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Russia's Gamaleya Institute Confirms No Thrombosis Cases After Use of Sputnik V Vaccine

© REUTERS / AGUSTIN MARCARIANA shipment of doses of the Sputnik V (Gam-COVID-Vac) vaccine against the coronavirus disease (COVID-19)
A shipment of doses of the Sputnik V (Gam-COVID-Vac) vaccine against the coronavirus disease (COVID-19)  - Sputnik International, 1920, 14.04.2021
MOSCOW (Sputnik) - No thrombosis cases were registered after the use of the Russian coronavirus vaccine Sputnik V, the vaccine's developer, Gamaleya Institute, said on Wednesday.

"A comprehensive analysis of adverse events during clinical trials and over the course of mass vaccinations with the Sputnik V vaccine showed that there were no cases of cerebral venous sinus thrombosis (CVST)," it said in a statement.

Adenoviral vector platform-based vaccines are different and not directly comparable, it noted.

"In particular, AstraZeneca’s ChAdOx1-S vaccine uses chimpanzee adenovirus to deliver the antigen, consisting of S-protein combined with leader sequence of tissue-type plasminogen activator. The vaccine from Johnson&Johnson uses human adenovirus serotype Ad26 and full-length S-protein stabilized by mutations. In addition, it is produced using the PER.C6 cell line (embryonic retinal cells), which is not widely represented among other registered products," it explained.

Sputnik V is a two-component vaccine using adenovirus serotypes 5 and 26, it said.

"A fragment of tissue-type plasminogen activator is not used, and the antigen insert is an unmodified full-length S-protein. Sputnik V vaccine is produced with the HEK293 cell line, which has long been safely used for the production of biotechnological products," the institute said, adding that extrapolation of safety data from one vaccine to safety data from other vaccines is not justified.

Sputnik V's quality and safety are also assured by a 4-stage purification technology that includes two stages of chromatography and two stages of tangential flow filtration, something other vaccine producers can't boast, it also said.

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