Serum Institute gets nod for Phase-2 and 3 trials of Oxford's Covid vaccine

Once the phase one results come in, it is seen by the supervisory body, who then allows the next phase
The Drugs Controller General of India (DCGI) has given approval to Serum Institute of India, Pune to conduct second and third phase clinical trials of the Oxford University-Astra Zeneca Covid-19 vaccine Covishield, a health ministry statement said. 

“This will hasten the development of the Covid-19 vaccine,” it added.

In an earlier interview with Business Standard, Serum's CEO Adar Poonawalla had said, “We have dedicated two of our facilities to produce millions of doses for Covid-19 vaccine, while withholding vast production of other products.” 

Serum Institute had studied almost 1,000 patients in the phase one trial. The next two phases 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, which will help in understanding the efficacy of the vaccine. 

While the price of the vaccine has not yet been decided, Poonawalla said that he would like to keep it under Rs 1,000. 

The Covid vaccine, experts believe, is likely to be administered in at least two doses. 

Vaccine trials start with pre-clinical toxicity studies on laboratory animals, after which phase-1 human trials begin. This phase checks for any direct toxicity or abnormal immune response to the vaccine. 

Once the phase one results come in, it is seen by the supervisory body, who then allows the next phase. 

In phase-2, the vaccine is given to those who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended and studied for antibodies and side effects.

In the third phase a large number of people are given the vaccine and monitored over time for efficacy and safety.

India is inching towards the 2 million mark after adding over 52,000 cases in a single day as of Monday morning. The number of covid deaths has risen to 38,135. 

“The current case fatality rate touched 2.11 per cent today. This is the outcome of the well-conceived and effectively implemented strategy of "Test, Track and Treat" which has guided the Covid management in the country,” health ministry statement said. 

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