Top US expert Fauci warns against rushing out coronavirus vaccine
CHICAGO/NEW YORK: The top US infectious diseases expert is warning that distributing a Covid-19 vaccine under special emergency use guidelines before it has been proved safe and effective in large trials is a bad idea that could have a chilling effect on the testing of other vaccines.
Scientists and health experts have expressed concern that President Donald Trump will apply pressure on the US Food and Drug Administration to deliver a vaccine before November to boost his chances of re-election.
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, declined to comment on the president, but said there are risks in rushing out a vaccine despite the urgent need.
"The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorisation) before you have a signal of efficacy.
"One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enrol people in their trial," Dr Fauci said.
Mr Trump stoked concerns of politicising the regulatory approval process with an announcement on Sunday of an emergency use authorisation for plasma from recovered Covid-19 patients to treat current patients before its benefits have been assessed in randomised, placebo-controlled clinical trials.
Mr Trump had tweeted on Saturday that "deep state" elements at the FDA were delaying progress on drugs and vaccines until after the Nov 3 election in order to hurt his re-election bid.
Safe and effective vaccines are seen as essential to ending the pandemic that has claimed the lives of more than 800,000 people worldwide, over 177,000 of them in the US.
But vaccine experts worry the White House may apply pressure on the FDA to push out a vaccine via an EUA before it has been fully tested.
Dr Fauci said the FDA's guidance on vaccines - both for full approval and for an EUA - explicitly requires a demonstration that it is both safe and effective.
An EUA is typically used for products to "diagnose, prevent and treat serious or life-threatening diseases where the known benefits outweigh the potential risks of the product," Dr Fauci said. - REUTERS