1. Pink Sheet

After First COVID-19 Vaccine Approval, How Will Other Trials Maintain Placebo Control?

 
• By Derrick Gingery

US FDA officials fear comparator arms would be unwieldy for ongoing trials as they consider alternative methods to measure efficacy if placebo controls can't be maintained for the studies of other candidate vaccines once a product is on the market.

Antibodies immunoglobulins attacking coronavirus covid-19 influenza virus cell, 3D immune system medical illustration background. Corona virus 2019-ncov sars cell, igm. Coronavirus sars-cov-2 disease
Alternative statistical approaches may be possible if placebo controls cannot be maintained. • Source: Shutterstock

US Food and Drug Administration officials are thinking about ways to ensure the randomized, placebo-controlled Phase III clinical trials for coronavirus vaccine candidates can continue even after a product successfully completes the regulatory process.

Once the FDA approves or grants an emergency use authorization to make a vaccine available, trial enrollment may become much...

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