[This text has been written by: Adelaida Sarukhan, scientific writer at ISGlobal, and Rafa Vilasanjuan, Policy and Global Development Director of ISGlobal]
All vaccines are based on the same principle: inoculate the inactivated pathogen or parts of it to generate an immune response that will protect us against it. However, each pathogen is different, and developing a vaccine against a new virus means finding the best strategy to generate immunity. This requires preclinical studies in animal models, followed by clinical studies in humans to assess its safety in small number of volunteers (phase 1) before studying its efficacy and confirming its safety at a larger scale (phases 2 and 3). Normally, the entire process takes at least ten years, and many vaccine candidates don’t make it: they are not safe or they are not effective.
In the case of the new coronavirus, this process is being accelerated in an unprecedented manner, thanks to certain shortcuts such as combining phases to test the vaccine in a larger number of people
In the case of the new coronavirus, this process is being accelerated in an unprecedented manner, thanks to certain shortcuts such as combining phases to test the vaccine in a larger number of people or using immune parameters as indicators of efficacy. In less than six months after the virus was identified, there are already over 100 vaccine candidates in the pipeline, with more than five in phase 1 assays and three entering phase 2 assays (although none of the three uses technology already approved for human use). Despite the sense of urgency, it is vital to not take shortcuts when it comes to safety —the consequences would be disastrous for COVID-19 and for the fragile vaccine trust among a segment of the population, particularly in Western countries.
Even if the safety and efficacy of one or several vaccines is demonstrated before the year ends, this does not mean they will be available to the population. Beyond the scientific aspects, three main challenges lie ahead: the large-scale production, the governance of the process, and the ownership of the vaccine.
Laboratory automated liquid-handling robots. (National Cancer Institute / Unsplash)
One thing is to develop a vaccine; to produce it at the scale and velocity that this pandemic requires is quite another. Vaccinating 50% of the world’s population would mean producing around 4,000 million doses, supposing one single dose confers life-long protection (which is not often).
Each type of vaccine requires special installations, with the appropriate infrastructure and equipment for its production. This challenge has triggered different initiatives to accelerate their production, even before knowing which vaccine or vaccines will “win”. The USA, for example, has announced an investment of over a thousand million USD in the Warp Speed project, to kick-start the production of one or several vaccines before knowing for sure if they are effective.
A global collaborative effort between the private and public sectors will be needed to produce billions of COVID-19 vaccine doses in the coming years
In turn, the World Health Organisation (WHO) launched an Access to COVID Tools (ACT) Accelerator. Together with the Coalition for Epidemic Preparedness Innovations (CEPI) and the Global Alliance for Immunization (GAVI), it proposes an ambitious aim: make the vaccine available and affordable for all countries. The idea is to advance the necessary resources to expand the manufacturing capacity that already exists in some middle-income countries such as India and Brazil, together with that of private laboratories in high-income countries, in exchange for agreements on their subsequent distribution. This bet implies an economic risk – it is not known which vaccine will work – but can save a considerable amount of time.
There are other challenges associated with vaccine production, starting with the manufacture of enough vaccine vials. The global stock of these vials, made of a special glass, is around 200 million units, far from the 4,000 million that would be needed.
It is clear that a global collaborative effort between the private and public sectors will be needed to produce billions of COVID-19 vaccine doses in the coming years while maintaining the production of the other existing vaccines.
Pregnant woman receiving influenza vaccination. (CDC / Unsplash)
It is logical to assume, therefore, that the COVID-19 vaccine will not reach everyone at the same time. This is why it is so important to ensure its fair and equitable distribution through a global governance system that puts public health criteria before those of the market.
The international community has emphasised the need to establish mechanisms to ensure that all countries will have access to the vaccines and treatments that are being developed. The WHO continues to play a key role in establishing priorities, supporting their implementation and setting public health guidelines, but it lacks both the resources and the power to guarantee the production and universal access to the vaccine.
It is so important to ensure its fair and equitable distribution through a global governance system that puts public health criteria before those of the market
CEPI and GAVI have proposed an alternative model for the taking of vaccine-related decisions —a model funded by the international community and which combines public and private sector capacities to implement the policies directly in each country. CEPI focuses on the development and production of the most promising vaccine candidates, while GAVI seeks to guarantee a timely, affordable and adequate supply for low-income countries. The WHO will define the guidelines to distribute and administrate the vaccine according to public health criteria.
Painted hands on a wall in Newberg, United States (Tim Mossholder / Unsplash)
At the end of the day, the availability and affordability of the vaccine(s) will be closely linked to the third challenge: who owns the vaccine?
Many of the candidate vaccines were funded by public money or by not-for-profit foundations during the first research stages. However, as they enter the clinical trials, most of them end up in hands of private laboratories.
A patent is necessary to ensure a return to investors, but at the same time, it can be a major obstacle to its distribution worldwide. Facing this situation, the great majority of WHO Member States declared the COVID-19 vaccine as a global public good, and that the trade and intellectual property agreements should be adapted to make it accessible worldwide. However, when the petition reached the WHO assembly, the declaration was diluted down to a general reference on immunisation.
Sharing the benefits of a patent with the affected populations does not mean renouncing to the rights it confers. Ten years ago, UNITAID created the Medicines Patent Pool, which allows pharmaceutical companies to voluntarily give up their rights. This model allowed to fabricate generic drugs that benefit tens of millions of people. Based on this precedent, the European Union is supporting the initiative led by CEPI, GAVI and the WHO, which combines “push” mechanisms – such as financing manufacturing capacities – with a purchase commitment from the countries, at an affordable price. The challenge is to limit prices not only in the poorest countries but also in those middle and low-income countries that do not qualify for GAVI aid but would not be able to afford the vaccine at a high price.
In the coming months, we will probably identify repurposed drugs that can reduce disease severity, accelerate recovery or decrease viral transmission
Even if we do have a vaccine in the coming year, it is unlikely that it will be widely available within a similar timeframe. However, there is hope even without a vaccine, as HIV shows. In the coming months, we will probably identify repurposed drugs that can reduce disease severity, accelerate recovery or decrease viral transmission. This, together with good diagnostic tools and contact tracing, can take us a long way, even without a vaccine.