An expert panel of India’s drug regulator on Friday sought additional data from drugmaker Dr. Reddy’s Laboratories on its Sputnik V Covid-19 vaccine trial, in its second such request after an initial evaluation in February.
Dr. Reddy’s has been conducting small clinical trials with Sputnik V in India under a deal with Russia’s wealth fund. Several Indian companies have signed deals to produce and supply over a half a billion doses of the vaccine.
The Committee asked the company to submit a comparative analysis of late-stage immunogenicity data from both its Indian studies and an ongoing Russian study, as well as data on serious adverse events and positive cases reported till date.
Source: Reuters