Europe to decide on Novavax’s COVID vaccine in October

(Reuters) -The European Medicines Agency (EMA) expects to decide on the use of Novavax’s updated COVID-19 vaccine in October, its director Emer Cooke said on Thursday.

The agency had started the evaluation process for the protein-based shot on Aug. 24, Cooke said at a press conference.

EU regulators recently gave the green light for an updated COVID-19 vaccine from Pfizer and its German partner BioNTech, which targets the XBB.1.5 variant of Omicron.

Moderna’s updated shot is also on track to win approval.

The EMA’s human medicines committee (CHMP) will discuss the shot at its meeting in October, following which the agency “should have an outcome”, Cooke said.

The CHMP is scheduled to meet from Oct. 9 to 12, according to the agency’s website.

Novavax said on Thursday it expects to be included in the meeting and plans to have the first doses delivered to European countries as early as October, under existing advanced purchase agreements.

The vaccine is also under review by the U.S. Food and Drug Administration.

Novavax said it was working closely with the FDA as the health regulator completes the review.

Updated mRNA-based shots from rivals Pfizer/BioNTech and Moderna have also been authorized for use in the United States.

Novavax’s shares were down about 2% at $6.89.

(Reporting by Bhanvi Satija in Bengaluru and Michael Erman in New York; Editing by Saumyadeb Chakrabarty and Sriraj Kalluvila)