With the FDA approval Vaxchora is the only FDA-approved vaccine for the prevention of cholera. The drug is for use with people aged 18 to 64, who are set to travel to cholera-affected areas.
Cholera is an infection of the small intestine, caused by some strains of the bacterium Vibrio cholerae. Symptoms include severe, watery diarrhoea; feeling and being sick; and stomach cramps. If untreated, the disease can be fatal. Of the different forms, according to the World Health Organization, serogroup O1 is the predominant cause of cholera globally.
In discussing the approval of the new vaccine, Dr. Peter Marks, who works for the FDA, said: “The approval of Vaxchora represents a significant addition to the cholera-prevention measures currently recommended by the Centers for Disease Control and Prevention for travelers to cholera-affected regions.”
Regions of the world where the risk is highest include those areas where there is poor quality water and inadequate sewage treatment. Areas affected include parts of sub-Saharan Africa, south and south-east Asia, the Middle East, Central America and the Caribbean. Currently visitors to such areas need to undertake careful measures, such as drinking bottled water. Should a person become infected there are established treatment regimens to follow. However, until now no preventative measures were in place.
This has changed with the vaccine. Vaxchora is a live, weakened (or ‘attenuated’) vaccine. It is administered as a single, oral liquid dose, and it taken 10 days (or earlier) prior to travel.
The efficacy of the vaccine has been assessed by clinical trial, using 197 U.S. volunteers (adults aged between 18 to 45 years of age.) The volunteers were vaccinated and then infected with the causative bacterium. The vaccine efficiency was 90 percent. Those infected, and who showed symptoms, were treated with antibiotics and fluid replacement therapy.
Based on the need for the vaccine, FDA has fast-tracked it through the approvals process. The vaccine is produced by PaxVax Bermuda Ltd., located in Hamilton, Bermuda. The accelerated approval was supported by many within the pharmaceutical community, with List Labs (@ListLabs) tweeting: “Congrats @PaxVaxInc on your FDA approval for #Vaxchora. Proud to see progress in vaccine research.”
