Pfizer and BioNTech said on Monday that three doses of their COVID-19 vaccine produced a strong immune response in children under the age of five in their clinical trial.
Pfizer and BioNTech said they found that the vaccine was up to 80.3% effective in children 6 months to under 5 years old.
The biotech companies said the analysis was based on 10 symptomatic COVID-19 cases discovered seven days after the third dose and accrued as of April 29, 2022.
Albert Bourla, Chairman and Chief Executive Officer of Pfizer, said their COVID-19 vaccine has been tested in thousands of children and adolescents.
“We are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” Bourla said.
Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech, said that a low dose of 3 micrograms or one-tenth the strength given to adults generated an immunological response comparable to adults ages 18 to 25 after their second dose and had a favorable safety profile.
“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” Sahin said in a statement.
Sahin said that Pfizer and BioNTech are preparing the necessary documents and expect to complete the submission process to the FDA this week, with submissions to EMA and other regulatory authorities to follow within the coming weeks.
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