First Cholera Vaccine Approved by FDA

The Food and Drug Administration (FDA) has approved Vaxchora (cholera vaccine; PaxVax Bermuda), an oral vaccine to prevent cholera caused by serogroup O1 in adults aged 18-64 traveling to cholera-affected areas. This is the only approved vaccine for the prevention of cholera. 

Travelers to cholera-affected areas have utilized preventive strategies such as safe food and water practices and frequent hand washing as recommended by the Centers for Disease Control and Prevention (CDC) to protect against cholera. Though the infection is often mild, severe cholera can be potentially life-threatening if appropriate antibiotics and fluid replacement is not initiated promptly. 

Vaxchora is a live, attenuated vaccine taken as a single-, oral liquid dose (~3 fl oz) at least 10 days prior to traveling to a cholera-affected area. Its efficacy was studied in a randomized, placebo-controlled human challenge study (n=197) of U.S. volunteers aged 18–45 years old. Of the total volunteers, 68 Vaxchora recipients and 66 placebo recipients were challenged by oral ingestion of Vibrio cholerae. The efficacy of Vaxchora was 90% among those challenged 10 days post-vaccination, and 80% among those challenged 3 months post-vaccination. 

In addition, two studies to assess the immune system’s response to Vaxchora were conducted in adults aged 18–64. Among adults aged 18–45, 93% of Vaxchora recipients produced antibodies indicative of protection from cholera. Among adults aged 46–64, 90% produced antibodies indicative of protection from cholera. The safety of Vaxchora was studied in four randomized, placebo-controlled, multi-center studies where 3,235 patients received Vaxchora and 562 received placebo. The most common adverse reactions were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, and diarrhea.