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International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine

 
• By Ian Schofield

A workshop led by the European Medicines Agency and the US Food and Drug Administration sought to reach alignment on adapting COVID-19 vaccines to emerging virus variants.

Background of OMICRON XBB.1.5 and syringe vaccine,Medical health concept
All eyes are on the Omicron XBB.1.5 variant • Source: Shutterstock

There is “broad agreement” that COVID-19 vaccines for use in the next winter season in the northern hemisphere should include only one virus strain and be based on the XBB family of Omicron subvariants, such as XBB.1.5, according to the International Coalition of Drug Regulatory Authorities.

Strain changes for existing vaccines could be approved based just on data on the manufacturing and quality of the vaccine, together with lab data, as long as post-authorization data on quality,

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