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First COVID-19 vaccine approval in the US for kids
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First COVID-19 vaccine approval in the US for kids

FDA approves Pfizer vaccine for children. Vaccine may be used for kids 12-15 yrs old.

Where: United States

The Facts

▪ The FDA approved the emergency use of the Pfizer-BioNTech vaccine in children 12-15 years of age on May 10, 2021.

▪ Acting FDA Commissioner Janet Woodcock stated, “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic.”

▪ Woodcock continued, “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data.”

▪ The CDC Advisory Committee on Immunization Practices will meet on May 12, 2021, to review the data before recommending the Pfizer vaccine for immunization of children aged 12-15 years.

▪ A Pfizer press release stated 100% efficacy and tolerance of the vaccine in the Phase 3 trial in children in the 12-15 years bracket.

▪ Pfizer-BioNTech has also submitted the trial data to other global health regulators, including the European Medicines Agency, for usage approval in the target age group.

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