A Zika vaccine candidate developed by Japanese pharmaceutical giant Takeda has entered an accelerated FDA review process.
Zika, a mostly mosquito-spread infection that can cause serious birth defects, is still an issue. Although it made waves mostly during its 2016 outbreak, concerns remain about a resurgence of Zika and the CDC still lists vast swatches of Latin America, South America, and Africa as a no-travel zone for pregnant women.
The fast-track designation is reserved for “the review of drugs and vaccines for serious conditions and that fill an unmet medical need,” Takeda announced Monday in a press release. As of now, there is “no vaccine or medicine” for Zika, says the CDC.
According to the Phase 1 study details, the vaccine is a purified, inactivated form of the Zika virus that will be delivered in a randomized, placebo-controlled, double-blind trial to about 240 participants. The vaccine is supplemented with aluminum hydroxide in order to kick start the immune response.
The trial will last about 13 months. Participants are being recruited currently in Kansas and New York, with more soon to be solicited in Florida and Puerto Rico.
WATCH: Miles reports on the 2016 Zika crisis–as well as possible solutions–on assignment in Brazil.
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