Updated: September 18, 2020 12:25:23 pm
A new vaccine is on display at the Nikolai Gamaleya National Center for Epidemiology and Microbiology in Moscow, Russia. (AP)
Pharmacist Dr. Reddy’s Laboratories (DRL) announced on Wednesday (September 16) that it will distribute 100 million (10 crore) doses of Russian Sputnik V Covid-19 vaccine in India after conducting final-stage human trials and receiving regulatory clearances here.
If India’s main drug regulatory body approves phase 3 trials in the country, Sputnik V will replace ‘Covishield’ from the Serum Institute of India (SII) as the leader in the race to produce a Covid-19 vaccine for India.
What is the Sputnik V vaccine?
It is a vaccine that uses what is known as “human adenoviral vector” technology. Adenoviruses cause a wide range of illnesses ranging from fever, cough, and sore throat to conjunctivitis, diarrhea, and bladder infections. 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 cells in the human body to produce the pointed outer shell (spike protein) of SARS-CoV-2, the virus that causes Covid-19.
This is expected to help the body recognize the spike protein as a foreign substance and develop an immune response against it so that it can fight the actual virus when it tries to infect.
Sputnik V uses two different genetically modified adenoviruses to carry the spike protein. The vaccine containing the second adenovirus is given 21 days after the first and is expected to “boost” the body’s immune response and develop “long-lasting immunity.”
Developed by the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology, the Sputnik V vaccine was approved for public use in Russia on August 11.
What does the DRL deal mean for India? How soon will it be available to the public in this country?
While India has been in talks with Russia to explore the possibility of using Sputnik V here for about a month, the DRL deal is the first concrete development showing that the vaccine will make its way to India.
DRL announced on Wednesday its agreement with the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund that has been closely involved in these discussions, to carry out phase 3 human clinical trials of the vaccine in India. , after which the vaccine will be distributed. here for public use.
If the schedule given by RDIF is to be believed, around 100 million (10 crore) Indians can expect to start receiving a Covid-19 vaccine by the end of this year. Each dose of the vaccine includes two vials containing separate adenoviral vectors, according to an RDIF spokesperson.
Following the government’s vaccination priorities, healthcare and frontline workers, as well as those working in occupations that would make them vulnerable to exposure to Covid-19, could be the first to receive this (or indeed any other) vaccine. After this, the older population and people with comorbidities can receive the vaccine.
Of course, this will depend on how long it takes for the phase 3 trials in India to conclude and whether the Indian regulatory authorities are convinced of the safety and efficacy data generated in these trials.
📣 Express explained is now in Telegram. Click here to join our channel (@ieexplained) and stay updated with the latest
The development of any vaccine is a long and complex process. What are the things to keep in mind in the future of the Russian candidate?
This vaccine was approved in Russia even before phase 3 trials were conducted. Even phase 1 and phase 2 human trials were conducted in a very small group of less than 100 people. While the findings from early studies showed the vaccine to be safe, the relatively small number of volunteers in the trials and the omission of phase 3 trials before approvals has drawn global criticism.
The only way to truly determine the safety and efficacy of this vaccine is to look at the long-term information from people vaccinated in previous trials, as well as to conduct larger phase 3 trials over a longer period of time.
Don’t miss Explained | What is the serial interval and how can it be managed to control Covid-19?
These phase 3 trials often enroll thousands of volunteers representing a more diverse population and verify whether the vaccine is capable of generating the required immune response effectively and without serious adverse reactions.
To this end, post-registration trials involving 40,000 volunteers are underway, according to RDIF. Brazil is also expected to approve the vaccine for local use only after phase 3 trials.
The performance of this vaccine in India will now depend on the protocol DRL follows, the results of the phase 3 trials here, and the data generated from post-registration trials in Russia and late-stage trials in other countries. DRL is expected to approach the Indian regulator with its request to carry out phase 3 testing here “shortly,” according to RDIF.
📣 The Indian Express is now on Telegram. Click here to join our channel (@indianexpress) and stay up to date with the latest headlines
For the latest news explained, download the Indian Express app.
© The Indian Express (P) Ltd
.
