Comments on the results of the Phase 3 clinical trials of the Sputnik V vaccine published in The Lancet

The article was published on 02.02.2021 under the title "Sputnik V COVID-19 vaccine candidate appears safe and effective" . Declared efficiency: 91.6%.





Below the cut is a brief retelling of the main provisions of the article.





TL; DR: the authors of the journal believe that everything is fine (the article was not written by the staff of the N.F. Gamaleya NITsEM).





Disclaimer: I am not an expert in this field (but I cannot pass by, since so far none of the experts have published this news here), and I can translate some terms incorrectly. I ask specialists to send corrections if there are errors in this text.






At the beginning of the article, it is said that the vaccine uses heterologous (heterologous) recombinant particles of adenoviruses 26 (Ad26) and 5 (Ad5) as vectors (delivery viruses) and the protein S gene inserted into them, which encodes the spike of the SARS-CoV-2 virus ... The vaccine consists of two doses, which are given 21 days apart.





Previously, this technology was applied at the N.N. NF Gamalei in the development of a vaccine against Ebola.





Oxford–AstraZeneca ( ChAdOx), Johnson & Johnson ( Ad26) CanSinoBIO ( Ad5).





(productive infection). , ( ). , .





.





, (payload), , , .





-18°C, .





, y 10¹⁰ 10¹¹ . - .





( , ).





:





  • 20000 , 75% .





  • 18+, 60% , .





  • (Comorbidities), COVID-19 , , .





( SARS-CoV-2) 62 4902 (1,3%).





( , 21 ) 16 14964 (0,1%).





, 60+.





, .





(adverse event, " "), , 45 23 .





Thus, based on confirmed infections (only infections after 21 days from the first dose are counted), the vaccine is 91.6% effective (95% CI: 85.6–95.2).





The Sputnik-V vaccine has been criticized for inappropriate haste, corner cutting, and lack of transparency. However, the results presented (apparently to the editorial office of the journal) are clear and correspond to the methods of evidence-based medicine, which means that another vaccine can now join the fight against the spread of coronavirus infection.








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