By Reuters Sept 9, 2020 9:29:07 AM IST (Published)
The head of the US Food and Drug Administration (FDA) said last month COVID-19 vaccines may not necessarily need to complete Phase 3 clinical trials – large-scale testing intended to demonstrate safety and efficacy – as long as officials are convinced the benefits outweigh the risks.
Nine leading US and European vaccine developers pledged on Tuesday to uphold the scientific standards their experimental immunisations will be held against in the global race to contain the coronavirus pandemic. The companies, including Pfizer , GlaxoSmithKline and AstraZeneca , issued what they called a ”historic pledge” after a rise in concern that safety and efficacy standards might slip in the rush to find a vaccine.
The companies said in a statement they would ”uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines”. The other signatories were Johnson & Johnson , Merck & Co , Moderna , Novavax , Sanofi and BioNTech .
The promise to play by established rules underlines a highly politicised debate over what action is needed to rein in COVID-19 quickly and to jumpstart global business and trade. Partners BioNTech and Pfizer could unveil pivotal trial data as early as October, potentially placing them at the centre of caustic US politics before the Nov. 3 presidential election.