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Pfizer and BioNTech have said their coronavirus vaccine has elicited a sustained immune response in children ages 5 to 11, and they plan to seek approval for its use in children in the United States, Europe and elsewhere. About it informs Reuters.
“Pfizer and BioNTech announced the results of a Phase 2/3 study demonstrating a favorable safety profile and sustained neutralizing antibody responses in children aged 5 to 11 using two 10 mcg doses given 21 days apart, which is less than 30 mcg. applicable to persons 12 years and older, ”the company said in a statement.
At the same time, it is indicated that the titer of antibodies in participants who received doses of 10 μg was comparable to that observed in the age group from 16 to 25 years old, immunized with doses of 30 μg. It is clarified that the dose of 10 μg was carefully selected as the preferred dose from the point of view of safety, tolerability and immunogenicity in children from 5 to 11 years old.
The vaccine showed strong immunogenicity in children one month after the second injection, the companies said. In addition, participants showed good tolerance to the drug, with side effects that were broadly consistent with those experienced in those aged 16 to 25 years.
“These test results provide a solid basis for approval for use of our vaccine in children ages five to 11, and we plan to urgently submit them to the FDA and other regulatory agencies,” the statement said.
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