Pfizer Inc PFE and BioNTech SE BNTX have reported Phase 3 trial data evaluating its COVID-19 vaccine BNT162b2 in 2,260 adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection.
Efficacy Data: Data demonstrated 100% efficacy and substantial antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated.
Albert Bourla, Chairman and CEO of Pfizer, said, "We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year."
Further, BNT162b2 administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age.
All trial participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Pfizer and BioNTech plan to submit the data for scientific peer review for potential publication.
Last week, the companies dosed the first healthy child in a global Phase 1/2/3 seamless study to further evaluate the safety, tolerability, and immunogenicity of its COVID-19 vaccine in children aged six months to 11 years.
The 5 to 11-year-old cohort started dosing last week, and the companies plan to initiate the 2 to 5-year-old cohort next week.
Price Action: PFE shares are up 0.7% at $36.36, and BNTX stock is up 2.6% at $107.19 in premarket trading on the last check Wednesday.
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