Abstract
Improving water and sanitation is the preferred choice for cholera control in the long-term. Nevertheless, vaccination is an available tool that has been shown to be a cost-effective option for cholera prevention in endemic countries or during outbreaks. In 2011 the first low-cost oral cholera vaccine for international use was given prequalification by the World Health Organization (WHO). To increase and prioritize use of the vaccine, WHO created a global stockpile in 2013 from which countries may request oral cholera vaccine for reactive campaigns. WHO has issued specific guidelines for applying for the vaccine, which was previously in short supply (despite prequalification for a second oral vaccine in 2015). The addition of a third WHO-prequalified oral cholera vaccine in 2016 is expected to increase the global stockpile considerably and alleviate supply issues. However, prioritization and best use of the vaccine (e.g. how, when and where to use) will remain challenges. We describe 12 past oral cholera vaccine campaigns, conducted in settings with varying burdens of cholera. These case studies illustrate three key challenges faced in the use of the oral cholera vaccines: regulatory hurdles, cold chain logistics and vaccine coverage and uptake. To pave the way for the introduction of current and future oral cholera vaccines, we discuss operational challenges and make recommendations for future research with respect to each of these challenges.
Highlights
The World Health Organization (WHO) estimates that there are 1.3 to 4.0 million cholera cases annually and that 21 000 to 143 000 of them result in death.[1]
Progress has been made towards providing universal access to piped water and water treatment,[4 663] million people worldwide still do not use improved drinking water sources that can reduce the spread of contaminants such as fecal matter.[4]
We focus on the stockpile for use in emergency settings and discuss the three key operational challenges faced with the use of oral cholera vaccines: regulatory hurdles, cold chain logistics and vaccine coverage and uptake
Summary
The World Health Organization (WHO) estimates that there are 1.3 to 4.0 million cholera cases annually and that 21 000 to 143 000 of them result in death.[1]. Protocols and available safety and immunogenicity data had to be submitted to the control authority for approval to use the vaccine, since the vaccine had been developed, licensed and WHO-prequalified in the Asian context, raising concerns about population differences Because this was a new vaccine in Ethiopia and, by law, the country does not permit the involvement of children in biomedical research, special permission for the clinical study was required. WHO is undertaking a major programme to strengthen national regulatory authorities by working with Member States to evaluate and improve regulatory system performance.[32] Evidence exists that vaccine adoption by low-income countries may take as long as 20 years, and is a function of several factors: price, political will, cost‒effectiveness and feasibility within a country’s existing service delivery networks.[33] international support for use of oral cholera vaccine is clearly needed, it should be emphasized to country health authorities that a multisectoral, integrated approach that is comprehensive and that includes surveillance and diagnostics will require strong political commitment. April and May 2014 Vaccine registration documents provided by manufacturer of ShancholTM to WWM
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