According to sources, the government has authorized exports of Russia’s single-dose COVID-19 vaccine, Sputnik light domestically produced. As of now, the vaccine is not approved for use in India’s emergencies. Russian officials have approved the export of 40 lakh doses of Indian drug firm Hetero Biopharma Limited’s Sputnik Light; sources told PTI.
After obtaining emergency use authorization from India’s Drug Regulator in April, the Russian vaccine component-1 called Sputnik Light is being used in the country’s COVID inoculation programme.
Sputnik Light, a vaccine developed by Hetero Biopharma, a partner in the vaccine production with the Russian Direct Investment Fund (RDIF), has been requested for export to Russia until India’s drug regulator has approved it.
– The Russian Ambassador to the Centre, Nicholay Kudashev, indicated that Hetero Biopharma Limited has already manufactured 1,000,000 doses of component 1 of Sputnik V.
– The FDA has approved two million doses of Sputnik Light. Still, the vaccine’s shelf life might expire before its registration, which will lead to wasted amounts, according to sources.
As a source stated, “The government has permitted Indian drug firm Hetero Biopharma to export 40 lakh doses of Sputnik Light to Russia. The decision was taken this week following detailed deliberations.”
The RDIF worked closely with Indian pharmaceutical companies in recent months to scale up the manufacturing of the Sputnik vaccine in India so that it is used both locally and internationally, the ambassador stated in his communication last month.
RDIF and Dr Reddy’s Laboratories are registering the Sputnik Light in India in conjunction with the authorities.
The ambassador stated to V K Paul, chairman of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC, “We would like to note that Indian manufacturers of the Russian vaccine are discouraged by the current ban that prevents the use of the produced Sputnik Light vaccine in India and its export to other countries.”
It is possible to grant permanent or temporary export licenses to Hetero Biophar Limited to export the produced Sputnik Light vaccine to RDIF for registration in India, increasing production of the vaccine and supplying more Sputnik Lights to the Indian market could result from this, it said.
Dr Reddy’s Laboratory Limited has been granted permission to undertake phase-3 bridging trials of Sputnik Light in India by the Drugs Controller General of India (DCGI). The DCGI gave its approval based on recommendations of the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organization (CDSCO), which convened on August 5 to discuss the matter.
Dr Reddy’s, in line with the recommendations of the SEC meeting last month, plans to market the vaccine in India in conjunction with the RDIF and presented a proposal to conduct a clinical study in India as a result of the Russian Phase III trial.
The SEC recommendation had said, “After detailed deliberation, the committee recommended for grant of permission for conduct of Phase III immune-bridging clinical trial in Indian population subject to the condition.”
The company has now presented safety and immunogenicity and the longevity of antibodies, which gives insight into the longer-term persistence of antibodies in the participants. Sputnik Light was denied an emergency-use authorization by the Central Drugs Standard Control Organization in July.
Russian mass vaccination program between December 5, 2020, and April 15, 2021, which administered Sputnik Light as a single dose, demonstrated 79.4% efficacy, based on an analysis of 28-day data. According to RDIF’s press release from May 6, the Gamaleya Centre has proven Sputnik Light effective against all new coronavirus strains during laboratory tests.
According to the Russian Direct Investment Fund, the sovereign wealth fund that supported the vaccine’s development, Sputnik V is approved for use in more than 70 countries. Unfortunately, neither the European regulator nor the World Health Organization has approved the vaccine.
