MSF Calls on WHO to Prequalify Hepatitis E Vaccine

Médecins Sans Frontières (MSF) is calling on the World Health Organisation (WHO) and Governments to prequalify a ground-breaking vaccine for Hepatitis E, a viral disease causing more than 50,000 deaths and 3,000 still births per year.?

In a?Lancet?article?on the hepatitis E outbreak in Chad, Dr Iza Ciglenecki says the lack of?prequalification?and logistical issues preclude the use of Hecolin?, the first developed hepatitis E vaccine in the world, despite the death of nearly 40 people and infection of hundreds more in the Lake Chad region.

WHO, in a position paper on hepatitis E vaccination published in May 2015, states that Hecolin? is a promising vaccine which has shown a high degree of efficacy against hepatitis E disease in 16-65 year-old healthy subjects in China.

But WHO also notes the lack of data about the vaccine’s efficacy in subgroups, including people younger than 16-years and pregnant women.

In situations such as outbreaks where the risk of mortality is high, WHO says Hecolin? should be deployed: “In particular, the use of the vaccine to mitigate or prevent outbreaks of hepatitis E should be considered, as well as the use of the vaccine to mitigate consequences in high risk groups such as pregnant women.”

Recent outbreaks of hepatitis E in Chad, Niger and Nigeria prompted a WHO-convened working group to advise use of Hecolin? but agencies, including MSF, say the lack of WHO prequalification and logistical difficulties prevents its use.

Dr Ciglenecki told?The Lancet:?“It’s not registered in these countries [and] it takes many steps to be able to use the vaccine. There needs to be a concerted effort from the policy-makers and the WHO [to make Hecolin? available and more broadly respond to the virus and outbreaks].”

Hepatitis E is a leading cause of hepatitis globally, with an estimated 3.3m cases annually, causing 56,000 deaths, says WHO. MSF puts annual hepatitis E-related deaths at more than 70,000 and the cause of 3,000 still births.

Mortality rates amongst pregnant women are as high as 25%, reports MSF. Without tackling Hepatitis E, says the not-for-profit medical organisation, WHO will fail to meet its goal of eradicating viral hepatitis as a public health threat around the world by 2030.

The Bill & Melinda Gates Foundation supported an assessment of the vaccine’s possible suitability for submission for WHO prequalification.

Hecolin? has been cleared for use by the China Food and Drug Administration and is currently licenced in China, mainly for use in the private market, and has been registered by the Drug Regulatory Authority of Pakistan in July 2017.

Its maker, Xiamen Innovax Biotech, vaccine arm of Yangshengtang Group, reaffirms its commitment to achieving prequalification. Mr. Steven Gao, General Manager of Innovax, said WHO’s position was encouraging but even in instances of outbreaks and resultant fatalities amongst pregnant women there was a reluctance among some governments to use the vaccine in the absence of a WHO prequalification.

Article Source: Crofsblogs?

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