Upon regulatory approval in India, RDIF will supply 100 million doses of Sputnik V to Dr Reddy's.
Dr Reddy's Laboratories will test the Russian COVID-19 vaccine Sputnik V on 100 Indian volunteers for phase 2 clinical trials. Dr Reddy's and Russian Direct Investment Fund (RDIF) had on October 17 announced getting the approval from the Drug Controller General of India (DCGI) VG Somani to conduct phase 2 and 3 clinical trials of the Sputnik.
The date and time of the test are yet to be determined by the Hyderabad-based drugmaker.
"Dr Reddy's Lab has said that the phase 2 clinical trial would include 100 subjects and for phase 3, it would take 1,400 subjects," LiveMint quoted an official as saying.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
"Once the pharma company would submit the safety and immunogenicity data of phase 2, it would be analysed by the expert panel and then they can proceed for the phase 3 trial," the official added.
Last week, the expert committee of DCGI had recommended granting permission to Dr Reddy's Laboratories for conducting the final trials of the Russian COVID-19 vaccine candidate.
The nod came after the company submitted a reworked application to the DCGI on October 13 with more information on phase 2 and 3 trials.
Developed by Moscow’s Gamaleya Institute, the Russian Defence Ministry and the Russian Direct Investment Fund (RIDF), Sputnik V is based on a modified human adenovirus as the vector that carries the SARS-CoV-2 virus protein.
Dr Reddy's has also collaborated with RDIF for the distribution of the vaccine. Upon regulatory approval, RDIF will supply 100 million doses of the vaccine to Dr Reddy's, the firm has said.
India's COVID-19 tally climbed to 78.14 lakh with 53,370 fresh cases on October 24. There are 6,80,680 active cases of coronavirus infection in the country.Click here for Moneycontrol's full coverage of the COVID-19 outbreak