Climate Magazine – April 2020 Edition

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C L I M AT E •

A Coronavirus Vaccine to Stop the Pandemic? Don’t Count On It. By Dr. Henry Miller, M.S., M.D. As the outbreak of coronavirus SARSCoV-2 (with the disease it causes designated COVID-19) accelerates, with cases now found on every continent except Antarctica, there is intense interest in the development of a vaccine. 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." The claims have become even more fantastic. From Fox News: 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. Once researchers have a candidate vaccine, the regulators at the Food and Drug Administration get into the act. And that's a significant obstacle. Dr. Antony Fauci, the long-time director of the National Institute of Allergy and Infectious Diseases, and prominent member of the federal coronavirus task force said: "Let me make sure you get the . . . information. A

Dr. Henry Miller, M.S., M.D.

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 is occurring in relatively large numbers. However, the medical communities in those countries, such as China, Italy, and Spain, are trying just to survive the pandemic, rather than to organize elaborate clinical trials. 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.

C Henry Miller, a physician and molecular biologist, is a Senior Fellow at the Pacific Research Institute. He was the founding director of the FDA's Office of Biotechnology. This column appears with permission from the National Review, where it was originally published.

April 2020 ·