Covid-19 vaccine: Dr Reddy’s seeks emergency use approval for Sputnik V; Why it is important for India

By: |
February 20, 2021 2:12 PM

Dr Reddy’s Laboratories has been conducting human trials of the Sputnik-V vaccine in the country with more than 1500 participants. While phase 2 of the human trial has already been wrapped up by the Indian company, the third phase is expected to come to a close by February 21.

At present, two Coronavirus vaccines are being used in the country namely Covishield and Covaxin, and the entry of another vaccine would further expedite the fight against Coronavirus.At present, two Coronavirus vaccines are being used in the country namely Covishield and Covaxin, and the entry of another vaccine would further expedite the fight against Coronavirus.

Even as the Coronavirus vaccination drive for healthcare and frontline workers in the country is going at full throttle with more than 1 crore beneficiaries so far, a new Coronavirus vaccine could give a further boost to the inoculation drive. According to a report by The Indian Express, Dr Reddy’s Laboratories has approached the Drug Controller General of India (DGCI) to get emergency use approval for the Russia-developed corona vaccine Sputnik-V. At present, two Coronavirus vaccines are being used in the country namely Covishield and Covaxin, and the entry of another vaccine would further expedite the fight against Coronavirus.

What is Sputnik V vaccine?

The vaccine named after the first Soviet satellite has been developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology and was one of the few vaccines which were used for emergency use in the Eurasian country. In association with the Russian authorities, Dr Reddy’s Laboratories has been conducting human trials of the Sputnik-V vaccine in the country with more than 1500 participants. While phase 2 of the human trial has already been wrapped up by the Indian company, the third phase is expected to come to a close by February 21, as per the Indian Express report.

How will Covid-19 fight get a boost with Sputnik-V?

Apart from becoming the third potent force in the armour of the Indian healthcare authorities against Coronavirus, the vaccine has also been claimed to be more efficient and effective than the other two vaccines presently in use in the country. The interim results of the study conducted by renowned scientific journal The Lancet had pegged the effectiveness of the vaccine at about 91.6 percent which is far more than that of Covaxin and Covishield. As far as the efficacy of Covishield and Covaxin are concerned, the former is understood to be effective in the range of 53 to 79 per cent whereas the latter’s efficacy is not known at present.

What now?

After submitting the emergency approval request with the DGCI, the company’s request will be taken into consideration by a Subject Expert Committee which will take the final call on the approval. Dr Reddy’s Laboratories has said that it has submitted all the data and safety profile collected during the phase 2 trial along with the interim data from the phase 3 trials.

It is pertinent to note that the DGCI had earlier given its go ahead to the indigenous vaccine ‘Covaxin’ developed by Hyderabad based Bharat Biotech even as the vaccine could not conclude its third phase human trials. It remains to be seen whether the DGCA does the same in the case of Sputnik-V. The vaccine which was developed in Russia had come into controversy after the Russian government had allowed the emergency use of the vaccine on its population without the completion of the human trials. However, the subsequent trials conducted in different studies have shown the vaccine to be substantially effective against Coronavirus.

Pharma companies including from India were initially hesitant to approach Russia for the vaccine due to the controversy, however the negotiations picked up pace as the human trials termed the vaccine effective.

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