WHO recommends global use of diarrhoea vaccine
This article was originally published in Scrip
The World Health Organization has recommended that the rotavirus vaccine be included in all national vaccination programmes to help prevent the 500,000 deaths seen each year from the virus, mostly children in developing countries.
To date, 22 countries have included rotavirus vaccine in their immunisation programmes, the WHO told Scrip. These are Australia, Bahrain, Belgium, Bolivia , Brazil, Colombia, Costa Rica, Cyprus, Ecuador, El Salvador, Honduras, Luxembourg, Mexico, Micronesia, Nicaragua, Palau, Panama, Peru, Qatar, South Africa, the US and Venezuela.
There are two rotavirus vaccines, both of which are live and can be taken orally, a bonus in low-resource settings: GlaxoSmithKline's Rotarix (two doses must be taken), which has worldwide WHO prequalification, and Merck & Co's RotaTeq (three doses), which is only prequalified for Europe and the Americas.
GSK, where Brazil and Mexico are currently the largest markets for Rotarix, told Scrip that it is holding pricing talks with the WHO. "Africa is the region we will focus on," a spokesperson for the firm said. GSK took an unusual approach five years ago, by launching the vaccine in developing countries first, as historically vaccines reach these countries as much as 15-20 years after their introduction in the US and Europe.
The new WHO advice comes from its SAGE committee (Strategic Advisory Group of Experts) after a clinical trial, conducted in high child-mortality settings in Malawi and South Africa, showed the rotavirus vaccine significantly reduced severe diarrhoea episodes due to the virus.
As oral vaccines can have variable efficacy in different settings, the trial was important to show its performance in a high-mortality one. The results of the Rotarix trial, funded partly by the GAVI Alliance and conducted by the WHO, PATH and GSK, is to be published in the summer in a peer-reviewed journal.
The advice builds on SAGE's 2005 advice that recommended that rotavirus vaccine could be used in the Americas and Europe, where clinical trials showed safety and efficacy in low- and intermediate mortality populations.
Another clinical trial was conducted in sites in Bangladesh and Vietnam, as well as Ghana, Mali and Kenya, using Merck & Co's vaccine, and data is expected in the autumn.
SAGE said that although data was unavailable on the efficacy of rotavirus vaccine in Asia, it recommended that the vaccine be used in all national programmes as available evidence indicates that efficacy data can be extrapolated to populations with similar mortality patterns, regardless of location.
The committee also advised that as diarrhoea has many causes, the vaccine be given as part of a diarrhoea control strategy, including improved water quality and the provision of oral rehydration solution and zinc supplements.
GAVI keen to boost vaccine use
The GAVI Alliance, a public-private partnership created in 2000 to increase access to vaccines in poor countries, told Scrip that the WHO move meant that more countries could apply for funding for the vaccine.
At the moment, 14 countries (in Eastern Europe and Latin America) are eligible for GAVI-funding for the vaccine, but that this could now rise to as many as 72 countries.
Four countries have received GAVI-approval for rotavirus vaccine introduction. These are Bolivia ($10,861,000), Guyana ($1,117,500), Honduras ($7,357,000) and Nicaragua ($7,299,500).
GAVI partners include national governments, UNICEF, WHO, the World Bank, the Bill & Melinda Gates Foundation, the vaccine industry and civil groups.