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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

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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

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  • 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

Related Post:- Pfizer to Acquire Seagen for ~$43B

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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