Pfizer is eying an October submission of safety and efficacy data for its COVID-19 vaccine to U.S. drug regulators in a bid to gain authorization for shots for children between the ages of 5 and 11, two company officials said Tuesday. Pfizer’s COVID-19 vaccine, made with German partner BioNTech, is currently only authorized for emergency use in the United States for those 12 to 15, with approval granted last month for Americans 16 and older. Pfizer is running a trial examining the safety, tolerability, and effectiveness of its vaccine in children between the ages of 6 months and 11 years. The data from the trial for those between the ages of 5 and 11 is expected by the end of September, Frank D’Amelio, Pfizer’s CEO, told a Morgan Stanley conference on Tuesday. That would set up an application for emergency use authorization in early October for that age group. If …
Pfizer Plans to Ask Regulators for COVID-19 Vaccine Authorization for Young Children in October
September 14, 2021
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