Rotavirus data must propel immunization – experts

Health experts hope the release of data showing the success of rotavirus vaccine will help compel policymakers to ensure all children will be immunized.

Rotavirus – the top cause of severe and often fatal diarrhoea and dehydration in children – kills some 527,000 children a year globally, nearly half of them in sub-Saharan Africa.

“It is our hope that these data will catalyze action so that one day we can live in a world where no child dies from diarrhoea,” Kathy Neuzil, senior clinical advisor for vaccines at the international health non-profit PATH, said in a 27 January statement.

Published on 27 January 2010 in the New England Journal of Medicine, results from first-ever clinical trials in South Africa and Malawi show that a live, oral rotavirus vaccine significantly reduces the episodes of severe rotavirus gastroenteritis in African children during the first year of life.

The data “provide policymakers with the critical information they need to make decisions about rotavirus vaccine introduction,” George Armah, professor and rotavirus expert at Ghana’s Noguchi Memorial Institute for Medical Research, said.

The trial results led the World Health Organization in June 2009 to recommend global use of the vaccine.

The Africa trials focused on the vaccine’s performance in high mortality, low-income settings, according to a 27 January 2010 communiqué by PATH and GAVI Alliance.

Health experts point out that while rotavirus infection in treatable, it has devastating and deadly impact in rural and poor areas where people cannot access medical care. “Vaccines represent the best hope for preventing the severe consequences of rotavirus infection,” Nigel Culiffe of University of Liverpool said in statement.

The trials were coordinated and co-funded through a partnership between GlaxoSmithKline Biologicals and the GAVI Alliance-funded Rotavirus Vaccine Trials Partnership – PATH, WHO and the US Centers for Disease Control and Prevention.

Source: IRIN, 27 Jan 2010

Rotavirus vaccination: WHO move boosts fight against fatal diarrhoea

The World Health Organization has paved the way for children in Africa and Asia to be vaccinated against a diarrhoea-causing virus that kills some 500,000 children annually worldwide – 85 percent of them in African and Asian developing countries. WHO has recommended that the vaccine for rotavirus – the leading cause of severe and often fatal diarrhoea and dehydration in under-five children – be included in national immunization programmes worldwide.

As of 2007 the organization had said more research was needed on the vaccine’s efficacy in developing countries with high child mortality; new data from clinical trials has led WHO to recommend global use of the vaccine, according to a 5 June communiqué. The decision means poor countries in Asia and Africa can now apply for funding to include rotavirus vaccines in their national immunization programmes.

“This [vaccine] will significantly reduce mortality and morbidity of rotavirus disease,” Samba Ousmane Sow, associate professor of medicine at University of Maryland and coordinator of the Centre for Vaccine Development in Mali, told IRIN. “For rotavirus, as with many infectious diseases, mortality is often a question of geography,” he said. “For the many people in rural Africa who cannot easily access medical care, the best and most practical solution [against this lethal illness] is to bring the vaccine to them.”

A child with rotavirus disease – which causes fever, vomiting and diarrhoea – can rapidly become dehydrated. Death from rotavirus is most common where there is no quick access to medical care, so vaccination is the most effective way to prevent severe cases and deaths, experts say.

Transmitted primarily by the faecal-oral route, the virus affects the vast majority of children globally before age three, according to WHO. The virus attacks the villi – tiny projections on the wall of the small intestine. Destruction of the affected cells reduces digestion and absorption of nutrients, resulting in diarrhoea with a loss of fluids.

The virus is resilient and traditional hygiene measures that might prevent other sanitation-related illnesses are not sufficient to limit its impact, according to PATH, an international health non-profit and one of the organizations conducting vaccine trials with WHO and the Global Alliance for Vaccines and Immunization (GAVI). But given that there are many causes of diarrhoeal disease, the rotavirus vaccine must be part of a comprehensive control strategy, including improving water quality, hygiene and sanitation and providing oral rehydration solution and zinc supplements, WHO says in its communiqué.

[N]ow governments will have to prepare an investment plan for including rotavirus vaccine in their immunization programmes. The GAVI Alliance uses a co-financing approach, in which countries procure some vaccines with non-GAVI funds; the intention is for countries to gradually increase their share of vaccines’ cost, making immunization programmes sustainable. The GAVI Alliance board is expected to decide at its November 2009 meeting whether all 72 GAVI-eligible countries will now become eligible to apply for funding to include the rotavirus vaccine in their immunization programmes, GAVI’s Ariane Leroy told IRIN.

Clinical trials of the vaccine are ongoing in Asia and sub-Saharan Africa, but WHO’s Strategic Advisory Group of Experts has recommended the vaccine for all populations given available evidence, WHO says.

Source: IRIN, 09 Jun 2009

See also: WHO backs anti-diarrhoea vaccine, BBC, 05 Jun 2009

Sanitation vs. vaccination in cholera control

IVI scientist Dr. Anna Lena Lopez with local children during oral cholera vaccine trial in Kolkata, India, Aug 2006. Photo: IVI

Only weeks away from the launch in India of an oral cholera vaccine significantly cheaper than available vaccines, community workers and health officials are still sceptical of whether a vaccine is the best way to control cholera, according to the International Vaccine Institute (IVI).

IVI’s director John Clemens told IRIN some water and sanitation programme managers argue that the focus in cholera control should be on safe water access rather than vaccine development.

[...] Introducing a cheaper vaccine in endemic countries “does not mean diminishing the importance of safe water access”, said IVI’s Clemens. “It is a false dichotomy to pit sanitation against vaccination. Improved water and sanitation is the ultimate, but still far-off, goal for impoverished [endemic] countries. Meanwhile we need to think about inexpensive ways to augment efforts [to control cholera].”

Clemens told IRIN that despite a decade of education about the importance of sanitation and safe drinking water, cholera infections have not declined. “Rather, in recent years there have been unprecedented outbreaks of unprecedented duration [in places] where [cholera] had not been [as serious] a problem in recent years.”

[...] People living in countries hardest hit by cholera can ill afford the only internationally licensed vaccine sold as Dukarol, Clemens told IRIN. [...] Dukarol can cost up to US$30 per dose and requires at least two doses with boosters. IVI’s new vaccine, Shanchol, is expected to cost about $1 per dose and calls for two doses.

Other more affordable oral vaccines are not licensed internationally.

IVI’s oral vaccine is in the final phase of a clinical trial in India where 70,000 patients have been tracked since 2006. The manufacturer is expecting to produce five million doses in the first year of immunisations. IVI’s director said the vaccine has not been tested on infants under one year old. IVI, based in Seoul, South Korea, started cholera research in 1999 with almost $40 million from The Bill & Melinda Gates Foundation. The institute received an additional $20 million in 2006 to introduce a cholera vaccine in endemic countries. As the cholera vaccine is licensed only in India, IVI will seek WHO’s approval in late 2009.

See IVI’s page on its cholera vaccine programme.

Source: IRIN, 14 May 2009

Pneumonia, diarrhea concerns in disease prevention: health alliance

Pneumonia and diarrhea, which kill one in three children around the world, are emerging as key concerns in disease prevention, a public-private partnership said.

In the coming year, more progress in getting vaccination against the two diseases would reach more countries, said the GAVI Alliance, which is a grouping of governments, philanthropists, vaccine industry players and international organizations such as the World Health Organization.

“Of prime concern are pneumonia and diarrhoea which together account for 36 percent of global child deaths. Progress in preventing these diseases is crucial to achieving the Millennium Development Goals,”" said the alliance in its annual report.

[...]

GAVI said it had adopted a two-phase strategy for rotavirus vaccine, with the first phase to make vaccines support available to Latin American [Bolivia, Guyana and Honduras were the first to apply] and European countries where the vaccine was already licensed for use.

“”Roll-out in Africa and Asia awaits the results of large-scale safety and efficacy trials,”" it said.

Read more: AFP / Tehran Times, 23 June 2008