BackSputnik V vaccine has 92% efficacy, shows 21-day interim data
Developers of the Sputnik vaccine are conducting a double-blind, randomized, placebo-controlled Phase 3 clinical trials in Russia involving 40,000 volunteersRDIF on Wednesday said it has received requests for more than 1.2 billion doses of Sputnik V vaccine from over 50 countries
PremiumThe Russian Direct Investment Fund (RDIF) on Wednesday said that interim trial results showed its Sputnik V vaccine is 92% effective at protecting people from covid-19. The interim results were obtained from over 16,000 volunteers of a phase 3 trial in Russia, 21 days after the first injection of either the vaccine or placebo.
“Positive interim results of Phase III give reasons to expect a successful outcome of Sputnik V clinical trials. We will continue to process and analyse all the data and look to the future with optimism, expecting that results of our work will help end the pandemic sooner," Denis Logunov, deputy director at Moscow’s Gamaleya National Research Center for Epidemiology and Microbiology, said. Gamaleya is the co-developer of the vaccine along with RDIF.
Developers of the Sputnik vaccine, RDIF and Gamaleya, are conducting a double-blind, randomized, placebo-controlled Phase 3 clinical trials in Russia involving 40,000 volunteers. Phase 3 trials of the vaccine are also ongoing in Belarus, United Arab Emirates, Venezuela and a few other countries, while a phase 2 and 3 trial of 1,500 participants will soon be started in India.
The interim data of Sputnik V vaccine, which is based on a combination of two adenoviruses, comes just two days after US-based firm Pfizer and its German partner BioNTech said that their messenger RNA vaccine was 90% effective against the novel coronavirus, based on infection of 94 participants who had contracted the disease from a total of around 40,000 people who got two doses of vaccine. The interim analysis was done seven days after receiving the second dose and 28 days after the first dose.
While Pfizer’s news is a sentimentally positive one for India, it is the Sputnik V vaccine’s successful interim data that is of greater relevance due to RDIF’s pact with Dr Reddy’s Laboratories for marketing of the vaccine in the country. RDIF is also looking for Indian manufacturers to produce the vaccine for use in India and world over.
“The Sputnik V vaccine uses a time-tested adenovirus platform with which regulators around the world are more familiar. Its freezer and cold chain temperature requirements are not as severely low as the mRNA vaccines. It is therefore more likely to be adopted if the Phase 3 trials clearly demonstrate efficacy and safety," K. Srinath Reddy, president of the Public Health Foundation of India, said.
Reddy anticipates that the advantages of a vaccine like Sputnik V would lead to great interest in data from the ongoing phase 3 trial when fully reported.
“While the mRNA vaccines are scientifically exciting as a new platform, the regulators will take time to study the results as no mRNA vaccine has been cleared so far. Their temperature requirements are also forbidding to many countries."
Dr Reddy’s has received an approval from the Drug Controller General of India (DCGI) to conduct the phase 2 and 3 study of the Sputnik V vaccine in India. The Hyderabad-based drug maker will sell 100 million doses of the vaccine in India if it gets the DCGI’s approval.
However, while the interim data of the vaccine is out, Dr Reddy’s expects to complete its phase 3 clinical trial only around March or later, the company’s chief executive officer Erez Israeli said last month.
In August, the Sputnik V vaccine Center was registered by Russia’s Health Ministry and became the world’s first registered vaccine against COVID-19. The following month, the results of 76 participants in a phase 1 and 2 trial were published in The Lancet, a leading peer-reviewed medical journal, which showed that the vaccine no serious adverse events and an effective immune response of those vaccinated.
RDIF on Wednesday said it has received requests for more than 1.2 billion doses of Sputnik V vaccine from over 50 countries. The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries, RDIF said in the statement. Currently, about 500 million doses of the Sputnik V vaccine can be produced annually outside Russia through RDIF’s existing contracts with international partners.
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