Sputnik V Phase-II trials to have 100 volunteers: Dr. Reddy's
Phase II clinical trials for the Russian COVID-19 vaccine, Sputnik V, will have 100 volunteers, the Indian Central Drugs Standard Control Organisation's Drug Controller General (DCGI) has told Sputnik. Sputnik V is the first vaccine for COVID-19 to have been registered. The pharmaceutical company Dr. Reddy's has struck a deal to conduct vaccine trials and distribution of Sputnik V in India.
The DCGI granted permission to Dr. Reddy's for the trial, however, the date/time will be determined by the company, Mint reported. The firm may proceed to Phase III trial after submitting the safety and immunogenicity data of Phase II, an official said. Dr. Reddy's has said the Phase II trial "would include 100 subjects and for Phase III, it would take 1,400 subjects."
Earlier on October 5, the Subject Expert Committee (SEC) had evaluated Dr. Reddy's previous application and directed the company to submit a fresh application with revised protocol and more information. On October 13, the company had submitted the fresh application seeking approval to conduct Phase II and III trials for Sputnik V, a human adenoviral vector vaccine.
Sputnik V has been developed jointly by the Russian Direct Investment Fund (RDIF) and the Gamaleya National Research Center of Epidemiology and Microbiology. It was registered by Russia's Health Ministry on August 11. In September, Dr. Reddy's had entered a partnership with RDIF for 100 million doses of the potential vaccine, which has been shown to induce a strong immune response among the participants.
As of Sunday morning, India reported a total of 78,64,811 COVID-19 cases, after witnessing a spike of 50,129 cases, according to the Union Health Ministry's data. Since the beginning of the pandemic, 70,78,123 patients have recovered, while 6,68,154 of the total cases are active infections. The death toll climbed to 1,18,534 with 578 more fatalities in the past 24 hours.