Russia has approved three coronavirus vaccines — first, Sputnik-V, then EpiVacCorona and CoviVac. But clinical trials for the last two are incomplete.
Russia wants the majority of its citizens to be vaccinated against the novel coronavirus, SARS-CoV-2, by the autumn of 2021. And it appears to be pushing three homegrown vaccines to meet that goal at all costs.
All three of those vaccines have been approved prior to completing large-scale phase 3 clinical trials — an internationally recognized scientific standard that aims to ensure the safety and efficacy of vaccines.
The country became the first in the world to approve a COVID-19 vaccine — Sputnik V — in early August 2020.
It was only then, after approval by Russian authorities, that large-scale clinical trials for the vaccine involving over 40,000 people took place.
A vaccine or drug would normally — and perhaps a pandemic is not normal — be released for use on the general public only after phase 3 clinical trials had been conducted, completed and verified by independent researchers.
Russia started its vaccination campaign in mid-January, with centers even in department stores, as here
During the COVID-19 pandemic, it has been possible for developers to conduct phase 2 and 3 trials in parallel to speed up the process and meet the demands of the global emergency.
But even after phase 3, trials do continue: Phase 4 trials are used to test a drug or vaccine on a much wider population over a longer time frame. So, there's still a lot of work to be done with the Russian vaccines.
Russia approved its second COVID-19 vaccine, EpiVacCorona, in October 2020 and in February 2021 it approved CoviVac. Neither have gone through phase 3 trials.
And there will be more like them. There are reports of about 20 Russian COVID-19 vaccines in development, including Mir-19, which recently completed the first stage of preclinical trials at Russia's Federal Medical Biological Agency (FMBA).
The EpiVacCorona vaccine relies on a chemically synthesized antigen — it does not contain the live virus. The antigen is a substance that causes the human immune system to produce antibodies against a virus. According to clinicaltrials.gov, a resource provided by the US National Library of Medicine, EpiVacCorona trials are ongoing, with results expected no sooner than May 2021.
It has passed phase 1 and phase 2 trials and been approved in Russia. It's not approved for use in any other country, apart from Turkmenistan, according to a report by the state-run Turkmenistan State News Agency (TDH). The vaccine's lack of approval has been highlighted by the Russian Embassy in Germany, where it appears people have been asking whether they can get a Russian vaccine. The embassy says, "No," not until the European Medicines Agency allows it.
As of March 1, the World Health Organization (WHO) had yet to receive an Expression of Interest (EOI) from EpiVacCorona's developers, "Vector," to enable WHO experts to evaluate their vaccine.
EpiVacCorona can be stored in standard refrigerators. Russian authorities claimed it was 100% effective in very early trials.
There is little or no detail on CoviVac via international or verified sources. We know that CoviVac is developed by the Chumakov Centre, a branch of the Russian Academy of Sciences.
The Regulatory Affairs Professionals Society of the USA lists CoviVac as an inactivated vaccine. But beyond that there is no mention of it at clinicaltrials.gov, the US Centers for Disease Control and Prevention, or the WHO's vaccine tracker.
To confuse matters, an American developer, Codagenix, is working on a COVID-19 vaccine of its own with a similar name, Covi-Vac (notice the hyphen). Sometimes, Russia's CoviVac is also spelled with a hyphen.
Russia's CoviVac is what's known as a whole virus vaccine — it includes the spike proteins on the outside of the viral envelope (its shell, as it were) and its genetic material on the inside. It's quite a common form of vaccine.
In the case of CoviVac, the virus has been inactivated so that its genetic material cannot infect cells or replicate but can still trigger an immune response.
The Chumakov Center says the vaccine can be stored at temperatures between 2 to 8 degrees Celsius (35-46 degrees Fahrenheit), which would make it suitable for transportation without deep refrigeration, as required for some other vaccines.
It has been reported by the Russian TASS news agency that CoviVac may be suited as a "secondary immunization" or booster. It may also be good for people with chronic diseases and older people, as its side effects are said to be less noticeable than those of other vaccines.
The Russian researchers say that because CoviVac is based on the whole virus, it will be effective against most variants or mutations.
Sputnik V uses two versions of the adenovirus, a common flu-like virus, as vectors — in a sense, transport vehicles — to deliver protection to the body.
Vectors are viruses that have been manipulated so that they cannot reproduce or infect the body. They do, however, spark an immune response. The first and second Sputnik V jabs also use different vectors, and that, say the scientists, makes the vaccine more effective over a long period of time.
Since its release, Sputnik V has undergone at least six phase 3 trials in Russia, India, Venezuela, Belarus and the United Arab Emirates, and has been approved, at least for emergency use, in more than 40 countries, excluding the USA and European Union (although Hungary, an EU member, has approved the vaccine).
It's said to be over 90% effective.
Outside of Russia, experts remain cautious about the three vaccines in the absence of independently verified or peer-reviewed studies.
The makers of EpiVacCorona have reportedly submitted study data from their phase 1 and phase 2 trials for publication by "foreign scientific journals."
But there is still the question of those missing phase 3 trials. And experts in Germany and Europe as a whole are declining to comment for now.
In an email to DW, a spokesperson at Germany's Federal Institute for Vaccines and Biomedicines, the Paul Ehrlich Institute (PEI), said the institute's experts would not comment before they had had a chance to study any "meaningful" data.
"Speculations are impossible," they said, adding that we should ask the European Medicines Agency (EMA). The EMA is responsible to approving drugs and vaccines in the European Union, and it told us to ask the PEI.
TASS reports that as of March 1, at least 7,885,000 sets of the Sputnik V vaccine and 45,000 doses of EpiVacCorona had been "released into civilian circulation" in a population of about 144 million.
By May, Russia wants to have produced 50 million doses of its vaccines.