Three doses of a child-size Pfizer vaccine is not just safe but effective for children between the ages of 6 months and 5 years old, the company said Monday.
Pfizer plans to submit its trial data to the Food and Drug Administration this week as parents of young children push frantically for protection for their tots.
The trial, which used 1,678 children, injected a third dose of a 1/10th strength jab while Omicron was at its peak. A month later, antibody levels showed a similar immune response as 16-to-25-year-olds with two doses, about 80% efficacy, Pfizer said.
The shot was “well tolerated” and most side effects were “mild or moderate.”
The first two doses in the trial were given three weeks apart and the final shot came at least two months later.
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“Our COVID-19 vaccine has been studied in thousands of children and adolescents, and 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,” Albert Bourla, the chairman and CEO at Pfizer, said in a statement.
“These topline safety, immunogenicity and efficacy data are encouraging, and we look forward to soon completing our submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible, subject to regulatory authorization.”
Children under the age of 5 are the only group of the population not yet eligible for a COVID-19 vaccine. Moderna submitted its own data to the FDA in late April.