https://www.statnews.com/2020/03/11...s-vaccine-trial-without-usual-animal-testing/
This article discusses the fast track development of a coronavirus vaccine by Moderna, a biotech company located in Cambridge, MA. and whether human testing might be allowed to go forward before all the “usual” animal safety testing has been completed.
Researchers rush to test coronavirus in humans before they know how well it works in animals
. . . The traditional vaccine timeline is 15 to 20 years. That would not be acceptable here,” said Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, whose work as chief public health and science officer at Merck Vaccines was instrumental in the development of the immunization against Ebola. “When you hear predictions about it taking at best a year or a year and a half to have a vaccine available … there’s no way to come close to those timelines unless we take new approaches.”
He knows that it’s important to see how well a new vaccine can stop infection in animals, but to him, given the current emergency, it makes sense to start human safety testing before those studies are finished.
“I personally think that’s not only appropriate; I think that’s the only option we have,” Feinberg went on.
Yet ethicists aren’t so sure that the eventual benefits of rushing this unproven vaccine into clinical trials will outweigh the risks. “Outbreaks and national emergencies often create pressure to suspend rights, standards and/or normal rules of ethical conduct. Often our decision to do so seems unwise in retrospect,” wrote Jonathan Kimmelman, director of McGill University’s biomedical ethics unit, in an email to STAT. . . .
This article discusses the fast track development of a coronavirus vaccine by Moderna, a biotech company located in Cambridge, MA. and whether human testing might be allowed to go forward before all the “usual” animal safety testing has been completed.
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