BNTX BioNTech SE

By Colin Kellaher

The U.S. Food and Drug Administration has approved an updated version of the Comirnaty Covid-19 vaccine from Pfizer and BioNTech that targets a highly contagious sublineage of the virus.

Pfizer and BioNTech on Monday said the FDA approved their Omicron XBB.1.5-adapted monovalent Covid-19 vaccine for people 12 years and older and granted emergency use authorization for those ages six months through 11 years.

The vaccine targets an Omicron subvariant called XBB.1.5, which dominated cases through the spring and summer. A newer subvariant, called EG.5, currently accounts for the most cases and is closely related to XBB.1.5, according to the World Health Organization.

Pfizer and BioNTech said preclinical data show their updated vaccine generates improved neutralizing antibody responses against multiple Omicron sublineages, including XBB.1.5 and EG.5.1, unofficially known as Eris.

New York drugmaker Pfizer and Mainz, Germany, immunotherapy company BioNTech previously said they had been producing the updated vaccine at risk so it would be ready to ship immediately upon an FDA green light ahead of an expected rise in demand with the upcoming fall and winter season.

This companies said the latest vaccine is indicated as a single dose for most people ages five and older, regardless of prior Covid-19 vaccination history, while those under the age of five may be eligible for additional doses if they haven't already completed a three-dose series with previous formulations.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 11, 2023 14:08 ET (18:08 GMT)

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