By Stephen Nakrosis

 

Pfizer Inc. and BioNTech SE said Monday the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, recommended a conditional marketing authorization for their Omicron BA.4/BA.5 bivalent-adapted Covid-19 vaccine.

The CHMP recommended the booster for individuals ages 12 years and older, the companies said. They also said the vaccine is ready to ship, pending approval from the European Commission.

The companies also said "the European Commission will review the CHMP recommendation and is expected to make a final decision soon."

According to the companies, the recommendation follows guidance from the European Medicines Agency, the World Health Organization and International Coalition of Medicines Regulatory Authorities "to advance bivalent vaccine candidates with the goal of making an Omicron-adapted vaccine available to European Union member states as soon as possible."

 

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

 

(END) Dow Jones Newswires

September 12, 2022 11:59 ET (15:59 GMT)

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