WHO seeks to ease cholera vaccine shortage with EuBiologics approval
In a move aimed at doubling the world's cholera vaccine supply, the World Health Organization has given its nod to South Korean's EuBiologics to provide vaccines under its prequalification program.
S. Korea's EuBiologics wins nod as WHO cholera vaccine supplier
South Korea's EuBiologics has won World Health Organization approval as the third company to supply oral cholera vaccines for its global campaign just as a massive effort in Iraq ended, leaving stocks nearly depleted.
Just a week after announcing a $105 million investment by Cerberus Capital, PaxVax is inching closer to getting its second vaccine--and potentially the first FDA-approved cholera vaccine--to market. The Redwood City, CA-based company announced Wednesday that the FDA accepted for filing and review the Biologics License Application (BLA) for Vaxchora, its cholera candidate.
Redwood City, CA-based PaxVax currently markets one vaccine, Vivotif, the typhoid vaccine it acquired from Johnson & Johnson's Crucell in July 2014. But PaxVax could be on the way to adding its cholera candidate, Vaxchora, to the list thanks to a $105 million investment from Cerberus Capital management.
Shanchol, the cholera vaccine used in endemic countries, is given in two doses 6 weeks apart. But some patients may simply not return for a second dose. If the second dose is delayed by more than 6 weeks, the WHO says, the whole regimen has to be restarted.
In a huge Bangladeshi trial, Shanchol, Shantha Biotechnics' affordable cholera vaccine, prevented almost 40% of cholera cases. When combined with increased hand-washing, the vaccine prevented 45% of cases.
Johnson & Johnson's Crucell is officially out of the cholera space, and France's Valneva is in. And that means it's Valneva that's about to inherit some hefty competition that's coming up through its rivals' pipelines.
Right now, there is no FDA-approved cholera vaccine for U.S. travelers heading to high-risk countries. A California company hopes to change that soon: On Monday, PaxVax said it planned to submit a Biologics License Application for its oral single-dose candidate in mid-2015.
When Merck's Indian JV, Hilleman Laboratories, teamed up in June with Swedish biotech Gotovax AB, the plan was to get an affordable cholera vaccine to the developing world. Just a few months out, it's inked a pact to make that happen faster.
PaxVax' single-dose oral cholera vaccine candidate, PXVX0200, posted positive results in a pair of challenge studies, the company announced earlier this week.