New Delhi: India said Tuesday that it will approve the use of all coronavirus vaccines that have been given an emergency nod by the World Health Organisation or regulators in the United States, Europe, Britain or Japan.
India's Health Ministry said the decision was aimed at hastening the use of shots made in other countries and expanding the “basket of vaccines” available for domestic use. The country of almost 1.4 billion people is seeing a crippling surge of infections that is threatening to overwhelm hospitals in hard-hit cities.
The only way out of the crisis, experts say, is to vaccinate more people.
But this has global implications since India is a major vaccine producer and India's domestic needs have delayed the delivery of shots to the UN-backed COVAX initiative that is aimed at distributing vaccines equitably.
India had earlier given the nod to the AstraZeneca vaccine made by Serum Institute of India and another one made by the Indian company Bharat Biotech. The Health Ministry said Tuesday that the Russian Sputnik V vaccine was also green-lit for emergency use.
Now, vaccines that have received emergency use authorization by regulators in the U.S., Europe, Britain, Japan or the World Health Organization can be used in India. The first 100 people who receive these shots will be monitored for a week to check for safety before being administered to more people, the Health Ministry said.
India to produce 850 mn Sputnik V doses annually: RDIF
The Russian Direct Investment Fund (RDIF) has said more than 850 million doses of the Sputnik V vaccine are going to be produced annually in India, which has also given approval for the emergency use of the vaccine against coronavirus infections in the country.
The Drug Controller General of India (DCGI) has registered the vaccine under the emergency use authorisation procedure. This is 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.
The vaccine has been approved for use in countries with a total population of 3 billion people or about 40 per cent of the global population, and India has become the 60th country to approve Sputnik V, RDIF, Russia's sovereign wealth fund, said in a statement.
India is also the most populated country to register the vaccine and also the leading production hub for Sputnik V, it added.
On Monday, sources said DCGI has granted permission for the restricted emergency use of Sputnik V with certain conditions.
Sputnik V will be the third vaccine to be used in India against coronavirus. In January, DCGI had given the emergency use authorisation for two COVID-19 vaccines - Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca manufactured by Serum Institute of India in Pune.
RDIF CEO Kirill Dmitriev said approval of the vaccine is a major milestone as both countries 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 per cent 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.
Noting that India is a vaccine-manufacturing hub and a strategic partner for production of Sputnik V, he said 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 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," he said.
According to the release, RDIF has agreements with India's Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech aimed at production of more than 850 million doses per year.
As per RDIF, Sputnik V has a number of key advantages, including that there are no strong allergies caused by Sputnik V.
The price of the vaccine is less than USD 10 per shot and it 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, it added.
Other countries that have approved use of Sputnik V include Argentina, Bolivia, Hungary, UAE, Iran, Mexico, Pakistan, Bahrain and Sri Lanka.
