First US cholera vaccine available

FDA approved the first US vaccine for cholera, Vaxchora, made by PaxVax Bermuda Ltd. in Hamilton, Bermuda. Vaxchora is the only single-dose vaccine for cholera currently licensed anywhere in the world.

“FDA approval of a new vaccine for a disease for which there has been no vaccine available is an extremely rare event,” said Nima Farzan, CEO and president of PaxVax. “We worked closely with FDA on the development of Vaxchora and credit the agency’s priority review program for accelerating the availability of this novel vaccine.”

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While cholera is rare in the United States, travelers to parts of the world with inadequate water and sewage treatment and poor sanitation are at risk for infection. “Cholera is an underestimated disease that is found in many popular global travel destinations and is thought to be underreported in travelers, said Lisa Danzig, MD, vice president of clinical development and medical affairs for PaxVax.

Cholera, a disease caused by Vibrio cholerae bacteria, is acquired by ingesting contaminated water or food and causes a watery diarrhea that can range from mild to extremely severe.

Often the infection is mild; however, severe cholera is characterized by profuse diarrhea and vomiting, leading to dehydration. It is potentially life threatening if treatment with antibiotics and fluid replacement is not initiated promptly, according to FDA.

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.

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Vaxchora’s efficacy was demonstrated in a randomized, placebo-controlled human challenge study of 197 US volunteers aged 18 through 45 years. Of the 197 volunteers, 68 Vaxchora recipients and 66 placebo recipients were challenged by oral ingestion of Vibrio cholerae, the bacterium that causes cholera. Vaxchora efficacy was 90 percent among those challenged 10 days after vaccination and 80% among those challenged 3 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 to 64 years. In the 18-to-45 year age group, 93% of Vaxchora recipients produced antibodies indicative of protection against cholera. In the 46-to-64 year age group, 90% produced antibodies indicative of protection against cholera.

However, the effectiveness of Vaxchora has not been established in persons living in cholera-affected areas.

The safety of Vaxchora was also evaluated in adults aged 18 to 64 years in 4 randomized, placebo-controlled, multicenter clinical trials; 3,235 study participants received Vaxchora and 562 received a placebo.

The most common adverse reactions reported by Vaxchora recipients were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite and diarrhea.

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