Two of the Trump administration’s top scientific advisers have said that it is unlikely that there will be a coronavirus vaccine ready by November – spelling trouble for Donald Trump’s hopes of rolling one out before election day.
Dr Moncef Slaoui, the scientific head of vaccine development programme Operation Warp Speed, told NPR’s Mary Louise Kelly on Thursday that the vaccine will almost certainly not be cleared this autumn — even though it is moving “incredibly fast” by the standards of vaccine development.
“Well, it’s a matter of planning, and the operation has been performing, I have to say, very, very well up to now, even better than I was hoping.
“There is a very, very low chance that the trials that are running as we speak could read before the end of October, and therefore there could be — if all other conditions required for an emergency use authorisation are met and approved,” Dr Slaoui said.
“I think it’s extremely unlikely but not impossible, and therefore it’s the right thing to do to be prepared in case,” he added.
Dr Slaoui went on to explain that the vaccine’s emergency use authorisation will not come through until it passes stringent efficacy and safety tests in phase three trials.
While he expects to have a vaccine available by the end of the year to inoculate high-risk people, he said that the full vaccination of the US population would have to wait until the middle of 2021.
On Friday morning, US surgeon general Dr Jerome Adams reiterated Dr Slaoui’s claims and told Good Morning America that it is “improbable” that a vaccine will be ready by November.
“It’s not just about having a vaccine that is safe and effective, but about being ready to distribute it,” Dr Adams said.
“So on the chance. that a vaccine might be available early, and Dr [Anthony] Fauci and [vaccine czar] Dr [Moncef] Slaoui both say that’s possible even though not probable, we want to make sure that states are ready to distribute it, hence the 1 November instructions from the CDC, just in case it’s ready, so we can quickly get it to the people who most need it,” he added.
Dr Adams said that US officials are not rushing the vaccine approval for election day and explained: “What people need to understand is that we have a Data and Safety Monitoring Board, who actually blind the data so it won’t be possible to move forward unless this independent thinks there is good evidence a vaccine is efficacious.”
Both the creation and development of Operation Warp Speed have concerned not just Mr Trump’s usual critics but also many public health experts, many of whom worry that any vaccine it produces will be rushed into production before adequate safety trials have been run.
At the root of these concerns is the fear that the race for a vaccine is being accelerated for the purposes of Mr Trump’s re-election campaign.
The Centres for Disease Control (CDC) this week notified public health authorities across the country to be ready to distribute a vaccine in early November, even with no definitive indications that an inoculation will be ready by election day.
At a campaign rally in Pennsylvania on Thursday night, Mr Trump doubled down on the claims and said a vaccine might “really might even be delivered before the end of October...How do you like that?”
The CDC and FDA have both come in for criticism recently over actions and statements some have called overly political, with the CDC recently suggesting that fewer Americans need to be tested — advice later confirmed to have been urged by the White House, and not signed off by top adviser Dr Anthony Fauci as first claimed.
FDA commissioner Stephen Hahn, meanwhile, last week had to apologise for publicly overstating the efficacy of a plasma treatment for Covid-19 patients — a treatment whose emergency authorisation was announced on the eve of the Republican National Convention, again raising suspicions it had been pushed out to flatter the administration at a critical moment.
However, asked whether he agreed the November date of the CDC’s advice had a whiff of politics about it Dr Slaoui agreed, but said the instruction to the states to prepare is less a political ploy than part of a strategy to ensure the country was ready.
Dr Slaoui said: “I get the point. You’re right. And my reading of that letter, which I — like you — discovered on the news, is one that says ‘we need to be prepared as of [1 November]’. And I do think there is a possibility that the clinical trials — albeit very low, as I said before, extremely low — but there is a possibility that the trials read out before the end of October.
“It would be irresponsible not to be ready if that was the case.”
According to Johns Hopkins University some 6.1m people have now tested positive for coronavirus in the US and the death toll has reached 187,464.
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