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COVID-19 Vaccine Sponsors Want US FDA To Find Alternatives For Control-Arm Data After First EUA

 
• By Sarah Karlin-Smith

US FDA must rethink guidance on maintaining placebo-control in COVID-19 trials after any vaccine gets an EUA, companies say, arguing current proposal may not be ethical or feasible. Disease organizations who agree with the hurdles to preserving placebo-control maintain this is a reason why any EUA must meet a very high standard.

Vial with placebo medicine and syringe for injection
Sponsors are worried they may not be able to maintain placebo arms once any COVID-19 vaccine gets an EUA • Source: Shutterstock

It is unrealistic to expect coronavirus vaccine clinical trials to maintain placebo-controlled studies following the availability of any COVID-19 vaccine under an emergency use authorization, sponsors and other health organizations told the US Food and Drug Administration in comments that push the agency to come up with other methods to collect the necessary data absent placebo-arms. 

The formal comments were submitted to the docket for the agency’s 22 October Vaccines and Related Biological Products Advisory Committee, which is expected to discuss studies needed both pre-and post-licensure for COVID-19 vaccines, though its unclear how much of the meeting will be truly geared towards helping the agency and how much is designed to educate the public on the vaccine approval process

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