‘Risk-Sharing’ as a Tool for Enabling Fast Access to COVID-19 Vaccines

As the COVID-19 pandemic has proliferated across the globe, so too have efforts to develop, manufacture and secure the supply of effective vaccines. At the time of writing, according to the WHO, more than 40 vaccine candidates have entered clinical development.¹ Additionally, several front-runners such as AstraZeneca and Pfizer-BioNTech have stated that they could begin delivering vaccines in the near future.^2,3

The challenges that procuring bodies such as governments and supranational organizations face are clear. On the one hand, they need to ensure that they secure supply and guarantee a vaccine is available as soon as possible in order to control the pandemic, protect healthcare systems and keep their economies open. On the other hand, they risk criticism if they back vaccines that ultimately do not gain approval or have an inferior efficacy and safety profile.

Traditional tender-based approaches to vaccine procurement often rely on buyers’ ability to make informed decisions, usually based on several available options. While vaccine procurement has evolved in recent years, such approaches are not fit for purpose during a pandemic when there is a race to rapidly develop and produce vaccines. To achieve this goal, manufacturers often need to ramp-up production capacities before knowing whether their vaccine will achieve regulatory approval. For example, AstraZeneca began manufacturing doses of its potential COVID-19 vaccine in early June – a considerable investment that will be wasted should the vaccine fail the approval process. However, despite efforts by manufacturers to scale-up capacity, demand for vaccines has typically outstripped supply during a pandemic. This presents a challenge for governments and other organizations responsible for procuring pandemic vaccines as they must compete on a global scale to secure enough of the limited supply.

This issue was highlighted during the 2009 H1N1 pandemic. Some countries entered into advanced purchase agreements very quickly and secured most of the available supply. Conversely, countries that were behind in deal-making faced being left without access to a vaccine. Fortunately, the H1N1 pandemic turned out milder than expected and the demand for immunization was low.⁴ As a result, countries that had entered advanced agreements either attempted to cancel orders, donate their supply or were forced to dispose of unused vaccines.

During the current COVID-19 pandemic, we have already seen stakeholders grappling with the issue of supply. In line with the H1N1 pandemic, many countries and supranational organizations have either entered into advanced purchase agreements with manufacturers of promising candidates or are currently in the process of developing such contracts. While these agreements are being made based on the science and currently available clinical data of a potential vaccine, there is a risk that safety and efficacy will not meet required standards and that procurers will have backed the wrong candidate. Conversely, apprehension and hesitancy to engage in a deal may lead some countries to wait too long to enter into agreements and be left with no or limited access to a vaccine pending approval.

Assuming the correct balance of risk is therefore an essential aspect of pandemic vaccine procurement as it not only secures immediate supply but also supports vaccine development and allows for the timely scale up of manufacturing capacity. In the current pandemic, we are witnessing varying approaches to assuming risk.

• Countries such as the U.S. and U.K. have entered into deals with multiple manufacturers and secured large volumes of vaccines – assuming they are approved.⁵ By their willingness to enter into agreements in the absence of complete clinical data, these countries have been able to spread their risk across multiple candidates and, even with a few failures, have likely secured an adequate supply of vaccine for the pandemic phase.
• By contrast, the EU’s Joint Procurement Agreement (JPA) – initially established in response to Member States being left without vaccines during the H1N1 pandemic – has been slow to enter into agreements. This comes despite the European Commission’s vaccine strategy document stating it aims to transfer some of the risks from industry to public authorities in return for assuring Member States of equitable and affordable access to a vaccine, should one become available.

While the challenges procurement bodies and manufacturers face may be clear, solutions to address them are less so. Governments must accept that, due to the urgent need for a vaccine, they need to assume more risk than in a typical vaccine procurement scenario. Failure to do so would delay vaccine availability.

Conversely, manufacturers need to be aware of the challenges procurement bodies face and be realistic in terms of their funding expectations and system affordability. In order to satisfy both parties it may be necessary to explore more innovative risk-sharing agreements such as multi-year contracts with staggered payments over time.

These types of deals would allow payers to make payments to manufacturers over fixed periods for each patient that is vaccinated. Structuring payments this way helps mitigate the high up-front cost that would otherwise be associated with intensive pandemic immunization programs.

Although simpler models could be introduced in the short term, in the future, payment models could be linked to achievement of specific patient outcomes after vaccination, requiring the collection of real-world outcomes data. This could also be a way for payers to address uncertainty around the clinical benefit of a vaccine due to the often-limited clinical evidence available at launch.

These types of agreements may provide a more agreeable distribution of risk while still providing early funding for manufacturing and development. Such flexibility, especially in the early years of a pandemic, will pay dividends downstream:

• This would also give companies flexibility on price during the early pandemic stage, allowing them to price affordably at the beginning while securing further commitments in the post-pandemic era.
• It will be a sign that a manufacturer recognizes the investments the public has made in their company and the importance of equitable access to a vaccine.
• This would also allow a platform for sharing risk over time – manufacturers and governments should develop co-responsibility for managing risks around safety and efficacy of a vaccine.

Furthermore, such agreements could act as longer-term solutions that are fit for purpose beyond just the initial rounds of vaccine procurement. This includes an openness to engage in dialogue and collaborate earlier on to ensure predictability for both parties and a willingness to adapt and refine traditional procurement models to facilitate fast access to potentially safe and effective vaccines moving forward.

References

1. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
2. https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-to-supply-europe-with-up-to-400-million-doses-of-oxford-universitys-vaccine-at-no-profit.html
3. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two
4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2957695/
5. https://www.bbc.co.uk/news/business-52917118

About the authors

Eva Marchese, PhD, is a Vice President at CRA who specializes in competitive strategy, pricing, market access, and research primarily in the pharmaceutical, biotech, and life sciences industries.

Anthony Barron is a Principal in the Life Sciences Practice of Charles River Associates based in Brussels. He has been working on European and international pharmaceuticals policy issues for more than 10 years.

Abhishek Kumar is an Associate Principal at CRA where he manages strategic projects in the area of pricing and market access, commercial strategy and portfolio strategy.

Kees Chamberlain is a Consulting Associate at CRA who has been supporting clients in developing strategies for COVID-19 vaccines.

The views expressed herein are the authors’ and not those of Charles River Associates (CRA) or any of the organizations with which the authors are affiliated.