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Pfizer Vaccine Shows 100% Efficacy Against COVID-19 In Longer-term Analysis In Adolescents

Pfizer Inc. (PFE) and BioNTech SE (BNTX) said that updated findings from pivotal phase 3 trial of their COVID-19 vaccine supported safety and high efficacy in Adolescents 12 through 15 years of age.

The updated data showed that a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose.

The companies noted that the data will support planned submissions for full regulatory approval of the vaccine in this age group in the U.S. and worldwide.

The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no serious safety concerns observed in individuals with at least 6 months of safety follow-up after the second dose, the companies said.

The vaccine is currently available for individuals 12 through 15 years of age under Emergency Use Authorization, granted by the FDA in May 2021. The companies also plan to submit these data to pursue regulatory approvals for this age group in other countries where emergency use authorizations or equivalents were initially granted.

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