New Delhi : Indian pharmaceutical company Zydus Cadila has received the approval of the Indian Drugs Regulator (DCGI) for the Phase III trial of its two-dose Covid-19 vaccine ZyCoV-D. “The company has received permission to conduct Phase III trials for a two-dose COVID vaccine,” Cadila Healthcare said in its regulatory application.
The first DNA vaccine ZyCoV-D is also the first indigenously developed vaccine that has been tested in children. The three-dose vaccine was granted an emergency use (EUA) by India’s drug regulators in August after interim clinical trial data showed it was 66% effective in preventing symptomatic COVID-19.
However, the company has not released details of this study or submitted it for a peer-review. Zydus Cadila began testing a two-dose regimen of the vaccine with 3 mg in each dose soon after the EUA was given.
Actually, all vaccines go through three phases of testing. In the first phase, the vaccine is given to a small number of people to test safety and dosage and see if it triggers an immune response.
Whereas in the second phase, the vaccine is tested in different groups, such as children, the elderly, etc. to see if it affects people differently.
After this, in the third phase, the vaccine is tested in thousands of people to check how many are infected with the virus compared to the placebo group. Phase II tests the safety of the vaccine while Phase III tests the efficacy rate of the vaccine.
Prime Minister Narendra Modi, while addressing the 76th United Nations General Assembly in New York on September 25, mentioned India to produce the world’s first DNA vaccine. He had said, “I want to inform UNGA that India has developed the world’s first DNA vaccine, which can be given to all people above 12 years of age.”
The Ahmedabad-based healthcare manufacturer is expected to release its three-dose vaccine from October, but the price of the vaccine remains an issue for the time being. The company is said to have proposed a price of Rs 1,900 for its three-dose vaccine, but the central government is in talks for a price reduction, and a decision on it is likely to be taken later this week. Is.