thevaccinereaction--2020-02-12--Cholera Vaccine Recommended by European Medicines Agency

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.
@ @ @ @ @ @ @ “ 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 @ @ @ @ @ @ @ , 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 @ @ @ @ @ @ @ 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 @ @ @ @ @ @ @ 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