The New Yorker:
With more than a hundred cases already discovered in the U.S., which had resulted in six deaths (the virus has since infected nearly four hundred people in the U.S., and killed at least nineteen of them), Trump was concerned. But he was also confused, despite having had several previous briefings with the Administration’s top health officials. Grasping for some good news, he pressed the executives to deliver a vaccine within a few months, at which point Anthony Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases (N.I.A.I.D.), spoke up. “A vaccine that you make and start testing in a year is not a vaccine that’s deployable,” he said. The earliest it would be deployable, Fauci added, is “in a year to a year and a half, no matter how fast you go.”
(click here to continue reading How Long Will It Take to Develop a Coronavirus Vaccine? | The New Yorker.)
Never a good sign when incompetence is the first word that executive leadership brings to mind.
And private industry is not going to give away billions of dollars of R&D, only governments can handle that, and should handle projects of that size.
John Shiver, the global head of vaccine research and development at the multinational pharmaceutical company Sanofi, which is developing a covid-19 vaccine, was at the meeting with Trump. “There was some confusion there,” Shiver said, that certain officials did not understand that “being in people,” as in human trials, is not the same as having a product. Clinical trials are conducted on healthy people, which is inherently challenging. “You certainly don’t want a vaccine that can make it worse,” Shiver said. “There have been some vaccine candidates historically that could actually enhance the disease.” Sanofi is working with the United States Biomedical Advanced Research and Development Authority, a sort of biomedical darpa, to advance a covid-19 vaccine based largely on the vaccine candidate it had developed for sars. Shiver told me that the authority doesn’t expect to have anything ready for human trials until much later this year. “It’s difficult,” Shiver said, “to see how, even in the case of an emergency, a vaccine could be fully ready for licensure in a year and a half.”
The Coalition for Epidemic Preparedness Innovations (cepi), an Oslo-based nonprofit organization, was established at Davos, in 2017, to help the world prepare for a “disease X” pandemic. One of its aims is to dramatically hasten the process of vaccine development. To create a viable, scalable vaccine “takes vast amounts of funding and R. & D.,” Rachel Grant, the advocacy and communications director at cepi, told me. “It is a long and complex business. It’s all doable, science can meet the challenges, but there is lots of attrition” before any vaccine gets to the point of licensure. The problem is twofold. First, there may never be a market for a vaccine at the end of the development process, because the epidemic is contained, or never comes to pass. Then, traditionally, if there is an epidemic, it may take hold in a developing country where the costs of research and development cannot be recouped. “The resources and expertise sit in biotech and pharma, and they’ve got their business model,” Grant said. “They’re not charities. They can’t do this stuff for free.”
cepi, with funding from the government of Norway, the Gates Foundation, the Wellcome Trust, and several other countries (the United States is not among them), is trying to bridge the gap. The challenge of vaccine development is “what cepi was set up to solve,” Grant told me, “played out writ large in an episode like this.” Since the novel coronavirus emerged, cepi has ramped up its grant-making expenditures to more than nineteen million dollars. Two grant recipients—a Massachusetts-based biotech startup named Moderna and a lab at the University of Queensland, in Brisbane, Australia—have, remarkably, already developed a vaccine candidate that they will start testing in human trials in the next few months, and another biotech startup supported by cepi is not far behind. But, ultimately, to get three different vaccines through the final phase of clinical testing, Nick Jackson, cepi’s head of programs and innovative technology, told me, will require an estimated two billion dollars.