1 in 7 volunteers experience side effects after taking Sputnik V: Latest updates on Russian coronavirus vaccine (image credit: sputnikvaccine.com)&
- Russia says 1 in 7 Sputnik V vaccine trial volunteers report predicted side effects such as weakness and muscle 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 novel coronavirus, are underway
Moscow: Russian health minister Mikhail Murashko said that one in seven volunteers have complained of side effects, including weakness and muscle pain after receiving the Sputnik V coronavirus vaccine, reported The Moscow Times. Results of the phase 1/2 trials of the vaccine published in The Lancet show no serious adverse effects and a stable immune response in 100 per cent of participants. Final clinical trials of the Sputnik V COVID-19 vaccine are currently ongoing.
Meanwhile, the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr Reddy’s Laboratories Ltd, a global pharmaceutical company headquartered out of India, have agreed to cooperate on clinical trials and distribution of 100 million of doses of the Sputnik V vaccine in India.
“Approximately 14 per cent have small complaints of weakness, muscle pain for 24 hours and an occasional increase in body temperature,” Murashko was quoted as as saying by the state-run TASS news agency.
Murashko said the symptoms ‘level off’ by the next day, adding the complications are described in the instructions and are predictable.
The TASS, citing Murashko, reported more than 300 out of the announced 40,000 study volunteers have been inoculated so far. Volunteers are expected to receive a second shot of the vaccine within 21 days of the first dose, added the report.
According to Murashko, the general population could be given Sputnik V in late November or early December, even as developers began distributing small batches of the vaccine across Russian regions in parallel with the Phase 3 trials.
RDIF and Dr Reddy’s team up for Sputnik V vaccine
On Wednesday, the Russian Direct Investment inked a deal with Dr Reddy’s Laboratories Ltd to conduct clinical trials and distribution of the Sputnik V COVID-19 vaccine in India. Upon regulatory approval in India, RDIF shall supply to Dr Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on 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 completion of successful trials and registration of the vaccine by regulatory authorities in India.
“We are very pleased 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 amongst most severely impacted countries from COVID 19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against COVID 19. RDIF partners will receive an effective and safe drug to fight the coronavirus. The platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences,” Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said.
The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organizations to have a diversified anti-COVID vaccine portfolio to protect their populations, said a joint press release by the parties.
“We are pleased to partner with RDIF to bring the vaccine to India. The phase 1 and 2 clinical trials have shown promising results. We will be conducting Phase-III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of the Indian regulators. Sputnik V vaccine could provide a credible option in our fight against COVID 19 in India,” G V Prasad, Co-Chairman and Managing Director of Dr Reddy’s Laboratories, said.
Prof Sergey Tsarenko, Deputy Chief Physician for Anesthesiology and Reanimation at Hospital No 52 in Moscow, 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 repeatedly encounter throughout our lives. Efficacy is achieved by using two different human adenoviruses sequentially, which differentiates this platform.”
Phase 3 clinical trials of Sputnik V underway
Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently underway. More than 55,000 volunteers have applied to take part in post-registration trials. 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 vectors platform. The vaccine was registered by the Ministry of Health of Russia on August 15.