Coronavirus, Russian vaccine: data published in The Lancet. The mayor of Moscow: “I did it, I feel good”

After the announcement of Vladimir Putin of an effective Russian vaccine against the coronavirus, the scientific community, in the absence of data on the experiment, had caused more than one perplexity. Today, data on the compound, pompously named Sputnik V, were published by the magazine of The lancet. Well, the test results show “a good safety profile without adverse events for 42 days “, in addition” one antibody response within 21 daysThe non-randomized phase I-II trials were carried out in 76 volunteers who received the vaccine in two hospitals in Moscow. The research was carried out by the Gamaleya Institute of Epidemiology and Microbiology (Moscow). Phase 3 of the experimentation of the vaccine in 40 thousand volunteers which will be constantly monitored through an online application.

The mayor of Moscow also tested the vaccine. “To give strength to my colleagues and to be sure that we have opened a window of opportunity in this situation”, that is, “that our effective national vaccine has really appeared in Russia, I made this decision. I feel good, God will be like that even later, ”he said. Serghei Sobyanin announcing, in videoconference with Vladimir Putin, to be vaccinated. Head of the Russian Fund for Direct Investments (Rdif) Kirill DmitriyevInstead, he argued that production outside Russia of the vaccine could start in November. “We have agreements with India, Brazil and many other countries, because we are really focused on the possibility of exporting this vaccine, produced outside Russia, to foreign markets already in November, thanks to the wonderful technology developed by the Gamaleya Institute”, explained in a news conference.

One of the studies looked at the frozen formulation of the vaccine and another at the lyophilized formula. The first is intended for large-scale use, the second has been developed for hard-to-reach areas, and as it is more stable, the future vaccine can be stored at 2-8 degrees Celsius. “Unprecedented steps have been taken to develop a vaccine against Covid in Russia – stressed Alexander Gintsburg, one of the curators of the studies at the Gamaleya Institute of Epidemiology and Microbiology – Preclinical and clinical studies have been carried out that have allowed the provisional approval of the vaccine under the current decree of the Government of the Russian Federation of April 3, 2020. This provisional authorization requires a large-scale study and it allows the vaccination of the population in the context of a phase 3 study, using the vaccine under strict pharmacovigilance and administering it to risk groups ”. Also because in the absence of a study and experimentation in accordance with the protocols, the vaccine could not be authorized and used outside the Russian borders.

The Russian vaccine includes two adenovirus vectors, recombinant human type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S), which have been modified to express the Sars CoV 2 spike protein. Adenoviruses also they are weakened so that they cannot replicate in human cells and cannot cause illnesses like colds, for example. In a comment linked to the study, Naor Bar-Zeev, from the International Center for Vaccine Access at the Johns Hopkins Bloomberg School of Public Health (USA), noted: “The peer studies are encouraging but small. Immunogenicity bodes well, although nothing can be deduced about immunogenicity in older age groups, furthermore, adds Naor Bar-Zeev, who was not involved in the research, the clinical efficacy of any Covid-19 vaccine is not yet known. has tried ”. Suffice it to say that other candidate vaccines, which are considered promising, have been tested in more than 1000 people in phase I and II and results from the last phase, in particular the Oxford / AstraZeneca one, are expected in 30 thousand people.