Some companies engaging in R&D for emerging infectious diseases, but pipeline mainly empty

• Only 5 of the 20 companies analysed by the Index are currently engaging in R&D for emerging infectious diseases other than COVID-19.

• Approvals of Johnson & Johnson’s Ebola vaccine and Bayer’s vector control product for mosquito-borne diseases are significant, but more companies need to invest in preventing future outbreaks.

The COVID-19 pandemic has underlined the urgent need for pharmaceutical companies to address other emerging infectious diseases (EIDs) via R&D. It is not a question of whether EIDs pose a significant global health risk – it’s a case of being prepared for when the next crisis hits. Yet, the 2022 Index shows that only five companies of the companies in scope are targeting EIDs other than COVID-19, and for the majority of EIDs identified as a priority, there are no projects in the pipelines of the world’s largest R&D-based pharmaceutical companies.

The rising global threat of emerging infectious diseases

Many people living in low- and middle-income countries (LMICs) already face the threats posed by EIDs. Recent outbreaks of Ebola, Marburg virus and Lassa Fever illustrate the urgent need for vaccines and treatments. Without access to products that target infectious diseases, many of the world’s most vulnerable people will continue to suffer. In addition, there are several factors that are already increasing the risks these diseases pose globally, including climate change, urbanisation, globalisation and migration.

Defining R&D priorities for emerging infectious diseases

The number of pathogens that pose a potential global health risk is vast, globally. The World Health Organization (WHO) lists priority diseases and pathogens based on their epidemic potential and/or whether there are no or insufficient countermeasures. This list aims to ensure R&D efforts against EIDs are focused and productive.

Global warming means that more places are reaching suitable temperatures for transmission of climate-sensitive diseases. The devastation left in the wake of unprecedented natural disasters also provides the perfect environment for infectious diseases to thrive. As more people migrate, moving to cities and across borders, these diseases will not remain confined to specific countries. The COVID-19 pandemic proved beyond doubt that pathogens can and will travel indiscriminately.

Some companies show the way, but more to be done

In spite of the COVID-19 pandemic, the 2022 Index shows little change in companies’ R&D efforts against emerging infectious diseases. Companies still have very few R&D projects targeting the EIDs considered to be the highest priorities for R&D; excluding projects targeting coronaviruses, the total number of EID projects is 12, compared to 13 and 15 in the previous two Indexes. Such an empty pipeline for so many dangerous diseases puts the world at risk of future epidemics and pandemics.

Bayer, Johnson & Johnson, Merck, MSD and Takeda are the companies in scope that engage in R&D efforts for EIDs other than COVID-19. However, these companies target a small number of priority pathogens, which means most diseases and pathogens capable of triggering the next pandemic or epidemic are going unaddressed. While there are companies outside the scope of the Index that are engaged in R&D projects targeting some of these diseases, the 20 companies assessed by the Index are some of the world’s largest and most well-resourced pharmaceutical companies, and greater investment from more of these companies could move the dial on tackling EIDs.

Successes in R&D

Despite this stark picture, the few companies that are currently engaging in R&D for other EIDs have had some significant successes. For example, Zabdeno® & Mvabea®, Johnson & Johnson’s two-shot Ebola vaccine regimen, was approved by the European Medicines Agency (EMA) in 2020. In April 2021, WHO granted prequalification status to the regimen.* This could accelerate registration in countries with high disease burdens, where an outbreak is likely to occur.

Bayer’s Fludora® Co-Max is a vector control product used to control adult mosquitos (Aedes spp. and Culex spp.). With its dual mode of action, it has the potential to prevent mosquito-borne diseases such as Zika and Chikungunya. The product has now received WHO prequalification, and Bayer also provided evidence that it plans to register the product in several countries in scope of the Index. In addition, after the period of analysis for the 2022 Index had ended, MSD announced that is working with the International AIDS Vaccine Initiative (IAVI) toward a formal agreement to produce and donate investigational vaccine doses for IAVI’s vaccine development programme targeting the Sudan ebolavirus.

What can be learned from R&D efforts against COVID-19?

Successive editions of the Index show that prior to the COVID-19 pandemic, pharmaceutical companies were largely not engaging in R&D for EIDs. This included coronaviruses, a group of viruses that had already been identified as having pandemic potential, but for which there were no R&D projects in the 2018 Index. Yet, by the end of May 2020, the number of R&D projects targeting the virus had already skyrocketed to 63, as shown in the 2021 Index.

This R&D effort led to results. During the period of analysis for the 2022 Index, between the 20 companies in scope, four preventative vaccines and ten medicines for COVID 19 were registered and approved.¹ The circumstances surrounding COVID-19 were unique, in that governments and international funds invested huge sums of money into private companies’ R&D and into contracts to buy COVID-19 vaccines and treatments. However, the number of COVID-19 products launched during the pandemic, and the speed with which they were launched, does indicate that companies have the capabilities to rapidly respond to urgent R&D needs and dedicate expertise and resources to finding solutions. Even without the same level of financial incentives seen during COVID-19, companies can now choose to invest – potentially with a public or private co-investor – in R&D for other EIDs that pose a grave danger both to people living in LMICs, and also to people worldwide.

What next?

The rapid development and authorisation of medicines and vaccines for COVID-19 indicates that the pharmaceutical industry is willing and able to respond quickly to public health emergencies. Through the 2022 IFPMA Berlin Declaration, pharmaceutical companies pledged to draw on lessons learned from the COVID-19 pandemic to ensure equitable access to vaccines and medicines in future pandemics. This includes manufacturing, sustainable supply and accelerating R&D to develop new health products. To fulfil this commitment, companies can make use of insights on how to accelerate R&D in order to create medicines, vaccines, diagnostics, and platform technologies to prevent future outbreaks of diseases that have been identified as posing a global health risk.

Companies that are serious about targeting EIDs must not only invest resources into R&D pre-emptively, but they need to engage in access planning in tandem with developing products. This will ensure that essential vaccines and products will reach those who need them – preventing unnecessary loss of life as well as curbing the spread of disease.

1 This includes projects that were granted emergency use authorisation or conditional marketing authorisation because of the urgent nature of the COVID-19 pandemic. Some have since received full regulatory approval.

*As four projects target Zika, dengue and/or Chikungunya, these have been included in several categories in the table.

** ‘Disease X’, added to this list in 2018, represents the knowledge that a serious epidemic or pandemic could be caused by a pathogen currently unknown to cause human disease. COVID-19 can be seen as a first example of Disease X.