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Pfizer and BioNTech Receive EMA's CHMP Positive Opinion Recommending Conditional Marketing Authorization for Omicron BA.4/BA.5 Bivalent Booster Vaccine

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Pfizer and BioNTech Receive EMA's CHMP Positive Opinion Recommending Conditional Marketing Authorization for Omicron BA.4/BA.5 Bivalent Booster Vaccine

Pfizer and BioNTech Receive EMA's CHMP Positive Opinion Recommending Conditional Marketing Authorization for Omicron BA.4/BA.5 Bivalent Booster Vaccine

Shots:

  • The EMA’s CHMP has adopted a positive opinion recommending CMA for a 30-µg booster dose of Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine in individuals aged ≥12yrs. The EC’s decision is expected shortly
  • The P-II/III trial results showed that the booster dose of BA.1-adapted bivalent vaccine elicited a superior immune response against Omicron BA.1 subvariant with a favorable safety profile. The booster dose of BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing Ab response against Omicron sublineages in pre-clinical results
  • The vaccine will be available in 27 EU member states within the coming days. The companies will file the data with other regulatory authorities in the coming weeks and will submit data to the US FDA and the EMA

Ref:  Businesswire | Image: Pfizer 

Click here to­ read the full press release 

Neha

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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