How to Make a Faster Coronavirus VaccineBloombergOpinion
(Bloomberg Opinion) -- As the coronavirus pandemic continues, Bloomberg Opinion will be running a series of features by our columnists that consider the long-term consequences of the crisis. This column is part of a package on public health. For more, see Joe Nocera on why federal disaster-management efforts have failed, Virginia Postrel on the renewed promise of telemedicine and Faye Flam on a grim future for the medical profession.
There are a few hard truths worth grappling with when it comes to the Covid-19 pandemic.
First, life may not fully return to normal until an effective vaccine is developed, manufactured in mass quantities and distributed worldwide. Anything but the cautious reopening of economies in the meantime will likely lead to significant second-wave outbreaks and renewed physical distancing. There's no substitute for herd immunity.
Second, despite recent scientific advances and heroic efforts to speed vaccines to market, the 12- to 18-month timeline that public-health officials keep referring to is an aspiration rather than a certainty. Private companies and government labs are rushing vaccine candidates into trials, but there’s no guarantee that they’ll prove safe, effective and easily scalable. The world simply hasn't made the sort of long-term investments needed for a pandemic-ready vaccine.
Emergency funding, hard work and ingenuity could well result in a relatively speedy vaccine. But the amount of uncertainty in that outcome and the death toll that will mount even in a best-case scenario suggest a need for a far more ambitious intervention.
Making vaccines is difficult and expensive in the best of times. It usually takes years to bring a candidate to market. On top of the scientific difficulty, vaccines must clear an exceptionally high safety bar: Unlike just about any other treatment, they're given to otherwise healthy people in large quantities. Any significant side effects can have disastrous consequences, and long and careful testing is required to avoid harm. By one estimate, getting a single epidemic infectious disease vaccine from the preclinical stage to large-scale testing costs between $319 million and $469 million.
These costs and risks are elevated further in a pandemic, because there’s no time for the usual lengthy and cautious process. Researchers are still trying to figure out what animals to use to test potential vaccines, for instance, yet preclinical testing, dose selection and human trials are proceeding at warp speed at dozens of labs. That increases the chances of mistakes that may not be caught until later. To have something available on a reasonable timeline, manufacturing capacity will have to be built before efficacy and safety are confirmed.
Looming on the other side of this enormously costly process is a series of abject market failures. Long vaccine timelines mean that epidemics often putter out, leaving no demand for the product. That's unlikely in this case, but companies that leaped into the challenge of developing SARS and Zika vaccines saw commitment and funding dry up and their work languish. In Congressional testimony in March, Peter Hotez, a Texas-based researcher, described being unable to find public or private funding to bring a promising SARS vaccine into trials once the transmission of the disease stopped. He wasn’t alone, and as a result, the world lacks valuable insight about a vaccine for a similar coronavirus.
Even if an effective vaccine does emerge on time, there's no guarantee of recouping costs, let alone making money. In many cases, infectious diseases emerge in developing countries with limited ability to pay. Covid-19 is a rare exception that is also ravaging wealthier nations. But that doesn't ensure a return. Germany’s parliament recently extended powers allowing the government to suspend patent rights in response to the crisis; emergency legislation in Canada permits the same thing. If nations don't like the price of a vaccine or sufficient quantities aren't available, they’ll just make it for themselves.
It's heartening that even against this challenging backdrop, there are already more than a dozen vaccine candidates in development. That variety should boost the chances of at least one success. However, few entrants have successfully developed and globally scaled a vaccine, and none has done so for a novel pathogen within 18 months.
The world needs a far more sophisticated effort to create incentives and keep companies investing in the face of significant risk.
An essential step in that direction is to offer a major prize, or better yet a generous guaranteed purchase order, for a Covid-19 vaccine that meets reasonable standards of efficacy and safety. A guaranteed payment helps reduce concerns about intellectual-property seizure and commercial viability. Various prizes have been suggested and offered in the past, but big problems require bigger incentives.
The Center for Global Development recently published a thoughtful report noting that there should also be rewards for better and slower options that advance science. This would encourage sustained investment and hedge against late-stage failure. Any award should also include an assessment of value: the safer and better the vaccine, the bigger the prize. Ideally, this would be an international effort, boosting the size and sustainability of the prizes while reducing the financial burden.
Getting to a viable vaccine is only step one, however. Manufacturing and distribution are going to require another coordinated, open-source international effort. Creating substantial manufacturing capacity for several candidates that use different and sometimes novel technologies — some of which will likely be failures — will be an enormously costly endeavor. Picking the wrong winner or waiting too long will have unacceptable consequences. It's the definition of a global-scale project and a public good.
Leaving manufacturing to individual countries or companies will likely lead to shortages and unequal distribution. It's all too easy to imagine wealthier nations vaccinating heavily as poorer countries with greater need and weaker health systems wait. Hefty coordinated investment in both adapting existing manufacturing capacity and creating new lines will solve part of the problem. The CDG report suggests making prizes conditional on the provision of low-cost licenses for lower-income countries.
These measures should be put in place sooner rather than later — anything to get a vaccine to market faster. There would also be a long-term benefit; the collective support of Covid-19 vaccines could serve as a foundation for better long-term disease prep. The world needs a financing system that plays a consistent role from discovery to manufacturing and allocation. In the current crisis, groups such as the World Health Organization and the Coalition for Epidemic Preparedness Innovations could administer these programs and get them running quickly. In the longer run, a new global agency should be created to dedicate the attention and funding this issue needs. A more established organization and a permanent prize system should create stable enough demand to encourage companies to invest in infectious diseases as a business proposition, rather than as charity.
Such a system would also create a better environment for so-called vaccine platforms, technologies that allow for the creation of vaccines for multiple pathogens via the same basic formula. Newer approaches, such as the mRNA vaccines in development by Moderna Therapeutics Inc., offer the potential for faster responses than were possible in previous epidemics. But these efforts are still untested, especially under rapid-response conditions. It’s likely that years of sustained support are needed to get novel platforms to the point where they can quickly deliver safe and effective vaccines.
A new vaccine development paradigm won't pop up overnight. But the current crisis is an opportunity to start on badly needed fixes.
This column does not necessarily reflect the opinion of Bloomberg LP and its owners.
Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.
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