- President Putin claims Russia has registered the worlds first Covid-19 vaccine
- The vaccine, however, still has to complete clinical trials
- Putin says the vaccine has been tested on his daughter
As Covid-19 cases continue to surge worldwide, researchers are racing to develop a vaccine. In the latest developments, a Russian health care regulator has become the first globally to approve a vaccine against Covid-19, President Vladimir Putin announced on Tuesday.
“As far as I know, a vaccine against a new coronavirus infection has been registered this morning, for the first time in the world,” he said at a meeting with members of the government, RIA Novosti reported.
Medical workers and teachers would be the first to be vaccinated, according to Russia’s health minister, Mikhail Murashko.
However, the development has been met with international scepticism as the vaccine has yet to complete clinical trials. Here’s what we know about the vaccine so far:
The vaccine hasn’t completed phase 3 trials
The vaccine, named Sputnik V, is a non-replicating viral vector (the same kind of technology used in the SA vaccine trial), and was developed by the Gamaleya Institute in Moscow.
The vaccine was tested in small, early clinical trials and was given to scientists who further developed it, as well as to 50 members of the Russian military and a handful of other volunteers, the Washington Post reports.
Clinical trials of the vaccine were completed in less than two months, while phase three trials are set to begin shortly. The World Health Organization (WHO) still lists the vaccine as being in Phase 1.
A previous Health24 article, explaining the different clinical trial phases, indicates that as a vaccine candidate moves to phase 3, it is determined whether it is effective in those who are exposed to the pathogen.
The process of phase 3, which is done to confirm and expand on the safety and effectiveness results from phase 1 and 2 trials, is usually seen as the only method of ensuring a vaccine is actually safe and effective, and ready to be rolled out to the population.
Following phase 3, approval and licensing are done by different regulatory bodies, but many vaccines still undergo an ongoing phase IV to ensure that they remain effective and up to date, the Health24 article goes on to explain.
Lack of transparency
According to the New York Times, the Russian ministry of health did not respond to detailed written questions about human trials and research into possible side effects of the vaccine. There is also an absence of published information about any late-phase testing of the vaccine and very few details about the research that have been made public.
“It works effectively enough, forms a stable immunity and, I repeat, it has gone through all necessary tests,” Putin told a Cabinet meeting on Tuesday, adding that one of his daughters had taken the vaccine.
The Washington Post notes that Dr Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said at a congressional hearing this month that it would be problematic if countries made a vaccine available before extensive testing was done.
“I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best,” he said.
An expert weighs in
Health24 reached out to Professor Thomas Scriba, deputy director of immunology and laboratory director at the University of Cape Town, for his views on the announcement.
“To be quite honest, there is a paucity of information on what processes were followed to develop this vaccine, what steps in the vaccine development process have been completed and what the results look like, so it is not possible to provide an informed comment on this,” Scriba said, further commenting:
“All I can say is that any new medical product that will be given to humans has to have been registered by a relevant regulatory authority. This registration requires review of extensive documentation and results (data) generated by very careful and rigorous steps, processes and meeting regulatory hurdles that are in place to ensure that the product is safe and tolerable in the first instance, and of course that it actually works, i.e. that the vaccine has efficacy against infection with SARS-CoV-2 or can prevent Covid-19 disease.
“These results can only be generated in clinical trials using careful design with appropriate control groups and blinding of trial investigators and participants to protect against bias, and executed with utmost rigour under monitoring by external boards and ethics committees.”
Scriba explained that the latest vaccine development process can be accelerated due to a situation like the current Covid-19 pandemic, as is currently happening for many drugs and vaccines worldwide, but that it is critical that no shortcuts are taken.
“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.
READ | Why vaccines need to be tried and tested in different populations across the world
READ | Covid-19 vaccine trial in SA: Will we have access to treatment if it is a success, and approved?
OPINION | Scientists are working to fast-forward Covid-19 research, but not at the expense of ethics
Image credit: Getty/Westend61