Pfizer Inc PFE and BioNTech SE BNTX have announced topline results from a longer-term analysis of the safety and efficacy of their COVID-19 Vaccine in individuals 12 through 15 years of age. The updated findings from the Phase 3 trial show that a two-dose series of the Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose.
- Data from almost 2,230 participants showed that 30 cases of COVID-19 were reported in the placebo group and 0 cases in the Pfizer-BioNTech vaccine group.
- The adverse event profile was generally consistent with other clinical safety data for the Vaccine.
- After the second dose, no serious safety concerns were observed in individuals with at least six months of safety follow-up.
- "These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 to 15 years of age," said Ugur Sahin, CEO and Co-founder of BioNTech.
- The companies say that these data will form the basis for a planned supplemental marketing application to expand approval of the Vaccine for use in individuals 12 years and older.
- The Vaccine is currently available for individuals 12 to 15 under Emergency Use Authorization.
- Related Link: COVID-19 Booster Shots From Moderna, Pfizer/BioNTech Score FDA Nod All Adults.
- Price Action: BNTX stock is up 1.26% at $293.97, and PFE shares are up 0.05% at $50.83 during the market session on Monday's last check.
- Photo by x3 from Pixabay
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