GAVI has offered support to the world's poorest countries to introduce rotavirus vaccines at nearly the same time as industrialised countries
New vaccine reaches poor countries with almost no delay
GAVI’s new and underused vaccine support programme (NVS) has offered financial support to help poor countries in the Americas and Europe introduce rotavirus vaccines into their routine infant immunisation programmes since 2006 -- the same year the United States and other industrialised countries introduced rotavirus vaccines into their national immunisation programmes.
GAVI’s NVS expanded its financial support worldwide in 2009, following WHO’s recommendation for universal rotavirus vaccination – allowing for introduction in low-income countries in Asia and Africa, where most rotavirus deaths occur.
Rotavirus vaccines have been introduced in the following GAVI-eligible countries: Nicaragua (2006), Bolivia (2008), Honduras (2009), Guyana (2010), Sudan (2011), Armenia (2012), Ghana (2012), Rwanda (2012), Malawi (2012), Moldova (2012), Tanzania (2012) and Yemen (2012).
GAVI has approved 22 additional countries for rotavirus vaccine support 20 of them in Africa, where more than 50%1 of all rotavirus deaths occur. By 2015, GAVI and its partners plan to support at least 40 of the world’s poorest countries in introducing rotavirus vaccines—immunising 50 million more children. Accelerating access to rotavirus vaccines in countries where they are needed most is one of the cornerstone objectives of GAVI's NVS programme.
Rotavirus vaccines available
There are two orally-administered rotavirus vaccines available today: Rotarix®, manufactured by GlaxoSmithKline and RotaTeq®, manufactured by Merck & Co., Inc.
RotaTeq® is given in three doses, and Rotarix® is given in two doses. Both vaccines have been shown to be safe and effective in clinical trials in Latin America, Africa, Asia, the United States and Europe.
In addition, countries that have introduced rotavirus vaccines have seen dramatic reductions in hospitalisations due to severe rotavirus diarrhoea. In just two to three years after their introduction in the United States, El Salvador, Belgium, and Australia, hospitalisations and clinic visits for rotavirus-related diarrhoea in children five years of age and younger have declined by a striking 60% to 94%2.
Because there are many causes of severe diarrhoeal disease, WHO’s Strategic Advisory Group of Experts (SAGE), has emphasised the importance of providing rotavirus vaccination in the context of a comprehensive diarrhoeal disease control strategy, including improvement of water quality, hygiene, and sanitation; provision of oral rehydration solution and zinc supplements; and overall improved case management.
Map of countries approved for GAVI's rotavirus vaccine support
GAVI's Accelerated Vaccine Introduction initiative and the Rotavirus Vaccine Program
In addition to providing financial support to poor countries for rotavirus vaccine introduction, GAVI provided financial support for the Rotavirus Vaccine Program (RVP), a partnership between PATH, WHO and the U.S. Centers for Disease Control and Prevention (CDC), to help speed up the time for introduction of rotavirus vaccines in low-income countries, which typically wait 10-15 years for new vaccines.
RVP established rotavirus surveillance in all regions of the world to provide data on rotavirus disease burden, to study the potential impact of rotavirus vaccines, and to demonstrate the cost-effectiveness of rotavirus vaccines. RVP also developed an investment case and strategic demand forecast that served as the basis for GAVI’s decision in 2006 to fund rotavirus vaccine introduction through its NVS programme.
In conjunction with Merck and GSK, RVP conducted pivotal clinical trials to demonstrate the safety and efficacy of rotavirus vaccines around the world. This clinical research laid the groundwork for the 2009 WHO recommendation for universal introduction. In addition, RVP supported studies that demonstrated significant reductions in the number of hospitalisations due to severe rotavirus disease following vaccine introduction (see 'The Issue').
Since January 2009, RVP’s work has transitioned to GAVI’s Accelerated Vaccine Introduction initiative (AVI) initiative, which aims to speed up and broaden access to rotavirus and pneumococcal vaccines and to create a platform for introducing other new vaccines.
Proof of concept
WHO's 2009 rotavirus vaccine recommendation was based on two clinical studies carried out in high mortality, impoverished settings in Asia and Africa:
- Clinical study in Asia (Bangladesh and Vietnam): during the first year of life, when children are at greatest risk for diarrhoea-related morbidity and mortality, the rotavirus vaccine significantly reduced severe rotavirus disease by 51 percent3.
- Clinical study in sub-Saharan Africa (Ghana, Kenya and Mali): rotavirus vaccination prevented 64% of severe rotavirus disease in African infants during the first year of life, when children are most vulnerable to rotavirus diarrhoea-related illness and death4.
- Clinical study in South Africa and Malawi: rotavirus vaccine significantly reduced severe rotavirus disease—by 61%—in African infants during the first year of life, when most of the severe disease and deaths from rotavirus occur5.
1Source: The Lancet Infectious Diseases, Volume 12, Issue2, Page136-141, February 2012.
2Source: Patel MM, Steele D, Gentsch JR, et al. Real-world impact of rotavirus vaccination. Pediatric Infectious Disease Journal. 2011;30 (Supplement 1):S1–S5.
3Source: Zaman K, Dang DA, Victor J, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. The Lancet. 2010;376(9741):615-623.
4Source: Armah GE, Sow SO, Breiman RF, et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. The Lancet. 2010;376(9741):606–614.
5Source: Madhi SA, Cunliffe NA, Steele D, et al. Effect of human rotavirus vaccine on severe diarrhoea in African infants. New England Journal of Medicine. 2010;362(4):289–298.