New Delhi: The makers of Sputnik V Covid-19 vaccine, the Russian Direct Investment Fund (RDIF), are now expecting India to approve their vaccine following encouraging results on its efficacy.
Interim analysis of the Phase 3 trial, conducted in Russia, has shown that Sputnik V has a 91.6 per cent efficacy against Covid-19, according to findings published in peer-reviewed journal The Lancet Tuesday.
“Clinical trials in India are also going incredibly well and we are expecting emergency use authorisation (EUA) of our vaccine by February or March,” Kirill Dmitriev, CEO, RDIF, said in a virtual press conference Tuesday. “We are working closely with (India’s) regulator.”
The Sputnik V vaccine — which is being developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation, in collaboration with the RDIF, the country’s sovereign wealth fund — has been undergoing clinical trials in India through the Hyderabad-based drugmaker, Dr Reddy’s Laboratories.
Answering questions from the global media on the production plan, Dmitriev said RDIF will be producing vaccines in a number of countries, including in India and Korea.
“We will also be starting production in China later this month. Trial volumes are also being produced in Brazil but bigger production will begin only by the end of this month,” he said. “Most of our vaccines will be produced in India and it (India) will play an important role. India has outstanding production capacity for manufacturing vaccines.”
India has been so far relying on two Covid-19 vaccines. On 3 January, the Drugs Controller General of India had granted ‘conditional approval’ to Oxford-AstraZeneca’s Covishield and state-owned Bharat Biotech’s Covaxin.
Covishield is being manufactured by Pune-based Serum Institute of India (SII).
The Sputnik V results
According to the results of Phase 3 study published in The Lancet, the trial involved 21,977 people who were assigned to either the vaccine or the placebo groups.
The randomised, double-blind, placebo-controlled trial included those who were 18 years or older and had tested negative on HIV, Hepatitis B and C, syphilis and SARS-CoV-2 PCR tests with no prior history of Covid-19.
The exclusion criteria also included “immunosuppression in the three months before enrolment”, “pregnancy or breastfeeding”, “acute coronary syndrome or stroke in the year before enrolment” among others.
Around 19,688 of the total participants “received two doses of vaccine or placebo and were included in the primary outcome analysis”.
“From 21 days after the first dose of vaccine (the day of dose 2), 16 (.1%) of 14,964 participants in the vaccine group and 62 (1.3%) of 4,902 in the placebo group were confirmed to have Covid-19,” the study states.
The vaccine efficacy was 91.6 per cent, it adds.
According to the study, data on serious adverse events were analysed for 21,862 participants who received at least one dose of the vaccine (16,427) or the placebo (5,435). Around 45 of 16,427 participants in the vaccine groups and 23 of 5,435 participants in the placebo group had serious adverse events but “none were considered associated with vaccination”.
“Four deaths were reported during the study (three<0·1%] of 16 427 participants in the vaccine group and one (<0·1%) of 5435 participants in the placebo group), none of which were considered related to the vaccine,” the study states.
Also read: Oversupply of Covid shot in Russia but skepticism dogs Sputnik V vaccine drive