REDWOOD CITY, Calif. – For the first time, Americans will be able to receive a Food and Drug Administration-approved vaccine for cholera, one of the most deadly disaster diseases in the world.
Considered a pandemic, cholera is highly-contagious and caused by the ingestion of contaminated food or water. The disease is most likely to strike in areas hit by natural disasters, war, or famine.
It results in an infection of the lower intestine and causes a person to suffer from profuse diarrhea, vomiting, and muscle cramps, ultimately leading to death.
Cholera thrives without proper sanitation or treatment of water and food, and was responsible for the deaths of up to 130,00o people worldwide in 2010. Annually, millions of people around the world are impacted by this disease, which can cause death in less than 24 hours if left untreated. More than 80 percent of reported U.S. cases are associated with travel to one of the 69 cholera-endemic countries in Africa, Asia and the Caribbean.
A recent report from the Centers for Disease Control suggests that the true number of cholera cases in the U.S. is at least 30 times higher than observed by national surveillance systems. Non-vaccine intervention to prevent cholera infection is the avoidance of contaminated water and food, but studies have shown that 98 percent of travelers do not comply with these precautions when traveling.
Now, the California-based PaxVax, Inc. can offer its vaccine, Vaxchori, in the U.S. as the country’s only vaccine for protection against cholera for those traveling to cholera-affected nations.
Vaxchora, a single-dose, oral vaccine, was approved by the FDA in June 2016 for use in adults as an active immunization against disease caused by Vibrio cholerae. Also in June 2016, The CDC and Prevention’s Advisory Committee on Immunization Practices voted unanimously to recommend Vaxchora for travelers to areas of active cholera transmission.
There are no announcements about whether the U.S. will allow for precautionary vaccinations to take place in areas that are struck by domestic disasters such as Hurricane Katrina.
And while this announcement does offer hope for U.S. citizens in or traveling to disaster zones, experts believe those seeking the vaccine should proceed with caution.
“Unfortunately with many pharmaceuticals, it can take years before all the negative effects start to be revealed,” said Eve Gonzales, an experienced disaster first responder and principal of Trading Post in The Woods. “Realize that as time goes on, and they inject more people, there will be more adverse reactions. If people know their options they will have better ideas on how to handle such diseases.”
The recent events in Haiti, where Hurricane Matthew hit the country, highlighted the serious threat of cholera. The disease has had a particularly devastating impact on Haiti since 2010, with approximately 10,000 deaths and 800,000 infections. The destruction caused by Hurricane Matthew has worsened the impact of the disease by creating circumstances that allowed it to spread and by making its treatment difficult.
“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 U.S. citizens, including members of the U.S. 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,” said Farzan.
Vaxchora is approved for use in U.S. residents 18 through 64 years of age. The effectiveness of Vaxchora has not been established in persons living in cholera-affected areas or in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a different cholera vaccine available in other countries.
Vaxchora is not approved for use outside of the United States.
The FDA approval of Vaxchora is based on positive results from a 10 and 90-day cholera challenge trial, as well as two safety and immunogenicity trials in healthy adults that demonstrated efficacy of more than 90 percent at 10 days and 79 percent at 3 months post vaccination. The most common adverse reactions were tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite and diarrhea. More than 3,000 participants were enrolled in the Phase 3 clinical trial program that evaluated Vaxchora at sites in Australia and the United States.
PaxVax develops, manufactures and commercializes innovative specialty vaccines against infectious diseases present and emerging in the developing world. PaxVax also has licensed vaccines for typhoid fever, and vaccines at various stages of research and clinical development for adenovirus, anthrax, hepatitis A, HIV, and Zika. PaxVax is focused on traditionally overlooked markets such as travel, and as part of its social mission, PaxVax is also working to make its vaccines available to broader populations most affected by these diseases. PaxVax is headquartered in Redwood City, Calif. and maintains research and development and manufacturing facilities in San Diego and Bern, Switzerland, and other operations in Bermuda and Europe.