Race for a Covid-19 Vaccine Might Have Political Side Effects

If either of these companies, or others in the vaccine race, such as
Moderna
(MRNA), deliver promising data from their large Phase 3 trials before the election, the result could be one of the most difficult decisions in the history of the FDA. A vaccine authorization before Nov. 3 could be a big political win for the Trump administration, which has made the rapid development of a vaccine the cornerstone of its pandemic response.

“It would be the ultimate October surprise,” says Chris Wilson, a Republican pollster, the former director of research for Ted Cruz’s 2016 presidential campaign, and now CEO of WPA Intelligence.

Yet former FDA officials warn that it could also undermine trust in the vaccine, kneecapping the overall recovery.

The Covid-19 pandemic and the economic crisis it has spurred have replaced a long list of issues that Republicans and Democrats expected to be arguing over this summer. And while some experts say that President Donald Trump can’t win on the issue, given his administration’s handling of the crisis so far, developments in the pandemic over the next 15 weeks could change the outlook.

Democratic pollster Peter Hart, chairman of Hart Research Associates, says that the damage to Trump is already done. “It is not as though there are a set of numbers that come into play that the public says, ‘Ah, it all feels good now,’’’ he says. “What they have experienced and are experiencing will not be erased or painted over suddenly by one piece of information.”

Projections from the Institute for Health Metrics and Evaluation at the University of Washington estimate that there will be just over 800 Covid-19 deaths a day by Nov. 1, up from the current average of over 700. If lockdown restrictions continue to lift, the institute sees the daily toll going as high as 1,300.

A vaccine authorization by then could offer hope. Health experts have held out a vaccine as the key to a return to normalcy, and Trump has repeatedly promised rapid progress. “I think you’re going to have some good news very, very quickly having to do with the vaccines,” the president said in a July 14 news conference.

There probably isn’t time for the FDA to approve a Covid-19 vaccine before the election. But the agency could issue an emergency-use authorization, which gives doctors the go-ahead to use an unapproved drug.

“There will be tremendous pressure placed on the FDA to, at minimum, get an emergency-use authorization out for a vaccine before the election,” says Chris Meekins, who was a deputy assistant secretary for preparedness and response at the U.S. Department of Health and Human Services from 2017 to 2019, and is now an analyst at Raymond James. “My belief is that they probably are more likely, assuming everything goes to plan, which is difficult to do in vaccine development, [to] issue an [emergency-use authorization] for a vaccine prior to Election Day.”

Yet former FDA officials say that a pressure campaign to approve a particular Covid-19 vaccine before the election would make it harder to convince the public that the inoculation is safe, thus slowing the overall recovery.

Part of the public is already suspicious of vaccines: An Associated Press poll found that a fifth of Americans say they would refuse one for Covid-19, and a third aren’t sure if they’d take it.

“Are the Trump people capable of putting massive pressure on the FDA?” asks Dr. Peter Lurie, an associate commissioner for public health strategy and analysis at the agency from 2014 through 2017. “Absolutely. There’s nothing about the epidemic that would reassure you otherwise.”

In March, the FDA issued an emergency use authorization for hydroxychloroquine to treat certain Covid-19 patients, after Trump promoted the drug. The FDA revoked the authorization last month, after studies showed the treatment wasn’t effective.

“What a lot of people, including myself, are concerned about is the kind of pressure that has been put not just on the FDA, but also on other scientific agencies of government during this difficult time,” says Dr. Jesse Goodman, the FDA’s chief scientist from 2009 to 2014. “Even if the FDA did not yield to that pressure, which I sincerely hope it would not, even the perception of that risks undermining people’s trust.”

There is some precedent. In 1976, months before that year’s presidential election, President Gerald Ford backed an effort to vaccinate every American against a new strain of flu thought to pose risk of a pandemic. That pandemic never came. The vaccine was administered to 40 million before being pulled after a small number of recipients developed Guillain-Barré syndrome, seeding some of the current distrust of vaccines.

FDA officials say that they will make their decisions about the Covid-19 vaccine based on the science. On an Economic Club of New York webinar this past week, the FDA’s commissioner, Dr. Stephen Hahn, said that the agency will “call balls and strikes on the data.”

Dr. Howard Koh, a professor at the T.H. Chan School of Public Health at Harvard University who served as an assistant secretary at the U.S. Department of Health and Human Services, says that the sizable number of outside eyeballs scrutinizing any vaccine data would keep the agency honest. “I don’t think the scientific and health community, and the global community, would accept anything that wasn’t at the highest level of science at a time like this,” he says.

Even if the FDA does authorize a vaccine before the election, it might not be a clear win for the president.

Dr. Luciana Borio, who worked at the FDA from 2008 through 2017 and then served on the National Security Council until 2019, warns that the immediate aftermath of a vaccine authorization will be messy. “It is possible that a lot of people will either not want to access a vaccine this early, or be upset they don’t have access to the vaccine, given its limited supply,” she says.

Write to Josh Nathan-Kazis at [email protected]