India
oi-Madhuri Adnal
New Delhi, November 12: Sputnik V vaccine for COVID-19, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology of Russia, has arrived in India following the go-ahead to Hyderabad-based pharmaceutical company Dr. Reddy’s Laboratories to conduct a phase 2/3 adaptive human clinical trial for vaccine in India.
A video of small containers bearing the Dr. Reddy’s and Sputnik V logo unloaded from a vehicle went viral on social media Wednesday.
The Conona Sputnik V vaccine arrived in India through the laboratories of Dr. Reddy. pic.twitter.com/jAVZr6A41m
– PNRai (@ PNRai1) November 11, 2020
The unloading of the Russian cold chain at the factory excited many people as they took videos and circulated them.
The arrival of vaccine doses means that vaccine trials will begin soon. Phase 2 and 3 trials will be conducted in India to understand the safety and efficacy of the virus.
After Pfizer, Russia Says Its Covid Sputnik V Vaccine Is Over 90% Effective
Meanwhile, the Russian Health Ministry said on Wednesday that the vaccine has shown an efficacy rate of 92 percent.
The confirmation is based on the first interim data from the largest randomized, placebo-controlled phase III clinical trials in Russia involving 40,000 volunteers, said a press release from Gamaleya and the Russian Direct Investment Fund (RDIF).
The trials evaluated efficacy among more than 16,000 volunteers who received the vaccine or placebo 21 days after the first injection.
In September 2020, Dr. Reddys and the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, partnered to conduct clinical trials of the Sputnik V vaccine and its distribution in India.
As part of the partnership, RDIF will supply 100 million doses of the vaccine to Dr. Reddys following regulatory approval in India.
On August 11, 2020, the Sputnik V vaccine was registered by the Russian Ministry of Health and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vector platform. Moreover, in September, the vaccine was administered for the first time to a group of volunteers from the “red zones” of Russian hospitals.
Observation of 10,000 additional vaccinated volunteers representing physicians and other high-risk groups under civilian use of the vaccine outside of clinical trials also confirmed the vaccines’ efficacy rate of more than 90 percent, the statement added.
On November 11, as part of clinical trials at 29 medical centers in Russia, more than 20,000 volunteers were vaccinated with the first dose and more than 16,000 volunteers with the first and second doses of the vaccine.
Also, as on the date, no unexpected adverse events were identified as part of the investigation. Some of those vaccinated had minor short-term adverse effects, such as injection site pain, flu-like syndrome, including fever, weakness, fatigue and headache, according to the statement.
Alexander Gintsburg, director of the Gamaleya Center, said that the publication of interim results of post-registration clinical trials convincingly demonstrating the efficacy of Sputnik V vaccines ushers in mass vaccination in Russia against COVID-19 in the next weeks. “Thanks to scalable production at new manufacturing sites, the Sputnik V vaccine will soon be available to a wider population, he said.
“This will break the current trend and lead to an eventual decline in COVID-19 infection rates, first in Russia and then globally,” he said. Pfizer Inc and BioNTech SE said Monday that their vaccine candidate was found to be more than 90 percent effective in preventing COVID-19.
