(Bloomberg Opinion) – As the coronavirus pandemic continues, Bloomberg Opinion will introduce a series of features by our columnists who examine the long-term consequences of the crisis. This column is part of a file on public health. For more, see Joe Nocera on the reasons for the failure of federal disaster management efforts, Virginia Postrel on the renewed promise of telemedicine and Faye Flam on a bleak future for the medical profession.
There are some harsh truths that deserve to be addressed with regard to the Covid-19 pandemic.
First, life may not return to normal before an effective vaccine is developed, produced in large quantities, and distributed worldwide. Anything but the careful reopening of economies in the meantime will likely lead to significant second wave surges and further physical distancing. Nothing can replace collective immunity.
Second, despite recent scientific advances and heroic efforts to speed up the time to market, the 12-18 month delay that public health officials continue to refer to is an aspiration rather than a certainty. Private companies and government labs are rushing vaccine candidates for testing, but there is no guarantee that they will prove to be safe, effective, and easily scalable. The world just hasn’t made the kind of long-term investments needed for a pandemic-ready vaccine.
Emergency funding, hard work and ingenuity may well result in a relatively quick vaccine. But the degree of uncertainty in this outcome and the number of deaths that will increase even in the best of cases suggests the need for a much more ambitious intervention.
Making vaccines is difficult and expensive at best. It usually takes years to put a candidate on the market. In addition to the scientific difficulty, vaccines must cross an exceptionally high safety bar: unlike almost all other treatments, they are administered to otherwise healthy people in large quantities. Any significant side effect can have dire consequences, and lengthy and careful testing is necessary to avoid damage. It has been estimated that getting a single vaccine against infectious epidemic diseases from the preclinical stage to large-scale testing costs between $ 319 million and $ 469 million.
These costs and risks are even higher in a pandemic, as there is no time for the usual long and careful process. Researchers are still trying to figure out which animals to use to test potential vaccines, for example, but preclinical testing, dose selection, and human trials are taking place at a distorted rate in dozens of laboratories. This increases the chances of errors that cannot be detected until later. To have something in a reasonable time, the manufacturing capacity will have to be strengthened before efficiency and safety are confirmed. On the other side of this extremely expensive process, there is a series of abject market failures. The long vaccination times mean that epidemics often die out, leaving no demand for the product. It’s unlikely in this case, but companies that have taken up the challenge of developing SARS and Zika vaccines have seen commitment and funding dry up and their work languishing. In a Congressional testimony in March, Peter Hotez, a Texas-based researcher, described his inability to find public or private funding to introduce a promising SARS vaccine into trials after the transmission of the disease was stopped. He was not alone, and therefore the world lacks valuable information about a vaccine against a similar coronavirus.
Even if an effective vaccine emerges in time, there is no guarantee of cost recovery, let alone money. In many cases, infectious diseases appear in developing countries with limited payment capacity. Covid-19 is a rare exception that also ravages the wealthiest nations. But this does not guarantee a return. The German parliament recently extended its powers allowing the government to suspend patent rights in response to the crisis; emergency legislation in Canada does the same. If countries do not like the price of a vaccine or if sufficient quantities are not available, they will simply do it for themselves.
It is encouraging to note that even in this difficult context, there are already more than a dozen vaccine candidates in development. This variety should increase the chances of at least one success. However, few participants have successfully developed a vaccine globally, and none have done so for a new pathogen within 18 months.
The world needs a much more sophisticated effort to create incentives and keep companies from investing in the face of significant risk.
An essential step in this direction is to offer a significant price, or better yet, a generous guaranteed purchase order, for a Covid-19 vaccine that meets reasonable standards of efficacy and safety. Guaranteed payment helps reduce concerns about foreclosure of intellectual property and commercial viability. Various prices have been offered and offered in the past, but the big issues require bigger incentives.
The Center for Global Development recently released a thoughtful report noting that there should also be rewards for better and slower options that advance science. This would encourage sustained investment and would protect against failure in the final phase. Any price must also include a value assessment: the safer and better the vaccine, the higher the price. Ideally, this would be an international effort, increasing the size and sustainability of prices while reducing the financial burden.
However, getting a viable vaccine is only the first step. Manufacturing and distribution will require a new international coordinated and open source effort. Creating substantial manufacturing capacity for several candidates using different and sometimes new technologies – some of which will likely fail – will be an extremely expensive undertaking. Choosing the wrong winner or waiting too long will have unacceptable consequences. It is the definition of a global project and a public good.
Exiting manufacturing to individual countries or companies will likely result in shortages and uneven distribution. It is all too easy to imagine that the richest countries vaccinate heavily while the poorest countries with greater needs and weaker health systems wait. Significant coordinated investment in adapting existing production capacity and creating new lines will solve part of the problem. The CDG report suggests making prices contingent on the provision of low-cost licenses for low-income countries.
These measures should be put in place as soon as possible – everything to get the vaccine to market faster. There would also be a long-term benefit; collective support for Covid-19 vaccines could provide the basis for better long-term disease preparedness. The world needs a funding system that plays a constant 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 make them work quickly. In the longer term, a new global agency should be created to devote the attention and funding that this issue needs. A more established organization and a permanent price system should create enough stable demand to encourage companies to invest in infectious diseases as a business proposition, rather than a charity one.
Such a system would also create a better environment for so-called vaccine platforms, technologies that allow the creation of vaccines against multiple pathogens via the same basic formula. New approaches, such as the mRNA vaccines being developed by Moderna Therapeutics Inc., offer the potential for quicker responses than were possible in previous epidemics. However, these efforts have not yet been tested, in particular under conditions of rapid response. It is likely that years of sustained support will be required to obtain new platforms to the point where rapid and safe vaccines can be delivered.
A new paradigm of vaccine development will not emerge overnight. But the current crisis is an opportunity to start with essential fixes.
This column does not necessarily reflect the opinion of Bloomberg LP and its owners.
Max Nisen is a Bloomberg Opinion columnist covering biotechnology, pharmaceuticals and healthcare. He previously wrote on management and business strategy for Quartz and Business Insider.
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