Hyderabad: The subject expert committee who suggested the drug controller General India (DCGI) has recommended that the Laboratory of Dr.
Reddy, Indian partners from Russian direct investment funds, conducted a phase III bridge study in India for Sputnik Light, a single version of Russian Covid-19 Vaccine Sputnik V .
the approval came after Dr.
Reddy handed safety, immunogenicity, and efficacy data from trials sputnik updated Phase-III of Russia.
Noting that Dr.
Reddy has presented data about safety and immunogenicity along with the longevity of antibodies, which gives the size of the persistence of antibodies to participants, seconds saying that after the detailed consideration recommends permission grants to do phase III clinical trials that bridged immune in the Indian population.
But SEC said permission is subject to conditions that “primary endpoints are assessed on day 42, 90 and 180 and temporary analysis can be made on day 42 because this data is not generated during the V Sputnik trial in India after the first dose, which is stated to be available to Just day “, as in the minutes of the meeting uploaded on the CDSCO website.
At the end of June, the SEC has indicated that only data from Russian trials is sufficient to give approval for single-jab sputnik lights that have shown the efficacy of 79.4% in Russian trials.