India's Bharat Biotech poised to enter clinic with Zika vaccine, report says

Chasing two U.S.-developed vaccine candidates, India’s Bharat Biotech says it’s ready to start testing its Zika shot in humans. It just needs the go-ahead from Indian officials to get started, according to a local media report.

The company has wrapped up preclinical work on Zikavac, an inactivated shot that Bharat believes could win fast-track support from authorities, and is awaiting a government nod to proceed, according to Livemint. India is among the countries most vulnerable to a Zika outbreak, a recent Lancet study found.

Bharat’s proposed Phase I trial would test the vaccine in about 100 participants, Livemint reported.

Earlier this year, as the Zika outbreak exploded around the globe and companies started jumping into the R&D fray, Bharat Biotech was routinely named as a frontrunner. Now, if it’s able to advance its candidate, the biotech would be among the first organizations to enter the clinic.

Inovio Pharmaceuticals and the U.S. National Institutes of Health have entered Phase I with their Zika vaccine candidates. Inovio hit the milestone first, in June, and NIH followed up in August.

Analysts estimate a Zika vaccine could be a $1 billion opportunity, or more, because travelers from the U.S. and Europe would be able to pay a high price for protection. In endemic areas, disease experts envision vaccination campaigns targeting girls before puberty, because of the virus' links to birth defects. In boys, a vaccine could protect against future sexual transmission.

Larger companies in the Zika vaccine R&D effort are Sanofi, GlaxoSmithKline and Takeda, which each have paired with U.S. government entities to advance their research.

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