Via Nature.com: Why emergency COVID-vaccine approvals pose a dilemma for scientists. Excerpt:
After a flurry of positive results from clinical trials of COVID-19 vaccines, developers are now seeking ‘emergency use’ approvals, which could see these immunizations deployed in potentially tens of millions of people. But scientists are concerned that this kind of early deployment could compromise the ongoing clinical trials that seek to show conclusively how well the vaccines work.
Following the release of early data from phase III trials on 9 November, vaccine makers Pfizer and BioNTech have sought regulatory permission to deploy their vaccine under emergency-use rules. The developer of another leading vaccine, Moderna, is expected to do the same within weeks.
Once a vaccine is granted emergency approval, there is pressure on developers to offer the immunization to trial participants who received a placebo. But if too many people cross over to the vaccine group, the companies might not have enough data to establish long-term outcomes, such as safety, how long vaccine protection lasts and whether the jab prevents infection or just the disease.
“It’s a real vaccine development dilemma,” says Klaus Stöhr, who formerly headed vaccine design at the pharmaceutical company Novartis in Cambridge, Massachusetts, and is now retired. Still, Stöhr thinks that the vaccine should be granted emergency use authorization because its effectiveness has been established and there is a dire need.
