Timeline Of Russian Sputnik V Covid-19 Vaccine, Approved For Emergency Use In India
A quick look at the journey of Russian Covid-19 vaccine Sputnik V, from its early days till its entry in India.
Russia's Covid-19 vaccine is the world’s first to be registered based on the human adenoviral vector-based platform.
Now, India has become the sixtieth country to approve the two-dose Sputnik V vaccine after the Drugs Controller General of India (DCGI) gave the green signal.
Here is the journey of Sputnik V and its entry into India.
June 2020: Russia’s sovereign wealth fund, Russian Direct Investment Fund (RDIF), Sistema PJSFC, and the Gamaleya National Research Institute of Epidemiology and Microbiology to organise a Sputnik V production site at the Alium plant in Moscow’s Zelenograd.
August 2020: On 11 August, Sputnik V was registered by the Russian health ministry and became the world’s first registered vaccine against coronavirus.
Towards the end of the month, the Gamaleya and RDIF announced the start of a post-registration clinical trial of the vaccine in Moscow.
September 2020: The RDIF announced the publication of a scientific on the results of Phase I-II clinical trials of Sputnik V in The Lancet.
Russia said that in 100 per cent of participants in the clinical trials, the vaccine generated a stable immune response.
The level of virus-neutralising antibodies was found to be 1.4-1.5 times higher than the level of antibodies in patients who had recovered from Covid-19.
Meanwhile, the Indian pharmaceutical company, Dr Reddy’s Laboratories Limited, decided to cooperate on clinical trials and the distribution of the Russian vaccine in India. While waiting for the regulatory approval, the RDIF agreed to supply 100 million (10 crore) doses to Dr Reddy’s.
October 2020: In India, the DCGI gave the nod to conduct an adaptive phase 2/3 human clinical trial for the Sputnik V vaccine.
Before receiving DCGI’s support for the trial, Dr Reddy’s announced a partnership with the Biotechnology Industry Research Assistance Council (BIRAC) (Department of Biotechnology, Government of India) for advisory support on clinical trials of the vaccine.
November 2020: Dr Reddy’s Russian partner, RDIF, announced that the first interim data analysis of the Sputnik V vaccine Phase 3 trials in Russia had demonstrated 92 per cent efficacy.
Later, the second interim analysis showed a 91.4 per cent efficacy for the vaccine on day 28 after the first shot, with a jump to over 95 per cent 42 days after the first dose.
Soon, Russia announced that the cost of the Sputnik V vaccine will be less than $10 (approximately Rs 750) in the international market.
Towards the end of the month, the RDIF and one of India’s leading generic pharmaceutical companies, Hetero, said that they agreed to produce over 100 million (10 crore) doses per year in India.
December 2020: Russian authorities began the vaccination programme in Moscow to inoculate those who are most at risk of contracting the virus.
Russian authorities then confirmed that the vaccine’s efficacy is 91.4 per cent based on data analysis of the final control point of the clinical trial in the country.
January 2021: Dr Reddy’s said that the 2/3 clinical trial of Sputnik V in India was a multicentre, randomised controlled study, which included safety and immunogenicity analysis.
Later, in India, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial – conducted on 100 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study.
According to an 11 January news release by Dr Reddy’s, the recommended phase 3 recruitment and to continue the trial without any changes. It also concluded that no safety concerns were identified and the study had met the primary end points of safety.
In mid-January, after analysing safety data from the phase 2 trial, the DCGI gave its nod to conduct a phase 3 clinical trial for the Sputnik V in India, involving 1,500 participants.
February 2021: Dr Reddy’s initiated the process with the DCGI mid-month for emergency use authorisation (EUA) of the Russian vaccine.
March 2021: Virchow Biotech Private Limited, one of the pharmaceutical producers in India, announced an agreement to produce up to 200 million (20 crore) doses per year of Sputnik V in the country.
April 2021: Panacea Biotec, one of India's leading vaccine and pharmaceutical producers, agreed to produce 100 million (10 crore) Sputnik V doses per year in the country.
According to reports, a committee of experts in India granted emergency-use approval to Sputnik V in the country on 12 April.
The next day, the DCGI approved the vaccine for emergency use, making it the third Covid-19 vaccine to be registered in India after Covishield and Covaxin.
Even though limited doses are likely to be manufactured by April-end, production will be ramped up gradually.
In India, trials are on for around 1,600 people from 18 to 99 and it is also being tested in the United Arab Emirates, Venezuela, and Belarus.
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