How to make a faster vaccine for coronavirus

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 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.
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.
—Bloomberg

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