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FDA approves first cholera vaccine in US

PaxVax’s oral vaccine Vaxchora will be launched by September
FDA

The US FDA has approved the first vaccine for travellers to the 50-plus countries in the world where cholera is endemic.

The one-dose vaccine - PaxVax's Vaxchora - is a one-dose oral vaccine that guards against cholera serogroup 01, which according to the World Health Organization (WHO) is the primary cause of cholera infections worldwide. It is due to be launched in the third quarter, according to the company.

PaxVax was awarded breakthrough status and priority review for Vaxchora, reflecting the fact that there are few options available to travellers from the US who wish to protect against cholera.

The approval also comes against the backdrop of a worldwide shortage in oral cholera vaccines, which include Valneva's Dukoral and the International Vaccine Institute's Shanchol. Last year, some countries where the water-borne disease is endemic - such as Sudan and Haiti - requested urgent supplies from the WHO saying they could not meet vaccination targets.

Cholera is rare in the US, but without access to a vaccine travellers to parts of the world with inadequate water and sewage treatment and poor sanitation have had to rely solely on preventive strategies such as safe food and water practices and frequent hand washing.

Vaxchora has been approved for use in adults aged between 18 and 64, and is the only single-dose cholera vaccine to be registered around the world. It is a live attenuated vaccine, incorporating a weakened strain of the Vibrio cholera bacteria that causes the disease.

Cholera incidence has increased steadily since the beginning of the millennium, and according to the WHO 3-5 million people suffer from this disease annually, with up to 200,000 deaths despite vaccination campaigns.

The areas worst affected are Sub-Saharan Africa and Asia, as well as some parts of the Caribbean and South America - areas affected by what the WHO has described as a "vicious cycle" of low demand, low production, high price and inequitable distribution.

In 2013 the WHO created the world's first OCV stockpile, undertaking to buy and use 2m doses a year in order to stabilize and create demand for the vaccines.

The WHO approved a third supplier of oral cholera vaccines - South Korea's EuBiologics - last December in a move designed to double production output to 6m doses a year. The company's EuVichol product was developed in collaboration with IVI.

Vaxchora will be distributed through PaxVax's US marketing and sales organisation, which currently sells oral typhoid fever vaccine Vivotif. PaxVax said it is also working to make its vaccines available "to broader populations most affected by these diseases".

Article by
Phil Taylor

13th June 2016

From: Regulatory

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