In a surprising move, Russia became the first country to grant approval for a COVID-19 vaccine named “Sputnik V”. This announcement brings some immediate questions in our mind. Does this mean the vaccine will come to the market now? If yes, how soon will India get the vaccine? Is the vaccine safe? This article will answer some of these important questions.
What is Sputnik V?
The “Sputnik V” is a vaccine developed by the Gameleya Institute of Epidemiology and Microbiology in collaboration with Russia’s Defence Ministry. It is a viral vector vaccine, that is expected to provide immunity from SARS-CoV-2 (the virus that causes COVID-19), for up to two years.
What is the regulatory status of Sputnik V?
The Phase I trials that began less than two months ago were conducted on 38 participants. The vaccine was reported to deliver positive and safe results post early phase trials.
Why this announcement is being criticized by scientists worldwide?
Scientists all over the world have criticized this announcement because ‘Sputnik V’ has not yet completed its phase-III trial, which involves wide-scale testing with thousands of participants. Sputnik V has only completed Phase I of clinical trial and there is no public data available regarding safety and efficacy of this vaccine. Moreover, WHO has said that Sputnik V is not among the nine vaccines that it considers in the advanced stage of testing.
Before any drug or vaccine is licensed for use in population, it needs to undergo three phases of testing. Generally, Phase I clinical trials for vaccines are small, involving 20-80 participants, and only assess the safety of the candidate. Phase II trials may involve 100-300 of people and assess the vaccine’s possible efficacy. Lastly, Phase III trial involves tens of thousands of people and evaluates whether the vaccine protects against infection and disease. Carefully conducted clinical trials are necessary to identify any problems with the vaccine.
Because of these reasons, Russia’s announcement with plans for quick distribution in the general population is being criticized by scientists worldwide.
When will the vaccine come in market?
Russia has reported that the first batch of the vaccine will be made available for medical personnel in the next two weeks. The Phase III clinical trials reported to start soon and mass production of the vaccine is set to start by September.
When will India get the vaccine?
Nearly 20 countries including India have reportedly expressed interest to procure doses of the Russian vaccine as well as to conduct large-scale clinical trials. However, stressing the importance of safety and efficacy, our National Expert Group on Vaccine Administration has made it clear that India is focusing on only those vaccines that are in Phase II or III trials. Hon’ble PM Modi has also declared that India will soon get a ‘Made in India’ Vaccine and presently, three vaccine candidates are at different stages of testing in the country.
Do you agree with India’s stand to focus on safety and efficacy of vaccine before rushing to vaccine approval?
- 1. Ghosh A (2020) ‘Govt got no requests for phase 3 trials of Russia’s Covid vaccine Sputnik V in India’, The Print, 13 August.(Accessed on 15 August 2020)
- 2. Wagner AL (2020) ‘COVID-19: It’s Risky to Cut Corners on Vaccine Clinical Trials – as Russia Is’ The Wire Science, 13 August. (Accessed on 15 August 2020)
- 3. ‘Russia’s coronavirus vaccine Sputnik V: How soon can India get the vaccine?’ Times of India, 13 August. (Accessed on 15 August 2020)