Vaxchora is the first approved vaccine for protection against cholera.
PaxVax has announced that Vaxchora, the only FDA-approved cholera vaccine, is now available in the Unites States.
Cholera is a highly contagious intestinal diarrheal infection that can result in death within 24 hours if left untreated. A majority of cases of cholera are the result of travelling to 1 of the 69 cholera endemic countries in Africa, Asian, and the Caribbean.
Vaxchora is a single-dose oral vaccine that has received approval for use in the United States for adults 18- to 64-years-old who are travelling to cholera-affected areas. The vaccine protects against the disease caused by Vibrio cholerae serogroup O1, according to a press release from PaxVax.
Within the same month that it received FDA-approval, the CDC also unanimously recommended the vaccine to travelers.
The FDA approval was based on results from a 10- and 90-day cholera challenge trial, and 2 safety and immunogenicity trials in healthy patients. These studies found that the vaccination demonstrated 90% efficacy at 10 days, and 79% at 3 months, PaxVax reported.
However, it has not been approved for use in any other countries. Vaxchora’s efficacy has not been established in individuals living in cholera-affected areas, in individuals who had prior exposure to V. cholera, or who have received a cholera vaccine, according to PaxVax.
The vaccine has also not been shown to prevent cholera caused by V. cholerae serogroup O139 or non-O1 serogroups. Common adverse reactions include tiredness, headache, abdominal pain, nausea, vomiting, lack of appetite, and diarrhea.
Besides a vaccination, cholera can be prevented by avoiding contaminated water and food in these countries. However, a majority of individuals do not comply with this when traveling, and then develop the infection.
Cholera was especially prevalent among individuals in Haiti, with approximately 10,000 deaths resulting from the disease. These cases are likely to significantly increase due to devastation that resulted from Hurricane Matthew (October 4, 2016), which makes spreading the disease easier and treating it more difficult.
PaxVax has recently made a donation to efforts to prevent and treat cholera infections in Haiti, according to the press release.
“We are excited that Vaxchora is now available to Americans traveling to areas affected by cholera. This is particularly timely in light of the number of US citizens, including members of the US military, joining relief efforts in Haiti,” said Nima Farzan, chief executive officer and president of PaxVax. “Vaccinating those traveling to cholera-affected areas can help mitigate its spread and can help protect them against the disease.”