Pfizer and BioNTech Receive the US FDA’s Emergency Use Authorization for 10-µg Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster
Shots:
- The authorization was based on the safety & immunogenicity data of 30-µg Omicron BA.1-adapted bivalent vaccine, non-clinical & manufacturing data of 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine in children aged 5-11yrs. & pre-clinical data of 30-µg Omicron BA.4/BA.5-adapted bivalent vaccine
- The P-II/III trial results showed that a booster dose of 30-µg vaccine elicited superior immune response and favorable safety profile over Omicron BA.1 subvariant & original vaccine
- In Sept 2022, the application has been submitted to the EMA requesting a variation of marketing authorization in the EU to add 10-µg COVID-19 vaccine in the same age group while similar applications will submit to regulatory bodies globally in the coming weeks
Ref: Pfizer | Image: Pfizer
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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.
