Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology-developed Sputnik V vaccine to fight the coronavirus disease (COVID-19) has arrived in India. Earlier, the government had allowed Hyderabad-based pharmaceutical company, Dr Reddy’s Laboratories, to conduct an adaptive Phase II/III human clinical trial for the vaccine in India.
A video of containers displaying the logo of Dr Reddy’s unloading Sputnik V from a vehicle went viral on social media on Wednesday. The unloading of the cold chain from Russia in the factory excited a lot of people.
The arrival of Sputnik V implies the trials for the vaccine will begin soon. Scientists will conduct the Phase II and III trials in India to understand the safety and efficacy of the vaccine.
Meanwhile, Russia’s health ministry today said — on the basis of the first interim data from the largest randomised, placebo-controlled Phase-III clinical trials in Russia involving 40,000 volunteers — that the vaccine had demonstrated an efficacy rate of 92%. At the press release from Gamaleya and the Russian Direct Investment Fund (RDIF), the presenters said the trials evaluated the efficacy among over 16,000 volunteers who received the vaccine or placebo 21 days after the first injection.
In September 2020, Dr Reddy’s and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India that has its own Covaxin that has gone under trials. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.
On 11 August, the Ministry of Health of Russia registered the Sputnik V vaccine. It became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Separately, in September, the administration administered the vaccine first to a group of volunteers from the ”red zones” of Russian hospitals.
The observation of additional 10,000 vaccinated volunteers representing medics and other high-risk groups under the civil use of the vaccine out of clinical trials also confirmed the vaccines efficacy rate of over 90%, the release read. As of 11 November, 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 — as part of the clinical trials in Russias 29 medical centres.
In addition, as of today, the scientists could identify no unexpected adverse events as part of the research. Some of those vaccinated had short-term minor adverse effects such as pain at the injection site, flu-like syndrome, including fever, weakness, fatigue, and headache, according to the release. Alexander Gintsburg, director of Gamaleya Centre, said the publication about the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccines efficacy gives way to mass vaccination in Russia against COVID-19 in the coming weeks.”
Given to the production scale-up at new manufacturing sites, Sputnik V vaccine would soon be available for a wider population, Gintsburg said. “This will break the current trend and lead to an eventual decrease in COVID-19 infection rates, first in Russia, then globally,” he said. Pfizer Inc and BioNTech SE on Monday said their vaccine candidate was found to be more than 90% effective in preventing COVID-19.