On Monday, according to the national paper of record, the Times of India, authorities in the capital, New Delhi, granted Emergency Use Authorization to the Russian-made vaccine. The move comes after an expert committee met earlier this week and agreed to request more information from Hyderabad-based healthcare giant Dr Reddy’s Laboratories, a domestic pharmaceutical company licensed to test and manufacture Sputnik V under agreement with its Russian developers.
The country has seen a record-breaking spike in cases in recent weeks, with 168,912 positive tests recorded in the country on Sunday alone. Since the beginning of the pandemic last march, more than 170,000 people have died with the virus, according to government figures.
The South Asian nation was home to 1.36 billion people as of 2019, and forecasts anticipate that it will overtake China as the world’s most populous country within the next five years. India has also been instrumental in the testing of a number of potential vaccine candidates, including British pharma company AstraZeneca’s formula.
Later on Monday, the RDIF said that it was yet to receive formal notification of the decision, and confirmed that “it is awaiting imminently the recommendation by the Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) of India to approve the use of the Russian Sputnik V vaccine against coronavirus in India.”
In January, Dr Reddy’s Laboratories announced that it had submitted safety data to local regulators based on a Phase II trial of Sputnik V. As part of a partnership with the Russian Direct Investment Fund (RDIF), which financed the development of the vaccine, Indian scientists were able to study its safety and efficacy.
In March, the RDIF announced that it had concluded contracts that will allow three separate Indian medicines manufacturers to produce vials within the country. Virchow Biotech, Stelis Biopharma and Gland Pharma will together make more than 750 million doses, enough for more than 300 million people. Dr Reddy’s Laboratories has had an agreement licensing it to supply Sputnik V in place since September last year.
Another 59 nations have already signed off on the use of Sputnik V, covering a total population of more than 1.5 billion people, many in developing countries. Mexico, Vietnam, Kenya and Hungary are among those already using the jab as part of national immunization programs.
Earlier this year, the UK’s leading medical journal, The Lancet, published preliminary Phase III trial data that showed the formula was both effective against Covid-19 and safe. The study, which recruited nearly 20,000 volunteers, found that Sputnik V had an overall efficacy rate of 91.6% in protecting against the virus, and 100% efficacy at preventing severe cases from developing.
India already manufactures two coronavirus vaccines; Covishield, the local brand name for AstraZeneca’s product, and Covaxin, a home-grown variant that has a reported 81% efficacy rate.
Think your friends would be interested? Share this story!