The FDA on May 10 expanded the Emergency Use Authorization…

The FDA on May 10 expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech SARS-CoV-2 vaccine to include adolescents ages 12 to 15, making it the first such vaccine available to children under age 16 in the US. The amendment to the original EUA is based on Phase 3 clinical trial results showing the vaccine is safe and effective among that age group. The CDC Advisory Committee on Immunization Practices will meet on May 12 to review the data on use among 12- to 15-year olds and is expected to recommend the vaccine be used in this age group. Pfizer-BioNTech are testing the vaccine among children aged 2 to 11 and plan to include children aged 6 months to 2 years in the coming weeks. Moderna and J&J-Janssen also are testing their vaccines in children. On May 7, Pfizer-BioNTech announced they have begun a Biologics License Application with the FDA for full regulatory approval of their SARS-CoV-2 vaccine for individuals ages 16 years and older. The companies will submit data to support the application on a rolling basis, with a goal of achieving full approval in the coming months.

 

CSSE is reporting 32,771,155 positive cases in the U.S. and 582,771 deaths. DOH reported 2,275,365 confirmed cases in Florida yesterday, with 35,831 deaths.

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