Pfizer, BioNTech's Omicron-Adapted Covid-19 Vaccine Gets E.U. Marketing Recommendation

By Michael Susin

Pfizer and BioNTech said on Friday that a committee from the European Medicine Agency recommended marketing authorization for its Omicron adapted vaccine to prevent Covid-19, meaning the vaccine is one step closer to becoming available across the European Union.

The drugmakers said the recommendation will be reviewed by the European Commission which is expected to make a final decision soon.

The recommendation from the Committee for Medicinal Products for Human Use applies for the Omicron KP.2-adapted monovalent Covid-19 vaccine for active immunization in individuals six months of age and older.

If approved, the vaccine will be available based on individual country government requests and national recommendations of the block.

This could be the companies' second Omicron-related vaccine authorized in the European Union. In July 2024, the European Commission granted marketing authorization for Pfizer and BioNTech's Omicron JN.1-adapted Covid-19 vaccine.

The Omicron KP.2-adapted vaccine was approved for use in the U.S on individuals 12 years of age and older, and granted emergency use authorization for individuals six months through 11 years of age on Aug. 22.

Write to Michael Susin at michael.susin@wsj.com

(END) Dow Jones Newswires

September 20, 2024 09:06 ET (13:06 GMT)

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