As the Kovid-19 crisis intensifies in the US, the scramble for an effective vaccine is about to hit the electoral calendar.
Pfizer (ticker: PFE) says it will seek Food and Drug Administration authority for its Kovid-19 vaccine in early October. The federal government’s Kovid-19 vaccine program, meanwhile, wants AstraZenecaOf
The (AZN) vaccine is still authorized.
If any of these companies, or others in the vaccine race, such as Modern (MRNA), give promising data from their large Phase 3 trials before the election, the result could be one of the hardest decisions in the history of the FDA is. A vaccine authority 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 epidemic response.
“This will be the final October surprise,” says Chris Wilson, a Republican pollster, former director of research for Ted Cruz’s 2016 presidential campaign and now CEO of WPA Intelligence.
Yet former FDA officials have warned that it may reduce confidence in the vaccine, ensuring overall recovery.
The Kovid-19 epidemic and the economic crisis resulting from it have replaced a long list of issues that Republicans and Democrats hoped to debate this summer. And while some experts say that President Donald Trump did not win the issue, his administration had to deal with the crisis so far, the development of the epidemic in the next 15 weeks changed the outlook.
Democratic pollster Peter Hart, chairman of Hart Research Associates, says Trump has already suffered a loss. He said, “It’s not like there’s a set of numbers that pops up that the public says, ‘Ah, it all sounds good now,”‘ he says. “What they have experienced and are experiencing will not be erased or painted abruptly with a piece of information.”
Estimates from the Institute for Health Metrics and Evaluation at the University of Washington estimated that just over 800 Kovid-19 deaths a day would average over 700, if the ban on lockdown continues, leaving the institute daily tolls to 1,300 Looks at
By then a vaccine authority could provide hope. Health experts have held a vaccine as the key to getting back to normalcy, and Trump has repeatedly promised rapid progress. “I think you are going to get some good news, with vaccines very quickly,” the president said at a conference held on July 14.
Perhaps the FDA does not have time to approve the Kovid-19 vaccine before the election. But the agency can issue an emergency-use authorization, which leads doctors to use an unproven medicine.
“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 McKins, deputy assistant secretary for preparedness and response at the US Department of Health. And Human Services from 2017 to 2019, and is now an analyst at Raymond James. “I believe they are probably more likely, assuming everything goes to plan, which is difficult to do in vaccine development,” [to] Issue [emergency-use authorization] For a commentary before Election Day. “
Yet former FDA officials say that a pressing campaign to approve a particular Kovid-19 vaccine before the election will make it difficult for the public to convince the vaccine that it is safe, thus slowing overall recovery.
Part of the public already suspects vaccines: An Associated Press poll found that a fifth of Americans say they would refuse one for the Kovid-19, and a third are not sure they will take it.
“Are Trump able to put heavy pressure on FDA?” An Associate Commissioner for Public Health Strategy and Analysis at the agency from 2014 to 2017, Drs. Peter asks Lurie. “absolutely. There is nothing about the epidemic that would assure you otherwise. “
In March, after Trump promoted the drug, the FDA issued an emergency use authority for hydroxychloroquine to treat some Kovid-19 patients. The FDA revoked the authorization last month, after the study revealed the treatment was not effective.
The FDA’s Dr. Jesse Goodman says, “A lot of people are concerned about themselves, that such pressure is not only on the FDA, but also on other scientific agencies of the government.” Chief Scientist from 2009 to 2014. “Even though the FDA did not yield to that pressure, which I sincerely hope it will not even be an assumption of risks that undermine people’s trust.”
There is some example. Months before that year’s presidential election, in 1976, President Gerald Ford thought about the risk of an epidemic that supported the effort to vaccinate every American against a new strain of the flu. That epidemic never came. The vaccine was administered up to 40 million before some seeds of the current mistrust of vaccines were pulled after a small number of those who developed seeding Guillain-Bere syndrome.
FDA officials say they will make their decisions about the Kovid-19 vaccine based on science. At an Economic Club in New York webinar last week, the FDA’s commissioner, Drs. Stephen Hahn said the agency would “call the balls and attacks on the data.”
Professor of Harvard University’s TH School of Public Health, who served as an assistant secretary in the US Department of Health and Human Services, Drs. Howard Koh says the agency will retain a large number of external eyeballs examining any vaccine data. honest. “I don’t think the scientific and health communities, and the global community, would not accept anything at the highest level of science at such a time,” he says.
Even if the FDA places a vaccine before the election, it may not be a clear victory for the president.
Dr. Luciana Borio, who worked at the FDA from 2017 to 2017 and then served on the National Safety Council from 2019, warned that a vaccine would go awry immediately after authorization. “It’s possible that a lot of people either don’t want to access this vaccine quickly, or are upset that they don’t have access to the vaccine, given its limited supply,” she says.
Write Josh Nathan-Kazis at [email protected]