- A registration certificate for Russia's Covid-19 vaccine has been released
- The certificate states that it can only be used in certain small groups of people, at least until 2021
- The vaccine has only been tested on 76 people so far, and has yet to undergo larger trials
Russia is the first country in the world to approve a vaccine against Covid-19. This was announced by President Vladimir Putin earlier this month, as reported by Health24. Putin stated that the vaccine has been approved for widespread use, and the chief of the Russian Direct Investment Fund, Kirill Dmitriev, said the vaccine could be distributed as early as September.
According to Science Magazine, the vaccine, named Sputnik V, has been approved for use in "a small number of citizens in vulnerable groups".
Phase 3 trials to kick off
Phase 3 clinical trials to assess the vaccine’s safety and efficacy more thoroughly, are scheduled to begin this week, the Associated Press reported.
According to the Washington Post, Sputnik V was previously tested in small, early clinical trials and then given to scientists who further developed it. It was also given to 50 members of the Russian military and a handful of other volunteers.
Putin has great confidence in the vaccine, saying that “it works effectively enough, forms a stable immunity and… has gone through all necessary tests”.
Widespread use only approved for 2021
Science Magazine expressed concern about the fact that the registration certificate issued by Russia's Ministry of Health only covers use by small groups, including healthcare workers and the elderly.
The certificate also states that the vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, cannot be approved for widespread use until January 2021, presumably after larger clinical trials have been carried out.
The vaccine is being manufactured by Binnopharm in Zelenograd, and the company is reported to have the capacity to produce 1.5 million doses of the product per year, and hopes to expand its manufacturing capacity.
Professor Thomas Scriba, deputy director of immunology and laboratory director at the University of Cape Town, previously told Health24 that the registration of a Covid-19 vaccine would require a review of extensive documentation and results (data) before it can be registered by a relevant regulatory authority.
“One would hope that these processes have been followed to ensure that the vaccine is indeed safe, well-tolerated and sufficiently efficacious against Covid-19 before it is registered for use in humans,” Scriba said.
Responding to a question during a webinar series on whether the vaccine might make its way to South Africa and be used on the population, Professor Glenda Gray, President and CEO of the South African Medical Research Council (SAMRC) said last week that South African regulatory authorities will not license a vaccine unless they have seen evidence that it works:
“Vaccines have to be manufactured in a safe way, and so SAPHRA (The South African Healthcare Products Regulatory Authority) will investigate the vaccine developers, making sure there is consistency from lot to lot.
“Normally, scientists publish their data first and show the world how and why it worked, so we need to see the biological evidence that his vaccine works before we can endorse it,” Gray said.