The Drugs Controller General of India (DCGI) has allowed Hyderabad-based Dr Reddy’s Laboratories to conduct phase 3 bridging trials of Sputnik Light, the single dose formulation of the Russia-made Sputnik V Covid-19 vaccine.
The approval was granted last month on the basis of a recommendation from the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), which assessed the updated safety, immunogenicity and efficacy data from phase 3 trials that happened in Russia.
The SEC in June had directed Dr Reddy’s to submit data from Sputnik Light trials in Russia before seeking permission to conduct local trials. Sputnik Light comprises the first dose of the usual two-dose regimen.
“In light of the recommendations of the SEC dated 30.06.21, the firm presented updated safety, immunogenicity and efficacy data of phase III clinical trial of Sars-Cov-2 virus vaccine (Sputnik Light) — single dose vaccine conducted in Russia along with the proposal to conduct phase III clinical trial. The committee noted that the firm has now presented the safety and immunogenicity along with the longevity of the antibodies which gives a measure of persistence of antibodies in the participants,” minutes of the meeting that HT has accessed said.
“After detailed deliberations, the committee recommended grant of permission for conduct of phase III immune-bridging clinical trials in the Indian population subject to the condition that the primary endpoint should be assessed at day 42, 90 and 180, and interim analysis can be conducted at day 42…,” it added.
{{/usCountry}}“After detailed deliberations, the committee recommended grant of permission for conduct of phase III immune-bridging clinical trials in the Indian population subject to the condition that the primary endpoint should be assessed at day 42, 90 and 180, and interim analysis can be conducted at day 42…,” it added.
{{/usCountry}}Sputnik V vaccine is developed by Russia’s Gamaleya Institute with assistance from Russia’s sovereign wealth fund, Russian Direct Investment Fund (RDIF), that is also marketing the vaccine globally.
Sputnik V, in its two-dose regimen, is one of six Covid-19 vaccines that have been granted emergency use approval by the Indian drugs regulator.
The vaccine has shown a 91.6% efficacy rate in preventing serious illness.