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
