The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the single-dose oral cholera vaccine Vaxchora, developed by multinational biopharmaceutical firm Emergent BioSolutions, Inc. of Gaithersburg, Maryland. On Jan. 30, 2020, the CHMP adopted a “positive opinion” on the granting of a marketing authorization for the bacterial vaccine.1 2 3
According to the EMA’s summary of opinion on Vaxchora, the vaccine will be available as an “effervescent powder and a powder for oral suspension.” It contains as an active substance “live attenuated cholera bacteria (V. cholerae O1 classical Inaba strain live attenuated CVD 103-HgR), which replicate in the gastrointestinal tract of the recipient and induce serum vibriocidal antibody and memory B cell responses.”4
The EMA notes that the most common side of effects of Vaxchora include tiredness, headache, abdominal pain, nausea/vomiting, and lack of appetite.4
The CHMP based its decision to approve Vaxchora on data from five randomized, double-blind, placebo-controlled clinical trials. Emergent BioSolutions noted that these trials included a “Phase 1 safety and immunogenicity study, a Phase 3 challenge study, where Vaxchora demonstrated 90.3% efficacy at 10 days and 79.5% efficacy at 3 months, a Phase 3 safety and immunogenicity study that examined lot-to-lot consistency, a Phase 3 study that demonstrated a similar immune response in older adults compared with younger adults, and a Phase 4 study in children that demonstrated a similar immune response in children compared to younger adults.”2
If Vaxchora is granted marketing authorization by the European Union (E.U.), the vaccine would become available for use by adults and children six years of age and over. The marketing authorization would apply to all 28 E.U. member countries.2 4
The U.S. Food and Drug Administration (FDA) approved Vaxchora on June 10, 2016 for adults 18-64 years old who travel to cholera-affected areas. It is the only cholera vaccine licensed in the United States for use against cholera caused by Vibrio cholerae serogroup O1, which is the main cause of cholera around the world.5
On May 11, 2017, the U.S. Centers for Disease Control and Prevention (CDC) published its recommendation for the use of Vaxchora in adults traveling from the U.S. to areas with cholera.6
A recent report by Allied Market Research found that the global cholera vaccine market generated $65 million in revenues in 2017. The report forecasts the value of the market to reach $207 million by 2025. The fastest growing segment of the market is North America, specifically due to the launch of Vaxchora and the increasing number of travelers to countries with cholera.7
1 Brown T. EU Panel Backs Cholera Vaccine Vaxchora for Adults, Children. Medscape Jan. 31, 2020.
2 Globe Newswire. Emergent BioSolutions Receives Positive CHMP Opinion for Vaxchora; Anticipates Near-Term Approval by European Medicines Agency
3 House DW. European advisory group backs Emergent BioSolutions cholera vaccine. Seeking Alpha Jan. 31, 2020.
4 European Medicines Agency. Summary of opinion (initial authorisation) – Vaxchora.
5 Press Release. FDA approves vaccine to prevent cholera for travelers. U.S. Food and Drug Administration June 10, 2016.
6 Press Release. CDC finalizes vaccine recommendation for adults traveling to areas with cholera. U.S. Centers for Disease Control and Prevention May 11, 2017.
7 openPR. Cholera Vaccine Market Share on Target to Reach $207 Million by 2025. Allied Market Research Jan. 24, 2020.