When president Donald Trump met with drug-company executives at the White House on Monday, one of the items on the agenda was the development of a vaccine to prevent infection with the new coronavirus, SARS-CoV-2 (the World Health Organization's designation for the virus). "We've asked them to accelerate" work, the president told reporters.
As the coronavirus outbreak accelerates, with cases now found on every continent except Antarctica, there is intense interest in the development of a vaccine, and several U.S. drugmakers have begun working on them, independently or with the National Institutes of Health.
The media are hungry for claims about vaccines — the more extravagant, the better.
This was reported by Fox Business:
"We were able to rapidly construct our vaccine in a matter of about three hours once we had the DNA sequence from the virus available because of the power of our DNA medicine platform," Dr. J. Joseph Kim, Inovio's [a Pennsylvania-based company] president and CEO, told FOX Business. "Our goal is to start phase one human testing in the U.S. early this summer."
Even more bullish was this statement, in a January 30 Wall Street Journal editorial:
It took scientists 20 months to develop a SARS vaccine to test on humans, but the NIH hopes to have a vaccine ready for human trials by April.
Once researchers have a candidate vaccine, the regulators at the Food and Drug Administration get into the act. And that's a significant obstacle — an obstacle of which at least two of the Trump administration's senior officials should be well aware. Secretary of Health and Human Services Alex Azar was a senior executive at drug company Eli Lilly, and Joseph Grogan, the director of the White House Domestic Policy Council, was a senior official at two drug companies and also at the FDA.
And yet, for whatever reason, the president seems not to have gotten the message. According to CNN, on Monday, President Trump was "asked about a timeline for a vaccine during the Cabinet Room meeting with pharmaceutical executives and members of his task force." He responded:
I don't know what the time will be. I've heard very quick numbers, that of months. And I've heard pretty much a year would be an outside number. So I think that's not a bad range. But if you're talking about three to four months in a couple of cases, a year in other cases.
Dr. Antony Fauci, the long-time director of the National Institute of Allergy and Infectious Diseases, quickly corrected the president: "Let me make sure you get the . . . information. A vaccine that you make and start testing in a year is not a vaccine that's deployable."
Dr. Fauci knows well the vicissitudes of vaccine development, testing, and approval, including the FDA's significant role in a debacle surrounding a vaccine against swine flu virus almost a half century ago. Of the 45 million people vaccinated against the swine flu in 1976, 450 developed a serious adverse reaction — the rare, paralytic Guillain-Barré syndrome. What made the situation even more unfortunate (for regulators) is that the predicted epidemic never materialized, so the vaccine wasn't needed.
Once burned, twice shy, the old saying goes. Regulators have a long memory, so the FDA's regulation of vaccines is especially conservative (read: defensive). The bar has been very high for approval of vaccines that would be administered to large numbers of healthy people. For example, before approval, the first rotavirus vaccine (RotaTeq) was tested on 72,000 healthy infants; the first human papilloma virus vaccine (Gardasil) on more than 24,000 people; and the newest shingles vaccine (Shingrix) on about 29,000 subjects. The agency was woefully slow, lagging behind other countries, in approving the first vaccine against meningococcus B, a life-threatening bacterial infection.
Just planning and getting clinical trials of that magnitude under way would be a major undertaking — recruiting medical practitioners and research institutions and obtaining permission from local Institutional Review Boards, to say nothing of actually producing sufficient vaccine (under stringent Good Manufacturing Practices conditions) for the trials. Then comes the accumulation, organization, and analysis of the data, first by the sponsors of the vaccine, then by regulators.
Moreover, to demonstrate efficacy — the ability of the vaccine to actually prevent the coronavirus infection — the trials would need to be done in places where the disease occurs in relatively large numbers. As things stand, that probably means China, where the apparatus for organizing and performing clinical trials is, shall we say, less than optimal.
And by the way, the SARS vaccine mentioned above was never commercialized. The outbreak faded away, as a result of international cooperation and strict, tried-and-true public health measures such as isolation, quarantine, and contact tracing.
A coronavirus vaccine in the foreseeable future? In spite of the rosy predictions by politicians and pundits, don't count on it.
Henry Miller, a physician and molecular biologist, was the founding director of the FDA's Office of Biotechnology.