The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for the approval of Emergent Biosolutions’ oral cholera vaccine, Vaxchora.
Authorization from the European Commission is anticipated within three months. The marketing authorization would be valid in all 28 member states of the European Union.
Vaxchora, if approved, would be the only single-dose oral vaccine for immunization against the disease in adults and children from 6 years of age.
“It is estimated that cholera is endemic in almost 70 countries worldwide, making travelers to these destinations vulnerable to cholera infection. Millions of Europeans travel to cholera-endemic regions each year. In addition to taking safe precautions with food, water, and hygiene, vaccination is recommended to help protect against this virulent disease,” said Abbey Jenkins, senior vice president and vaccines business unit head at Emergent BioSolutions. “Emergent is pleased with receiving CHMP positive opinion, which brings us a step closer to providing a single-dose vaccine to address this travel health threat. As a company whose mission is to protect and enhance life, we seek to bring peace of mind to patients and healthcare professionals by offering a consistent supply of a new option for cholera prevention.”
Cholera is a disease transmitted by the ingestion of food and water contaminated with Vibrio cholerae. It has a broad range of symptoms, including diarrhea. The World Health Organization (WHO) estimates that only 5-10 percent of cases are officially reported.
“The positive opinion of the CHMP for the approval of this single-dose oral cholera vaccine is excellent news for all those who are dedicated to the practice of Travel Medicine. In this global world that we live in today, this new vaccine represents an advanced tool to help in the protection of European travelers against immuno-preventable diseases when traveling abroad to cholera-affected areas,” said Dr. Rogelio López-Vélez, head of the National Referral Unit for Tropical Diseases of the Ramón y Cajal University Hospital in Madrid, Spain.
Vaxchora was approved in the United States in 2016. It is the only vaccine licensed by the U.S. Food and Drug Administration for active immunization against cholera.