Rotavirus vaccine support

Meeting country demand

Demand for rotavirus vaccines by many GAVI-eligible countries is high.

GAVI and its partners plan to support the vaccination of more than 50 million children in at least 40 of the world’s poorest countries by 2015.

Diarrhoea is one of the leading child killers in the world - an estimated 751,000 children die from diarrhoeal diseases each year, accounting for 12% of under five deaths in GAVI-eligible countries. Rotavirus is the leading cause of severe childhood diarrhoea in both developed and developing countries and results in more than 450,000 deaths each year.

Vaccination against rotavirus will make a significant impact on global efforts to achieve Millennium Development Goal 4 (MDG 4) – reduce child deaths by two-thirds by 2015.

MDG 4 specifically addresses the need to revitalise efforts against diarrhoea. 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.

Immunisation against rotavirus provides an excellent opportunity to promote a comprehensive prevention and treatment approach to control all causes of diarrhoeal disease.

First countries

With the rotavirus vaccine initially accepted for use in 14 countries in the Americas and Europe only, Nicaragua, Bolivia, Guyana and Honduras became the first countries to benefit from GAVI rotavirus funding.

The opportunity to avert many more future deaths was presented in 2009 after WHO's Strategic Advisory Group of Experts (SAGE) recommended that rotavirus vaccine be included in all national immunisation. This enabled GAVI to widen its potential rotavirus support to Africa and Asia.

Since 2011, Sudan, Ghana, Rwanda, Moldova, Yemen, Malawi, Armenia and Tanzania have introduced rotavirus vaccines into their national immunisation programmes. 22 other countries are expected to introduce rotavirus vaccines in the next two years.

More on this topic

From the GAVI site

Bolivia's successful rotavirus vaccine initiative

 

Milestone in preventing child deaths from diarrhoea in Africa

 

From other sites

• Rotavirus Vaccine Program

• WHO | Immunization surveillance, assessment and monitoring

• WHO | Immunization, Vaccine and Biologicals

• WHO | Initiative for Vaccine Research: Diarrhoeal Diseases

• WHO | New and Under-utilized Vaccines Implementation

• WHO | Vaccine safety

Leading cause of severe and fatal diarrhoea in children

Rotavirus is the leading cause of severe and fatal diarrhoea in children under five years of age. WHO estimates that more than 450,000 children under five die from rotavirus infection -- nearly 1,200 each day. Worldwide, 37% of hospitalisations for diarrhoea in under fives are due to rotavirus.

Nearly every child in the world will suffer a rotavirus infection by their third birthday. While rotavirus infects children in every country, more than 95%¹ of rotavirus deaths occur in low-income countries in Africa and Asia, where access to treatment for severe rotavirus-related diarrhoea is limited or unavailable.

Children six months to 24-months are most vulnerable to infection, and they can pass rotavirus to family members and other people with whom they have close contact. In addition to severe watery diarrhoea, symptoms include vomiting, fever, and abdominal pain. In serious cases, children urgently need intravenous fluids, or they risk dying from dehydration.

Improvements in water quality and sanitation, which help prevent other types of diarrhoea caused by bacteria and parasites, do not adequately prevent the transmission of rotavirus. The virus is so contagious and resilient that improving hygiene also has little impact on incidence or mortality.

Map of the global burden of rotavirus diarrhoeal disease

Rotavirus vaccines save lives and costs

Vaccination is the best way to prevent severe rotavirus infection – it cannot be cured with drugs such as antibiotics. WHO recommends that rotavirus vaccines be included in all national immunisation programmes.

More than 2.4 million child deaths can be prevented by 2030 by accelerating access to lifesaving rotavirus vaccines in GAVI-eligible countries, where 95% of deaths due to rotavirus occur.
Each year, in GAVI-eligible countries, use of rotavirus vaccines could prevent an estimated 180,000 deaths and avert 6 million clinic and hospital visits, thereby saving US$ 68 million annually in treatment costs².

Countries that have introduced rotavirus vaccines have seen a dramatic improvement in child health. Recent studies show the swift and significant impact of rotavirus vaccines in the two to three years following their introduction in national immunisation programmes.

In Mexico, diarrhoeal deaths in children five years of age and younger plummeted by 46% during 2007-2009, in the three years following vaccine introduction³. In the United States, El Salvador, Belgium, and Australia, between 2007 and 2010, hospitalisations and clinic visits for rotavirus-related diarrhoea in children five years of age and younger have declined by a striking 60% to 94%⁴.

This dramatic reduction of severe and fatal diarrhoea following the introduction of rotavirus vaccines underscores the incredible potential for rotavirus vaccines to save children’s lives.

¹Source: Tate JE, Burton AH, Boschi-Pinto C, et. al. 2008 estimate of worldwide rotavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis. The Lancet Infectious Diseases. 2012;12(2):136–141.

²Source: Atherly DE, Lewis KDC, Tate J, Parashar UD, Rheingans, RD. Projected health and economic impact of rotavirus vaccination in GAVI-eligible countries: 2011-2030. Vaccine. 2012;30(Suppl 1):A7–A14).

³Source: New England Journal of Medicine 2011; 365:772-773 / August 25, 2011

⁴Source: Pediatric Infectious Disease Journal: January 2011 - Volume 30 - Issue 1 - pp S1-S5

More on this topic

From the GAVI site

Bolivia's successful rotavirus vaccine initiative

 

Milestone in preventing child deaths from diarrhoea in Africa

 

From other sites

• Rotavirus Vaccine Program

• WHO | Immunization surveillance, assessment and monitoring

• WHO | Immunization, Vaccine and Biologicals

• WHO | Initiative for Vaccine Research: Diarrhoeal Diseases

• WHO | New and Under-utilized Vaccines Implementation

• WHO | Vaccine Safety

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.

WHO recommendation

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.

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.

More on this topic

From the GAVI site

Bolivia's successful rotavirus vaccine initiative

 

Milestone in preventing child deaths from diarrhoea in Africa

 

From other sites

• Rotavirus Vaccine Program

• WHO | Immunization surveillance, assessment and monitoring

• WHO | Immunization, Vaccine and Biologicals

• WHO | Initiative for Vaccine Research: Diarrhoeal Diseases

• WHO | New and Under-utilized Vaccines Implementation

• WHO | Vaccine Safety