: A subject expert committee that advises 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 enhance availability of the vaccine, followed a proposal from the Hetero group firm that included interim safety and immunogenicity results from the Phase III clinical trial it had conducted.
The committee, which examines COVID-19 related proposals under an accelerated approval process, at its meeting on September 16 recommended to the Central Drugs Standard Control Organization (CDSCO) that Hetero Biopharma be allowed to manufacture the vaccine. “After detailed deliberation, the committee recommended for grant of permission to manufacture Sputnik V vaccine for restricted use in emergency situations subject to various regulatory provisions," the panel said as per the minutes of the meeting.
Sputnik V (Gam COVID Vector vaccine) is one of the three vaccines being used in India’s inoculation programme. The Drugs Controller General of India had accorded emergency use authorisation for the Russian vaccine in April this year. However, four months after a pilot launch of the Sputnik V in the country, the vaccine is available only in select towns and cities.
Hetero is among a clutch of firms with whom Russia’s sovereign wealth fund RDIF, which is globally marketing the vaccine, had entered into manufacturing partnerships, a list that also includes the largest vaccine maker Serum Institute of India.
While recommending grant of permission to Hetero Biopharma, the expert committee said regulatory provisions that would apply include the firm submitting the safety and immunogenicity data from the ongoing clinical trial in the country for review, as and when available, besides submitting the PI (Product Information), SmPC (Summary of Product Characteristics) and Factsheet to CDSCO after incorporating the latest safety and immunogenicity data.
The Russian Direct Investment Fund (RDIF) had in November announced the partnership with Hetero Biopharma to manufacture over 100 million doses annually.
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