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A 3rd pediatric dose of the Pfizer-BioNTech COVID-19 vaccine in youngsters 6 months to below 5 years of age prompted a robust immune response, with a security profile that was just like placebo, the businesses mentioned.
Pfizer’s pediatric COVID-19 vaccine has an efficacy of 80.3%, in accordance with a preliminary evaluation, and meets “all immunobridging standards required for Emergency Use Authorization,” the corporate mentioned Monday. The outcomes are based mostly on medical trials through which children from six months to age 5 received three doses of the corporate’s vaccine.
Pfizer and its associate, BioNTech, plan to submit the brand new information to the Meals and Drug Administration this week, bringing households with younger youngsters one step nearer to a long-awaited vaccine.
The scale of Pfizer’s pediatric dose is one-tenth of its grownup dose. The corporate had initially examined a two-dose routine, however combined outcomes prompted Pfizer to check a three-dose routine.
The third dose was “nicely tolerated amongst 1,678 youngsters below 5 years of age with a security profile just like placebo,” Pfzier mentioned because it introduced the information.