REDWOOD CITY, CA – May 11, 2017 – PaxVax announced today that the U.S. Centers for Disease Control and Prevention (CDC) has adopted and published the recommendation of the Advisory Committee on Immunization Practice (ACIP) regarding the use of Vaxchora™ (Cholera Vaccine, Live, Oral), the only vaccine available in the U.S. for active immunization against cholera. The recommendation states that Vaxchora should be used in adults (18-64 years old) traveling to an area of active cholera transmission. This recommendation is the same one unanimously voted for by the CDC’s ACIP in June 2016. This recommendation has been adopted by the CDC and published in the May 12, 2017 issue of Morbidity and Mortality Weekly Report (MMWR), the CDC’s primary vehicle for publication of authoritative public health information and recommendations for healthcare providers, epidemiologists and others.
“Cholera represents a rising global public health challenge,” said Jason Harris, M.D., Massachusetts General Hospital, Harvard Medical School. “Its prevalence has increased since the start of the millennium and outbreaks continue to have devastating effects. In addition, the number of countries where cholera is endemic has increased and the disease is now endemic in over 60 countries.”
There are an estimated three million cholera cases per year around the world and more than 8 million U.S. travelers per year going to countries where cholera occurs. More than 80 percent of reported U.S. cases are associated with travel to cholera-endemic countries in Africa, Asia and the Caribbean.1 Of the top 20 international destinations of U.S. travelers; five are to cholera-endemic countries, including the Dominican Republic, Jamaica, China, India and the Philippines. Additionally, in recent years, there has been a rapid spread and re-emergence of cholera in the Americas, with cases reported in Cuba, Mexico, Ecuador and Haiti. Despite this, cholera remains underreported.
“Cholera has shown itself to be an emerging pathogen in the Western hemisphere,” said Bradley A. Connor, M.D., Clinical Professor of Medicine at the Weill Cornell Medical College, Attending Physician at the New York Presbyterian Hospital-Cornell Campus and Medical Director, The New York Center for Travel and Tropical Medicine. “The recent outbreak in Haiti demonstrated that cholera can evolve to become an even larger issue in areas we haven’t seen before. These new CDC guidelines will help educate healthcare providers who see travelers to consider vaccination for those who may be at risk for contracting cholera.”
Vaxchora, a single-dose vaccine, was approved by the U.S. Food and Drug Administration (FDA) in June 2016 for active immunization against disease caused by Vibrio cholerae serogroup O1. The approval was based on positive results from a 10-and 90-day cholera challenge trial that demonstrated vaccine efficacy of 90.3% at 10 days and 79.5% at three months post-vaccination, as well as two safety and immunogenicity trials in healthy adults.
Cholera, transmitted by ingestion of food and water contaminated with Vibrio cholerae, is an important cause of diarrhea that may be severe and life-threatening in some individuals. If untreated, death may result in 24 hours.1 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 traveling.4
About Vaxchora (Cholera Vaccine, Live, Oral)
Vaxchora is an oral vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. Vaxchora is approved for use in adults 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 Vibrio cholerae or receipt of a cholera vaccine. Vaxchora has not been shown to protect against disease caused by Vibrio cholerae serogroup O139 or other non-O1 serogroups.
Vaxchora is contraindicated in people with a history of severe allergic reaction (e.g., anaphylaxis) to any ingredient of Vaxchora or to a previous dose of any cholera vaccine. The safety and effectiveness of Vaxchora have not been established in immunocompromised persons. Vaxchora may be shed in the stool of recipients for at least seven days. There is a potential for transmission of the vaccine strain to non-vaccinated close contacts (e.g., household contacts). Use caution when considering whether to administer Vaxchora to individuals with immunocompromised close contacts. The most common adverse reactions (incidence >3%) were: tiredness (31%), headache (29%), abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%) and diarrhea (4%).
For the full Prescribing Information, please visit www.vaxchora.com.
PaxVax is a leading independent vaccine company that is devoted to bringing specialty vaccines that protect against overlooked infectious diseases to market, providing effective tools for health care providers who serve the 100 million people per year who travel to countries where these diseases are present. It commercializes vaccines for typhoid fever (Vivotif®) and cholera (Vaxchora™), and has a robust pipeline with vaccines at various stages of preclinical and clinical development for adenovirus, chikungunya, hepatitis A, HIV and Zika. As part of its social mission, PaxVax is also committed to making its vaccines available for use in developing world and increasing access to vaccines for the people who need them most. More information is available at http://www.paxvax.com/.
1. World Health Organization website. Cholera Fact Sheet. July 2015. http://www.who.int/mediacentre/factsheets/fs107/en/. Accessed September 2016.
2. Ali M, Nelson AR, Lopez AL, Sack DA. Updated Global Burden of Cholera in Endemic Countries. PLoS Negl Trop Dis 2015;9(6):e0003832.
3. Scallan E et al. Foodborne Illness Acquired in the United States –Major Pathogens. Emerg Infect Dis. 2011. http://dx.doi.org/10.3201/eid1701.P11101.
4. 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.
5. Chen WH et al. Single-Dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection with Vibrio cholerae O1 El Tor. Clinical Infectious Diseases 2016. 62 (11) 1329-1335.