The Food and Drug Administration (FDA)-approved COVID-19 vaccine from Pfizer and BioNTech should not be prescribed off-label for children under 12, as no data exists on proper dosing or safety in youth, an FDA official said on Monday. Acting FDA Commissioner Dr. Janet Woodcock told reporters that the federal agency does not believe it would be appropriate for children under age 12 to get the vaccine, saying it “would be a great concern if people vaccinate children because we don’t have the proper data.” “We don’t have the safety data, nor do we have all the efficacy data, as well,” Woodcock said. “We are not recommending that children younger than age 12 be vaccinated with this vaccine. It would not be appropriate.” COVID-19 vaccines currently aren’t available for children under the age of 12 in the United States. However, Pfizer said in a statement in June that it was beginning …
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