COVID Mutants: Vaccine Changes Likely To Need Immunogenicity Studies, Not Big Efficacy Trials

US FDA considering approach that is similar to, but more stringent than, influenza strain changes, CBER Director Marks says. Meanwhile, vaccine developers face challenge of when to change antigens to get the best results, NIH’s Graham notes. As FDA and sponsors gain more experience with tweaking the vaccines to account for new coronavirus variants and strains, the process may be expedited further.

New Coronavirus variant outbreak and covid-19 virus cell mutation — New coronavirus variants are complicating the vaccination effort • Source: Shutterstock

The US Food and Drug Administration is considering requiring immunogenicity studies in lieu of large efficacy trials that measure hard clinical outcomes in order to gain the agency’s sign off on tweaks to already authorized or approved COVID-19 vaccines that are updated to address new virus variants or strains.

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Brazil’s ANVISA Clarifies Registration Procedures For Biologicals

24 Apr 2025

• By Francesca Bruce

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.