After First COVID-19 Vaccine Approval, How Will Other Trials Maintain Placebo Control?
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.
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COVID-19 Vaccine Sponsors Want US FDA To Find Alternatives For Control-Arm Data After First EUA
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.
After EUA, COVID Vaccine Sponsors Need Plans For Continuing Trials
EUA request should also include plan for a sponsor’s active follow-up for safety among individuals given the vaccine under EUA – including assessing deaths, hospitalizations and other clinically significant adverse events – to inform ongoing benefit-risk determinations to support the continued authorization, US FDA says in its finally-released guidance.
India’s Draft Guidelines For COVID-19 Vaccines Follow WHO, US Lead
India has rolled out draft guidelines for development of vaccines with special focus on COVID-19 vaccines, drawing from those of other regulatory bodies and the WHO. Experts suggest the primary efficacy endpoint of minimum 50% is acceptable given that vaccines against respiratory diseases are difficult to develop though not necessarily enough to snuff out a pandemic.