Zydus Cadila, the Indian pharmaceutical company, has received the Indian drug regulator’s nod for conducting phase III trials of its two-dose Covid-19 vaccine ZyCoV-D.
The company has “got the permission for conduct of phase III trials for two-dose Covid vaccine,” Cadila Healthcare said in a regulatory filing.
ZyCoV-D, the first DNA vaccine, is also the first indigenously developed vaccine that has been trialled in children. The three-dose regime of the vaccine was granted an emergency use authorisation (EUA) by India’s drug regulators in August after interim clinical trial data showed it was 66% effective in preventing symptomatic Covid-19. The company has, however, not released details of the study or submitted it for a peer-review.
Zydus Cadila had started testing a two-dose regime of the vaccine with 3 milligrams in each dose soon after being granted an EUA.
All vaccines go through three phases of trials, in the first phase the vaccine is given to a small number of people to test safety and dosage, and to see if it triggers an immune response, in the second phase the vaccine is tested in different groups such as children, the elderly et al to see if it affects people differently, and in the third phase the vaccine is tested in thousands of people to check how many are infected with the virus in comparison to the placebo group. The second phase tests the safety of the vaccine while the third tests the efficacy rate of a vaccine.
Prime Minister Narendra Modi had mentioned India was producing the world’s first DNA vaccine while addressing the 76th United Nations General Assembly in New York on September 25. “I want to inform UNGA that India has developed the world’s first DNA vaccine, which can be administered to all people above the age of 12 years,” he said.
The Ahmedabad-based healthcare manufacturer expects a roll-out of its three dose regime from October but pricing of the vaccine has remained an issue. The company is said to have proposed a price of ₹1,900 for its three-dose jab, but the Union government is negotiating for a reduction in price, and a decision on the same is likely to be taken later this week, news agency PTI reported on Monday.