‘Operation Warp Speed’ Has Wash U Scientist Worried
Michael Kinch is as eager as anyone for a COVID-19 vaccine. But the Washington University professor of biochemistry and molecular biophysics is worried about the potential implications of rushing through development and U.S. Food and Drug Administration approval, especially with so much political pressure in the mix.
Kinch, who has written extensively on the history of vaccines and human immunity, joined St. Louis on the Air on Wednesday to explain his concerns, which he first expressed late last month in a Stat piece. That article seems to have struck a nerve, with further coverage of similar topics in the Washington Post and the New York Times in the days since.
In recent conversations with people either associated with the FDA or who interact closely with the agency, Kinch has heard consistent worries expressed about the possibility of “undue pressures upon the regulators at FDA to approve a vaccine.”
“And the concern [is that] if you approve a vaccine and you start to distribute it, [and] people start to use it — before adequate evidence of safety and efficaciousness that it works — if we do that too soon, then there could be a number of ramifications that extend beyond just COVID-19.”
The context of all of this during a presidential campaign is particularly concerning, Kinch said.
“This ‘October surprise’ idea — that there may be an announcement of a vaccine approval simply to boost the ratings of one candidate or another ... that is troubling,” he said, “because science and medicine need to be independent of any politics.”
On average, Kinch noted, a vaccine takes between 10 and 20 years to be approved, so the urgent and “amazing” work on a coronavirus vaccine is to be commended.
“It’s a huge positive for the scientific and medical communities,” he said. “But again, we don’t want to mess it up on that last leg of this relay race.”
Kinch also has concerns about the broader ramifications of approval of a substandard vaccine, such as potentially further fueling the anti-vax movement.
“We have so many safe, effective and reliable vaccines already, and the anti-vaccine movement has been persistently growing,” he said. “And we do not want to give this irrational idea any more ammunition.
“If we end up approving a substandard vaccine for COVID, it could end up impacting measles, mumps, rubella and many other diseases, and making people say, ‘Well maybe I don’t want my children or myself to be vaccinated.’ And that would be a tragedy.”
Kinch points to examples in history as timely lessons for today, including the way in which the administration of President Gerald Ford handled fears of a swine flu epidemic in the 1970s.
“It was a well-meaning decision,” Kinch explained, “where the Ford administration had to decide whether they were going to launch a vaccine prematurely before all the safety was in versus the risk that we could have a repeat of the 1918. ... And they elected to move with the premature vaccine.
“And the consequence was that it turned out to be a rather mild flu, and more people were probably injured by the vaccine in that case, because of the rush, than would have been had there been no attempt to make that particular vaccine.”
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