Russia has registered the world’s first vaccine against COVID-19, dubbed Sputnik V, in reference to the Soviet satellite that triggered global space research. Scientists believe the vaccine, developed by the Gamaleya Research Centre, will similarly create a so-called “Sputnik effect” for the rest of the world fighting against the pandemic.
Sputnik has spoken to Denis Logunov, deputy research director at the Gamaleya Centre, to learn more about the scientific research into the Russian coronavirus vaccine, which will be published shortly in international scientific journals. Logunov also explained how they managed to create the vaccine so quickly, although it usually takes at least 1.5 years.
Sputnik: Last Sunday you submitted the results of clinical trials to the Russian Ministry of Health. The results haven’t been published yet. What are the main findings of these studies?
Denis Logunov: We have conducted a full range of preclinical studies on the vaccine’s safety and efficacy, which were followed by two clinical studies that examined the vaccine in terms of safety and immunogenicity involving healthy volunteers. Based on the results of these studies, the vaccine showed a good safety profile and high immunogenicity. Speaking about specific indicators and numbers achieved, the volunteers’ average geometric titer of antibodies reached more than 1 in 14,000, nearly 1 in 15,000. One hundred percent of the volunteers had seroconversion.
Seroconversion is when a person’s antibody titer increases more than 4 times compared to the initial, background values. Humoral immunity parameters were also assessed via a virus neutralisation reaction, that is, the virus’s direct inactivation by antibodies.
Virus neutralising antibodies have been found in all the volunteers immunised with our vaccine, both when using the dry and the liquid forms of the vaccine. Various cellular immune response indicators were also analysed, in particular, cytotoxic lymphocytes, which is a very important antiviral immunity parameter.
Cytotoxic lymphocytes, which remove virus-infected cells from the body, have been found in all the vaccinated volunteers. Thus, the vaccine has shown very good results in terms of immunogenicity. As for safety, the expected adverse events in the form of temperature and pain at the injection site weren’t observed in all the volunteers. These specific numbers will be published shortly.
Sputnik: How many people were involved in the first and second phases of testing?
Denis Logunov: The first and second phases involved 38 people each, a total of 76. The two protocols differed in that the vaccine’s active substance was the same, but its physical state was different. One form was freeze-dried, the other was frozen. There was one active substance but two forms of the vaccine. That is why there were 76 people.
Sputnik: What was the age range of the participants?
Denis Logunov: Volunteers for the first and second phases were recruited from the 18-60 age group.
Sputnik: Media outlets have repeatedly said that it takes at least a year and a half to develop a safe and reliable vaccine. Could you explain how the scientists at the Gamaleya Research Centre managed to create a vaccine so quickly, literally in 5-6 months?
Denis Logunov: It would be wrong to say that we’ve managed to create a vaccine from scratch in a short time. Four decades have passed since adenoviral vector technology was introduced into practice. Over these four decades, a technological platform was created that has been tested on tens of thousands of people, both on the basis of the 5th and the 26th serotype vector. Since 2015, more than 3,000 people have been vaccinated with adenoviral vector-based vaccines developed at the Gamaleya Centre. Therefore, it was not a 5-month effort in any way, but work over several decades.
Adenoviral vector-based vaccines were not only created in Russia. China, CanSino, and Johnson & Johnson are also working with adenoviral vectors. First of all, it’s about developing vaccines against Ebola. These platforms are well-known and well-studied in clinical trials. Apart from clinical trial results, what can be said in favour of these adenoviral vector-based platforms’ safety is that we all suffer from adenoviruses, and no one ever has any consequences in the form of somatic diseases.
The Americans have done quite a lot of work on immunising people with the 4th and 7th serotype of adenoviruses. All US Army recruits are vaccinated with adenoviruses. A large retrospective correlation study on more than 100,000 vaccinated people didn’t reveal any abnormalities. Moreover, we’ve been living with adenovirus for millions of years, and there are no associations with somatic pathologies after adenovirus infections. We are not working with live adenoviruses, but with adenovirus vectors.
These are viruses, which have parts of their genomes removed, and they can’t reproduce in human cells. It turns out that living with adenoviruses is not that scary, while living with vectors that are not able to reproduce is completely safe. And my words are supported by tens of thousands of studies of these vectors, including many clinical studies.
These adenoviral vector platforms enable rapid product development. We can quickly clone a gene of interest, in this case the gene encoding the S-protein of the coronavirus, the spike that forms the “corona” of the SARS-COV-2 coronavirus. This spike should be delivered to the body to form immunity. Gene synthesis and cloning it into a vector is the quickest part, while what I said before about studying the adenoviruses themselves, studying and producing adenovirus vectors, and creating technological platform takes decades. Therefore, it cannot be called a quick story. The quick story started from the moment we obtained a technology platform.