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Now Russia’s Covid-19 vaccine, Sputnik V, claims 92 per cent efficacy

Our Bureau Mumbai | Updated on November 11, 2020

Bottles with Russia's 'Sputnik-V' vaccine against the coronavirus disease are seen before inoculation at a clinic in Tver, Russia.

Follows analysis of late stage Phase III trials involving 40,000 volunteers

Russia’s Gamaleya Centre and the Russian Direct Investment Fund (RDIF) have said Sputnik V, their Covid-19 vaccine, has shown efficacy of 92 per cent after its second dose.

The announcement comes within days of American company Pfizer claiming over 90 per cent efficacy, following an interim analysis from late stage Phase III trials.

RDIF said its announcement comes on the back of interim data from the largest double-blind, randomised, placebo-controlled Phase III clinical trials in Russia, involving 40,000 volunteers.

“The trials evaluated efficacy among over 16,000 volunteers, who received the vaccine or placebo 21 days after the first injection. As a result of a statistical analysis of 20 confirmed cases of coronavirus, the case split between vaccinated individuals and those who received the placebo, indicates that the Sputnik V vaccine had an efficacy rate of 92 per cent after the second dose,” said the note from RDIF, Russia’s sovereign wealth fund. The data will be published in international peer-reviewed medical academic journals, it added.

First coronavirus vaccine

Registered in early August, Sputnik V was the world’s first vaccine against coronavirus, created on the platform of human adenoviral vectors. The vaccine came in for criticism from some scientific quarters for rushing through with its registration, though some countries proceeded with efforts to acquire it.

RDIF Chief Executive, Kirill Dmitriev, stressed the importance of international cooperation among vaccine-developing states. “Vaccines should be above politics. The world needs a diversified portfolio of high-quality vaccines with Sputnik V, based on the well-tested human adenoviral vector platform, being an important element of it,” he said.

In India, the vaccine is undergoing trials through an alliance with Dr Reddy’s Laboratories.

Mass use

In September, the vaccine was first administered to a group of volunteers from the “red zones” of Russian hospitals, RDIF said. The observation of an additional 10,000 vaccinated volunteers, medics and other high-risk groups, under the civil use of the vaccine out of clinical trials, also confirmed the vaccine’s efficacy rate of over 90 per cent, the note claimed.

Gamaleya Center Director, Alexander Gintsburg, said the latest development has paved the way for mass vaccination against Covid-19 in Russia in the coming weeks. “Thanks to the production scale-up at new manufacturing sites, the Sputnik V vaccine will soon be available for a wider population,” he said.

As part of clinical trials in Russia’s 29 medical centres, more than 20,000 volunteers were vaccinated with the first dose and over 16,000 volunteers with the first and the second dose of the vaccine. “No unexpected adverse events were identified as part of the research,” the note said, adding that some of the vaccinated had short-term minor adverse events such as pain at the injection site, flu-like syndrome, including fever, weakness, fatigue, and headache. Observation of study participants would continue for six months, it added.

Global supplies

Late-stage trials on Sputnik V are underway in Belarus, the UAE, Venezuela and other countries. A separate detailed study of the vaccine’s safety and immunogenicity for elderly people is being conducted, the note added.

Over 50 countries have requested over 1.2 billion doses of Sputnik V vaccine and these global supplies will be produced by RDIF’s international partners in India, Brazil, China and South Korea, it said, without giving details on the Indian partners. About 500 million doses of Sputnik V will be made available internationally, annually, through existing contracts, it added.

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Published on November 11, 2020

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