Indian pharmaceutical company, Zydus Cadilla 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.
Zydus Cadila had started testing a two-dose regime of the vaccine with 3 milligrams in each dose soon after being granted an EUA.
The drug regulator had in August given Emergency Use Authorisation to the three-dose vaccine for everyone above the age of 12.
The company is now evaluating a two-dose regime with 3mg in each dose.
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 Rs 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.
Prime Minister Narendra Modi while addressing the 76th United Nations General Assembly in New York on September 25 had mentioned India was producing the world’s first DNA vaccine. “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.
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