New Delhi: The Indian Council of Medical Research (ICMR) said on Tuesday three vaccine candidates against the coronavirus disease (Covid-19) are in the clinical stage of trials in India and one of them will soon begin Phase 3 trials after getting clearances.
Covid-19 vaccine candidates being manufactured by Cadila Healthcare and Bharat Biotech have completed the first phase of the trial while the Serum Institute of India (SII) will begin with Phase 3 trial after getting the nod, Balram Bhargava, ICMR’s director general, said during the health ministry’s briefing.
Union Health Ministry Secretary Rajesh Bhushan, who was also at the press conference, said no one has presently applied for the emergency authorisation of the vaccine.
Bhargava said the country distributed the Covid-19 curve in such a way that it did not have many deaths and did not witness a huge peak. The comments came against the backdrop of All India Institute of Medical Sciences Director Dr Randeep Guleria’s statement that India is witnessing a second wave of coronavirus in some areas.
“During the peak in Europe and the US, there were huge numbers of mortalities. We took learning from that and were able to distribute the curve in such a way that we did not have those deaths. This was attributed to the lockdown. We were able to distribute the curve and did not have a huge peak at all,” said Bhargava, at a press conference, on being asked about the second wave.
India Tuesday reported a spike of 83,000 new coronavirus cases in the last 24 hours, taking the country’s total case tally past 49 lakh. The country’s overall Covid tally stands at 49,30,237 and 9,90,061 of them are active cases.
Emergency authorisation is not only for vaccines but for drugs, with an existing provision in the Drugs and Cosmetic Act for this. It is an accelerated process which permits the regulator to grant permission which is distinct from regular marketing authorisation.
One example is the US FDA giving emergency authorisation to Remdesivir. Similarly, emergency authorisation to Remdesivir was given by the India regulator too.
About the Sputnik vaccine, Bhushan said: “Russia has a good history of vaccine manufacturing and hence, we assume that this vaccine is also good. There is a dialogue going on between the high-level committee of the governments of India and Russia. We are trying to work out its mechanism.”
Sputnik V, an adenovirus vector-based vaccine, was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, along with the Russian Direct Investment Fund and was registered on August 11.
Earlier, NITI Aayog member, Dr. V.K. Paul had said that the Russian government has sought India’s help in manufacturing the Sputnik V vaccine and also to conduct Phase-3 trials or bridging studies in the country.
