNTech coronavirus vaccine failed to produce an adequate response in children aged two to five years.
Businesses announcement the results of critical trials underway on Friday and said that after testing children 6 months to 5 years old with a–tenth of the adult dose, children between 6 months and 2 years old produced an immune response similar to that of people 16 to 25 years old after two doses, but children between 2 and 5 years old did not.
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“The companies will modify the clinical study evaluating the safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 6 months to less than 5 years of age,” the statement said. “The study will now include the evaluation of 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.”
The companies said if the three-dose study is successful, they plan to seek emergency clearance in the first half of 2022.
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A children’s version of Pfizer’s vaccine is already available for children aged 5 to 11, or one-third the dose given to everyone aged 12 and over.
No security issues were detected in the study, the companies said.
Pfizer’s vaccine research chief Kathrin Jansen cited other data showing that a booster for people 16 and older restores strong protection, a jump in immunity that scientists say will help also to push back the new variant of the omicron.
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The companies are also preparing to test a booster for children aged 5 to 11, who have just received their vaccines in two doses. And they’re testing different dose options for teen boosters.
Jansen said if the additional pediatric tests were successful, “we would have a consistent approach to the three-dose vaccine for all ages.”
Associated Press contributed to this report
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