Pfizer and BioNTech Receive the US FDA’s EUA for Omicron BA.4/BA.5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years
Shots:
- The US FDA granted EUA of Omicron BA.4/BA.5-adapted bivalent vaccine in children aged 6mos. through 4yrs. The EUA was based on the P-I/II/III study evaluating the 4th dose of the bivalent vaccine in 3020 patients
- The results showed that a booster (fourth) dose of the Omicron BA.4/BA.5-adapted bivalent vaccine elicited improved Omicron BA.4/BA.5-neutralizing Ab responses over the original vaccine. The safety & tolerability profile was similar to that original vaccine
- The bivalent vaccine was authorized in the EU as a booster dose for patients aged ≥5yrs. For use of Omicron BA.4/BA.5-adapted bivalent vaccine in children aged ≤5yrs., both companies intend to submit applications to other regulatory authorities globally
Ref: Pfizer | Image: Pfizer
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