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.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

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.

Related Articles:
Inovio kicks off its second Zika vax trial
Thanks to travelers, Zika could be a $1B+ vaccine opportunity: Reuters
Sanofi enlists for top Army hospital’s fight against Zika virus
Takeda joins frenzied Zika vaccine hunt in $312M deal with U.S. government
GSK jumps into Zika vax hunt on heels of Sanofi's deal
NIH kicks off PhI trial for Zika vax as caseload rises in U.S.

Suggested Articles

FDA officials say Novartis took too long to launch a formal probe into allegations of Zolgensma data manipulation.

Should Johnson & Johnson owe billions to fix Oklahoma's opioid crisis? After weeks of trial testimony, a judge will have his say Monday afternoon.

After Endo and Allergan agreed to settle with two Ohio counties on opioid charges this week, the state’s AG has a message: You’re not off the hook.