Hyderabad: Vaccine maker Bharat Biotech International Ltd., which is working on a vaccine candidate to prevent the Zika virus infection in humans, said it had crossed an important milestone by completing pre-clinical studies and has sought government approval to begin phase-1 trials, a top executive said.
“We have completed pre-clinical toxicology studies in animals successfully, and have sought permission from Drug Controller General of India (DCGI)," said D.V.J.A. Harshavardhan, director of viral vaccines and international affairs at Bharat Biotech.
In the proposed phase-1 trials, the vaccine candidate will be tested on around 100 people for safety.
Bharat Biotech;s Zika vaccine candidate, which is called Zikavac, is an inactivated vaccine, or the one that contains a dead virus.
Harshavardhan said there were indications that the government could fast-track the approval process for Zika vaccine.
In cases of health emergency, the Indian drug regulator fast-tracks drug or vaccine development by speeding up the approval process.
In February, the World Health Organization (WHO) 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.
The vaccine maker said it’s in constant touch with WHO and sharing details about the vaccine’s development.
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.
The candidate, though, may take years for trials to be completed before making it to the final vaccine stage.
Though there have been no known cases of Zika so far in India, 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 study cited India as one of the countries most vulnerable to an outbreak of the Zika virus.