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US FDA Sets Immunogenicity Bar High For Changes To COVID-19 Vaccines

 
• By Sue Sutter

Modified vaccines targeted at new SARS-CoV-2 variants must generate immune response rates not more than 10% below those of the original vaccine, agency says in one of a suite of guidances on medical product development to address variants.

Railroad tracks change
FDA guidance explains steps COVID-19 vaccine manufacturers should take when they want to change strains. • Source: Shutterstock

Immunogenicity studies to support variant-targeted changes in current COVID-19 vaccines should demonstrate that the modified product generates immune response rates not more than 10% below those of the original vaccine, the US Food and Drug Administration said.

In an updated

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