The White House will approve the FDA's stricter guidelines for getting an COVID-19 vaccine approved, according to a Tuesday Wall Street Journal report.
Operation Warp Speed chief Dr Moncef Slaoui said Tuesday that his program will not have the first 'readout' on COVID-19 vaccine efficacy before November.
Trump said Monday that vaccines are coming 'momentarily' and has had his sights set on emergency use authorization by November 3.
The FDA's Vaccines and Related Biological Products Advisory Committee has published guidelines for approving a coronavirus vaccine.
Officials recommend that any jab have two months of safety data before being app roved for Emergency Use Authorization (EUA).
Vaccine makers will also have to submit manufacturing process and controls information no less than one month prior to submitting an EUA request.
Experts say this makes it near impossible that a COVID-19 immunization will be approved by Election Day.
New, stricter guidelines were submitted two weeks ago, but they 'stalled' in the office of White House chief of staff Mark Meadows.
The White House will sign off on the stricter guidelines for emergency approval of coronavirus vaccine proposed by the Food and Drug Administration (FDA) last month, the Wall Street Journal reported on Tuesday.
Trump administration officials have decided to drop their objections to new requirements that would make it nearly impossible for a shot to get approved before Election Day in a reversal of the roadblock the Trump administration had planned, according to a Monday night New York Times report.
Coronavirus vaccine makers will have to collect two months of data on trial participants after they get their second doses before submitting data for emergency or full FDA approval under the new guidelines.
Pfizer and Moderna only launched their late- stage trials in late July, with shots given 28 days apart, making it nearly impossible for them to collect that data BEFORE Election Day. It's perhaps the final nail in the the coffin of Trump's hopes to have a COVID-19 vaccine by November 3.
Tuesday brought a quick succession of blows to that possibility.
The first 'readout' of data on coronavirus vaccine efficacy will not be available before November, Operation Warp Speed chief Dr Moncef Slaoui said separately on Tuesday.
In other words, the vaccine czar does not expect to be able to deliver a shot before November 3. It's unclear if the availability date for a data readout was due to the new guidelines or other factors.
'The vaccines are coming momentarily,' Trump said on Monday night in a video posted to his Twitter account, upon his return to the White House from Walter Reed National Medical Center.
With his administration's approval of the new FDA guidelines, it's next to impossible for any vaccine to come sooner than a month from now.
However, Dr Slaoui said he feels 'comfortable' that one or two vaccines will have proven effective within the next two months, and will have enough doses for about 30 million people, he said during a Johns Hopkins webinar on Tuesday.
Earlier on Tuesday, an advisory committee at the US Food and Drug Administration (FDA) recommended that any coronavirus jab have two months of safety data before being approved for Emergency Use Authorization (EUA).
The agency posted briefing documents for the Vaccines and Related Biological Products Advisory Committee's meeting on COVID-19 immunizations scheduled for October 22, in the hopes that seeing the proposal 'helps the public understand our science-based decision making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved,' regulators said.
In addition to the safety data requirements, the committee has asked vaccine makers to submit their manufacturing process and controls information no less than one month prior to submitting an EUA request.
Although the recommendations have not been made official, and the FDA is not bound to accept them, they all but assure a shot for the virus that has killed more than 210,000 Americans will not be made available before Election Day.
It comes on the heels of a report that the Trump administration blocked the approval of stricter COVID-19 vaccine approval guidelines.
it has reached out to the FDA for comment.
'The likelihood of an EUA happening before Election Day is zero,' Professor Peter Pitts, former FDA Associate Commissioner, told it.
'Even if these guidelines ultimately do not become accepted, I don’t think you’re looking at any type of EUAs before the end of the year, at the earliest.'
For a vaccine to be approved prior to November 3, its manufacturing process information would have had to have been submitted to the agency earlier this month.
Pitts said it is very important that the FDA be careful before approving any jab because many of the vaccines are using technology that has never been used on a mass-scale.
Among them is mRNA, which tricks the body into producing some of the viral proteins, which the immune system then recognizes and builds a defensive response against.
'The urgency of the FDA understanding the validity of the manufacturing data is always crucial and even more crucial now,' Pitts said.
He adds that it is important to watch not the infection rates from COVID-19 but the death rates, which are continuing to remain stable.
'The lesson learned there is we've got a lot to keep the at-risk population alive and that will also, I think, factor into the FDA's decision relative to EUAs for a vaccine,' Pitts said.
'When the death rates are low and stable, that reduces the rationale for a hasty decision.'
President Donald Trump, who is now battling COVID-19 himself, has continually hinted that a vaccine could be available by Election Day, raising concern that the FDA and vaccine makers might bow to political pressure rather than prioritize shot safety.
According to a report by The New York Times, his administration has already blocked the approval of stricter coronavirus vaccine approval guidelines proposed two weeks ago.
Since being submitted for approval by the Office of Management, sources told the Times that the proposed changes have been 'stalled' by White House Chief of Staff Mark Meadows.
Operation Warp Speed itself already has recommended the vaccine candidates it is supporting observe 'a two-months follow-up after completion of the immunization process before the company will consider filing for an emergency use authorization,' vaccine czar Dr Moncef Slaoui said last month.
'We completely agree with it,' Slaoui said, referring to the stricter FDA regulations during a virtual Town Hall event on last month organized by the Rainbow Push Coalition in Atlanta.
But the White House does not agree with the more protracted timeline.
The new recommendations from the advisory committee are expected to escalate already high tensions between regulators and the White House.
According to a Pew Research Center survey last month, only 32 percent of Black adults said they would definitely or probably get a COVID-19 vaccine, compared with 52 percent of White adults, 56 percent of Hispanics and 72 percent of Asians.
At that rate, it seems nearly impossible either company's shot could get approval before the election, although Moderna anticipates it will know whether its shot works by November, and Pfizer plans to announce its results in late-October.
FDA Commissioner Dr Stephen Hahn, has not addressed the possibility of new vaccine approval standards.
Trump himself handpicked Dr Hahn to ascend to the head of the FDA, over-stepping presumptive commissioner Ned Sharpless.
Dr Hahn, plucked from his position as an executive at Texas's renowned MD Anderson Cancer Center, has since found himself caught between politicians and scientists with regularity.
He's been in Trump's crosshairs after refusing to endorse the president's claims that most coronavirus case are 'harmless,' while drawing the ire of scientists after his agency gave emergency approval to the use of coronavirus survivors' plasma to treat those who were still sick, against the advice of the National Institutes of Health.
After that controversial approval, Dr Hahn inaccurately pulled the statistic that plasma saved more than one-third of people treated with it from an unpublished, poorly-designed study and had to apologize.