Pfizer and BioNTech Receive the EMA’s CHMP Positive Opinion Recommending Marketing Authorization for Omicron XBB.1.5-adapted COVID-19 Vaccine
Shots:
- The EMA’s CHMP has recommended marketing authorization for Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (Comirnaty Omicron XBB.1.5) as a single dose for individuals aged ≥5yrs.
- The recommendation was based on the previous clinical, non-clinical & real-world evidence of COVID-19 vaccines. The recommendation is also based on pre-clinical data showing that the COVID-19 vaccine generates an improved response against multiple XBB-related sublineages
- The committee also recommended the updated vaccine for children aged 6mos. to 4yrs. given as part of all of the primary three-dose vaccination series or as a single dose for individuals with a complete COVID-19 primary vaccination course. In the pre-clinical data, the updated vaccine induces serum Abs that neutralize the WHO-designated variant of interest EG.5.1 (Eris)
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.
