As the US was on the verge of 6m coronovirus cases on Sunday, FDA Commissioner Stephen Hahn told the Financial Times in an interview published on Sunday that he was ready to issue an emergency use authority for the Kovid-19 vaccine. Phase 3 human trials that inject the drug through stringent testing for safety and efficacy.
He said that the standard he would apply instead would “reduce the risk in a public health emergency”.
Hahn told the newspaper that his decision would not be taken under political pressure amid the feudal atmosphere of the upcoming US presidential election. “It’s going to be a science, medicine, data decision. This is not a political decision.
But several public health experts on Sunday expressed their concern about a clear desire to consider fast tracking outside of what is considered a gold test testing process.
The FDA has come under pressure in recent weeks from Donald Trump, who wants to see a vaccine ready to come on stream or announce before the November election, and a public-private vaccine development fund program called Operation War Speed is underway is.
Trump has openly attacked the FDA, stating that it is within a foot of dragging its feet on the process of vaccine approval for its approval, despite having no evidence to support the latest version of a right-wing conspiracy theory. Citing the “deep state” is foundational. The Trump administration’s original campaigners, Steve Bannon, have rejected.
According to Johns Hopkins University data, the number of confirmed cases of Kovid-19 was up to 6m in the US as of Sunday afternoon, while the recorded deaths are 182,612 – almost a quarter of all global deaths.
California became the first state to pass 700,000 confirmed cases over the weekend.
Since the onset of the epidemic in January, Trump has steadily reduced the severity of the crisis and sidelined scientists, including those at the FDA.
Hahn has been criticized for the efficacy of misleading plasma treatments that take blood plasma from Kovid-19 survivors and inject it into victims.
At a White House media launch last week, Hahn said standing with Trump, plasma treatment would save 35 out of every 100 patients when the study actually tallied 3 to 5 lives. He was forced to apologize.
Scientists and public health experts were quick to warn about Hain’s comments about cutting short trials of the vaccine.
A virologist at Columbia University in New York, Drs. Angela Rasmussen said: “We absolutely cannot tolerate or accept an emergency authorization for any Kovid-19 vaccine without reliable safety and efficacy data from phase three clinical trials”.
Writing on Twitter, She said that it would be unethical to ensure before testing that testing has proved that both the safety and efficacy of the vaccine.
“The large number of people at risk for potential harm on a large scale” and “would be a catastrophic blow to public confidence in both the vaccines and the regulatory mechanisms in place”, she wrote.
Eric Topol of Scripps Translational Research Institute said The test for the safety of the vaccine will take several months to be fully determined, “Despite Stephen Hahn’s subordination to Trump … any shortcut would prevent the final rollout of the vaccine and lose public confidence for vaccination , Which is already compromised. ”
Hahn’s predecessor Scott Gottlieb as head of the FA told CBS’s Face the Nation that “I don’t know what it means to say before Phase 3 trials are complete … they’re waiting for these tests Before they can read. Decide on the efficacy of these vaccines. ”
Earlier this month the news that Russia had produced a vaccine was welcomed with widespread skepticism as it was approved and was being given to people including Vladimir Putin’s daughters before the phase three trials.