Developing Vaccines For A Developing World
Since vaccines arrived onto the world stage, we have been able to eliminate or reduce the effects of diseases like smallpox and polio, saving countless lives in the process and facilitating the acceleration of international development efforts. It is believed that the introduction of vaccines in developing countries will make a considerable contribution to the achievement of the Millennium Development Goals. Nevertheless, significant challenges remain in the design and implementation of vaccines for the developing world with many factors at play such as military conflict, limited healthcare infrastructure and socioeconomic issues. From the perspective of vaccine provision, the main goals are to improve vaccine coverage, efficancy and delivery.
‘Big pharma’ have been
shown to be adept at
helping societies in
need, particularly when
they get credit for it
Currently, in terms of infectious diseases, the three big killers in developing countries are known to be HIV/AIDS, Tuberculosis and Malaria. But if children below five years of age are considered, the picture changes substantially. Of the 20 countries in the world with the highest child mortality under 5 years of age, 19 are in Africa (the exception being Afghanistan). About a third of total child mortalities in Africa are due to neonatal causes (26%) with another third due to diarrheal diseases and pneumonia (together accounting for 37%). The remaining third is mostly represented by Malaria (18%) followed by all other causes, such as HIV/AIDS (6%) and Measles (5%). This area is where vaccines can have a major impact.
Despite being among the most cost-effective public health interventions, vaccines are not achieving their full potential. In developing countries, children are more likely to die from vaccine-preventable diseases than in developed countries. There are 25 million children in the world who need vaccinating against life-threatening diseases, but factors like poverty, conflict, corruption and inadequate infrastructure prevent this from happening.
Vaccines might be divided into three classes: vaccines yet to be developed (HIV/AIDS, malaria, TB and others), under-utilized (human papillomavirus, cholera, typhoid, haemophilus influenza, rubella, japanese encephalitis, Influenza, yellow fever and others) and implemented vaccines (rotavirus, pneumococcal, measles, polio, tetanus, pertussis, diphtheria and others).
A huge amount of funding has been fed into finding vaccines for the first group. A malaria vaccine is currently undergoing clinical trials yet it is unknown when, and indeed if, it will be broadly available. Promising data exists also for HIV and TB vaccines, although they are far from the production line. However, much success has been seen from campaigns to develop and distribute vaccines for the latter group.
Quite Simply, It Works
One example is the Rotavirus vaccine introduced by the Global Alliance for Vaccines and Immunisation (GAVI), a non-profit organisation that supplies the poorest countries of the world with vaccines. Rotavirus is one of the most common causes of diarrheal disease and accounts for 500,000 paediatric deaths each year worldwide. GAVI support for the rotavirus vaccine became available in 2007. In January 2009, four countries - Bolivia, Guyana, Honduras, Nicaragua - were approved for GAVI funding, which led to a surge in vaccinations against the virus in those countries. This was soon followed by a fall in the number of mortalities caused by the virus.
Polio is another disease often referred to in the context of successful vaccination programmes. The disease is now endemic at an all-time low in four countries - Nigeria, India, Pakistan and Afghanistan - and we are now in the so-called ‘final mile’ for eradicating this disease globally, a target achieved before only by the eradication of smallpox. This is the result of the efforts of organizations such as the Rotary Foundation and the Bill and Melinda Gates foundation.
This mass immunisation campaign required a considerable amount of investment and aid, including the participation of over 20 million volunteers. Nevertheless, efforts are often hindered by prevailing political climates. One such instance of this is the Democratic Republic of Congo (DRC). In late 2010, the UN called for a ceasefire in DRC in response to a sudden rise in polio cases so that vaccinations could be carried out without the further risk of loss of lives. This is just one of many complications faced by vaccine programmes when operating in troubled regions.
As with any development programme operating in low-income countries, finance is a central issue. The main actors in financing vaccine development and distribution are global health partnerships between the private and public sectors, known as ‘Public-Private Partnerships’ (PPPs). PPPs represent the best hope for long-term solutions concerning public health in developing countries.
One such PPP is between the Bill and Melinda Gates Foundation and GAVI. The Gates foundation announced at the 2010 World economic forum a funding of $10 billion over the next 10 years – after investing $4.5 billion over the last ten years – and announced that vaccines will be their number one priority. The Foundation is a founding partner of the GAVI Alliance that, in partnership with several governments, has immunised 250 million children over the last 10 years, preventing 5 million deaths. Furthermore, The Global Fund donors have committed another $11.7 billion over the next three years. Global Fund has already provided antiretroviral treatment to 2.8 million people and TB treatment to 7 million just to name a few achievements. Other main contributors are the United Nations Foundation, the World Bank, the European Commission, humanitarian and nongovernmental organizations and corporate partners. Some donor governments, as part of the MDGs, committed to reaching the long-standing target of 0.7% of gross national income by 2015 (the European Union has recently reaffirmed its commitment to the 0.7% aid targets).
In the private sector, pharmaceutical companies are increasingly involved in aid for neglected diseases prompted by pressure to demonstrate corporate responsibility and the need to expand into developing markets. There are now many examples of support given by companies in the field of neglected diseases in terms of drug donation (with collaboration such as the Schistosomiasis Control Initiative at Imperial College), bed nets for Malaria, and vaccines.
‘Big pharma’ have been shown to be adept at helping societies in need, particularly when they get credit for it. On this basis, the Access to Medicine index was created with the aim of improving transparency and ranking the world’s largest pharmaceutical companies on their efforts to increase access to medicine for societies in need. Companies are assessed on the clarity and comprehensiveness of their access to medicine management systems, policies, research, pricing, distribution, donation and philanthropy. The ranking is based on 106 indicators that measure activities across four strategic and seven technical areas and results are published for the general public and for stakeholders. GSK, Merck and Novartis are at the top the list, with other large multinationals following closely behind. The goal is to improve transparency of existing efforts and stimulate future involvement by promoting sustainable support for the provision of access to medicine for developing countries.
Academic institutions also play a key role in this process, in particular in policy development, regulatory and ethics for global health. As Professor Lord Ara Darzi, Chairman of the Institute of Global Health Innovation at Imperial College, recently underlined, major advances in technologies and medicines need implementation strategies and policies to make an impact.
One recent example of that is the cholera outbreak in the post-earthquake Haiti. The risk of an epidemic was known but there was no capacity for an immunisation campaign. Although countries such as Russia offered the vaccine to Haiti, there was no ability to distribute it. In the end, most deaths were due to lack of capacity to provide simple but prompt rehydration therapies to infected children.
Two keys to success in the implementation of effective vaccine programmes in developing countries have been identified. First is through international collaboration and partnership with companies who have expertise in vaccine manufacturing. Second is national capacity building in the country of interest. This includes local involvement of the community, development of regulatory and ethical frameworks, scientific infrastructure, clinical trials and laboratory expertise. An increasing number of examples support the feasibility of such approaches.
In 2009, Rwanda, with contributions from GAVI and UNICEF, became the first low income country in the world to integrate the pneumococcal vaccine into routine immunisation programmes. Vaccination levels have reached over 90% – a value fully comparable to developed countries – and the country is on track to reach the MDG on reducing child mortality.
‘Anyone Who Hears About Vaccines’ Success History, They Want to Get Involved’
In conclusion, medical practice has shown that vaccines work and are cost effective. While ten years ago immunization rates were decreasing, now we are again seeing a rise in immunisation and vaccine coverage. For basic vaccinations such as the DTP3 (third dose of diphtheria, tetanus, pertussis) in the poorest countries the rate of immunisation has reached 79% – the highest on record in history.
With ongoing global co-operation and sustained effort, rates of vaccine-preventable infectious diseases in developing countries have the potential to change dramatically in the near future. To quote Bill Gates: ‘Anyone who hears about vaccines’ success history, they want to get involved’.
Dr Francesco Berlanda Scorza is currently completing a Marie Curie Fellowship at the Centre of Molecular Microbiology and Infection at Imperial College London. Before coming to Imperial, he worked at the Novartis Vaccine Institute for Global Health in Siena, Italy.