Serum gets DCGI nod for phase II, III trials of vaccine
The Drugs Controller General of India (DCGI) has given the green light to Serum Institute of India, Pune, to conduct second and third phase clinical trials of Oxford University-astra Zeneca’s Covid-19 vaccine Covishield, a health ministry statement said.
“This will hasten development of the Covid-19 vaccine,” it added.
Serum’s Chief Executive Adar Poonawalla had earlier told Business Standard: “We have dedicated two of our facilities to produce millions of doses of Covid-19 vaccine, while withholding vast production of other products.”
Serum Institute had studied almost 1,000 patients in phase I trial. The next two phas e s will include 5,000 - 10,000 individuals. Of these, over 4,000 are expected to be from India, Poonawalla had said. He had said that there are a number of trial sites across Mumbai and Pune, since these cities have several hotspots. This will help in understanding the efficacy of the vaccine.
While the price of the vaccine has not yet been decided, Poonawalla said he would like to keep it under ~1,000. Covid vaccine, experts believe, may have to be administered in at least two doses.
Vaccine trials start with preclinical toxicity studies on laboratory animals after which the phase I human trials begin. This phase checks for any direct toxicity or abnormal immune response to the vaccine. Once the phase I results come in, it is seen by the supervisory body, which then gives nod for the next phase. In phase II, the vaccine is given to people and studied for antibodies and side effects. In the third phase, a large number of people are given the vaccine and monitored over a period of time for efficacy and safety.