India has become the 60th country to authorize the use of the Russian Sputnik V vaccine against coronavirus, and the vaccine is now approved in countries with a total population of 3 billion, or 40 percent of the world’s population, the Russian Direct Investment Fund (RDIF) said on Monday.
“The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announces that Drug Controller General of India (DCGI) has approved the use of the Russian Sputnik V vaccine against coronavirus in the country. India has become the 60th country to approve Sputnik V,” the RDIF said in a statement.
The vaccine has been registered in India under the emergency use authorization procedure based on results of clinical trials in Russia as well as positive data of additional Phase III local clinical trials in India conducted in partnership with Dr. Reddy’s Laboratories, according to the company.
Sputnik V ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators.
The vaccine has also been approved in Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (entity of Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent and the Grenadines, Kazakhstan, Uzbekistan, Gabon, San-Marino, Ghana, Syria, Kyrgyzstan, Guyana, Egypt, Honduras, Guatemala, Moldova, Slovakia, Angola, Republic of the Congo, Djibouti, Sri Lanka, Laos, Iraq, North Macedonia, Kenya, Morocco, Jordan, Namibia, Azerbaijan, Philippines, Cameroon, Seychelles, Mauritius, Vietnam, Antigua and Barbuda, Mali and Panama.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said in a statement: “We appreciate the decision of India’s regulatory bodies to grant authorization for Sputnik V. Approval of the vaccine is a major milestone as Russia and India have been developing an extensive cooperation on clinical trials of Sputnik V in India and its local production.”
“The Russian vaccine has efficacy of 91.6% and provides full protection against severe cases of COVID-19 as demonstrated by the data published in one of the leading medical journals The Lancet,” he added.
The efficacy of Sputnik V is 91.6 per cent as confirmed by the data published in the Lancet, one of the world’s oldest and most respected medical journals; it is one of only three vaccines in the world with an efficacy of over 90 per cent; Sputnik V provides full protection against severe cases of COVID-19.
The storage temperature of Sputnik V at +2+8 C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.
Russian Ambassador to India Nikolay Kudashev said that Moscow hoped that the approval by the Drugs Controller General of India (DCGI) “will be completed soon”.
“We note the reports that a committee of experts recommended #SputnikV for use in #India. This step would definitely contribute to the efforts of the Indian government to counter the COVID-19 pandemic. We hope the approval by the DCGI will be completed soon,” he wrote in a tweet.
On Sunday, government sources told ANI that by end of the third quarter of this year, India will be getting vaccines from five additional manufacturers.
“India currently has two Covid-19 vaccines being manufactured locally: Covishield and Covaxin, and we can expect five more vaccines by Q3 2021. These vaccines are the Sputnik V vaccine (in collaboration with Dr. Reddy’s), Johnson & Johnson vaccine (in collaboration with Biological E), Novavax vaccine (in collaboration with Serum India), Zydus Cadila’s vaccine, and Bharat Biotech’s Intranasal Vaccine. Safety and efficacy are the Union government’s primary concerns while granting emergency use authorisation (EUA) to any Covid-19 vaccine in the country,” the sources had told ANI.
The Russian vaccine has an effectiveness of 91.6 per cent. Russia registered Sputnik V for public use in August, the first country to do so, though the approval came before the start of the large-scale trial in September.
The EUA of Sputnik V comes at a time when India is facing the second wave of Covid-19 pandemic with the number of new cases increasing each day.