FDA approves vaccine to prevent cholera for travellers

Vaxchora is a live, weakened vaccine that is taken as a single, oral liquid dose of approximately three fluid ounces

The US Food and Drug Administration has approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults aged 18 to 64 travelling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.

Cholera is caused by Vibrio cholerae bacteria and is acquired by ingesting contaminated water or food. Often the infection is mild; however, severe cholera is characterised by profuse diarrhoea and vomiting, leading to dehydration. It is potentially life threatening if treatment with antibiotics and fluid replacement is not initiated promptly. According to the World Health Organization, serogroup O1 is the predominant cause of cholera globally.

'The approval of Vaxchora represents a significant addition to the cholera-prevention measures currently recommended by the Centres for Disease Control and Prevention for travellers to cholera-affected regions,' said Peter Marks, Director of the FDA’s Centre for Biologics Evaluation and Research.

While cholera is rare in the US, travellers to parts of the world with inadequate water and sewage treatment and poor sanitation are at risk of infection. Travellers to cholera-affected areas have relied on preventative strategies recommended by the CDC to protect themselves against cholera, including safe food and water practices and frequent hand washing.

The approval of Vaxchora represents a significant addition to the cholera-prevention measures currently recommended

Vaxchora is a live, weakened vaccine that is taken as a single, oral liquid dose of approximately three fluid ounces at least 10 days before travel to a cholera-affected area.

The vaccine's efficacy was demonstrated in a randomised, placebo-controlled human challenge study of 197 US volunteers aged 18–45. Of the volunteers, 68 Vaxchora recipients and 66 placebo recipients were challenged by oral ingestion of Vibrio cholerae. Vaxchora efficacy was 90% among those challenged 10 days after vaccination and 80% among those challenged three months after vaccination.

Two placebo-controlled studies to assess the immune system’s response to the vaccine were also conducted in the US and Australia in adults aged 18–64. In the 18–45 age group, 93% of Vaxchora recipients produced antibodies indicative of protection against cholera. In the 46–64 years age group, 90% produced antibodies indicative of protection against cholera. The effectiveness of Vaxchora has not been established in persons living in cholera-affected areas.

The safety of Vaxchora was evaluated in adults aged 18–64 years of age in four randomised, placebo-controlled, multicentre clinical trials; 3,235 participants received Vaxchora and 562 received a placebo.

The FDA granted the Vaxchora application fast track designation and priority review status.

Vaxchora is manufactured by PaxVax Bermuda, located in Hamilton, Bermuda.

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