WASHINGTON -- A vaccine against cholera has, for the first time, received FDA approval, Friday.
To be sold as Vaxchora, the product contains live but attenuated Vibrio cholerae bacteria. It is taken as a single oral liquid dose.
The FDA said that, since cholera is rare in the U.S., the vaccine is indicated primarily for people traveling to areas where the infection is endemic. It should be taken at least 10 days before travel to such areas.
Efficacy was demonstrated in a placebo-controlled, 197-person challenge trial involving young adults. The vaccine was 90% effective against challenge 10 days after dosing and 80% effective for participants challenged at 3 months.
Two other placebo-controlled studies assessing antibody responses indicated that about 90% of participants, including those up to 64 years old, developed antibody titers "indicative of protection against cholera," the FDA said.
Safety was evaluated in multiple trials with a total of nearly 4,000 participants, three-fourths of whom received the vaccine. The most common adverse effects were tiredness, headache, abdominal pain, nausea and vomiting, diarrhea, and lack of appetite.
Vaxchora is manufactured by PaxVax Bermuda of Hamilton, Bermuda. This is a different product than the killed-cell vaccine that was the subject of a New England Journal of Medicine article last month.
Cost information for Vaxchora was not immediately available.