Why emergency Covid-vaccine approvals pose a dilemma for scientists

‘Immunizations are speeding towards approval before clinical trials end, but scientists say this could complicate efforts to study long-term effects...

‘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.’

Read here (Nature, Nov 23, 2020)

Only 15 per cent in 13 advanced economies in Europe, North America and Asia approve of US handling of the coronavirus: Pew Research Centre survey

‘The median percentage of people polled in 13 countries who said the US has done a good job dealing with the coronavirus was only 15 per cent, the study says... China received a median approval rating of 37 per cent, while nearly two out of three people believed the WHO, from which the US withdrew this year over allegations of a bias toward China, had done a good job. The study “clearly indicates that around the globe no one is buying the Trump administration’s ardent efforts to pin blame on the pandemic upon China and the WHO,” said Allen Carlson, an associate professor in Cornell University’s government department.’

Read here (South China Morning Post, Sept 15, 2020)

Quick and affordable saliva-based COVID-19 test developed by Yale scientists receives FDA Emergency Use Authorisation

‘A saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public Health to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. Food and Drug Administration (FDA). With the FDA’s emergency use authorization, the testing method is immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the nation — and, perhaps, beyond — in the coming weeks, the researchers said. A key component of SalivaDirect, they note, is that the method has been validated with reagents and instruments from multiple vendors. This flexibility enables continued testing if some vendors encounter supply chain issues, as experienced early in the pandemic.‘

Read here (Yale News, August 15, 2020)

China drug regulator says Covid-19 vaccines must have 50 percent efficacy rate to be approved for use

‘China's drug regulator has said COVID-19 vaccine candidates must have a 50 percent efficacy rate and be able to provide users with at least six moths' immunity from the virus if they are to be approved in the country. A draft document released by the Chinese Centre for Drug Evaluation (CCDE) laid out the guidelines, stipulating that while 50 percent efficacy is the minimum, the target is that vaccines should be effective for 70 percent of the population.’

Read here (Newsweek, August 15, 2020)

Coronavirus saliva test gets FDA emergency use approval, Rutgers University says

• The Food and Drug Administration granted emergency use authorisation for a coronavirus test relying on saliva samples developed by a Rutgers University-backed entity, Rutgers said Monday.
• The test could increase, by tens of thousands of tests per day, the number of screenings for Covid-19, Rutgers said.
• The test was developed by Rutgers’ RUCDR Infinite Biologics and its collaborators, Spectrum Solutions and Accurate Diagnostic Labs.

Read here (CNBC, April 13, 2020)