The White House has reportedly backed away from a battle with the U.S. Food and Drug Administration (FDA), which has been advancing a timeline for a coronavirus vaccine that suggested an approval wouldn’t happen before Election Day.
The FDA has said it will need two months of observation in late-stage trials of any coronavirus vaccine in order to consider an emergency use authorization — an objective that conflicted with President Donald Trump’s desire to have an inoculation by early November. However, the White House signed off on the new guidelines Tuesday afternoon, backing away from a potential standoff that had worried health experts.
Trump, fresh from a stint in the hospital after being diagnosed with COVID-19, re-ignited the political debate over a vaccine timeline, putting him at odds with the FDA. In a video Monday evening, Trump also said that “vaccines are coming, momentarily” — even as FDA guidelines suggest a release wouldn’t happen until well after Election Day.
Trump said as much late Tuesday on Twitter, tagging FDA Commissioner Stephen Hahn while posting, “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”
The White House was previously citing pharmaceutical companies’ objections to the two-month period.
Pfizer (PFE) CEO Albert Bourla said Tuesday the company has not been in touch with the White House on the topic and “we believe (FDA)’s independence is today more important than ever as public trust in (COVID-19) vaccine development has been eroded by the politicization of the process.”
In interviews in the past 24 hours, FDA’s top vaccine official, Dr. Peter Marks said a minimum of 7 weeks would be acceptable.
“We’ve made it clear we want to see a median of two months of follow-up for any of the vaccines...while it would be nice to have much more, we have to balance the safety we get up front with the need to try to save lives,” Marks said in an interview with the Journal of the American Medical Association.
He added that an emergency use authorization of a vaccine is likely by the end of the year, since it only takes weeks to review an EUA filing, compared to months of review for a full license approval.
But even that EUA filing could remain a question. Moncef Slaoui, head of Operation. Warp Speed, said during a symposium co-hosted by Johns Hopkins University and the University of Washington that he has advised companies not to file for an EUA until they have enough vaccine to distribute.
A critical date will come on October 22, the date established by a key FDA advisory body to determine official guidelines, even though Trump could still override any decision made then.
“Data from Phase 3 studies that includes a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” according to the Vaccines and Related Biological Products Advisory Committee Meeting material.
Dr. Arthur Caplan, a bioethicist and founding head of New York University School of Medicine’s Division of Medical Ethics, said the battle is transparently political, and it is endangering regulatory efforts in more ways that one. He suggested Trump is clearly relying on good news to surface by Election Day.
“Trump’s greatest vulnerability to Election is COVID. He has staked his re-election on a vaccine,” Caplan said. He added that “there is no reason for the White House to press the FDA to go faster,” even as the pandemic continues to add to its toll of infections and deaths.
In addition to putting the credibility of the FDA at stake, the White House’s involvement may give fodder to anti-vaccine forces that will resist a cure if it appears to be rushed. It also opens the door to liability to any vaccine company’s reputation, Caplan argued.
The companies have “an incentive to sell, to be first, and to reap the benefits of the stock market and investors,” Caplan said, adding that they also have to weigh the constraining factors of liabilities.
Pfizer (PFE) and BIoNTech (BNTX) are two front-runners in the U.S. vaccine race. Pfizer’s CEO has said the company could have an indication of the vaccine’s efficacy by the end of October — just in time for Election Day.
If two months is accepted as an official guideline, it would push the data reading out to late November. Moderna (MRNA), the second candidate, has already indicated it would not have data ready by Election Day.
“No one will have a vaccine by Election Day in their arm,” Caplan said.
Dr. Meghan Fitzgerald, a global health care expert and adjunct associate professor at Columbia University, echoed a similar sentiment — noting that the industry has always been involved in the process.
“The U.S. drug approval system has a long history of integrity and transparency due to a strong partnership” between pharmaceutical companies and the FDA,” she said.
“Right now we need partisan politics to stand down and let the science unfold,” she said, adding that the public will lose trust in the FDA if a vaccine is rushed.
“And that would be a public health disaster. We have come too far and lost too much for that to happen,” Fitzgerald stated.
Dr. Peter Hotez, a top vaccine expert and professor at the Baylor College of Medicine, said the FDA’s guidelines make sense, and he’s “not sure why the White House (is digging) their heels in, certainly not on scientific grounds.”
Meanwhile, Trump is back at the White House Tuesday, in a medical unit where he will continue to be treated for COVID-19, as fear and fury grow among staffers who are now infected, or worried about infection.
Upon returning to the White House, the president once again downplayed its lethality — and even floated the idea of attending next week’s presidential debate in Miami, in person.
Trump stirred new controversy immediately upon returning from Walter Reed Military Medical Center, where he took off his mask after entering the White House, and subsequently told Americans in a Twitter video not to be afraid of the virus.
That messaging, along with a new tweet that once again compared COVID-19 to the flu, concerned health experts, who had hoped the infection would change Trump’s stance downplaying the virus impact.
Amid the political debate, the U.S. Health and Human Services department has pushed a new focus on how the virus is impacting mental health. Late Monday, HHS announced a mental health working group, co-chaired by Sec. Alex Azar, to submit a plan addressing the mental health impacts of COVID-19.
“We know that the COVID-19 pandemic has created or exacerbated serious behavioral health challenges for many Americans, both adding new stresses and disrupting access to treatment,” Azar said in a statement.
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