Impact of BRICS’ investment in vaccine development on the global vaccine market
Miloud Kaddar a, Julie Milstien b & Sarah Schmitt c
a. 48 Rue de Genève, 01210 Ferney Voltaire, France.
b. Montpellier, France.
c. Prangins, Switzerland.
Correspondence to Miloud Kaddar (email: email@example.com).
(Submitted: 13 December 2013 – Revised version received: 31 March 2014 – Accepted: 31 March 2014.)
Bulletin of the World Health Organization 2014;92:436-446. doi: http://dx.doi.org/10.2471/BLT.13.133298
Through their vaccine manufacturers, Brazil, the Russian Federation, India, China and South Africa have a substantial and increasing role in the global vaccine market. Together, these countries known as BRICS are increasing the production capacity for vaccines with a high global demand and vaccines that are required specifically in the developing world. BRICS are also generally replacing multinational corporations as sources of traditional vaccines – i.e. the five vaccines originally included in the World Health Organization’s (WHO) Expanded Programme on Immunization1 – and enhancing competition and lowering prices in the United Nations’ and national vaccine markets.
In this paper, we analyse the growth of vaccine production, vaccine regulation and development in BRICS over the past 20 years. We evaluate the impact of that growth on the global vaccine market, by comparing vaccine production in each of the five countries in 1993 and 2013, analysing the relevant technology sources and collaborations, following the evolution of national regulatory authorities, and determining temporal trends in the numbers of vaccines prequalified by the WHO that were produced. We also identify some of the current limitations of BRICS’ vaccine-related strategies and explore ways in which the international community might help reduce those limitations.
BRICS’ role in the global vaccine market
The vaccines needed for the Expanded Programme on Immunization1 and the subsequent national immunization programmes were initially sourced from both national and international manufacturers. Recombinant hepatitis B and Haemophilus influenzae type b vaccines became available in the 1980s but their production was felt too complex for many vaccine manufacturers. Three major developments subsequently influenced the global vaccine market. One was the introduction, in 2001, of highly profitable products such as the conjugate pneumococcal vaccine, which produced profits measured in billions of United States dollars (US$).2 The second major development was the growth of funding initiatives to introduce new vaccines nearly simultaneously throughout the developing world.3 The third major development was the emphasis placed on quality control and assurance standards for all vaccines used worldwide. This emphasis was mainly the result of the establishment of WHO’s programme of vaccine prequalification in 19874 and that programme’s collaboration with large vaccine procurement agencies such as the Supply Division of the United Nations Children’s Fund (UNICEF) and the Revolving Fund of the Pan American Health Organization (PAHO). Vaccine production has become a research-based global business with high industrial standards for quality and the potential for substantial profits. In the early days of the Expanded Programme on Immunization, the prices of the traditional vaccines used in the developing world were low because multinational corporations could produce the vaccines using existing capacity that the corporations did not need to supply their more usual, higher-priced markets. As new more-profitable vaccines became available, however, most of the multinational corporations stopped producing the older vaccines. Fortunately, the growth of vaccine manufacturing in some of the BRICS countries has helped to keep the prices of traditional vaccines relatively low.
Vaccine manufacturers and markets in emerging economies
Some manufacturers in low- and middle-income countries have been included in WHO’s vaccine prequalification programme since the programme was established. Examples include the Pasteur Institute of Senegal and some manufacturers in the formerly communist states of central and eastern Europe – represented by the Canada-based buying group, Conpharma. By 2007, nearly 50% of the manufacturers of prequalified vaccines were based in emerging economies.5 Around that time, such economies also became key importers of new vaccines.6
Special characteristics of BRICS
In the early 1990s, the Children’s Vaccine Initiative performed assessments in countries that could possibly play an enhanced role in vaccine supply. All five BRICS countries were included in these assessments. Recently, the BRICS group has attracted increasing attention as a market and development force – and not just for vaccines.7
The main functional areas of vaccine development and supply comprise clinical studies and vaccine research, development, regulation and production. Four of the BRICS countries are undertaking all of these activities and the exception – South Africa – is engaged in all but production.
We examined vaccine production in each of the BRICS countries between 1993 and 2013. There are no data available on the general quality of the vaccines produced in 1993 (Table 1), although a measles vaccine produced by the Serum Institute of India was prequalified by WHO. In 1995, yellow fever vaccines produced in Brazil and the Russian Federation came from laboratories that were approved by WHO for the production of such vaccines.8
Table 1. Vaccine production, Brazil, China, India, the Russian Federation and South Africa (BRICS), 1993
Table 2 tracks the development and production of WHO-prequalified vaccines by the BRICS countries between 1986 and 2013. The number of prequalified products from manufacturers in BRICS – and other emerging economies – has increased over the last two decades but appears to have levelled off in recent years.
Table 2. Global production of prequalified vaccines, Brazil, the Russian Federation, India, China and South Africa (BRICS), 1986–2013
Over our study period, vaccines from manufacturers in BRICS represented a major proportion of the purchases made via the UNICEF Supply Division (Table 3) and the PAHO Revolving Fund (Table 4) from manufacturers in low- and middle-income countries – in terms of both volume and value. In 2012, just four Indian manufacturers supplied over 95% of the vaccines bought from manufactures in BRICS by the Revolving Fund – again in terms of both volume and value.
Table 3. Vaccine purchases by the United Nations Children’s Fund’s Supply Division, 2000–2012
Table 4. Vaccine purchases by the Pan American Health Organization’s Revolving Fund, 2005–2012
The share of vaccines purchased via PAHO and UNICEF from vaccine manufacturers in low- and middle-income countries decreased after 2005, probably as the result of the introduction of new vaccines. For PAHO, for example, this share fell from 56.42% of vaccine doses in 2005 to 31.27% in 2010. Although the general trend in the size of this share has been downwards, peaks have occurred when vaccine manufacturers in low- and middle-income countries have supplied vaccines needed for particular mass vaccination campaigns. There is also some evidence to suggest that the share of vaccines purchased via PAHO and UNICEF from vaccine manufacturers in low- and middle-income countries began to increase after 2010.
By 2013, manufacturers in BRICS were producing many types of vaccines (Table 5). Although most of the vaccines might be considered traditional, some were more innovative products, such as a meningococcal type A conjugate vaccine and a genetically engineered Japanese encephalitis vaccine from India and a live attenuated Japanese encephalitis vaccine from China. A novel cholera vaccine manufactured by Shantha Biotechnics in India was created using technology that was developed in Sweden before being transferred – by the International Vaccine Institute – to Viet Nam and then to India. Although not WHO-prequalified, the world’s first hepatitis E vaccine – a recombinant Escherichia coli-based virus-like particle vaccine – was recently launched in China.
Table 5. Vaccines produced in Brazil, the Russian Federation, India, China and South Africa (BRICS), 2013
For each of the BRICS countries, we investigated vaccine products in the pipeline and the partnerships for vaccine innovation that have been set up (Table 6). The capability of each country to master intellectual property provisions that relate to vaccine development has been discussed in earlier publications.19–21
Table 6. Vaccines in the pipeline and vaccine-related partnerships, Brazil, the Russian Federation, India, China and South Africa (BRICS), 2013
There are some important and innovative vaccines in the pipeline in the BRICS countries, such as the conjugate vaccines being developed in India, an influenza vaccine made from virus-like particles being developed in the Russian Federation, a dengue vaccine – based on technology from the United States National Institutes of Health – being developed in Brazil, and pneumococcal conjugate vaccines being developed in both China and India. Chinese manufacturers have developed their own technologies for rotavirus, live Japanese encephalitis, human papillomavirus and hepatitis vaccines.
Over the study period, many partnerships between vaccine manufacturers and multinational corporations in BRICS have been established. In India, agreements with five multinational corporations account for an estimated 22% of pipeline vaccine products.19 Five partnerships to support technology transfer in Brazil in 200619 included agreements for the transfer of knowhow but no licences for patents rights. Conversely, an agreement for the transfer of dengue vaccine technology, from the United States National Institutes of Health to the Instituto Butantan in Brazil, included a licence for patent rights but no explicit authorization for the transfer of knowhow. In October 2013, Brazil’s government-funded Oswaldo Cruz Foundation announced that it was going to develop an affordable measles and rubella vaccine with the support of the Bill & Melinda Gates Foundation. The Brazilian Ministry of Health is allocating funds to support this plan, including US$ 727 million for the construction of a plant at the Bio-Manguinhos site to produce the vaccine.
Two vaccine manufacturers – Bio-Manguinhos in Brazil and Biological E. in India –illustrate the use of partnerships to assess innovative technologies. Bio-Manguinhos is a state-supported institution that has been charged with providing general access to any vaccine that the national health authorities consider to be a priority, as soon as possible. To help achieve this goal, Bio-Manguinhos is using agreements with GlaxoSmithKline, complemented by its own development activities and many collaborative activities with several universities.19 Bio-Manguinhos has already had several technology transfer agreements with GlaxoSmithKline, relating to the development of H. influenzae type b conjugate, rotavirus and pneumococcal conjugate vaccines, as well as straight bulk-filling agreements for oral polio, measles, mumps and rubella and measles, mumps, rubella and varicella vaccines. The partnership agreement for the H. influenzae type b conjugate project specified a reference price, which was the PAHO Revolving Fund’s price minus a discount for the cost of the bulk. In return, Bio-Manguinhos received technical assistance. The agreement also specified maintenance of secrecy and knowhow for 10 years and limited export to the Mercosur countries. In addition, the agreement stipulated that Bio-Manguinhos would be charged a 4–5% running royalty for 5 years from the start of selling its own product.19
Biological E. is a private sector company that strives to develop and introduce standard and innovative vaccines in a manner consistent with their financial viability, using partnerships to access new technologies. One such partnership was set up with a public sector organization – the former Netherlands Vaccine Institute22 – to develop a pentavalent combination vaccine.19 For this vaccine, Biological E. used innovative methods to circumvent the patent-obstructed steps in the standard production process. Biological E. now has a WHO-prequalified pentavalent product that has been brought to market at the lowest price to date and is expected to capture a large share of the global pentavalent market for 2013–2015.23 Biological E. has also licensed technologies – from Intercell – for the development of a Japanese encephalitis virus vaccine, for which it has the rights to market in low- and middle-income countries. In August 2013 this vaccine was prequalified by WHO for use in adults, and Biological E. expects it to be licensed soon for use in children.24
A vaccine manufacturer’s success on the global market depends on the market’s perception of the quality – or likely quality – of that manufacturer’s products.25 Much of that perception relies on an effective system of vaccine regulation. For each of the BRICS countries, we therefore investigated the functionality of the relevant national regulatory authority – as assessed by WHO, the judgements of consumers or other regulatory authorities as to the suitability for procurement of vaccines from the country, and the regulation of clinical trials of vaccines.
National regulatory authorities
The national regulatory authority of each BRICS country has been successfully assessed by WHO and four of the authorities – all but that of South Africa – have been judged as functional in their role as overseers of WHO-prequalified vaccines.26 After WHO first judged its national regulatory authority to be functional in this role, in March 2011, China sought WHO prequalification for many Chinese products. Some of the necessary assessments by WHO are now under way. India’s national regulatory authority most recently received a positive assessment by WHO in December 201227 – after an exceptional review that was triggered by the withdrawal or delisting of several Indian products from WHO’s list of prequalified vaccines.
In a country that has never exported its locally produced vaccines – such as South Africa – WHO will only assess the national regulatory authority if such an assessment is requested. In such cases, it is left to the regulatory authority to publish or not to publish the results.
The national regulatory authorities of four of the BRICS countries – Brazil, China, India and South Africa – were included as founding members of WHO’s Developing Country Vaccine Regulators Network, along with those of Cuba, Indonesia, the Republic of Korea and Thailand. By May 2012, the national regulatory authority of the Islamic Republic of Iran joined the Network.28,29
Other regulatory groups
Brazil, China, the Russian Federation and South Africa are members of the European Pharmacopoeia.30 South Africa’s Medicines Control Council also participates in the Pharmaceutical Inspection Co-operation Scheme.31 Brazil is a member of PAHO’s Pan American Network for Drug Regulatory Harmonization network.32 South Africa is a member of the African Vaccine Regulatory Forum, which participates in the joint clinical review of applications for clinical trials in African countries.33
Oversight of clinical trials
Each of the BRICS countries has a system for the registration of clinical trials carried out within its borders. The latest available data on the number of vaccine trials conducted (Table 7) indicate that most of the recent vaccine trials in BRICS involved new vaccines. This indicates both the dynamism of the national regulatory authorities in BRICS and the high level of innovation involved in vaccine production in most of the countries – particularly in China and India.
Table 7. Registered clinical trials on vaccines, Brazil, the Russian Federation, India, China and South Africa (BRICS), 2013
Impact on vaccine prices
Table 8 and Box 1 document the impact of the BRICS manufacturers – notably Indian manufacturers – on the global vaccine market.
Table 8. Prices of pentavalent vaccines paid by the Global Alliance for Vaccine and Immunization, 2001–2014
Box 1. The impact of suppliers in Brazil, the Russian Federation, India , China and South Africa (BRICS) on vaccine prices
Prices of pentavalent vaccines
Table 8 documents the changes seen in the price of pentavalent vaccine since 2001. The Global Alliance for Vaccines and Immunization (GAVI Alliance) believes that growth in predictable demand has created a sustainable market for this vaccine – a market that is required to attract manufacturers and create the competition needed to lower prices. Such competition has, however, taken several years to develop. Between 2001 and 2005, the only supplier was GlaxoSmithKline and the supply was quite limited. Because Crucell supplied a more desirable liquid product in 2006–2007, there was no decrease in the mean price per dose paid by the GAVI Alliance. In 2008, two new suppliers entered the market – Panacea and Shantha, both from India – and the price began to drop. The Serum Institute of India joined the market in 2010 and in 2011, introduced 10-dose vials of the liquid vaccine that were then competitively priced. In 2012, however, the pentavalent vaccine of another Indian manufacturer – Biological E. – was prequalified and soon offered at a 30% lower price per dose.40 This price decrease was leveraged by suppliers from a single BRICS country – India – that had high-volume capacity and the ability to profit from sales at a relatively low price point.1
Prices of other vaccines
The pentavalent vaccine story is not unique. As documented in a Médecins Sans Frontières publication, The Right Shot,41 tetravalent meningococcal – A, C, W-135 and Y – conjugate vaccines were developed in 2005 and 2010. In 2011, one of these vaccines was being sold to the public sector in the United States of America at a price of 82.12 United States dollars (US$) per dose. In contrast, the meningitis A conjugate developed by the Serum Institute of India and the Meningitis Vaccine Project was prequalified in 2010 and priced at about US$ 0.50 per dose. This and other developments by BRICS suppliers helped drive or keep down the prices of meningitis vaccines – as revealed by the prices paid for meningitis polysaccharide vaccines by the United Nations Children’s Fund between 2001 and 2013. The long-term supplier, Sanofi-Pasteur, initially supplied meningitis AC polysaccharide vaccine to the Fund at US$ 0.25 per dose. By 2013, Sanofi-Pasteur’s price for the same presentation had risen to US$ 1.22 per dose. Between 2004 and 2012, the Brazilian supplier Bio-Manguinhos was selling the same vaccine type for about US$ 0.85 per dose. There are other examples of BRICS suppliers being able to undercut prices charged by multinational corporations. For example, Valneva produces Ixiaro, an inactivated Japanese encephalitis vaccine made in cell culture. The per-dose price of this vaccine in the United States is currently about US$ 195.42 The corresponding Biological E. product, which is made using the same technology but manufactured in India, costs less than US$ 16 per dose.43 A live attenuated vaccine based on the same strain of virus has been developed in China and has been offered to low- and middle-income countries at a price similar to measles vaccine44 – i.e. only about US$ 0.50 per dose.45
BRICS: Brazil, the Russian Federation, India, China and South Africa.
Currently, of the vaccine manufacturers in BRICS, the Indian ones are the most globally active. The Brazilian manufacturers are also quite active but those in the Russian Federation are currently more focused on upgrading facilities – to improve production capacity and compliance with international standards – than on vaccine exports. The potential impact of Chinese manufacturers, who are now entering the global market, is immense but has yet to be realized. In South Africa, vaccine manufacturing has been slow to develop and may have greater potential regionally than globally.
The focus of vaccine manufacturers in BRICS has been on the domestic market, the United Nations’ market or both. These manufacturers are yet to make a substantial impact on several broader and potentially more profitable vaccine markets – such as those involving new vaccines and the vaccine demands and needs of wealthier countries and the private sector within their own countries and of many middle- and high-income countries. Full exploitation of such markets is likely to push the manufacturers in BRICS into harder competition with each other for supply agreements. For each such manufacturer, the risk of loss of a substantial market share to a new supplier and the frequent lack of a large portfolio of vaccines and other products – that would allow the flexibility of easy diversification – may be major challenges to the sustainability of turnover and profit.
Given the relatively low returns from their vaccines – in absolute values – and the limited markets in which they are currently active, the vaccine manufacturers in BRICS must invest a greater percentage of turnover to research and development than the multinational corporations that also produce vaccines.
With increasing links through technology transfer, outsourcing and restricted supply arrangements, the more innovative vaccine manufacturers in BRICS are becoming ever more attractive targets for mergers and acquisitions by multinational manufacturers. They are therefore at increasing risk of a loss of autonomy and national and regional focus.
Most of the BRICS countries are having substantial impacts on the global vaccine market, albeit to varying degrees. The production of important traditional vaccines within BRICS is contributing to the achievement of Millennium Development Goal 4. Such production is a key component in increasing access to affordable vaccines of good quality, as it allows large-scale supplies to domestic and United Nations’ markets. Through collaborations with universities, donors, international partners and multinational corporations, vaccine manufacturers in BRICS have not only provided increased production capacity for important underutilized vaccines but also developed novel vaccines for specific use in low- and middle-income countries. These manufacturers rely heavily on public sector arrangements and supply agreements with United Nations’ agencies. Such reliance could stop manufacturers in BRICS from reaching their full economic potential and full sustainable impact.
The same manufacturers face several other weaknesses and challenges. These include low levels of financial and technical investment in vaccine research, the need to innovate, a dependence on limited markets, and low levels of diversity in product portfolios. Among manufacturers in BRICS, the emphasis is generally more on competition – for the same limited markets and product segments – than on cooperation. The five countries represented by the BRICS acronym are far from being a coherent group. There is a real risk of the absorption and acquisition of vaccine production facilities by multinational firms and the subsequent loss of autonomy.
In general, vaccines from the BRICS countries are currently competitively priced because the manufacturing costs in BRICS are relatively low. The prices of such vaccines may have to rise, however, to allow greater investment in vaccine research and development and the use of new processes and updated facilities to produce more complex vaccines. The prices may also have to rise as the mean income per capita in the emerging economies and, therefore, the living standards expected by the workforce increase.
It is expected that China will soon emerge as a major player in the global vaccine market and that there will be increasing differentiation between the national vaccine manufacturers that have sufficient capacity to compete with the multinational corporations and the ones who lack the capacity. Vaccine manufacturers in BRICS could either enter into fierce competition with the multinational corporations, for an adequate share of the global vaccine market, or focus on a niche market, such as the vaccines that have more local importance.
The international public sector could help strengthen vaccine production in BRICS, perhaps by exploiting the Global Vaccine Action Plan’s Decade of Vaccines Strategy. Under certain conditions, the United Nations’ procurement agencies could perhaps provide targeted support to vaccine manufacturers in BRICS, so as meet global needs for specific vaccines. Support from donors like the Bill & Melinda Gates Foundation could be focused on more upstream areas, such as research and development, technology platforms and intellectual property rights. More cooperation between academia, biotechnology firms and public health institutions should also be encouraged.
The authors would like to acknowledge and thank all the peer reviewers for their valuable feedback and suggestions. Thanks also to Michael Hinsch for his assistance in the data mapping.
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