REDWOOD CITY, Calif., Oct. 24, 2016 /PRNewswire/ -- PaxVax, Inc. announced that Vaxchora™ is now available in the United States (U.S.) as the country's only vaccine for protection against cholera, a highly contagious intestinal diarrheal infection that can cause death in less than 24 hours if left untreated.1
Vaxchora, a single-dose vaccine, was approved by the U.S. Food and Drug Administration (FDA) in June 2016 for use in U.S. adults traveling to cholera-affected areas as an active immunization against disease caused by Vibrio cholerae serogroup O1. Also in June 2016, The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend Vaxchora for travelers to areas of active cholera transmission.
Estimated to be widespread in 69 countries, primarily in Africa, Asia, and the Caribbean, cholera is acquired by ingesting contaminated water or food. Annually, millions of people around the world are impacted by this extremely infectious disease.2 A recent report from the CDC suggests that the true number of cholera cases in the U.S. is at least 30 times higher than observed by national surveillance systems.3 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 travelling.4
The recent events in Haiti, where Hurricane Matthew hit the country on October 4, 2016, have highlighted the serious threat of cholera. Cholera 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 cholera to spread and by making its treatment difficult.5,6
"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.
PaxVax has also made a donation to international medical organization Partners In Health (http://www.pih.org) to support the relief efforts in Haiti with specific focus on cholera prevention and treatment.
Vaxchora is not approved for use outside of the United States.
Annually, millions of people around the world are impacted by this highly contagious disease, which can cause death in less than 24 hours if left untreated.1,2 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.7,8 A recent report from the CDC suggests that the true number of cholera cases in the U.S. is at least 30 times higher than observed by national surveillance systems.3 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 travelling.9
About Vaxchora (Cholera Vaccine, Live, Oral)
Vaxchora is an oral vaccine indicated for active immunization against disease caused by Vibrio cholerae (V. cholerae) serogroup O1. Vaxchora is approved for use in U.S. residents 18 through 64 years of age traveling to cholera-affected areas. 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 cholera vaccine. Vaxchora has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.
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.10 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.
For full Prescribing Information visit http://www.vaxchora.com.
PaxVax develops, manufactures and commercializes innovative specialty vaccines against infectious diseases present and emerging in the developing world. PaxVax has licensed vaccines for typhoid fever (Vivotif®) and cholera (Vaxchora™), 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, California and maintains research and development and Good Manufacturing Practice (GMP) facilities in San Diego, California and Bern, Switzerland and other operations in Bermuda and Europe. More information is available at http://www.PaxVax.com.
CONTACT: David Polk, Biosector 2, 310-309-1029, David.Polk@inventivhealth.com
1 Centers for Disease Control and Prevention. Cholera: General Information. November 2014. Available at http://www.cdc.gov/cholera/general/. Accessed October 2016.
2 World Health Organization. Cholera Fact Sheet. July 2015. Available at http://www.who.int/mediacentre/factsheets/fs107/en/. Accessed October 2016.
3 Scallan E et al. Foodborne Illness Acquired in the United States—Major Pathogens. Emerg Infect Dis. 2011;17(1):7-15.
4 Kozicki M et al. Boil it Cook it, Peel it or Forget it': Does this Rule Prevent Travellers' Diarrhoea? Int J. Epidemiol. 1985; 14(1):169‐72.
5 The New York Times: "Cholera Deepens Haiti's Misery After Hurricane." October 14, 2016.
Available at http://www.nytimes.com/2016/10/15/world/americas/cholera-haiti-hurricane-matthew.html. Accessed October 2016.
6 Wired: "Cholera in Haiti Isn't Just Bad News; It Isn't Going Away." October 14, 2016. Available at https://www.wired.com/2016/10/haitis-cholera-outbreak-isnt-just-bad-news-old-news/. Accessed October 2016.
7 Loharikar A et al. Cholera in the United States, 2001-2011: A Reflection of Patterns of Global Epidemiology and Travel. Epidemiology Infect. 2015;143(4):695-703.
8 Ali M et al. Updated Global Burden of Cholera in Endemic Countries. PLoS Negl Trop Dis. 2015; 9(6): e0003832.
9 Kozicki M et al. Boil it, Cook it, Peel it or Forget it': Does this Rule Prevent Travellers' Diarrhea? Int J. Epidemiology. 1985; 14(1):169-72.
10 Chen WH et al. Single-Dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection with Vibrio cholerae O1 El Tor. Clin Infect Dis 2016. 62 (11) 1329-1335.
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SOURCE PaxVax, Inc.