Viewpoint: Is a coronavirus vaccine on the horizon? Antiquated FDA regulations make it unlikely one will emerge in the US

| February 18, 2020
Credit: Philadelphia Inquirer/Monica Herndon
This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

As the outbreak of a novel coronavirus accelerates in China, and sporadic cases continue to appear elsewhere in Asia, North America, Australia and Europe, there is intense interest in the development of a vaccine. Several US drug makers have begun working on them in collaboration with other companies 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.”

If they can meet those timelines, good for Inovio and NIH, but then the regulators at the Food and Drug Administration, get into the act. And that’s a problem. Phase 1 human testing is a long way from a commercially available vaccine.

The FDA had a significant role in a debacle surrounding a vaccine against swine flu virus almost a half century ago, and regulators have both a long memory and an intense desire to stay out of trouble. 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.

Since then, the regulatory bar has been very high for approval of vaccines that would be administered to vast numbers of healthy people. For example, before approval, the first rotavirus vaccine (RotaTeq) was tested on 72,000 healthy infants, and the first human papilloma virus vaccine (Gardasil) on more than 24,000 people.

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. And to ascertain efficacy — the ability of the vaccine to actually prevent the infection — the trials would need to be done in places where the disease occurs in relatively large numbers. As things stand, that means China, where the apparatus for organizing and performing clinical trials is, shall we say, less than optimal.

Follow the latest news and policy debates on agricultural biotech and biomedicine? Subscribe to our newsletter.
Related article:  How would a coronavirus antibody test work?

Completing the trials and compiling the data isn’t the end of the story.  Without belaboring the point, the FDA’s record on vaccines is less than sterling. The agency was woefully slow, lagging behind other countries, in approving the first vaccine against meningococcus B, a life-threatening bacterial infection. Regulators have also erected arbitrary post-approval obstacles. A decade ago, the FDA asked pediatricians to “pause” in administering Rotarix, a vaccine made by GlaxoSmithKline that prevents rotavirus infection, a diarrheal illness that can cause severe dehydration. The rationale was that small amounts of DNA from a pig virus had been detected in the vaccine preparation. That might sound like a good reason for concern — except that the FDA itself confirmed that the material was present throughout the vaccine’s development.

In other words, all of the studies that confirmed the safety and efficacy of the vaccine had been performed with the viral DNA present, and according to the FDA, “extensive studies, including placebo-controlled, randomized clinical studies involving tens of thousands of vaccine recipients, support the safety and effectiveness of the vaccine.” More specifically, no safety problems emerged from the pre-approval clinical trials in 90,000 subjects or during postmarketing surveillance covering more than 69 million doses of the vaccine. The head of the agency, Margaret Hamburg, even announced, “We’re not taking this action on the basis of a safety concern.”  So what was the basis – her horoscope?  She never explained it.

Consider these facts as well: The virus is commonly consumed in pork products and does not cause disease in any known host, including humans and pigs. One must wonder, then, what the problem was that the FDA was trying to fix by interrupting the use of the vaccine.

image update img

The story gets richer: Regulators requested the Rotarix pause, in part, because of the availability of an alternative vaccine, RotaTeq, produced by Merck. But using a new, high-sensitivity assay, Merck soon thereafter detected DNA fragments from two pig viruses in its vaccine. So, did FDA officials also pause administration of the Merck vaccine? No — instead, they rescinded the recommended pause on administration of Rotarix, the GlaxoSmithKline drug.

The drugs were, and are, clearly safe, on the basis of the extensive clinical trials and post-approval surveillance, but the FDA appeared to be making its decisions in order to protect itself, rather than to protect public health. Regulators’ bumbling fueled the hysteria of anti-vaccine activists, and some parents were sufficiently confused that they delayed vaccinating their children, endangering them. Thus, regulators created a wholly gratuitous public health problem.

And by the way, the SARS vaccine mentioned in the first paragraph was never commercialized. The outbreak faded away.

A coronavirus vaccine in the foreseeable future? I’m not holding my breath.

An earlier version of this article appeared in Issues & Insights.

Henry I. Miller, a physician and molecular biologist, is a Senior Fellow at the Pacific Research Institute.  A 15-year veteran of the FDA, he was the founding director of the agency’s Office of Biotechnology. Follow him on Twitter at @henryimiller

The GLP featured this article to reflect the diversity of news, opinion and analysis. The viewpoint is the author’s own. The GLP’s goal is to stimulate constructive discourse on challenging science issues.

Outbreak Daily Digest

podcasts GLP Podcasts More...
Biotech Facts & Fallacies
Talking Biotech
Genetics Unzipped

video Videos More...
stat hospitalai ink st x mod x

Meet STACI: STAT’s fascinating interactive guide to AI in healthcare

The Covid-19 pandemic underscores the importance of the technology in medicine: In the last few months, hospitals have used AI ...

bees and pollinators Bees & Pollinators More...
mag insects image superjumbo v

Disaster interrupted: Which farming system better preserves insect populations: Organic or conventional?

A three-year run of fragmentary Armageddon-like studies had primed the journalism pumps and settled the media framing about the future ...
dead bee desolate city

Are we facing an ‘Insect Apocalypse’ caused by ‘intensive, industrial’ farming and agricultural chemicals? The media say yes; Science says ‘no’

The media call it the “Insect Apocalypse”. In the past three years, the phrase has become an accepted truth of ...

infographics Infographics More...
breastfeeding bed x facebook x

Infographic: We know breastfeeding helps children. Now we know it helps mothers too

When a woman becomes pregnant, her risk of type 2 diabetes increases for the rest of her life, perhaps because ...

biotechnology worker x

Can GMOs rescue threatened plants and crops?

Some scientists and ecologists argue that humans are in the midst of an "extinction crisis" — the sixth wave of ...
food globe x

Are GMOs necessary to feed the world?

Experts estimate that agricultural production needs to roughly double in the coming decades. How can that be achieved? ...
eating gmo corn on the cob x

Are GMOs safe?

In 2015, 15 scientists and activists issued a statement, "No Scientific consensus on GMO safety," in the journal Environmental Sciences ...
glp profiles GLP Profiles More...
Screen Shot at PM

Charles Benbrook: Agricultural economist and consultant for the organic industry and anti-biotechnology advocacy groups

Independent scientists rip Benbrook's co-authored commentary in New England Journal calling for reassessment of dangers of all GMO crops and herbicides ...
Screen Shot at PM

ETC Group: ‘Extreme’ biotechnology critic campaigns against synthetic biology and other forms of ‘extreme genetic engineering’

The ETC Group is an international environmental non-governmental organization (NGO) based in Canada whose stated purpose is to monitor "the impact of emerging technologies and ...
report this ad report this ad report this ad


News on human & agricultural genetics and biotechnology delivered to your inbox.
Optional. Mail on special occasions.
Send this to a friend