The Ahmedabad-based pharmaceutical company Zydus Cadila has received approval from the Drugs Controller General of India(DCGI) to conduct phase III trials of the COVID-19 vaccine – ZyCoV-D.
ZyCoV-D is the first indigenously developed vaccine that has included trials on children. Post the data showed that the three-dose regime of the vaccine was 66 percent effective in preventing symptoms after its interim clinical trial data, India’s drug regulators granted an emergency use authorisation (EUA) to the vaccine.
Soon after being granted emergency use authorisation, the company had started testing a two-dose regime of the vaccine with 3 milligrams in each dose.
The vaccines go through three phases of trials. In the first phase, the vaccine is administered to a small number of people to see if it triggers an immune response and whether it is safe. In the second phase of the trial, the vaccine is to be tested in different groups based on age to see if it affects people differently. The third phase includes the vaccine to be tested on thousands of people to check how many are infected with the virus in comparison to the sample group. The second phase tests and determines the safety while the third phase tests and determines the efficacy rate of the vaccine.
Zydus Cadila expects a roll-out of its vaccine from October in the market. It is said to have proposed Rs 1,900 for its three-dose jab. However, the Union government is still negotiating for the reduction of price – which will be probably announced later this week after negotiations.
