- President Donald Trump wants to report on health regulations to approve a coronavirus vaccine for the US election.
- He wants to provide a vaccine that is being developed by Oxford University and AstraZeneca for emergency use, allowing it to be installed in the US without complying with full regulatory approval, according to the Financial Times.
- A representative of the Department of Health and Human Services said suggestions that the US Food and Drug Administration’s vaccine developed in the UK would be “absolutely false”.
- Trump on Saturday accused the FDA of trying to delay a fax to seize its chances in the Nov. 3 election.
- The UK government claims it will first have access to Oxford’s vaccine once it is approved.
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President Donald Trump wants to report that the approval of an experimental coronavirus vaccine is being developed in the United Kingdom so that it can be used in the US for the presidential election.
In a bid to secure a coronavirus vaccine by November 3, Trump wants the U.S. Food and Drug Administration to release a license for the vaccine being developed by Oxford University in the weeks leading up to the election, even if it is not yet full approval of regulations, reports the Financial Times, citing unname sources.
The Oxford vaccine, which is being developed in collaboration with the pharmaceutical company AstraZeneca, is set to be tested on 10,000 volunteers in the coming weeks; However, US health authorities have indicated that a vaccine must be successfully tested on 30,000 volunteers in order to receive authorization.
Two senior figures in the Trump administration told House Speaker Nancy Pelosi last month in a meeting that the president wanted to circumvent these requirements by granting the emergency permit, an unnamed source informed the meeting to the Financial Times.
The two figures – White House Chief of Staff Mark Meadows and Treasury Secretary Steven Mnuchin – said they expected a fax machine to be used for emergency use before the election and possibly as soon as next month.
A Treasury spokesman denied that Mnuchin commented on AstraZeneca at the meeting, saying he was “also unaware of any plans the FDA may have regarding any authorization for emergency use of potential vaccine, other than what he said in public. has heard. “
Michael Caputo, a representative of the Department of Health and Human Services, denied that the FDA would grant emergency use authorization for vaccines before the election, calling the idea “absolutely false.”
He told the Financial Times that the stated goal of developing a vaccine by the first quarter of 2021 had not changed and that one-on-one conversation available to the public in October was a “lurid resistance fantasy.” Caputo said: “Irresponsible talk of an unsafe or ineffective vaccine that is approved for public use is designed to undermine the president’s reaction.”
At the same time, President Donald Trump has publicly expressed a wish to have a fax machine sooner. On Saturday, Trump accused the FDA – without proof – of trying to delay a vaccine for coronavirus until after the election for political purposes.
In a tweet that Dr. Stephen Hahn, the FDA commissioner, tagged, Said Trump: “The deep state, or whatever, at the FDA makes it very difficult for drug companies to get people to test the vaccines and therapeutics. Of course, they hope to delay the response until after November 3. Must focus on speed, and rescue life! “
Pelosi said on Saturday that the president’s tweet was “extremely dangerous” and that “even for him, it went further in terms of how he would endanger the health and well-being of the American people.”
Dr Anthony Fauci warned earlier about the dangers of insufficient testing
Chamber member Nancy Pelosi at a news conference on July 24.
Tom Williams / CQ-Roll Call, Inc. via Getty Images
Oxford researchers are considered to be leading the race to produce a fully tested vaccine and have agreed with AstraZeneca to produce a maximum of 2 billion doses. The team, led by Dr. Sarah Gilbert, began human trials for the vaccine in April, at which point she said a vaccine could be proven effective until early September.
Dr Anthony Fauci, the director of the U.S. National Institute of Allergy and Infectious Diseases, has cautioned about the frontal status of Oxford, however, reflecting the fact that most vaccines do not receive regulatory approval.
“You have to be careful when you temporarily lead the way against a vaccine that will actually work,” he told the BBC last month in comments reported by Bloomberg.
Fauci, the top expert on infectious disease, also warned of the danger of the rapid detection of a vaccine against coronavirus, after Russian President Vladimir Putin announced this month that Russia had approved a vaccine and hoped to join soon. mass production. Russia’s vaccine has not completed its Phase 3 investigations, which are considered key in demonstrating the safety and effectiveness of a vaccine and are normally completed before regulatory approval is given.
Fauci said while the US had several faxes in development, “if we wanted to take the opportunity to hurt a lot of people or give them something that doesn’t work, we could start this, you know, new week if we wanted to – but that not the way it works. “
German Health Minister Jens Spahn has also warned about the risks of rolling out a vaccine to the public before conducting sufficient tests. Speaking about the Russian vaccine, he said: “It can be dangerous to vaccinate millions, if not billions, of people too early, because it can pretty much kill the acceptance of vaccination if it goes wrong, so I’m very skeptical about what continue in Russia. “
A spokesman for UK Prime Minister Boris Johnson on Monday ruled out the possibility that the US would gain access to the vaccine, ahead of the United Kingdom, by circumventing its normal procedures.
“We have been clear all along that we will only issue a vaccine once it has been considered safe and effective by our regulators,” the person said.
“AstraZeneca has made a number of agreements with other countries, but we are clear once it is found effective. We have signed a deal for 100 million doses and once it is effective, the UK will get first access.”
