Viewpoint: ‘We can’t afford miscommunication or bureaucratic foot-dragging’ in the quest for a coronavirus vaccine

| May 11, 2020
ctab vaccine
This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

A draft government report forecasts the possibility of about 200,000 new cases of COVID-19 each day by the end of this month, and that the daily death toll could reach about 3,000, a 70 percent increase from the current toll of about 1,750. 

Whether or not these dire statistics come to pass, in the absence of a vaccine, the nation’s near-term future will look very different than it did before the pandemic.

The medical community and the public are hungry for news about vaccines, but accounts of progress have been exaggerated. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and senior member of the White House coronavirus task force, has put into perspective the overly optimistic predictions of a vaccine available within the target of 12 to 18 months: “A vaccine that you make and start testing in a year is not a vaccine that’s deployable.” There is a world of difference between testing a vaccine candidate and millions of people lining up for a shot.

Clearly, there is a sense of urgency. What, then, is standing in the way of the rapid deployment of a vaccine? For one, unproven technologies—which are being used by virtually all of the Covid-19 vaccine developers—present significant safety concerns. And once researchers have a vaccine candidate, the risk-averse regulators at the Food and Drug Administration get involved. The regulatory process can be sped up, but corners can’t be cut without sacrificing confidence about the safety and efficacy of the product.

The regulatory bar is very high for vaccines that would be administered to healthy people. Before approval, the first successful 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.

boosting vaccine response in older individuals

Planning and executing clinical trials of that magnitude is a major undertaking. Researchers need to recruit medical practitioners and research institutions, with competition among some 78 developers of Covid-19 vaccines. Developers have to make sufficient quantities of the vaccine under conditions that meet the FDA’s Current Good Manufacturing Practices standards for purity and potency. And all the data must be accumulated, organized and analyzed, first by the sponsor of the vaccine, then by regulators.

Another complication is that to demonstrate efficacy—the ability of the vaccine to prevent the coronavirus infection—trials need to be done in places where relatively large numbers of people are infected. This is important to attain sufficient statistical power to show a difference between those given the vaccine and the placebo groups.

Finally, there’s no guarantee that any of the vaccines in development will work. Of vaccine candidates that begin clinical trials, only about 16% are ultimately approved. Scientists have tried unsuccessfully for decades to develop a vaccine to prevent HIV/AIDS and a “universal” flu vaccine that wouldn’t need to be reformulated and readministered every year. All have been duds.

Related article:  Coronavirus might push us towards a more automated society
Follow the latest news and policy debates on agricultural biotech and biomedicine? Subscribe to our newsletter.

Covid-19 is a genuine emergency. Drug and biotech companies and academic institutions are doing their part, and regulators need to, as well. Having been a research virologist who spent 15 years at the FDA as the agency’s “biotechnology czar,” I have some suggestions:

  • The FDA should allow developers to perform the more advanced preclinical (animal) studies at the same time as Phase 1 clinical trials, which are performed in a small number of healthy subjects.
  • Lower to 10 days the usual 30-day waiting period from the time the application is submitted to the FDA to the start of the Phase 1 trials.
  • In collaboration with experienced vaccine developers, the FDA should publish a template “master protocol” for streamlined Covid-19 vaccine development. Trials should have an “adaptive” design: If one vaccine candidate is found not to work, investigators can quickly move on to testing the next most promising one without delay.
  • “Unblind”—that is, review—the results early in the clinical trials so researchers can be aware of obvious positive or negative findings sooner.
  • Set up a process for regularly sharing data and other information between the sponsor and the FDA via virtual meetings.
  • Allow a “rolling” Biologics License Application—the official request to the FDA for approval—so that evaluation of parts of the application can begin when each is ready, instead of submitting all at once.
  • The FDA should issue “accelerated approvals” after testing in only limited populations. Additional subgroups—children, pregnant women, etc.—can be tested after approval. The accelerated approvals should be granted before the duration of postvaccination immunity has been ascertained. More-comprehensive trials can then confirm safety, efficacy and the length of time that immunity lasts.
  • Establish reciprocity of approvals between the FDA and trusted counterparts in certain foreign countries (Australia, Canada, New Zealand, Japan, the Scandinavian countries and the European Medicines Agency), so that if one of them approves a vaccine, it is automatically approved in the other countries.

We can’t afford miscommunication or bureaucratic foot-dragging—or, for that matter, excessive haste. To avoid all that, regulators and their political masters must work quickly and cleverly while respecting scientific integrity.

Henry Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He has worked in research virology and was founding director of the FDA’s Office of Biotechnology. Follow him on Twitter @henryimiller

A version of this article previously ran on the Wall Street Journal and has been republished here with permission. Follow the Journal on Twitter @WSJ

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
Biotech Facts & Fallacies
Talking Biotech
Genetics Unzipped
a a b b a f ac a

Video: Death by COVID: The projected grim toll in historical context

The latest statistics, as of July 10, show COVID-19-related deaths in U.S. are just under 1,000 per day nationally, which is ...
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 ...
types of oak trees

Infographic: Power of evolution? How oak trees came to dominate North American forests

Over the course of some 56 million years, oaks, which all belong to the genus Quercus, evolved from a single undifferentiated ...
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 ...
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 ...
Share via
News on human & agricultural genetics and biotechnology delivered to your inbox.
Optional. Mail on special occasions.
Send this to a friend