Evan Lee and Jon Bastow*
Of all the investment in research and development that’s underway to meet the challenges of COVID-19 pandemic, the work on new vaccines has received the most attention. There was early success in sequencing the genome of SARS-CoV-2 and in establishing real-time, accessible databases to track mutations as they occur. The use of novel approaches such as recombinant DNA ,and an mRNA platform to enable our own cells to start producing the antigens which in turn will trigger an immune response have led to hopes that vaccine development - which often takes several years - will occur in as short as 12-18 months. In mid-March the first Phase 1 clinical trials were started with Moderna’s mRNA vaccine, and as of mid-May, over 130 vaccine projects were being tracked. The speedy creation of new public-private partnerships, such as the ACT-Accelerator, offer end to end approaches from R&D through manufacturing at scale, procurement, and deployment that will be coordinated to ensure rapid and equitable universal access.
In the interim, while we also wait for treatment options, preventive measures such as social distancing and the use of PPE will be required, and the scale-up of tools that are already available, including diagnostics based on RT-PCR and newly available ones such as serology, will be required. There are other interventions that are much in the news: treatments being repurposed from other diseases - from antivirals, antimalarials to bleach!
From our years of experience working in global health, the authors applaud the creation of the ACT-Accelerator, noting that it appears to build off of many years of experience in global health with building public-private partnerships that mobilize unique capabilities of researchers, governments, industry, and international organizations such as the World Health Organization, PDP’s ( Product Development partnerships), The Global Fund,GAVI, Unitaid and CEPI.
We thought it would be informative to draw on how we’ve seen the availability of recent innovations are impacting prevention, diagnosis, and treatment of two other diseases of public health importance: malaria and Hepatitis C.
Malaria:
In 2018 there were an estimated 228 million cases of malaria, causing 405,000 deaths in 2018 - over 90% of which occurred in Sub-Saharan Africa. Of the 5 known parasite species that cause malaria, P. Falciparum is generally regarded as the most lethal, and after many years of research, a malaria vaccine against P. Falciparum was approved by the European Medicines Agency in 2015. The trial results indicated that the vaccine was less than 50% effective for protection against malaria infection. The WHO is coordinating a multi-country pilot to test real-world effectiveness.
Hepatitis C:
Hepatitis C is caused by a blood borne virus that affects over 70 million people globally, with an estimated 1.75 million new infections per year. Oral treatments have rapidly evolved that enable treatment combinations across all 6 genotypes in as little as 8-12 weeks with over cure rates of 97%.
Management of these diseases still requires a full range of complementary interventions
Current WHO recommendations still call for “universal access to malaria prevention, diagnosis, and treatment”.(https://apps.who.int/iris/bitstream/handle/10665/176712/9789241564991_eng.pdf?sequence=1)
For Hepatitis C the same joined up approach is critical , with prevention, diagnosis, and treatment being essential to a successful public health approach
The key takeaway for Covid-19 is that despite the potential of a new vaccine, it’s going to be crucial to invest in other innovations around treatment, diagnostics and prevention, as well as investing in global access to the full range of interventions. Since Covid-19 is air droplet- borne and highly transmissible it's even more important to leave no country behind from an epidemiology point of view, in addition to the health-as-a-human right argument.
Considering specifically the promise of a vaccine for COVID-19, what might we take away from the world’s experience with a malaria vaccine and a highly effective hepatitis c treatment?
It's reassuring, as well as necessary, to see multiple ‘shots on goal’ underway to develop a vaccine and a universal and a recognition that it’s worth throwing everything at this - a healthy vaccine pipeline of in excess of 120 projects and similar scale with treatments and diagnostics. A Vaccine will probably be the biggest game changer, but we will need to wait 12-18 months at least and even then the achieved product profile may disappoint ( cf malaria vaccine with ‘modest efficacy’, possible side effects and not recommended for certain groups, e.g. pregnant women)
It’s also reassuring to see that new partnerships between the governments, industry, academia and the UN system are being formed to amplify the resources available to tackle COVID-19. WHO, The Global Fund, GAVI and Unitaid are playing stronger leadership roles and this will accelerate the wide deployment of future interventions. The global health world has paved the way in showing how these can work to pull the range of resources, funding, and know-how together for success.
But our two examples also tell us that we need to be prepared that for COVID-19 a vaccine will be unlikely to replace prevention, diagnostics, and treatment interventions. The malaria and hepatitis C experience reminds us of the deep investment that is also needed in health system capability to manage new tools as they become available: this includes mobilization of front-line health workers, ongoing training, and product distribution. These are multi-year investments. This ‘operational research’ could happen much more quickly than in the past, with the leadership of some of the organisations mentioned above.
Specific to COVID-19, emergency measures such as drive-by testing may have to become permanent, accompanied by systems and people to enable contact tracing; supermarkets and other outlets may need to have shelf space devoted to PPE; and stores and restaurants will need guidance and support to reconfigure establish testing capacity; and hospitals and health systems will have to be funded and supported to ensure reserve capacity.
* Authors
Evan Lee is a Geneva-based consultant and an expert in global health policy. He has previously worked for pharmaceutical company Eli Lilly, the Foundation for Innovative New Diagnostics (FIND), Management Sciences for Health and Medicines Sans Frontieres. A medically qualified doctor by training, he has a BA in chemistry and physics from Harvard University, a medical degree from New York University School of Medicine and an MBA from Massachusetts Institute of Technology.
Jon Bastow helps organisations accelerate innovation across R & D and Access in healthcare. He brings over 30 years of experience, having led R&D and access projects across multiple diseases. He has held senior roles in pharmaceutical companies and international organisations such as FIND and The Global Fund, building partnerships between private sector healthcare and tech companies, NGO’s and governments addressing major problems of poverty. Jon is a member of the Chartered Institute of Marketing, holds degrees in Biochemistry and Philosophy and has given lectures at IMD, London Business School, INSEAD and the Graduate Institute in Geneva.