The Subject Expert Committee (SEC) of India's drug regulator has recommended for grant of approval to the Hyderabad-based Hetero Biopharma to conduct phase 3 trials of Russian Sputnik V Covid-19 vaccine in India.
Earlier in November 2020, Hetero had signed a deal with Russian Direct Investment Fund (RDIF), the co-developer of Sputnik V Covid-19, to produce over 100 million doses of the Covid-19 vaccine in India.
According to the SEC's minutes of the meetings, the expert panel of the Central Drugs Standard Control Organisation (CDSCO) has asked the company to study and monitor the vaccine's immunogenicity on days 21, 24, and 48 of the trial, reports Economic Times.
The SEC has also asked Hetero to assess the neutralising antibodies and gamma interferon during the study.
It should be noted that the Drug Controller General of India (DCGI) had approved the Russian Covid-19 vaccine for emergency use in the country.
Hetero is among many manufacturing partners in India that RDIF had partnered with to produce the Sputnik V Covid-19 vaccine.
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