- Pfizer Inc PFE and BioNTech SE BNTX have announced results from one cohort from a Phase 2/3 trial evaluating its COVID-19 vaccine on a two-dose schedule (approximately 21 days apart).
- The data from over 2,200 children aged 5 to 11 years showed a favorable safety profile and robust neutralizing antibody responses using a two-dose regimen of 10 µg, a smaller dose than the 30 µg dose used for people 12 and older.
- The antibody responses in the participants given 10 µg doses were comparable to those in a prior study in people 16 to 25 immunized with 30 µg doses.
- Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.
- The companies plan to submit the data to the FDA and other health regulators "as soon as possible."
- Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and 6 months to 2 years are expected in Q4 of 2021.
- Read Next: FDA Panel Votes Against Approval Of Pfizer/BioNTech's COVID-19 Booster Shot For General Public.
- Price Action: PFE stock is down 1.53% at $43.22, while BNTX stock is down 5.27% at $340.24 during the premarket session on the last check Monday.
- Photo by x3 from Pixabay
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