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Donald Trump after returning to the White House: "We're looking at this"
Photo: NICHOLAS KAMM / AFP
The US drug agency FDA has tightened the requirements for the emergency approval of a Covid-19 vaccine, according to US media reports, apparently against the will of the White House.
With the recommendations now in place, it has become even less likely that a vaccine against Covid-19 will be available before the US presidential election on November 3rd.
The US President Donald Trump had promised exactly that in the election cup several times.
According to the US media, the FDA had already submitted the draft for the new guidelines to the White House on September 21.
The most important points are:
Subjects in phase III vaccine studies should, on average
, be observed for at least two months
after receiving the last dose of immunization.
This is to ensure that the potential immunity is not short-lived.
In order to be able to make reliable statements, at
least five severe cases of Covid-19
would have to occur in the
placebo group
.
In addition, the data from the studies should be
evaluated
by
independent experts
before the FDA grants an emergency approval.
In the video: Trump's return to the White House
Just days after the draft was circulated, Trump initially left it open at a press briefing on whether the White House would approve the new guidelines.
"We're looking at it," said the US President a good two weeks ago about the FDA's tightened proposals and indirectly imputed that the agency was intervening in the election campaign: "I think it's more about politics than anything else."
He has great faith in these "enormous companies" that test vaccines.
According to US media reports, the White House is said to have tried to remove the two-month rule again.
It would not be the first time that Trump had to deal with authorities in the corona crisis.
In August, he had accused the FDA of deliberately delaying the search for a vaccine.
And only to prevent a possible approval before the upcoming presidential elections, he railed on Twitter.
Trump gave a rough idea of who his supposed enemies are and spoke of a "deep state" - a state within a state that rebels against the government, a popular theory especially in right-wing US circles.
Such attacks leave Trump a political back door.
If the first approval does not come - as he announced - before the upcoming presidential elections, he could put the blame on supposedly sedate and politically influenced authorities.
No matter how baseless that claim would be.
It is more than questionable whether a possible vaccine will receive emergency approval before the upcoming elections on November 3rd.
Only a few vaccine candidates are already in the crucial phase.
The two pharmaceutical companies Moderna and Pfizer, whose clinical studies are furthest advanced to date, started the third test phase at the end of July.
Since the second dose of vaccine is administered 28 days after the first dose, the follow-up period required by the FDA for the very first subjects would end in October.
However, so far only the manufacturer Pfizer has indicated that the first data on effectiveness could be available in October.
Experts doubt the forecasts.
Pfizer is working together with the Mainz-based company Biontech on an RNA vaccine.
The potential vaccine started its first approval process with the European Medicines Agency Ema on Tuesday.
(Read here exactly what that means.)
Even an initial approval would probably not be the savior for which Trump is selling it.
The head of the US disease protection agency CDC, Robert Redfield, had emphasized that a possible vaccine would not be available to the broader population of the US until spring at the earliest.
Trump then described Redfield as "confused".
(I do not understand that)
The actions of the US President damage the reputation of the authorities as well as the science and ultimately the corporations alike.
Last week, in the renowned New England Journal of Medicine, scientists accused the FDA of having approved hydroxychloroquine, advertised by Trump as a miracle drug, for the treatment of Covid-19, although decisive study results were not yet available.
This creates the worrying impression that it was not a data-focused process that led to the FDA's decision, but political pressure.
The FDA had to withdraw the approval a short time later after studies had shown that the agent actually used for malaria did not bring any benefits and even potential risks for Covid 19 patients.
Should Trump actually have been responsible for the urgent emergency approval of hydroxychloroquine, could he also push through a potential vaccine?
"With a vaccine that would not be acceptable"
"The approval of a vaccine is based on a completely different basis," says Florian Krammer, professor of vaccination science at the Institute of Microbiology at the Icahn School of Medicine at Mount Sinai in New York, to SPIEGEL.
A drug is supposed to help a seriously ill patient.
Hydroxychloroquine is also already approved as a remedy, albeit not for the therapy of Covid-19.
According to Krammer, certain risks are justifiable.
However, such risks are unacceptable with a vaccine.
After all, it is given to healthy people in the hope of protecting them from a disease - which they may not get at all.
"Especially with a vaccine that may be administered to millions of people, you have to be damn sure that it is effective, safe and well-tolerated," says Krammer.
He is therefore not surprised that the stricter guidelines of the FDA are being implemented - regardless of whether the White House should have blocked it or not.
In fact, even before the new guidelines were published, several vaccine manufacturers had announced that they would follow the recommendations of the FDA.
In this respect, Trump has evidently been right with his "great confidence in the enormous companies that test vaccines".
Nevertheless, US confidence in a possible vaccine seems to have already been damaged.
In a survey in May, 72 percent of Americans could imagine getting vaccinated against Covid-19, the figure is now only 51 percent.
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