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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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More from Vaccines

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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US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
• By Derrick Gingery

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway

 
• By Eliza Slawther

The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.