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Alarm as FDA prepared to difficulty Covid-19 vaccine earlier than stringent security testing


Photograph: Alex Brandon/AP

Public health experts have reacted with alarm to remarks by the head of the US Food and Drug Administration (FDA) that he might give the green light for a US Covid-19 vaccine before the normal clinical trial process had reached its conclusion.

As the US was on the verge of 6m coronavirus cases on Sunday, Stephen Hahn, the FDA commissioner, told the Financial Times in an interview published on Sunday that he was prepared to issue emergency use authorization for a Covid-19 vaccine before the end of Phase 3 human trials that put the drug through stringent testing for safety and efficacy.

He said the standard he would apply instead would be “that the benefit outweighs the risk in a public health emergency”.

Hahn told the newspaper that his decision would not be swayed by political pressure amid the febrile atmosphere of the upcoming US presidential election. “This is going to be a science, medicine, data decision. This is not going to be a political decision,” he said.

But several public health experts expressed their concern on Sunday about an apparent willingness to consider fast-tracking a vaccine outside what is considered the gold standard testing process.

The FDA has come under intensifying pressure in recent weeks from Donald Trump, who wants to see a vaccine come on stream or ready to announce before the November election, and has a public-private vaccine development funding program underway called Operation Warp Speed.

Trump has openly attacked the FDA, baselessly citing a supposed “deep state” within it of dragging its feet on the vaccine approval process, despite no evidence to support the latest version of a right-wing conspiracy theory that even one of its most enthusiastic, original Trump administration propagators, Steve Bannon, has dismissed.

The number of confirmed cases of Covid-19 was approaching 6m in the US by Sunday afternoon, according to figures from Johns Hopkins University, while recorded deaths stand at a catastrophic 182,612 – almost a quarter of all global fatalities.

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Over the weekend California became the first state to pass 700,000 confirmed cases.

Since the beginning of the pandemic in January, Trump has consistently downplayed the severity of the crisis and sidelined scientists, including those at the FDA.

Hahn has been criticized for misleading the public about the efficacy of convalescent plasma treatment which takes blood plasma from Covid-19 survivors and injects it into sufferers.

At a White House media launch last week Hahn, standing beside Trump, said the plasma treatment would save 35 lives out of every 100 patients when in fact studies put the figure at 3 to 5 lives. He was forced to apologise.

Scientists and public health specialists were quick to issue warnings about Hahn’s comments about cutting short the vaccine trials.

Dr Angela Rasmussen, a virologist at New York’s Columbia University, said: “We absolutely cannot tolerate or accept an emergency authorization for any Covid-19 vaccine without reliable safety and efficacy data from phase three clinical trials”.

Writing on Twitter, she said it would be unethical to give the go-ahead before the trials had conclusively proved that both the safety and efficacy of the vaccine.

It would place “huge numbers of people at risk for massive potential harm” and would deal “a catastrophic blow to public confidence in both vaccines and the regulatory mechanisms in place”, she wrote.

Eric Topol of the Scripps Translational Research Institute said that it would take many months for the safety of the vaccine to be fully determined at trial, “irrespective of Stephen Hahn’s subservience to Trump… Any shortcuts will imperil the ultimate rollout of the vaccine and lose the public trust for getting immunized, which is already compromised.”

Hahn’s predecessor as head of the FDA, Scott Gottlieb, told CBS’s Face the Nation that “I don’t know what is meant by saying before the phase 3 trials are completed… They are going to wait for these trials to read out before they can make a decision about the efficacy of these vaccines.”

The news earlier this month that Russia had produced a vaccine was greeted with widespread skepticism because it had been approved and was being given to people, including one of Vladimir Putin’s daughters, before phase three trials.


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