Trump says he could block FDA request for stricter Covid vaccine safety

Administration’s stated goal of deploying vaccine by November has many observers worried that political impact is being prioritised over safety and efficacy checks

Donald Trump has said he might not approve new rules to make sure any coronavirus vaccine is safe before rolling it out, calling increased safety checks “a political move”.

The remarks, made at Wednesday’s White House press briefing, represent another instance of Mr Trump downplaying the importance of scientific advice while accusing health authorities of deliberately hindering him.

The Food and Drug Administration (FDA) is reportedly preparing strict new standards to govern any emergency authorisation for a vaccine that could be released in the coming months.

The Trump administration has turbo-charged vaccine development under an initiative known as Operation Warp Speed, which has seen several vaccines already reach late-stage trials but also raised worries that the usual scientific standards are being brushed aside so that an inoculation can be rolled out in time for the election.

Asked whether he was “okay” with the FDA’s proposed new rules, Mr Trump was equivocal.

“Well, I’ll tell you what, we’re looking at that, and that has to be approved by the White House. We may or may not approve it.

“That sounds like a political move, because when you have Pfizer, Johnson & Johnson, Moderna, these great companies coming up with these – the vaccines, and they’ve done testing and everything else, I’m saying: ‘Why would they have to be, you know, adding great length to the process?’

“We want to have people not get sick. The vaccine is very important. It’s the final step. I believe it’s going to be the final step. And no, we’re looking at that, but I think it’s – I think that was a political move more than anything else.”

The reason for the enhanced safety checks is to ensure that the vaccine, which will be used after being developed at unprecedented speed, does not cause dangerous side-effects that could harm up to tens of millions of people without prior warning. Vaccines are usually put through years of development and testing before being deployed, allowing such risks to be minimised.

There are also worries that without being able to demonstrate that a vaccine has been vetted as carefully as possible, US health authorities will be unable to effectively combat anti-vaccine misinformation and conspiracy theories that are already gaining traction – raising the risk that not enough people will accept the jab for it to protect the population as a whole.

Pressed on this point, the president focused on his own trust in vaccine producers to get the job done. “Well, I have tremendous trust in these massive companies that are so brilliantly organised,” he said, “in terms of what they’ve been doing with the tests. I mean, I don’t know that a government, as big as we are, could do tests like this. We’ve made it possible for them to do the tests in rapid fashion.

“But when they come back, and they say that we have something that works and absolutely works, and they’re coming back with great numbers and statistics and tests and everything else that they have to come back with, I don’t see any reason why it should be delayed further. Because if they delay it a week or two weeks or three weeks, you know, that’s a lot of lives you’re talking about.”

At this point, Mr Trump called on Scott Atlas, the controversial head of his coronavirus task force who has no background in immunology or public health, asking him to explain why the enhanced safety measures are supposedly unnecessary.

Like Mr Trump, Mr Atlas framed the new measures as political “punishment”, though he did not spell out precisely what he meant.

“There is zero cutting of safety concerns,” said Mr Atlas of the speed of the vaccine’s development. “There should be no hesitation about the safety. You shouldn’t be punished by doing something faster than other people could have done or thought; it’s the opposite. We have a pandemic. The urgency is the pandemic, not politics.”

Mr Atlas has previously made assorted contentious remarks about the pandemic, including claiming that asymptomatic people need not be tested, that children “almost never” transmit the disease (which is false), and that some studies on the protective value of masks are “garbage”.