Top U.S. infectious diseases expert Anthony Fauci said on Thursday it is unlikely a COVID-19 vaccine will be ready by the end of October, but that it is not impossible.
‘I think most of the people feel it’s going to be November, December,’ Dr Fauci said in a CNN interview when asked about the possibility of an earlier release.
It’s the first time Dr Fauci has spoken since documents leaked to the New York Times revealed yesterday that the Centers for Disease Control and Prevention (CDC) sent instructions to state health departments to prepare for the arrival of COVID-19 vaccines by the end of October.
He added that a clinical trial could prompt drug developers to decide a vaccine works sooner.
‘It is conceivable that you can have it by October, though I don’t think that that’s likely.’
Dr Fauci had previously said that regulators would have a ‘moral obligation’ to end vaccine trials early if the data provided overwhelming evidence that the shots were safe and effective.
Moderna and Pfizer’s coronavirus vaccine trials are in their final (phase 3) stages before they are ready to be submitted to the Food and Drug Administration (FDA) for approval.
Each company has said it can have millions of doses ready by year-end and Pfizer previously stated it thought i could be ready for regulatory submission by October.
Dr Fauci has estimate that the Moderna trial would be fully enrolled by summer’s end, and that results could be available by November.
The leaked CDC forms provide guidance for storing, administering and distributing ‘Vaccine A’ or ‘Vaccine B,’ which were unnamed, in the event that either is granted emergency use authorization by the end of October 2020 – just days before Americans hit the voting booths and decide whether to re-elect President Trump on November 3.
Currently, the vaccines being developed by Moderna and Pfizer are the furthest along in their clinical trials, with AstraZeneca’s close behind.
The documents suggest that, if ‘Vaccine A’ is given emergency use authorization by October, ftwo million doses will be shipped then, with as many as 50 million additional doses going out by year-end.
For ‘Vaccine B,’ up to one million doses could be shipped by the end of October, and up to 35 million by year-end, according to the documents issued last Wednesday.
It comes after Dr Anthony Fauci, top infectious disease expert in the US, said that, if data clearly shows that a COVID-19 vaccine is safe and effective ahead of planned trial end-dates, an emergency use authorization could be issued early.
While Americans are eager for life to return to some semblance of normality, a recent Stat News and Harris Poll survey found that 78 percent of people in the US think that the fast progress toward approval for a coronavirus vaccine is driven not by science, but by politics.
And experts share their fears.
‘This gives me concern,’ Dean of the School of Tropical Medicine at Baylor College of Medicine and vaccine delivery expert Dr Peter Hotez told DailyMail.com.
‘All of this together gives me the impression that this potentially more of a stunt than an expression of concern for public health, especially coming in the weeks before the election.’
Millions of Americans are counting on a COVID-19 vaccine to curb the global pandemic, which has killed more than 180,000 people in the US, and sickened well over six million.
The Trump Administration launched Operation Warp Speed in an effort to expedite vaccine development via billions of dollars of investment in partner companies.
Operation Warp Speed has homed in on five lead candidates, of which three – those being made by AstraZeneca (with Oxford University), Moderna and Pfizer (with BioNTech) – are in their final-stage trials.
Moderna and Pfizer are currently in phase 3 clinical trials – the final run of human testing in tens of thousands of healthy volunteers – before they can apply for FDA approval.
Each company expects that could have significant data on whether or not their shots are safe and effective as early as this fall, and expect full results by the end of this year or start of next.
But clinical trials for coronavirus vaccines could be stopped weeks early, if data from the tests is ‘overwhelmingly’ positive that the shots work, and are safe, Dr Fauci told Kaiser Health News (KHN).
In fact, the nation’s top infectious disease doctor said researchers would have a ‘moral obligation’ to stop the trials short to expedite approval of shots if there is little reason to believe they won’t work or will pose significant side effect risks.
It’s not an unprecedented move.
In fact, after review of data from the National Institutes of Health (NIH) trial of the antiviral remdesivir for treating severely ill coronavirus patients, the experiment was stopped short for the same reasons.
The FDA’s emergency use authorization (EUA), a kind of stopgap form of approval that is faster, but requires less stringent review than formal approval, has had its a checkered history amid the pandemic.
‘It’s a substandard review, [for] something that is going to be given to maybe hundreds of millions of Americans,’ Dr Hotez said.
‘The EUA mechanism has been tainted – we’ve seen what happened with hydroxy[chloroquine] release and retracted,’ he added, referring to the FDA’s March issuance of an EUA for the malaria drug touted by Trump, and subsequent decision to revoke its authorization, in June.
‘Americans don’t trust it, [and] many would not accept a coronavirus vaccine any way.’
And trust in the safety and effectiveness of a shot, as well as trust in the agency responsible for assessing and approving it is key.
If Americans don’t trust a shot, they’re unlikely to be willing to get one, and if a sufficient percentage of the population (estimated to be somewhere between 20 and 50 percent) is not vaccinated or has antibodies from surviving the infection, the US will not reach the threshold of herd immunity.
Polling of American attitudes toward prospective coronavirus vaccines has consistently shown that only fewer than half of people in the US plan to get a COVID-19 shot.