: A subject matter expert committee advising India’s drug regulator has recommended Hetero Biopharma’s proposal to manufacture Sputnik V, the Russian COVID-19 vaccine.
The panel’s decision, which will help increase the availability of the vaccine, followed a proposal by the Hetero Group firm that included interim safety and immunogenicity results from a Phase III clinical trial.
The committee, which examines COVID-19 related proposals under the expedited approval process, recommended to the Central Drugs Standard Control Organization (CDSCO) in its meeting on September 16 that Hetero Biopharma be allowed to manufacture the vaccine. “After detailed deliberations, the committee recommended allowing the manufacture of Sputnik V vaccine for restricted use in emergency situations subject to various regulatory provisions,” the panel said according to the minutes of the meeting.
Sputnik V (Gam COVID Vector Vaccine) is one of three vaccines being used in India’s inoculation programme. India’s Drug Controller General granted emergency access for the Russian vaccine in April this year. However, four months after the pilot launch of Sputnik V in the country, the vaccine is available only in select towns and cities.
Hetero is one of the firms with which Russia’s sovereign wealth fund RDIF, which is marketing the vaccine globally, entered into a manufacturing partnership, a list that also includes Serum Institute, India’s largest vaccine maker. .
Recommending permission to Hetero Biopharma, the expert committee said that regulatory provisions that would be applicable would include, besides submission of PI (product information), safety and immunogenicity data from ongoing clinical trials in the country for review. Presenting firm. ), SMPC (Summary of Product Characteristics) and factsheet to CDSCO after incorporating the latest safety and immunogenicity data.
The Russian Direct Investment Fund (RDIF) in November announced a partnership with Hetero Biopharma to manufacture more than 100 million doses annually.
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