The RDIF, which is marketing the Sputnik V, and Dr Reddy’s Laboratories in September announced their partnership to run clinical trials and distribute the vaccine in India.
India’s drug regulator has knocked back a proposal from Dr Reddy’s Laboratories Ltd to conduct a large study in the country to evaluate Russia’s Sputnik-V COVID-19 vaccine and has asked it to first test the vaccine in a smaller trial.
The recommendations by an expert panel of the Central Drugs Standard Control Organisation (CDSCO) noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.
India’s move comes as a setback for Russia’s plan to roll-out the vaccine even before full trials show how well it works, while pushing back its efforts to win approval for the vaccine in the country that leads the world on average number of new infections.
India is expected to overtake the United States over the next several weeks as the country with the world’s largest number of cases.
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.
The Russian Direct Investment Fund (RDIF), which is marketing the Sputnik V, and Dr Reddy’s Laboratories in September announced their partnership to run clinical trials and distribute the vaccine in India.
Russia was the first country to grant regulatory approval for a novel coronavirus vaccine, and did so before large-scale trials were complete, stirring concerns among scientists and doctors about the safety and efficacy of the shot.RDIF and Dr Reddy’s did not immediately reply to Reuters’ requests for comment outside business hours.