1 in 7 volunteers experience side effects after taking Sputnik V: Latest updates on Russian coronavirus vaccine (Image credit: sputnikvaccine.com)
Key points
- Russia Says 1 in 7 Sputnik V Vaccine Trial Volunteers Report Anticipated Side Effects such as Muscle Weakness and Pain
- Russia’s sovereign wealth fund and Dr. Reddy’s laboratories will collaborate on clinical trials and distribution of the vaccine in India.
- Late-stage clinical trials of the Sputnik V COVID-19 vaccine, which became the world’s first registered vaccine against the new coronavirus, are underway.
Moscow: Russian Health Minister Mikhail Murashko said one in seven volunteers have complained of side effects, including muscle weakness and pain after receiving the Sputnik V coronavirus vaccine, it reported. The Moscow Times. Results from phase 1/2 trials of the vaccine published in The Lancet show no serious adverse effects and a stable immune response in 100 percent of participants. Final clinical trials of the Sputnik V COVID-19 vaccine are ongoing.
Meanwhile, the Russian Direct Investment Fund (RDIF), the Russian sovereign wealth fund and Dr Reddy’s Laboratories Ltd, an India-based global pharmaceutical company, have agreed to cooperate in clinical trials and distribution of 100 million doses of the Sputnik V vaccine. In India.
“About 14 percent have minor complaints of weakness, 24-hour muscle pain and an occasional rise in body temperature,” Murashko said, according to the state agency. TASS news agency.
Murashko said symptoms “stabilize” the next day, adding that complications are described in the instructions and predictable.
The TASS, citing Murashko, reported that more than 300 of the announced 40,000 study volunteers have been inoculated so far. Volunteers are expected to receive a second injection of the vaccine within 21 days of the first dose, the report added.
According to Murashko, the general population could receive Sputnik V in late November or early December, even as developers began distributing small batches of the vaccine in Russian regions in parallel with phase 3 trials.
RDIF and Dr. Reddy’s team up for Sputnik V vaccine
On Wednesday, Russian Direct Investment signed an agreement with Dr Reddy’s Laboratories Ltd to conduct clinical trials and distribution of the Sputnik V COVID-19 vaccine in India. Following regulatory approval in India, RDIF will supply Dr. Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on a well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic.
Deliveries could potentially begin in late 2020, subject to the completion of successful trials and registration of the vaccine by regulatory authorities in India.
“We are very happy to partner with Dr Reddy’s in India. Dr Reddy’s has had a very well established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India. India is among the countries most affected by COVID 19 and we believe that our human adenovirus dual vector platform will provide a safe and scientifically validated option for India in the battle against COVID 19. RDIF partners will receive an effective and safe drug to combat the coronavirus. The human adenoviral vector platform, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and has been shown to be safe with no potential long-term negative consequences. ”- Kirill Dmitriev, CEO of the Russian Direct Investment Fund, he said.
The agreement between RDIF and Dr. Reddy’s reflects the growing awareness of countries and organizations to have a diversified portfolio of anti-COVID vaccines to protect their populations, said a joint press release from the parties.
“We are pleased to partner with RDIF to bring the vaccine to India. Phase 1 and Phase 2 clinical trials have shown promising results. We will conduct phase III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of Indian regulators. The Sputnik V vaccine could provide a credible option in our fight against COVID 19 in India, ”said GV Prasad, Co-President and Managing Director of Dr Reddy’s Laboratories.
Professor Sergey Tsarenko, Deputy Chief Physician for Anesthesiology and Resuscitation at Moscow Hospital No. 52, said: “The main criteria for evaluating a vaccine are safety and efficacy. In Sputnik V, safety is ensured by the use of human adenoviral vectors, which we encounter repeatedly throughout our lives. Efficacy is achieved by using two different human adenoviruses sequentially, which sets this platform apart. “
Sputnik V Phase 3 Clinical Trials Ongoing
Post-registration clinical trials of the Sputnik V vaccine are currently underway, involving 40,000 volunteers. More than 55,000 volunteers have applied to participate in post-registration tests. The first results of these trials are expected to be published in October-November 2020.
The Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology became the world’s first registered COVID-19 vaccine based on the human adenoviral vector platform. The vaccine was registered by the Russian Ministry of Health on August 15.
