• Inherent biological complexity: as they say, the product is the process. The inclusion of the pathogen antigen within the vaccine means that the manufacturing process for vaccines is inherently variable, requiring highly sophisticated manufacturing and testing technologies. This creates high barriers to entry for potential players in terms of both expertise and cost.

• Lack of incentives: the high costs and lengthy development and manufacturing periods, compounded by the relatively small market size in relation to other areas such as oncology, mean that pharma companies are often not incentivized to invest in vaccine R&D. This challenge is exacerbated for infectious diseases that are more prevalent in developing countries. For instance, three of the main killers in the developing world – AIDS, tuberculosis and malaria – still lack an effective vaccine, even though these three diseases take around five million lives each year. Sanofi Pasteur SVP Thomas Triomphe lamented in an article on Devex that “despite these and other important benefits of vaccinations, health care systems are not generally set up to reward the prevention of disease and instead favor reimbursements for costly treatments. It’s harder for governments to justify broad vaccination to avoid thousands of cases of influenza — a disease known to trigger life-threatening pneumonia — than it is to reimburse the hospital stays for patients who don’t get vaccinated and end up in the hospital with severe cases of pneumonia.”

Emerging epidemic response

Vaccine development efforts have proceeded at an unprecedented pace in 2020 in response to the global COVID-19 pandemic, with pharma companies and other related stakeholders including regulators and service providers essentially working 24/7 to address the global health crisis. These efforts have certainly paid off, with a number of COVID-19 vaccines now available for emergency use in a number of countries globally, barely a year after the novel coronavirus was first discovered.

However, this is perhaps the exception rather than the rule. Pharma companies have previously expressed that they face a lot of disruption – and risk – when they are summoned out of the blue to address emergency epidemics. For instance, following the 2009 H1N1 flu pandemic, flu vaccine manufacturers like GSK, Sanofi and Novartis rushed to develop vaccines that only became ready after the initial outbreaks – and public concern – had subsided. Some countries refused to accept (and pay) for their full orders.

In 2017, the US Biomedical Advanced Research and Development Authority (BARDA) abruptly pulled its funding from Sanofi’s Zika vaccine efforts right before the Phase 3 trial, leading the French drugmaker to pull the plug on that program shortly after. BARDA had committed USD 43 million in research funding, but an additional USD 130 million intended for late-stage trials was pulled, a result attributed to what Sanofi called the “evolving epidemiology” of the Zika virus – i.e. the slowing of the virus spread globally.

In a press release regarding the decision, Sanofi Pasteur highlighted that in February 2016 when the Zika virus emerged as a threat, the company had “urgently responded to the WHO’s declaration of a public-health emergency of international concern (PHEIC). In doing so, we assumed significant opportunity costs and delayed other internal pipeline priorities to lend our expertise to the Zika global public health threat. The epidemiology of the disease has changed significantly since that time, but we continue to believe that public-private partnerships are the right model to address these public health challenges and should continue to play a major role in response to emerging infectious diseases.”

The fundamental issue with these kinds of last-minute research efforts in response to public health outbreaks as they emerge and evolve has been called out by a number of global stakeholders, and in 2017, the Coalition for Epidemic Preparedness Innovations (CEPI) was established with the mission to invest in and accelerate vaccine research before future epidemics occur.

Public-private partnerships

To untie the knot of unaligned or misaligned incentives, public-private partnerships have been established to offer novel models for the discovery, development and deployment of vaccines to developing markets. The Global Alliance for Vaccines and Immunizations (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI), the Innovative Medicines Initiative (IMI), and the European Vaccine Initiative (EVI) are all examples of global efforts to bridge demand and supply.