Sputnik V phase 3 trials could be conducted in India
The Gamaleya Research Institute of Epidemiology and Microbiology in Russia has reportedly submitted "comprehensive data" on its COVID-19 vaccine candidate to Indian authorities. The data is now being evaluated by authorities in India, according to a report in The Indian Express. The report added that conducting phase 3 clinical trials of the potential vaccine in India is being kept as an option.
The Sputnik V website is a two-part vaccine that uses two adenovirus vectors: rAd26-S and rAd5-S. The adenovirus vectors have been modified to generate the SARS-CoV-2 spike protein to trigger an immune response against the novel coronavirus. Sputnik V has been cleared for public use by Moscow regulators. The production of the vaccine is expected to start in September 2020.
A source told TIE, "We're now deeply engaged with Russia on the vaccine front." Indian officials had sought data from the Russian institute on the vaccine's safety and efficacy. The data has been shared and is being evaluated by Indian experts. The vaccine engagement is being coordinated by Department of Biotechnology Secretary Renu Swarup in India and Indian Ambassador DB Venkatesh Varma in Russia.
According to the official Sputnik V website, at least 20 countries have "expressed interest in obtaining the Sputnik V," including India. The other countries include the United Arab Emirates (UAE), Saudi Arabia, Indonesia, the Philippines, Brazil, and Mexico.
TIE reported that one option is to conduct separate phase 3 clinical trials of Sputnik V in India after obtaining necessary approvals from regulators. The Sputnik V website states that Russia plans to conduct phase 3 trials in many countries, including Saudi Arabia, UAE, Brazil, and the Philippines. The trials will involve 40,000 volunteers who will be constantly monitored through an online application.
On Friday, Russian researchers had published the results of phase 1/2 trials of Sputnik V in The Lancet. Two open and non-randomized trials of two formulations at two hospitals in Russia had been conducted. It was found that the vaccine is "safe, well-tolerated, and does not cause serious adverse events in healthy adult volunteers." The study noted that the vaccine is "highly immunogenic."