NEW DELHI: The second interim analysis of clinical trials has shown 91.4% efficacy for Covid-19 vaccine Sputnik V, 28 days after the first dose and efficacy of over 95% 42 days after the first dose, Russia announced on Tuesday.
Russia’s National Research Centre for Epidemiology and Microbiology and the Russian Direct Investment Fund said that the evaluation of efficacy was carried out among 18,794 volunteers 28 days after receiving the first dose and 7 days after the second dose of the vaccine or placebo.
A total of 39 Covid-19 cases were observed of whom 31 were among 4,699 people who didn’t receive the vaccine while 8 cases were seen in the other group (14,095 people) who had been vaccinated.
No unexpected adverse event during the trials have been reported, as per the details shared internationally.
“Preliminary data on volunteers on the 42nd day after the first dose (equivalent to 21 days after the second dose), when they have already formed a stable immune response, indicates the efficacy rate of the vaccine is above 95%,” said the RDIF in a statement.
The next interim data analysis will be conducted upon reaching the third control point of 78 confirmed coronavirus cases among the study participants.
It was also announced that in international markets, the cost of the vaccine will be less than $10 per dose (Rs 740) starting from February 2021, which means the cost of vaccination per person will be $20 (Rs 1,480) for the required two doses.
Russia, in September, had tied up with Hyderabad based Dr Reddy’s Laboratories, a pharmaceutical company for clinical trials and distribution of Sputnik V in India and had declared that it will supply 100 million doses to Dr Reddy’s by the year-end, upon regulatory approval.
Sputnik V, which is being tested in 40,000 volunteers in Russia, apart from participants in several other countries, is also undergoing phase 2 and 3 trials in India.
RDIF said that for the adenovirus-based vaccine that can be stored at a comfortable 2-8 degree Celsius, it along with partners launched production of the lyophilized (dry) form of the vaccine.
“Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates,” it said in a statement.
The current agreements between RDIF and leading foreign pharmaceutical companies allow the Sputnik V vaccine to be produced abroad for 500 million people per year, starting from 2021.
The first international deliveries of the Russian Sputnik V vaccine will be made to customers in January 2021 based on the existing partnerships with foreign manufacturers.
Those customers, who have recently submitted their requests, will be able to receive the first batches of the vaccine starting from March 2021, said RDIF.
So far, Covid-19 vaccines by Moderna and Pfizer-BioNTech have reported efficiency of about 95%. The trial data released by AstraZeneca-Oxford University on Monday had said that its vaccine was about 70 % effective as per trial data so far. For this vaccine, the Serum Institute of India is a major manufacturing partner.