Bharat Biotech’s Zikavac to enter phase-I clinical trials

The company's Zika vaccine has completed pre-clinical studies and is now awaiting the regulator's approval to begin phase-1 trials


New Delhi:  Bharat Biotech has recently completed pre-clinical studies on its novel Zika vaccine candidate- Zikavac and is now seeking the approval of the government to begin phase-1 trials. As per company’s announcement, if the proposed phase-1 trials, the vaccine candidate will be tested on around 100 people for safety.

Bharat Biotech in February unveiled two of its vaccine candidates to protect humans against the mosquito-borne Zika virus and claimed that it is probably the first in the world to file for a global patent for Zika vaccine candidates.

“We have completed pre-clinical toxicology studies in animals successfully, and have sought permission from Drug Controller General of India (DCGI),” mentioned D V J A Harshavardhan, Director of viral vaccines and international affairs at Bharat Biotech. The officials also indicated that the government could fast track the approval process of the vaccine.

Zikavac, is an inactivated vaccine, or the one that contains a dead virus. The vaccine maker said it’s in constant touch with WHO and sharing details about the vaccine’s development. The World Health Organization (WHO) had recently declared a global public health emergency because of Zika’s apparent link to microcephaly, a birth defect marked by small heads and serious developmental problems in infants.

Recently detected in Brazil, Zika is currently wreaking havoc in the Southeast Asian countries. Though India has no known cases of the virus so far, a Lancet study in September said that 2.6 billion people living in parts of Asia and Africa could be at risk of infection, based on a new analysis of travel, climate and mosquito patterns in those regions.

The US CDC had recently issued a travel warning stating that pregannat women must avoid travel to 11 countries in Southeast Asia where theZika virus was circulating. The countries cited in the new advisory by the C.D.C. include Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, the Maldives, Myanmar, the Philippines, Thailand and Vietnam.