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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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Vaccine Developers To Benefit From CEPI’s ‘World First’ Adjuvant ‘Matchmaking’ Service

 
• By Eliza Slawther

Selected vaccine developers will soon be able to use a new adjuvant “matchmaking” initiative that could help create more “effective, potent” vaccines against epidemic and pandemic threats, the Coalition for Epidemic Preparedness Innovations has said.

Double Duty At US FDA: Tidmarsh Will Temporarily Lead Both CDER And CBER

 
• By Sarah Karlin-Smith

Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.

Vinay Prasad Out At US FDA

 
• By Sarah Karlin-Smith

The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.

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UK Medicines Shortages Inquiry Eyes Full Reshoring of Drug Manufacturing

 
• By Neena Brizmohun

A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.

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A Crossroads for Global Health: Strengthening the Future of Vaccines

Learn how advances in vaccine adjuvants are shaping the future of global health and driving more effective immunization strategies

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.