Rotavirus infections, the most common cause of severe childhood diarrhoea, result in approximately 527 000 child deaths every year. The majority of these deaths occur in low-income countries, particularly in Africa and Asia. (1)
Rotavirus-associated diarrhoea can be prevented by new live attenuated human rotavirus vaccines. These vaccines have proved safe and efficacious in large-scale clinical trials and post-licensure studies have confirmed their effectiveness in middle- and high-income countries. (2,3)
However, they have only been partially implemented in national immunization programmes in low-income countries, even though these countries have higher rates of death from rotavirus infection. (4)
The pharmaceutical companies behind the two internationally licensed rotavirus vaccines, Rotarix. (7) (GlaxoSmithKline Biologicals, Rixensart, Belgium) and RotaTeq * (Merck & Co. Inc., Whitehouse Station, United States of America), have recently pledged to the United Nations Children's Fund and the international donor community to provide their vaccines to low-income countries at greatly reduced prices. (4,5) In spite of these reductions, rotavirus vaccines continue to be more expensive than most traditional childhood vaccines included in the Expanded Programme on Immunization (EPI). This rekindles the traditional debate surrounding access to new childhood vaccines in low-income countries.
In this paper, we examine whether the newly-proposed vaccine prices are low enough to make rotavirus vaccines universally accessible to the millions of children in need of protection against rotavirus infection, a major threat to child health. Furthermore, we discuss the steps that need to be taken in the future to facilitate the introduction of rotavirus vaccines and ensure their sustained financing in low-income countries.
Rotavirus vaccine introduction
At least 43% of the 527 000 child deaths and 51% of the 27 million annual medical visits that take place in low-and middle-income countries on account of rotavirus-associated diarrhoea could be prevented if universal rotavirus vaccination were achieved. The savings in treatment and societal costs would be enormous. (6) As a result, the World Health Organization (WHO) has recommended including the rotavirus vaccine in national immunization programmes worldwide. So far, however, rotavirus vaccines are only being routinely used in 14 countries in Latin America and one African country. Notably, only four of the world's 56 poorest countries are routinely using the vaccine. (4) Several factors account for this delay in implementing vaccination against rotavirus in low-income countries. Clinical trials are seldom conducted in these settings, and few data are available on the disease burden and treatment costs that could be averted by vaccination. Furthermore, rotavirus vaccines must compete for scarce resources with other new childhood vaccines, such as the pneumococcal conjugate vaccine and the meningococcal A conjugate vaccine. The high cost of these vaccines is another major barrier to their introduction. (1) In general, new vaccines are becoming more expensive and immunization expenditures have risen over the past decades. In 2000, the annual expenditure on vaccination in low-income countries averaged 6.00 United States dollars (US$) per live birth, but by 2015, it will exceed US$ 30.00 per live birth. (1) Consequently, the governments of low-income countries wishing to sustain existing immunization programmes and to add to them newly developed vaccines face a serious financial challenge.
New requirements for the development, production and licensure of new vaccine candidates have caused a marked rise in manufacturers' investment costs. (1) To pay off these investments in research and development and generate profits while the manufacturer monopolizes the market, new vaccines are generally marketed at higher prices than the traditional childhood vaccines included in the EPI. …