FDA Extends EUA for Remdesivir in Covid Patients

02.09.2020 - The US Food and Drug Administration (FDA) has come under fire again as the federal health agency issued its third Emergency Use Authorization (EUA) for a Covid-19 treatment since the beginning of the pandemic. This extended the authorization for Gilead’s remdesivir, which it markets as Veklury.

The FDA’s latest action came less than a week after its EUA for convalescent blood plasma treatment of hospitalized patients who have tested positive for the novel coronavirus.

In May, following publication of a study showing that patients on remdesivir recovered faster than those who had received a placebo, the FDA allowed it to be used for hospitalized adults who required oxygen, but not those on ventilation. The latest authorization extends use to all Covid patients, including children.

A second study conducted in August this year with patients described as “less severely ill” showed that five days of treatment with remdesivir was better than standard care, though the difference was described as being of “uncertain clinical importance.” Neither study produced any evidence that the treatment saved lives.

In all of the EUA cases, US president Donald Trump had urged the relaxation of traditional rules that restrict application of novel treatments without peer reviewed controlled studies and critics asserted that no published research underpins widespread use any of the treatments, and all decisions were political.

In a statement justifying the decision, FDA Commissioner Stephen Hahn said the data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus. The FDA, he said, uses the emergency authorization process to approve products that, based on scientific evidence, “it is reasonable to believe may be effective, when there are no adequate, approved and available alternatives.”

Some physicians said they were surprised at the FDA's approval of remdesivir for all hospitalized patients, with one expressing concern that expanded use may make it harder to get the drug for patients who need it. This was the case when Trump first began touting the old malaria drug hydroxychloroquine as a Covid-10 treatment. The price of the drug also soared.

 The three EUAs – the first authorizing hydroxyhloroquine was later withdrawn – have done little to boost the US scientific and medical communities’ confidence in Hahn. The radiation oncologist and former chief medical executive of the MD Anderson Cancer Center in Houston has only held the commissioner’s job since December 2019. 

Many were critical about his allowing manufacturers of Covid-19 antibody tests to sell their products as long as they registered with the FDA, without any other restrictions. The rules were later tightened.

With the Trump administration promising to have a Covid vaccine approved and ready to administer before the US elections on Nov. 3, fears are that Phase 3 trials will be cut short, as Hahn seemed to suggest in a recent interview with UK business newspaper Financial Times.

Eric Topol, vice president for research at Scripps Research in La Jolla, California and a national expert on the use of data in medical research, said he believes the FDA has already sacrificed its credibility with the public. Without widespread a acceptance of vaccines, he said, there will be no way to end the COVID-19 pandemic.

Nevertheless, in a late August statement, Hahn pledged that the process and review for vaccine development “will be as open and transparent as possible.” 

A discussion scheduled for Oct. 22 with the agency’s Vaccines and Related Biological Products Advisory Committee, made up of outside scientific and public health experts, will help ensure clear public understanding regarding clinical development of the vaccines 19 and the data needed to facilitate their authorization or licensure. “It is critical for people to see FDA’s expectations for data to support safety and effectiveness,” Hahn said.

A poll by US political journal POLITICO published last month showed that nearly a fifth of adults would refuse a coronavirus vaccine if one were available, in some cases over fears that any approval would be motivated by politics rather than science. Altogether 14% percent of those planning to vote in November said they would be likely to take a vaccine recommended by president Trump.


Author: Dede Williams, Freelance Journalist