WHO seeks to ease cholera vaccine shortage with EuBiologics approval

Cholera bacteria--Courtesy of CDC

In a move aimed at doubling the world's cholera vaccine supply, the World Health Organization has given its nod to South Korea's EuBiologics to provide vaccines under its prequalification program.

EuBiologics joins Sanofi's ($SNY) Shantha unit as WHO-approved cholera vaccine providers actively providing doses. Johnson & Johnson ($JNJ) was a supplier with its Crucell unit but sold its vaccine, Dukoral, to Valneva in January 2015 for €45 million.

WHO's EuBiologics approval comes as the world battles shortages for vaccines against a disease that infects between 1.4 million and 4.3 million people each year. Last year, sole WHO supplier Shantha produced 3 million doses, enough to protect 1.5 million people after a two-dose treatment.

Cholera, usually spread in water, causes severe diarrhea and can kill within hours due to extreme dehydration.

The WHO's prequalification program ensures that cholera vaccines purchased by countries and international agencies meet quality, safety and efficacy requirements. With the approval, countries can apply for procurement or buy directly from EuBiologics.

While the WHO nod will likely mark an uptake in cholera vaccine availability, the market could get increasingly crowded with new entrants as developers seek to develop vaccines that boast different advantages. In 2014, Merck's ($MRK) Indian joint venture Hilleman Laboratories teamed with Sweden's Gotovax AB to work on a vaccine the pair hopes can be inexpensive and easy to administer. Hilleman Labs then said in November it's looking for potential partners to fund a $46 million affordable vaccines project with cholera included.

And last month, the FDA accepted PaxVax's Biologics License Application for a cholera vaccine that, if approved, would be the first single-dose treatment. That came a week after the Redwood City, CA-based company netted a $105 million investment from Cerberus Capital and one year after the candidate, Vaxchora, passed a Phase III trial. Marketed to travelers, Vaxchora would be the first cholera vaccine available in the U.S.

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