EU Panel Backs Cholera Vaccine Vaxchora for Adults, Children

Troy Brown, RN

Disclosures

January 31, 2020

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended marketing authorization for cholera vaccine (recombinant, live, oral) (Vaxchora, Emergent Netherlands BV) for protection against cholera in adults and children, according to an EMA summary of opinion.

The vaccine will be sold as an effervescent powder and a powder for oral suspension.

The US Food and Drug Administration approved Vaxchora June 10, 2016, for adults aged 18 through 64 years.

"Vaxchora is a bacterial vaccine (ATC code: J07AE02) containing as 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," the EMA writes in the summary of opinion.

The vaccine's benefits include the prevention of moderate to severe diarrhea caused by cholera bacteria in immunologically naive individuals. The most frequently seen adverse effects are fatigue, headache, abdominal pain, nausea, vomiting, and lack of appetite.

The cholera vaccine's full indication is "active immunization against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 6 years and older. This vaccine should be used in accordance with official recommendations."

The summary of product characteristics will include detailed recommendations for use of the product and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.

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