DR REDDY’S Laboratories (DRL) announced on Wednesday that it will distribute 100 million (10 crore) doses of Russia’s Sputnik V Covid-19 vaccine in India after conducting final-stage human trials and receiving regulatory clearances here.
Should India’s top drug regulatory body sign off on phase 3 trials in the country, Sputnik V will replace Serum Institute of India’s (SII’s) ‘Covishield’ as the front runner in the race to produce a Covid-19 vaccine for India.
Q. What is Sputnik V?
A. This is a vaccine that uses ‘human adenoviral vector’ technology —basically vaccines that make use of ‘adenoviruses’ known to cause a wide range of illnesses, ranging
from fevers, coughs and sore throats to pink eye, diarrhoea and bladder infections. The adenovirus is modified and weakened so that it cannot replicate in the human
body. Instead, it will act like a Trojan Horse, carrying instructions for the cells in the human body to produce the spiky outer layer (spike protein) of SARS-CoV-2, the virus that causes Covid-19. This is expected to help the body recognise the spike protein as a foreign substance and build an immune response against it so that it can tackle the real virus when it tries to infect.
Q. What does DRL’s agreement Mean for India? How soon will It be available to Public here?
A. While India has been in discussions with Russia to explore the possibility of using Sputnik V here for around a month now, this is the first concrete development that shows the vaccine will come to India. DRL on Wednesday announced its agreement with the Russian Direct Investment Fund (RDIF)—Russia’s sovereign wealth Fund that has been closely involved in these discussions—to perform phase3 human trials of the vaccine in India following which it would distribute the vaccine here for public use.
If the timeline given by RDIF is to be believed, this means that at least 100million(10crore) Indians can expect to start getting a Covid- 19 vaccine by the end of this year itself—one dose of the vaccine includes the two vials consisting the separate adenoviral vectors.
Going by the government’s vaccination priorities, healthcare and front line workers and those who work in occupations that would make them vulnerable to Covid might be the first to get it.
Q. What are the potential issues that we should keep in mind with this vaccine ? What is the road ahead?
A. This vaccine was approved in Russia even before phase3 trials were conducted.
Even the Phase- 1 and 2 human trials were conducted on less than 100 people.
While findings from the earlier studies showed that the vaccine was safe, the relatively smaller number of volunteers in the trials and lack of phase3 trials before approvals had drawn global criticism.
The only way to truly ascertain the safety and effectiveness of this Vaccine is to look at long-term information from those vaccinated in the earlier trials as well as to conduct larger phase 3 trials over a longer period of time.
These phase3 trials often enrol thousands of volunteers representing a more diverse population and checks for whether the vaccine is able to generate the required immune response effectively and without any serious adverse reactions. To this end, post-registration trials involving 40,000 volunteers are now underway, according to RDIF.