The terrible outbreak of Ebola in West Africa has shown the challenges of containing such a virulent infectious disease. The effort to defeat Ebola is focused on infection prevention and control by establishing cordon sanitaires and supplying medical staff with personal protective equipment, including gloves, gowns and masks. Rigorous infection control remains the best defence when these outbreaks occur, but vaccines to prevent and medicines to treat the infection could make a vital contribution to defeating this disease.
Faced with the current sudden outbreak of Ebola, the World Health Organization (WHO) consulted experts and researchers engaged in Ebola therapies and vaccines research and development (R&D) earlier this month. They decided to expedite the development of two of the most advanced vaccines identified so far, one which GlaxoSmithKline (GSK) is co-developing with the Vaccine Research Center of the US National Institutes of Health, and the other being developed by Crucell, one of the Janssen Pharmaceutical Companies of Johnson and Johnson, supported by the US National Institutes of Health.
The research-based industry has a long-standing and continuing commitment to fighting infectious diseases. Unfortunately, the standard economic model for drug development, in which industry takes all of the risk in R&D and gets a return on investment from successful products, does not work for diseases that primarily impact low income countries and developing healthcare systems. Therefore, in order to tackle these diseases and progress research, pharmaceutical companies have established cross-sector research partnerships, open access through cross-licensing of products and technologies, and philanthropic funding of laboratories.
Collaborations with academia and government now account for the majority of research efforts; 86% of R&D projects involving industry are partnerships1. For example, Sanofi partnered with non-profit drug developer Drugs for Neglected Diseases Initiative which has treatments in development for sleeping sickness, leishmaniasis, Chagas disease, filariasis, malaria and paediatric HIV. GSK works with Medicines for Malaria Venture and the Global Alliance for TB Drug Development. Many companies have partnered with theBill & Melinda Gates Foundation which has supported research and interventions in infectious diseases to the tune of $1.02 billion. Such partnerships have created a sustainable platform for R&D and bring public and private resources and expertise together to tackle global public health challenges.
Dedicated facilities within companies allow scientists to focus on priority diseases and to tap into companies’ other research efforts and data. Examples include the Novartis Institute for Tropical Diseases, Novartis Vaccines Institute for Global Health, and GSK’s Tres Cantos Diseases of the Developing World Medicines Development Campus.
These investments have already yielded significant results that have saved thousands of lives around the world. GSK and Pfizer work with the GAVI Alliance to provide patients in developing countries with access to their pneumococcal vaccines. Janssen has developed a new antibiotic to treat multi-drug resistant TB. Since 2001, Novartis has provided more than 400 million treatments for malaria, saving an estimated one million lives. Now there is a new hope in the fight against malaria after GSK worked with the non-profit Path Malaria Vaccine Initiative to develop a vaccine against malaria. Sanofi hope to get approval for a dengue fever vaccine next year.
The outbreak of Ebola has rightly put a spotlight on the research efforts underway and needed to win the fight against global health threats and also on the way by which novel treatments can be fast-tracked when the world faces a public health emergency.
The experimental Ebola vaccine proved to be effective in monkeys and is now being tested in a small phase one clinical trial in the US. With support from an international consortium involving the Wellcome Trust, the Medical Research Council and the UK Government, further phase one trials are starting in the UK and Africa. These will test whether a good immune response to Ebola can be generated and to study the safety of the vaccine. If the results, which are expected by the end of the year, are successful, stocks could immediately be made available to the WHO to allow emergency use in high-risk populations such as healthcare workers.
The industry must work with regulators and the WHO to ensure that promising vaccines and medicines can be fast-tracked through approval processes. This requires judgement on the level of uncertainty that is acceptable given the need to respond urgently to a killer threat. This means that treatments which might usually take years of development to ensure the highest standards of safety and efficacy can be accelerated to patients in a public health emergency. While this is an appropriate urgent response, the quiet, meticulous and arduous research being carried out by scientists in academia, research institutes and industry should not be forgotten. Indeed, the greatest hope of ensuring that the disease threats of tomorrow can be prevented, contained and beaten comes from the public private partnerships being forged across the world.
ABPI Policy Manager