By World Healthcare Journal-
The Trump administration is considering bypassing usual US regulatory standards to fast-track an experimental coronavirus vaccine ahead of the presidential election, according to information gained by the Financial Times.
According to the Financial Times, one option currently being explored by the Trump Administration to speed up the availability of a vaccine would involve the US Food and Drug Administration awarding “Emergency Use Authorisation” (EUA) to President Trump in October.
The vaccine in question is the Oxford University vaccine, currently being developed in partnership with AstraZeneca. The Oxford vaccine has recently had successful results from relatively small sample groups in Stage-I and Stage-II testing, but is still currently in Stage-III testing.
The current standard for vaccine safety that US scientific agencies have set requires a vaccine to be studied on more than 30,000 people to pass the threshold for authorisation. Whilst the AstraZeneca study has currently enrolled 10,000 volunteers, AstraZeneca is will also be conducting a more extensive study with 30,000 volunteers, although the results from both trials will not be available for some time.
The first inclination of a sped-up vaccine authorisation comes from the Financial Times who discovered that Mark Meadows, White House Chief of Staff, and Steven Mnuchin, Treasury Secretary, allegedly told top Democrats that the Trump Administration was considering fast-tracking a vaccine.
The pair reportedly held a meeting over the possibility of fast-tracking the Oxford/AstraZeneca vaccine in September with Nancy Pelosi, the Democrat Speaker of the House of Representatives.
The Financial Times suggested that early access to the vaccine before the election could allow President Donald Trump to claim he has turned the tide on a virus that has killed more than 170,000 Americans, following widespread criticism of his handling of the pandemic.
In his DNC speech, Joe Biden, the Democratic Party nominee for President, said that the US response to the virus was the “worst performance of any nation”.
Experts believe that the Trump Administration is seriously considering rushing through emergency authorisation ahead of the election by bypassing standard Government guidelines in order to repair public confidence in the administration through the largest mass-immunisation programme in US history.
Despite these findings, a spokesperson for the Treasury Secretary stated that Mnuchin is not aware of any plans to fast-track the vaccine.
“Secretary Mnuchin did not make any comments regarding AstraZeneca, nor is he familiar with the specifics of the AstraZeneca vaccine candidate. He is also not aware of any plans the FDA may have regarding any emergency use authorisation for any potential vaccine, beyond what he has heard publicly stated," the spokesperson said.
Furthermore, there is already an existing precedent for issuing an EUA for Covid-19 treatment. The FDA recently issued an EUA for using convalescent plasma for the treatment of Covid-19 in hospital patients, in what the White House defined as a “major therapeutic breakthrough” in battling Covid-19.
“This is what I’ve been looking to do for a long time. This is a great thing. ” President Trump stated, referencing the EUA for plasma. However, he did not address the issue of a vaccine EUA - only hinting at that discussion over vaccine developments would occur in the near future.
The Financial Times also reported the intention of a string of resignations from within the FDA if it were to grant emergency approval to the Oxford/AstraZeneca vaccine.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told Reuters that he would resign if the agency were to approve a vaccine before definitive data showing it was safe and effective.
“I could not stand by and see something that was unsafe or ineffective that was being put through,” Dr Marks said. Insisting that“You have to decide where your red line is, and that’s my red line," he says.
In yet another infamous tweet, President Trump lashed out at the FDA in which the accused the agency of slowing down enrolment in coronavirus vaccine and drug trials to delay the results of studies until after the election.
Some commentators have suggested that this is simply political posturing from President Trump, whilst others have viewed it as a move to ensure that he can gain an EUA for the experimental vaccine before the election.
Michael Caputo, a spokesperson for the US Health and Human Services Department, spoke to the Financial Times and stated that any claim that the administration would issue an EUA before the election was “absolutely false”.
Mr Caputo went on to say that the administration was hopeful that a vaccine would be developed by the first quarter of 2021, whilst Anthony Fauci, Chief of the National Institute of Allergy and Infectious Diseases, has stressed the importance of scientific rigour and assurance.
A spokesperson for AstraZeneca spoke to the Financial Times, and reaffirmed that it had “not discussed emergency use authorisation with the US government” and that it “would be premature to speculate on that possibility”.
There are previous examples of the use of emergency approval from the FDA for experimental treatment, such as the early approval for hydroxychloroquine, repeatedly touted by President Trump, before it had to reverse its decision after multiple studies showed the drug was not effective as a coronavirus treatment.
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