Pfizer and BioNTech Receive the US FDA’s Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine
Shots:
- The authorization was based on the clinical, pre-clinical & manufacturing data from the P-II/III trial to evaluate BA.4/BA.5-adapted bivalent COVID-19 vaccine (30-µg booster dose) in patients aged ≥12yrs. with COVID-19
- The results showed a superior immune response against the Omicron BA.1 subvariant over the COVID-19 vaccine & has a favorable safety profile. In the pre-clinical data, the vaccine demonstrated a strong neutralizing Ab response against Omicron BA.1, BA.2, BA.4, and BA.5 subvariants along with an original virus
- The company plans to submit an application to the US FDA in early October for Omicron-adapted bivalent vaccine in children aged 5 through 11yrs. The companies collaborated with the US FDA to submit an application for children aged 6mos. and 4yrs.
Ref: Businesswire | Image: Pfizer
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