As the Covid-19 crisis intensifies in the United States, the fight for an effective vaccine is about to collide with the electoral calendar.
Pfizer (ticker: PFE) says it will seek authorization from the Food and Drug Administration for its Covid-19 vaccine starting in October. Meanwhile, the federal government’s Covid-19 vaccine program says it wants AstraZeneca‘s
(AZN) vaccine licensed by then.
If any of these companies, or others in the vaccine race, like Moderna (MRNA), deliver promising data from their big Phase 3 trials ahead of the election, the result could be one of the most difficult decisions in the history of the FDA. A vaccine authorization before November 3 could be a major political victory for the Trump administration, which has made the rapid development of a vaccine the cornerstone of its response to the pandemic.
“It would be the biggest surprise in October,” says Chris Wilson, a Republican pollster, former director of research for the 2016 Ted Cruz presidential campaign and now CEO of WPA Intelligence.
However, former FDA officials warn that it could also undermine confidence in the vaccine, hurting overall recovery.
The Covid-19 pandemic and the economic crisis it has sparked have replaced a long list of issues that Republicans and Democrats hoped to discuss this summer. And while some experts say President Donald Trump cannot win on the issue, given his administration’s handling of the crisis thus far, the evolution of the pandemic in the next 15 weeks could change prospects.
Democratic pollster Peter Hart, president of Hart Research Associates, says the damage to Trump has already been done. “It is not as if there is a set of numbers that come into play that the public says, ‘Oh, it all feels good now,’ ” he says. just information. “
Projections from the University of Washington Institute for Health Measurement and Assessment estimate that there will be just over 800 Covid-19 deaths per day by November 1, above the current average of more than 700. If restrictions closing continue to increase, the Institute considers that the daily toll reaches 1,300.
A vaccine authorization by then could offer hope. Health experts have presented a vaccine as the key to a return to normalcy, and Trump has repeatedly promised rapid progress. “I think they are going to have good news very quickly related to vaccines,” the president said at a press conference on July 14.
There’s probably no 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 medication.
“There will be tremendous pressure on the FDA to, at a minimum, obtain an emergency use authorization for a vaccine before the election,” says Chris Meekins, who was the assistant deputy secretary for preparedness and response in the US Department of Health. And Human Services from 2017 to 2019, and is now an analyst at Raymond James. “I think they are probably more likely, assuming everything goes according to plan, which is difficult to do in vaccine development, [to] issue a [emergency-use authorization] for a shot before Election Day. “
However, former FDA officials say a lobbying campaign to approve a particular Covid-19 vaccine before the election would make it difficult to convince the public that the inoculation is safe, slowing down overall recovery.
Part of the public already suspects the vaccines: An Associated Press survey found that a fifth of Americans say they would reject one for Covid-19, and a third are unsure if they would take it.
“Are the Trump People Able to Massive Pressure on the FDA?” asks Dr. Peter Lurie, associate commissioner of strategy and public health analysis at the agency from 2014 to 2017. “Absolutely. There is nothing in the epidemic to reassure him 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 was ineffective.
“What concerns many people, including myself, is the kind of pressure that has been brought to bear not only on the FDA, but also on other government scientific agencies during this difficult time,” says Dr. Jesse Goodman of the FDA Chief Scientist from 2009 to 2014. “Even if the FDA did not give in to that pressure, which I sincerely hope it did not, even the perception of that runs the risk of undermining people’s trust.”
There is some precedent. In 1976, months before that year’s presidential election, President Gerald Ford endorsed an effort to vaccinate all Americans against a new strain of flu believed to pose a pandemic risk. That pandemic never came. The vaccine was administered to 40 million before being withdrawn after a small number of recipients developed Guillain-Barré syndrome, sowing some of the current mistrust of the vaccines.
FDA officials say they will make their decisions about the Covid-19 vaccine based on science. At a New York Economic Club webinar last week, FDA Commissioner Dr. Stephen Hahn said the agency “will call the ball and attack the data.”
Dr. Howard Koh, a professor at Harvard University’s TH Chan School of Public Health who served as an assistant secretary in the US Department of Health and Human Services, says that the considerable number of external eyeballs that Analyzing the vaccine data would keep the agency honest. “I don’t think the scientific and health community, and the global community, accept something that is not at the highest level of science at a time like this,” he says.
Even if the FDA authorizes a vaccine before the election, it may not be a clear victory for the president.
Dr. Luciana Borio, who worked at the FDA from 2008 to 2017 and then served on the National Security Council until 2019, warns that the immediate consequences of a vaccine authorization will be messy. “Many people may not want to get a vaccine this early or become angry that they don’t have access to the vaccine, given its limited supply,” she says.
Write to Josh Nathan-Kazis at [email protected]
.
