Imagine mobilizing the world’s brightest and most creative minds — from biotech and pharmaceutical industries, universities, government agencies, and more — to work together using all available knowledge, innovation, and infrastructure to develop an effective vaccine against Covid-19. A true “people’s vaccine” that would be made freely available to all people in all countries. That’s what an open letter by more than 140 world leaders and experts calls for.
Unfortunately, that is not how the race for a Covid-19 vaccine is being run. The rules of that game are oblivious to the goal of maximizing global health outcomes and access.
Despite a pipeline of more than 100 vaccine candidates reflecting massive public and private efforts, there exists no public-health-focused way to design or prioritize the development of the most promising candidates. Instead, the world is adopting a laissez-faire approach and letting individual groups and companies compete for marketing authorization, each with their proprietary vaccine candidate, and assume that the winner of that race will be the best vaccine to tackle the pandemic.
Science thrives, and technological progress is made, when knowledge is exchanged and shared freely, generating collective intelligence by building on the successes and failures of others in real time instead of through secretive competition. Regrettably, market logic has come to overtake medicinal product innovation, including the unproven premise that competition is an efficient way to advance science and deliver the best solutions for public health.
But it doesn’t need to be that way.
Designing a vaccine through collective intelligence
For a vaccine to work, it must have the right antigen, a safe and effective mode of delivery, and all the elements that make it capable of inducing an effective immune response in people.
In the classic approach to vaccine development, private companies invest in proprietary platform technologies including their own vectors, adjuvants, delivery systems, and manufacturing processes (either developed in house or acquired from biotech companies or academia) that they adapt depending on the target disease, in this case Covid-19. None of the individual elements of each proprietary platform is necessarily best suited for a Covid-19 vaccine, but each developer — despite brilliant scientists in their teams — is bound to work within its proprietary technology, unable to use other possibly better elements owned by competitors.
That process lends itself, almost by design, to generate a portfolio of suboptimal candidates, because it’s very unlikely any one developer will have the ideal combination of elements.
If a vaccine could be designed unconstrained by intellectual property or trade secrets, developers would have the freedom to combine the best elements of different vaccine technology platforms and approaches. Such an approach would allow them to generate a truly innovative and diverse portfolio of Covid-19 vaccine candidates that could be advanced in parallel and comparatively, always with the end goal of universal access to an effective vaccine in mind.
Running a race with a public-health-focused finish line
In the ongoing vaccine race, the main factor in determining the winners will likely be financial and industrial backing more than innovative product characteristics or public health impact. The vaccine research and development playing field is shaped by wealthy countries (through their agencies engaged in medical R&D, financing, or purchasing the end products) and powerful actors like philanthropic foundations and pharmaceutical corporations who each place their bets, allotting large amounts of money to propel their chosen candidates toward marketing authorization (likely via emergency use authorization shortcuts) well before robust evidence of effectiveness and utility is on the horizon.
The only obvious finish line in this race is obtaining marketing approval, typically at the U.S. Food and Drug Administration and/or the European Medicines Agency. But that’s the wrong finish line, because the criteria regulators use to allow a vaccine on the market are not designed to respond to the critical question at hand: Which vaccine has the potential to significantly improve global public health outcomes for Covid-19?
Regulators will assess any vaccine that comes their way at face value, on a first-come, first-served basis. Their mandate does not include prioritizing or evaluating which vaccine candidate is best in terms of safety and efficacy, or which is most suited to use as a public health intervention, including in resource-limited settings. Nor are they in a position to assess a company’s intentions and capabilities around availability or access or pricing.
Only a handful of large companies — mainly GlaxoSmithKline, Merck, Johnson & Johnson, AstraZeneca, Pfizer, and Sanofi — have the in-house capacity and resources to do what’s needed to obtain FDA or EMA marketing authorization, especially with the additional public funds that are being provided by some governments. That puts these companies at a significant advantage in the “race” towards obtaining marketing approval for a Covid-19 vaccine, even if their vaccine candidate might not have the best public health value.
In fact, it may well be that we will end up with a series of poorly effective first-generation vaccines from these players, who are competing for regulatory approval rather than developing the best vaccine for public health. Commercial and political pressures will push for their rapid rolled out, making the development of better-suited vaccines even more challenging as financial and political support will falter as competition for trial participants increases.
For small companies or academic labs engaged in the race, their best bet is to partner with a major player to ensure manufacturing capacity and market access, for instance Moderna with global manufacturer Lonza, BioNTech with Pfizer, or Oxford University with AstraZeneca.
We need a portfolio approach focused on public health
Faced with the Covid-19 pandemic, business-as-usual R&D is not an option. We urgently need a portfolio approach to vaccine R&D, including designing and prioritizing vaccine candidates according to our collective public health needs, including equitable access. This doesn’t mean an overregulated, top-down process but a public-health-driven, open, collaborative, global R&D effort that makes it possible to prioritize the vaccines to be developed. It means we need to decide collectively which vaccines will be tested first — or at all — and clarify how their effectiveness and global health utility will be measured and compared to best serve the public health interest.
Several experts have suggested criteria and processes to try and bring some public health sense in the ongoing “rat race” of Covid-19 vaccine development. The World Health Organization, for instance, has proposed a collaborative efficacy trial to directly compare the performance of different vaccines. Financially strong developers, however, will likely prefer to set up their own trials instead of having their vaccines compared to other candidates, which could not only slow their path towards marketing authorization but also hurt their vaccines’ commercial prospects.
Others have argued for more collaboration and coordination in the management of the global vaccine portfolio from a risk-sharing perspective. While that would mitigate some of the problems of vaccine nationalism, it remains grounded in competition as an efficient mechanism to select the best public health solutions. With four vaccine candidates currently being tested in the U.S., and five in China, a geopolitical dimension has been added to the race, becoming a competition for technological dominance.
There is a massive injection of public money from the U.S. and other governments, as well as from big philanthropies, that is going to finance R&D, manufacturing, stockpiling, and purchase of Covid-19 vaccines. This is a totally unprecedented situation, in which companies will receive massive sums of money for delivering — or contributing to — a vaccine. We are wasting a lot of that money by throwing it at an ineffective competitive and commercial business model instead of investing it into an open, collaborative, public interest R&D model that can deliver vaccines at cost.
So what can be done? The most optimistic projections (leaving President Trump’s Operation Warp Speed aside) indicate that an effective vaccine might be available in 12 to 18 months, though more conservative (realistic?) projections put that timeline much further back, implying that none of the current frontrunners in the race might live up to their promise.
As unfortunate as that would be for global health, it would provide an opportunity to drastically rethink the way we’re going about this challenge and create a radically open and collaborative global vaccine R&D endeavor under a collective governance mechanism. It is only in this way that we’ll be able to achieve the most important mission of our lifetime, a true people’s vaccine for Covid-19 as a “global public good.”
Els Torreele is a biomedical scientist and advocate for access to medical innovation who worked with Médecins Sans Frontières, Open Society Foundations, and the Drugs for Neglected Disease initiative.