R&D for COVID-19 has increased, yet other pandemic risks go unaddressed
Despite years of warnings that novel coronaviruses were among the pathogens most likely to cause a global health emergency, the pharmaceutical industry, as well as society at large, was ill-prepared for the COVID-19 pandemic.
In the period before the start of the pandemic, R&D pipelines targeting pathogens most likely to cause a pandemic were largely empty. However, after the pandemic hit, the portfolio of experimental drugs and vaccines to treat coronavirus filled up – while the R&D effort by 20 of the world’s largest pharmaceutical companies into other priority emerging infectious diseases (EIDs) remains alarmingly low.
Research activity is at an extremely low level even for the few cases where there is work being done, such as the mosquito-borne chikungunya virus that has spread rapidly in recent years, including across the Americas, Africa and in India. From the companies in scope, there are just 13 R&D projects across five non-coronavirus diseases and zero for the remaining ten. Those ten diseases also had empty pipelines in 2018.
Concerning low level of R&D for EIDs
Research activity against EIDs is concentrated among a few companies. In 2020, 17 companies are targeting coronavirus. Nine companies are targeting other EIDs: Bayer, Boehringer Ingelheim, Eisai, Gilead, Johnson & Johnson, MSD,† Merck,‡ Roche and Takeda. These diseases could be the next ones to cause death rates to spike and to stall the global economy. They matter more than ever in today’s inter-connected world that presents viruses with heightened opportunities to spread at the speed of a jet plane, increasing the risk of future pandemics.
Large pharma companies’ respond to COVID-19
Large research-based pharmaceutical companies have a critical role to play in preparing for the next pandemic. While academic groups and small biotechs can pioneer new research ideas, big companies are essential in ensuring rapid development and access to vaccines, therapeutics and diagnostics, including providing the capacity for scaled-up manufacturing and global distribution without disrupting supply chains leading to shortages and stockouts.
Many large companies have moved to fulfil this role in response to COVID-19, helping to facilitate the development and deployment of vaccines in record time. However and to a large extent, this industry only mobilised against COVID-19 once it became clear that the outbreak affected rich as well as poor countries, thereby opening up the possibility of substantial recurring pharmaceutical revenues. Yet, not all pandemics lead to the creation of such a substantial market for new products. Without sustained commitment by large pharmaceutical companies to pandemic preparedness, the world will remain worryingly vulnerable to pandemics and epidemics, particularly those that mainly affect low-income countries.
Without sustained commitment by large pharma companies to pandemic preparedness, the world will remain worryingly vulnerable to pandemics.
Few projects suitable for resource-limited settings
The COVID-19 pandemic has seen a range of responses by pharmaceutical companies. Apart from for projects developed within the COVID-19 Tools Accelerator (ACT-A), there was little evidence in the first months of the pandemic response of structures for ensuring access to COVID-19 vaccines and treatments in poorer countries. By June 2020, only seven out of 24 late-stage coronavirus projects analysed (Phase II or III) were covered by an access plan, such as a licensing agreement or pricing commitment.
Out of 63 projects, only five are antivirals, nine are vaccines, and 11 are antibody-based treatments. Amongst the projects, there are several existing medicines that are repurposed for COVID-19 patients. Unfortunately, many of the non-vaccine products in development will be challenging for low- and middle-income countries to get to patients, either due to their comparatively high cost or because of technical requirements – for example, monoclonal antibodies that need to be administered by sterile infusion, may need monitoring and require highly specialized health workers and sophisticated diagnostics Some vaccines, too, are less suitable for resource-poor settings because of their high cost and the need for ultra-cold storage.
What next? Prepare for the next pandemic through EID R&D
and broader use of IP-sharing and other tools
Arrangements for preparing for and preventing future pandemics exist but are precariously positioned, due in part to weak engagement by the research-based pharmaceutical industry. The lesson of COVID-19 is that pandemic preparedness requires a robust and diverse range of private and public sector entities to engage in research against EIDs. This must include companies that can accelerate the passage of products through clinical development and approval, and manufacture and supply at global scale without disrupting existing activities. Vaccines take at least a year to develop, even at an accelerated pace. R&D targeting EIDs must begin before epidemics break out, for example to develop platform technologies or to share IP to accelerate discovery-stage R&D.
The Index shows that, before COVID-19 struck, there was very little engagement in EID research by large pharmaceutical companies, despite clear prioritisation by WHO and others. Incentives for pharmaceutical companies to engage were limited, as many EIDs offered little in terms of commercial prospects, such as Ebola, Zika, dengue fever and malaria. To counter this in-built reluctance to engage, there are organisations such as the Coalition for Epidemic Preparedness Innovations (CEPI) focused on developing vaccines, Gavi, the Vaccine Alliance, to enable sustainable vaccine markets, and the Access to COVID-19 Tools (ACT) Accelerator, which includes IP-sharing, launched by WHO and partners.
Ending a pandemic requires suitable products to be developed and fairly distributed so that people in low- and middle-income countries (LMICs) are not last in line or left behind altogether. The lag in access planning, despite hefty public funding for much R&D, suggests that pharmaceutical companies must do more: demonstrate a sustained commitment to invest more in EID R&D; embed equitable distribution into their strategies; and show greater flexibility on sharing intellectual property.
† Merck & Co, Inc (Kenilworth, NJ USA)
‡ Merck KGaA (Darmstadt, Germany)
* Including Lassa Fever
** Including EV71, D68
*** Other highly pathogenic coronaviral diseases (incl. COVID-19). Includes products that are being repurposed to improve patient outcomes.
CCHF: Crimean-Congo haemorrhagic fever
SFTS: Severe fever with thrombocytopenia syndrome
MERS-COV2: Middle East respiratory syndrome coronavirus
SARS: Severe acute respiratory syndrome