Rotavirus vaccine support

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With donor support, GAVI plans to introduce rotavirus vaccine in more than 30 countries by 2015

Key step towards lowering child mortality and achieving MDG4

GAVI09 Jeffrey Rowland Vietnam Rotavirus

Meeting country demand

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

By 2015, GAVI and its partners plan to support the introduction of life-saving rotavirus vaccines in more than 30 of the world’s poorest countries. Accelerating access to rotavirus vaccines in countries where they are needed most is one of the cornerstone objectives of GAVI.

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.

Rotavirus vaccine rollouts

Track rollouts country by country from our rotavirus vaccine support timeline as the world's poorest countries receive the rotavirus vaccine at the same time as industrialised countries.

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 programmes. This enabled GAVI to widen its potential rotavirus support to Africa and Asia.

Since 2011, Sudan, Ghana, Rwanda, Moldova, Yemen, Malawi, ArmeniaTanzania, Georgia, Haiti, The Gambia, Burkina Faso, Ethiopia, Zambia and Burundi have introduced rotavirus vaccines into their national immunisation programmes. Fifteen other countries are expected to introduce rotavirus vaccines in the next two years with GAVI support.

A new vaccine to protect children from severe diarrhoea comes to Africa

Sudan was in 2011 the first GAVI-eligible country in Africa to introduce vaccines against rotavirus infections.

Read more

Sudan rota rollout - Dr treats child 21082011

Rotavirus is the leading cause of severe diarrhoea and diarrhoeal deaths in children worldwide

WHO recommends universal rotavirus vaccination

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, approximately 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.

Nearly every child in the world will suffer a rotavirus infection by their third birthday.

Children 6 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 spread of rotavirus. The virus is so contagious and resilient that improving hygiene also has little impact on preventing illness or death.

Map of the global burden of rotavirus diarrhoeal disease

Rotavirus global disease burden 

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 five 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, Austria, Finland and Australia, between 2007 and 2012, hospitalisations and clinic visits for rotavirus-related diarrhoea in children five years of age and younger have declined by a striking 50% to 90%.

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

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), Georgia (2013), Guyana (2010), Haiti (2013), Honduras (2009), Sudan (2011), Armenia (2012), Ghana (2012), Rwanda (2012), Malawi (2012), Moldova (2012), Tanzania (2012), Yemen (2012), Georgia (2013), Haiti (2013), The Gambia (2013), Burkina Faso (2013), Ethiopia (2013), Zambia (2013) and Burundi (2013).

GAVI has approved 15 additional countries for rotavirus vaccine support, 14 of them in Africa, where more than 50%1 of all rotavirus deaths occur. By 2015, GAVI and its partners plan to support more than 30 of the world’s poorest countries in introducing rotavirus vaccines. 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 five years after their introduction in the United States, El Salvador, Belgium, Austria, Finland and Australia, hospitalisations and clinic visits for rotavirus-related diarrhoea in children five years of age and younger have declined by a striking 50% to 90% between 2007 and 20122.

WHO recommendation

Because there are many causes of severe diarrhoeal disease, WHO 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
 

Countries approved for Rotavirus 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 (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.

Rotavirus factsheet

GAVI_FS Rotavirus_2013_En

Download the Rotavirus factsheet 

+243,000,000

GAVI support will assist countries to immunise a further 243 million children from 2011 to 2015.

GAVI Alliance

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