fiercepharmaMarch 08, 2017
Tag: dengue vaccine , Scientists
Progress on a late-stage dengue vaccine candidate developed by U.S. scientists is threatened as its licensee—the Butantan Institute in Brazil—recently lost its top boss.
Researchers have protested the removal of former Butantan Institute Director Jorge Kalil by the state government in São Paulo, arguing that his leadership was instrumental in moving the dengue program forward, according to Science.
A team at the NIH developed the vaccine and the agency licensed it to the Butantan Institute early last year. At the time, it was set to undergo phase 3 testing in 17,000 people. Science reports that work will cost about $100 million, to be sponsored by Brazilian authorities.
The government says Kalil was removed due to "grave administrative problems" at the state-owned vaccine organization, according to the publication. Authorities insist work on the shot and others won’t be disrupted.
But some in the scientific community see things differently. Workers at the institute protested, and a factory there had to shut down for half a day late last month, Science reports.
In a public letter, the Brazilian Society for the Advancement of Science wrote the government to request that the "apparent conflict of political interests of those involved in this crisis does not interrupt projects so relevant to Brazil and the world."
Stephen Whitehead—who led the vaccine development at the National Institute of Allergy and Infectious Diseases—and Johns Hopkins’ Anna Durbin also wrote letters praising Kalil’s leadership, Science notes. Durbin led earlier trials on the shot.
São Paulo Governor Geraldo Alckmin wanted Kalil to continue running the dengue program, but the former director declined, according to the report.
Brazil’s dengue vaccine is among a group of candidates that, with success, could eventually challenge Sanofi’s first-of-a-kind Dengvaxia. Sanofi’s shot has come out slow since first winning approvals in late 2015; the French drugmaker spent $1.5 billion and 20 years working on its vaccine.
Sanofi recorded €50 million in sales for the shot last year, a far cry from initial company estimates of €200 million. Last summer, execs said political and economic turmoil in Latin America hurt the rollout.
Aside from Butantan Institute, Takeda is also in the late stages with its vaccine, an achievement one of its execs recently said demonstrates a new vaccines unit with a "global footprint." Analysts have predicted Takeda’s candidate could steal market share by 2020.
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