Donald Trump is reportedly considering releasing a coronavirus vaccine before it has been fully tested, a move that America’s top infectious diseases expert Dr Anthony Fauci has warned could have dangerous consequences.
The US president is expected to put pressure on the US Food and Drug Administration (FDA) to fast-track the approval of a vaccine so it’s delivered before November, according to some scientists and health experts. Such a move could boost Trump’s chances of re-election.
It comes after the president announced on Sunday, August 23, that the FDA had issued an emergency use authorisation (EUA) for convalescent plasma to treat people with severe COVID-19 – despite the fact randomised, controlled trials haven’t yet shown any benefit of the plasma on patients.
Vaccine experts believe such use of an EUA could lead to a vaccine being pushed out before it has been fully tested, something Dr Fauci stressed could be dangerous.
‘The one thing that you would not want to see with a vaccine is getting an EUA before you have a signal of efficacy,’ Fauci told . ‘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.’
And although a vaccine intended for widespread use has never before been released via an EUA before being fully tested, experts worry that could soon change if the White House applies pressure on the FDA to do so.
An EUA is typically used to ‘diagnose, prevent and treat serious or life-threatening diseases where the known benefits outweigh the potential risks of the product’, Fauci said.
As such, an EUA might be appropriate once studies have shown a potential vaccine is both safe and effective, but certainly not before the FDA has completed its formal review of the company’s marketing application, he said.
Dr Fauci said the FDA’s guidance on vaccines explicitly states a demonstration is required to show safety and effectiveness before approval is granted. ‘To me, it’s absolutely paramount that you definitively show that a vaccine is safe and effective, both,’ Fauci said.
Dr Peter Hotez, an infectious disease expert and vaccine researcher at Baylor College of Medicine, agreed, stating:
I would be very worried about using an EUA mechanism for something like a vaccine. It’s very different from plasma therapy.
The announcement that an EUA had been issued further fuelled concerns that Trump is prepared to endanger American lives solely for political gain, after he tweeted about the FDA’s progress on Saturday, August 22.
In the tweet, Trump criticised the FDA for delaying progress on a vaccine until after the upcoming November election for the sole purpose of hurting his re-election bid. Because of course, that’s what matters here.
‘The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,’ he wrote. ‘Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!’
Obviously, a safe and effective vaccine is absolutely essential if we hope to end a pandemic that has so far claimed the lives of almost 820,000 people worldwide – more than 178,000 of them in the US.
Hopefully then, such a vaccine will be released and not one that’s been rushed out prematurely purely so the president of the worst-hit country in the world can attempt to make himself look better in time for the upcoming election.