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Thursday, July 23, 2020

Is Trump on track for an October vaccine surprise?


President Donald Trump’s bet that a proven-effective coronavirus vaccine will be the October surprise to catapult him into a second term is facing increasingly long odds.

But that doesn’t mean he won’t find just enough reason to declare victory anyway.

While the race to find an effective vaccine for Covid-19 has crucial implications for nations around the world, it also carries political ramifications in the United States — with Trump banking heavily on finding a vaccine to quell both the pandemic and mounting unhappiness over his handling of the coronavirus response.

Buoyed by a series of encouraging early trial results, the administration is laying the groundwork for a high-profile rollout of initial coronavirus vaccines in as little as three months. It’s a best-case timetable that also tracks with the final weeks before the Nov. 3 election. The White House’s Operation Warp Speed has poured billions of dollars into developing a vaccine in record time, funding several efforts in parallel and buying up doses of the experimental shots in a wager that one will ultimately pay off.

“We’ll end up with a cure,” Trump asserted on Tuesday. “We’re very close to the vaccine — I think we’re going to have some very good results.”

It’s a hope that the president has fixated on amid months of grim news — and one that’s unnerved many researchers across the country, who worry the White House will turn delicate scientific process into yet another political flash point.


There is virtually no chance that the U.S. will have a proven vaccine by Election Day, several top vaccine experts told POLITICO. It could also take well into 2021 to produce and distribute the hundreds of millions of shots needed to inoculate the entire country.

Yet at the same time, drugmakers’ sprint through early clinical trials means leading vaccine candidates could begin to show indications of their effectiveness by late October, offering Trump the opportunity to seize on them as a potential game-changer.

“I think that is perfectly possible,” Paul Offit, director of the Children’s Hospital of Philadelphia’s vaccine education center, said of the odds the White House heralds a vaccine as a success based solely on its earliest results. “But I think that would be a mistake.”

Two groups — one led by biotech firm Moderna and the other a collaboration between Pfizer and German drugmaker BioNTech — are planning to start phase 3 trials for their prospective vaccines by the end of the month, marking the final step toward determining whether their candidates will be both safe and effective.

A third candidate from the University of Oxford and drug company AstraZeneca, which has received more than $1 billion from the federal government to preemptively secure 300 million doses, will begin a final trial next month. China’s CanSino Biologics is already in phase 3, but the U.S. doesn’t have any agreement with the company.

It’s a critical stage with no fixed timeline, as the companies are seeking 30,000 healthy volunteers to participate in each trial and then need to hit specific markers for determining how and whether it effectively fights the disease. That could take months to complete, experts cautioned, without any guarantee a vaccine will pan out. Under Food and Drug Administration guidelines issued in June, a vaccine will need to be at least 50 percent effective to win approval.

But while the Trump administration has insisted that it won’t cut corners on safety — a vow the vaccine developers have taken as well — it’s left the door open to short-circuiting the process before those trials are complete. The FDA guidelines indicate the administration could issue emergency authorizations as soon as it’s convinced a vaccine is safe and effective, clearing it for distribution to the public.

In a statement, White House spokesperson Judd Deere stressed that any vaccine “must be thoroughly tested to ensure it is safe and effective,” calling it Trump’s highest priority. But he also touted the administration’s engineering of the “fastest-ever launch of a trial,” and did not address a question on whether the White House harbored any concerns about distributing a vaccine before it’s officially approved.

The result could be a major milestone in the pandemic’s trajectory, days before an election that’s evolved into a referendum on Trump’s management of the spiraling crisis. It could also jump the gun on the scientific process, undermining public confidence in any eventual vaccine and raising the risk that the initial round of shots won’t work — or worse, will lead to unpredictable side effects.

“That’s the concern, not that Trump might boost his poll ratings by a couple percent but that we could make a catastrophic mistake,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. “Anything in October is going to be politicized. And the last thing this pandemic needs is more politicization.”


Keeping a focus on science, not politics, could be especially critical for a coronavirus vaccine, amid a search effort that’s drawn intense public interest and progressed at world-record speed. The fastest that scientists have developed a new vaccine to date is four years; if successful, a viable coronavirus shot could be found in less than one.

It’s a tribute to the unprecedented amount of companies and resources dedicated to the issue, vaccine experts said. But they also worried that the pace threatens to raise public skepticism of an eventual vaccine — a challenge that the administration has already contributed to by spending months promising a breakthrough by winter.

“I think the government was right to do Warp Speed — I just wish they called it something else,” Offit said, warning that the emphasis on producing a vaccine quickly risks casting doubt on its scientific underpinnings.

Offit — a member of a National Institutes of Health vaccine group that met recently with Warp Speed official and Army Lt. Gen. Paul Ostrowski — also described the government as treating Warp Speed like a “secret weapon,” and opting to shield much of its activities from the public.

Others stressed that the first round of coronavirus vaccines may not even end up being the most effective, leaving the U.S. still far from the all-encompassing “cure” that Trump has long promised.

“An amazing amount has been done in that short space of time, and so far, not much has gone wrong,” Moore said of the first six months of work toward a vaccine. “The hardest steps are probably still to come, all the timelines are rosy, and in the real world, very few things go quicker than planned.”

Scientists won’t know for months after distribution of an approved vaccine has begun whether it will prove effective over the long term, or if there are variations in how well it protects different people. Children, for example, won’t be included in any of the upcoming phase 3 trials. Older people have weaker immune systems, and they’re among the most vulnerable to the virus. A partially effective vaccine might not work for them.

All those uncertainties are at odds with the political incentive to declare victory over the virus.

“There is clearly a political goal for the president to say, ‘I’ve delivered a vaccine,’” said Barry Bloom, an infectious disease expert and public health professor at Harvard. “But we will not know in three months, or six months — by January — how long the antibodies last.”

Advisers to Trump in recent weeks have stressed those low odds that a vaccine will arrive in time to boost his candidacy, urging the president to refocus on more immediate steps and take a more active role in leading the pandemic fight.

“We’ve counseled him on that, and it’s not like he’s got his head in the sand on it,” said one campaign adviser, who nevertheless lamented Trump's relative disinterest in the day-to-day response effort. “He looks at it like, Mike Pence has got it — Pence is handling it.”

Another Republican close to the administration chalked up the focus on a vaccine to internal divisions over how to manage the more pressing aspects of the response, making it easier to unite behind the idea that a shot will end the pandemic once and for all.

Trump has since returned to the White House briefing room after weeks of sliding poll numbers and rising caseloads, looking to seize back control of the administration’s response messaging. Still, as he took the podium on Wednesday, Trump returned to the prospect of a quick solution to the crisis.

“That would be great if we could go into the hospital and just cure people,” he said. “We think in a very short period of time we’ll be able to do that.”



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