In recent days, experts have become increasingly convinced — and alarmed — that President Trump is pushing to cut corners and rush the release of a COVID-19 vaccine before Nov. 3 to improve his chances in the election.
But imagine, for a moment, if Trump did the opposite. What if he pledged to wait until Nov. 4 at the earliest — that is, the day after the election — to announce that a COVID-19 vaccine had been authorized for public use? What if he pledged to wait — to take politics off the table — regardless of whether he had the power to make the announcement a few days earlier?
Vowing not to unveil a vaccine on the eve of the election might seem politically counterproductive to the president, which is why he probably won’t do it. But it would almost certainly be better for the American people, and it could even be better for Trump.
The reason has as much to do with trust as with medicine.
Reports suggest that Trump has long hoped, with his accelerated Operation Warp Speed vaccine program, to turn the COVID-19 vaccine into an October surprise — a last-minute plot twist with the potential to sway voters. In April, the Department of Health and Human Services told the White House that America should aim to develop a vaccine as quickly as possible. The proposed deadline? “Enable broad access to the public by October 2020,” read the first slide in the presentation. The date was in bold. According to the New York Times, “it escaped no one that the proposed deadline also intersected nicely with President Trump’s need to curb the virus before the election in November.”
“There are a lot of people on the inside of this process who are very nervous about whether the administration is going to reach their hand into the Warp Speed bucket, pull out one or two or three vaccines, and say, ‘We’ve tested it on a few thousand people, it looks safe, and now we are going to roll it out,’” Dr. Paul Offit of the University of Pennsylvania, a member of the Food and Drug Administration’s vaccine advisory committee, told the Times. “They are really worried about that. And they should be.”
Developments this week have only deepened those concerns. On Aug. 30, FDA Commissioner Stephen Hahn confirmed that he could clear a coronavirus vaccine before the completion of late-stage clinical trials if he believes the benefits of rushing one into production outweigh the risks. To do so, Hahn would simply have to issue a so-called emergency use authorization (EUA).
A few days later, various outlets reported that the Centers for Disease Control and Prevention had notified public health officials in all 50 states and five large cities to prepare to distribute a coronavirus vaccine to health care workers and other high-risk groups by late October or early November. At the same time, CDC Director Robert Redfield sent an urgent letter to governors asking them to bypass regulations in order to open vaccine distribution sites “by Nov. 1” — two days before the election.
President Trump speaks on Aug. 27, during the Republican National Convention, from the South Lawn of the White House. (Al Drago/Bloomberg via Getty Images)
Meanwhile, Trump promised in his Republican National Convention speech that America “will produce a vaccine before the end of the year, or maybe even sooner.” The “maybe even sooner” line was delivered dramatically, with the verbal equivalent of a wink and a nod.
“The deep state, or whoever, over at the FDA,” Trump tweeted at Hahn, once again saying the quiet part out loud, “is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after Nov. 3.”
Finally, as if on cue, U.S. drugmaker Pfizer announced Thursday it should know by the end of October whether its candidate vaccine is successful — adding that it will submit for approval immediately if that’s the case. The same day, top Operation Warp Speed adviser Moncef Slaoui acknowledged that the CDC is eyeing the Pfizer vaccine for fast-track approval, along with one by Moderna. Both are currently undergoing phase III trials.
Experts have raised all kinds of red flags about the medical complexities of an October or early November release. Phase III trials pit the vaccine against a placebo by giving both to thousands of people who then go about their daily lives. If after a long time the vaccinated group shows no dangerous side effects and turns out to be less likely to get sick than the placebo group (in a statistically significant way), the vaccine is deemed safe and effective.
To date, Moderna and Pfizer have enrolled more than half of the 30,000 participants required for each of their trials. But they still need to enroll tens of thousands more.
Usually, the FDA waits for the trials to finish with full enrollment before spending months reviewing the data and determining whether a vaccine is safe and effective. An EUA would not only prematurely end that process; it would also open the door, theoretically, to a looser standard of safety and effectiveness. According to the 2004 law that created the EUA system, authorization merely requires that “it is reasonable to believe that the product may be effective.” Also, the FDA “recognizes that there could be rare adverse events not detected in a trial of 15, 000 to 20,000 patients,” which is why the agency typically continues to watch for side effects over a much longer period.
This has proved to be a problem before. In the run-up to the 1976 election, President Gerald Ford rushed out a swine flu vaccine. It was only after 45 million people were vaccinated that authorities discovered that about 450 of them — one in 100,000 — had developed a paralyzing neurological condition called Guillain-Barré syndrome. Of those, more than 30 died.
Perversely, an EUA could also make it harder to develop other, potentially superior vaccines. Once people are sure they can get the initial EUA vaccine, they will be reluctant to enroll in new trials and risk getting a placebo. That could prevent a better drug that’s still in the pipeline from ever securing approval.
In short, there are reasons why no civilian vaccine has ever received emergency authorization before, and why, said an op-ed in the New York Times, “no vaccine since the 1950s has been approved and licensed without completing large, prospective, placebo-controlled studies of safety and effectiveness.”
This does not mean the FDA will authorize an unsafe or ineffective vaccine just to satisfy Trump. The agency has promised it won’t issue an EUA for any vaccine that shows less than 50 percent efficacy in phase III trials, a higher bar than prescribed by law; it also has to follow standard protocols for authorization, including allowing an independent board to assess the data at specified intervals.
Luciana Borio, a former acting chief scientist at the FDA, says the agency should go further by “consult[ing] its advisory committee before taking regulatory action” and putting in place “a strong pharmacovigilance program to monitor for safety signals; a plan to collect additional data (e.g., duration of immunity); clarity as to who should receive [the] vaccine first (some vaccines may not be appropriate for everyone); clear, consistent and truthful communications; and a competent system to manage one of the most complex vaccine distribution programs in public health history.”
If followed, those procedures probably mean that a vaccine would arrive in November or December, Dr. Anthony Fauci, the nation’s top infectious disease expert, told CNN on Thursday. Yet Fauci added that “it is conceivable that you can have it by October” if strong signals on safety and efficacy prompt drug developers to decide that a vaccine works sooner.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. (Erin Scott-Pool/Getty Images)
“I do think there is a possibility that the clinical trials — albeit very low, as I said before, extremely low — but there is a possibility that the trials read out before the end of October,” Slaoui, the Operation Warp Speed adviser, said the same day. “It would be irresponsible not to be ready if that was the case.”
And so it’s possible that the administration checks every box and delivers a safe and effective vaccine before Election Day. The hitch is that even if that happens, it will be much harder to convince the American public that the decision was made without taking politics into account if the announcement comes at the moment of maximum political impact that Trump is clearly pushing for.
Which is why, medical considerations aside, Trump should vow to wait.
Understandably, the president’s supporters will disagree. Why shouldn’t Trump get credit for Operation Warp Speed before voters decide whether he deserves a second term? they would argue. It would be political malpractice to delay.
Even Slaoui disagrees. “I have to say, maybe even despite my personal political views, that I don’t think that’s right, because 1,000 people die every day [from COVID-19],” he told Science this week. “If a vaccine [had evidence of safety and efficacy] on 25 October, [an EUA] should be [requested] on 25 October. If it’s 17 November, it should be 17 November. If it’s 31 December, it should be 31 December.”
But there’s a counterargument too. Requesting an EUA before the election is one thing. Announcing and campaigning on its approval is another. On the “extremely low” chance the EUA request comes before Nov. 3, it would likely be coming right before Nov. 3. The supply chain is already being set in motion. The number of actual vaccinations likely to be delayed by hitting pause until the appearance of political influences passes would be very small.
Meanwhile, promising to hold the announcement for what is unlikely to amount to more than a few days could actually turn out to be a smarter political strategy for Trump than dropping a vaccine during the final hours of the campaign. Voters already expect him to rush-release a vaccine as a campaign stunt; no minds will change, either way, if he does.
Announcing in advance, however, that he will take politics out of the equation — something he could do by pledging not to announce until after Nov. 3 — could be just the sort of surprising gesture of public-spiritedness that swing voters would weigh when deciding how to vote. And of course Trump would still be free to tout the progress Operation Warp Speed has made. He’d just avoid tainting its success at the last minute.
Waiting could also save far more lives than rushing. Trump may view the vaccine as his accomplishment, but it’s a different kind of accomplishment than, say, killing a terrorist leader. The latter is an event; the former is a process. Developing the drug is only half of that process. The other half is making sure hundreds of millions of Americans — the 60 to 80 percent of the population that experts believe is needed to achieve herd immunity — actually get vaccinated.
That’s where public trust comes in — and right now, that trust is lacking. The FDA and CDC have already appeared to cave to political pressure from the White House on multiple occasions: when they authorized clearance for Trump’s favorite antimalarial drug, hydroxychloroquine (a decision that was revoked after studies showed the drug was harmful, not helpful); when they allowed the administration to hype convalescent plasma as a game-changing breakthrough hours before the Republican National Convention (even though it was merely an incremental advance); and when they abruptly stopped recommending testing, against all expert advice, for people who think they’ve been exposed to the virus but have yet to experience any symptoms (a shift that happened to align with Trump’s oft-stated desire to reduce testing).
Mend Urgent Care workers conducting COVID-19 testing for students and faculty at Woodbury University in Burbank, Calif. (Kevin Winter/Getty Images)
The public now believes that similar pressures are influencing Operation Warp Speed. According to a new survey from STAT and the Harris Poll, 78 percent of Americans worry that the vaccine approval process is being driven more by politics than science. Predictably, the overwhelming majority of Democrats (82 percent) expressed that fear. But even 72 percent of Republicans agreed.
To get a sense of how corrosive such bipartisan perceptions can be, consider these findings from the July 30 Yahoo News/YouGov poll. Overall, just 42 percent of Americans said they planned to get vaccinated for COVID-19 — the smallest share to that date. More than two-thirds (69 percent) said they were very or somewhat concerned about the safety of “fast-tracked” vaccines; those numbers were identical among Democrats, Republicans and independents. Only 26 percent of those who intend to vote for Trump said they trust experts such as “the Centers for Disease Control and Prevention and public health authorities” to “judge the risks of vaccines.” And every time a realistic caveat was added to the question about whether people planned to get vaccinated — Would you take a vaccine if it caused side effects such as fever and headaches in one-third of recipients? Would you take a vaccine if it was only 60 percent effective at preventing COVID-19 infection? Would you take a vaccine if it required multiple doses over a couple of weeks? Would you take a vaccine if it required waiting in line for hours at a time or scheduling an appointment weeks in advance? — the number who said yes declined.
In other words, this could go either way. Thanks to the anti-vax movement, trust in vaccines is generally more fragile than it used to be; trust in a fast-tracked vaccine for a novel virus is more fragile still. Most Americans are at least open to getting inoculated, which is something that most of them will have to do if the U.S. hopes to stop the pandemic anytime soon. They’re also ready to flee at the first sign of funny business.
By reversing course and refusing to unveil any vaccine before Election Day, Trump has the power to depoliticize whatever drug eventually emerges — to reassure the public that no corners were cut to help him stay in office.
He should consider using that power.
Read more from Yahoo News: