The top U.S. infectious diseases expert,Dr Anthony Fauci, 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.
"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."
Mr. Trump stoked concerns of politicizing the regulatory approval process with an announcement on Sunday of an emergency use authorization for plasma from recovered COVID-19 patients to treat current patients before its benefits have been assessed in randomized, placebo-controlled clinical trials.
Scientists and health experts have expressed concern that President Donald Trump will apply pressure on the U.S. Food and Drug Administration（FDA)to deliver a vaccine before November to boost his chances of re-election.
F. D.A. ‘Grossly Misrepresented’ Blood Plasma Data
Dr. Stephen M. Hahn, the F.D.A. commissioner, erroneously said 35 out of 100 Covid-19 patients “would have been saved because of the administration of plasma.”on Sunday that convalescent plasma would have saved 35 percent of coronavirus patients this year.
Over the next couple of months, as data emerges from vaccine clinical trials, the safety of potentially millions of people will rely on the scientific judgment of the F.D.A. That’s a problem if they’re starting to exaggerate data.
However, if the government does rush through emergency authorisation ahead of the election by skirting normal government guidelines, it could dent already shaky public confidence in the safety of vaccines ahead of one of the largest mass-immunisation programmes in US history.