When President Trump met with drug-company executives at the White House on March 2, at the top of the agenda was the development of a vaccine to prevent COVID-19, the respiratory infection caused by the Wuhan 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, and the world is hit with widespread social and economic disruption, 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.
As Fox Business reported on February 13:
"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."
The claims have become even more fantastic. Fox News published this on Monday:
A group of Texas scientists claims to have created a vaccine to prevent the coronavirus and, according to the CEO of the Houston-based engineering company, it could be approved and available to the public by the end of the year.
"We're confident in the vaccine, the quality of the vaccine completely. The end result will be what the government wants to do in terms of testing," John Price, CEO of Greffex, told "America's Newsroom," Monday.
The article noted, helpfully, that the vaccine would not be made available to hundreds of millions of healthy people simply on the basis of the confidence of the manufacturer's CEO: "The vaccine will go through numerous testing stages and is not likely to be available to the public, pending approval, until the end of the year."
Available to the public by "the end of the year."
Let me inject a little reality testing and relevant history into this fairy tale.
Once researchers have a candidate vaccine, the regulators at the Food and Drug Administration get into the act. And therein lies a significant obstacle—an obstacle of which Price should be aware.
The FDA had a significant role in a debacle surrounding a vaccine to prevent swine flu virus infections 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. But regulators have a long memory, and the FDA's regulation of vaccines is especially conservative (read: defensive). The bar has been very high for the 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 papillomavirus vaccine (Gardasil) on more than 24,000 people; and the newest shingles vaccine (Shingrix) on about 29,000 subjects. Also, the FDA 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 underway 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 actually to 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 earlier aforementioned SARS vaccine was never commercialized. The SARS 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? Let's get real. In spite of the rosy predictions by self-interested corporate executives, politicians, and pundits, don't count on it.
Henry I. Miller, a physician, molecular biologist, and former influenza virus researcher, was the founding director of the Office of Biotechnology at the FDA. Please follow him on Twitter: @henryimiller.