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

 
• By Sarah Karlin-Smith and Bowman Cox

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.

These studies would likely be done in a few hundred people to make sure that the vaccines are trigging an...

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EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

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Global Pharma Guidance Tracker - June 2025

 
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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.