Sputnik V vaccine authorized in India

Sputnik V vaccine authorized in India

India has become the 60th country to approve Sputnik V

Sputnik V is one of only three vaccines registered in India

The Russian vaccine has been approved for use in countries with total population of 3 billion people

Moscow, April 12, 2021 – 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.

Sputnik V is one of only three coronavirus vaccines registered by India’s regulatory authorities.

India is the most populated country to register the Russian vaccine. Total population of 60 countries where Sputnik V is approved for use is 3 billion people or about 40% of the global population.

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.

India is the leading production hub for Sputnik V. RDIF has reached agreements with the leading pharmaceutical companies in the country (Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech) aimed at production of more than 850 million doses per year.

Sputnik V ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators.

Sputnik V 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:

“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.

India is a vaccine-manufacturing hub and our strategic partner for production of Sputnik V. RDIF has created partnerships with a number of India’s leading pharmaceutical companies for production of Sputnik V which will provide for both vaccination of the population in India and global distribution of the Russian vaccine. Over 850 million doses of Sputnik V are going to be produced in India annually sufficient to vaccinate more than 425 million people around the world.”

Sputnik V has a number of key advantages:

·        Efficacy of Sputnik V is 91.6% 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 efficacy of over 90%; Sputnik V provides full protection against severe cases of COVID-19.

·        The Sputnik V vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years.

·        Sputnik V uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.

·        The safety, efficacy and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades.

·        There are no strong allergies caused by Sputnik V.

·        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.

·        The price of Sputnik V is less than $10 per shot, making it affordable around the world.