Russia’s Sputnik V COVID-19 Vaccine Begins Global Phase 3 Trials

Russia’s Sputnik V, the world’s first registered vaccine against COVID-19, has begun Phase III clinical trials.

Similar to the approach adopted for the AstraZeneca-Oxford COVID-19 vaccine, the Sputnik-V vaccine also uses the common cold-causing adenovirus that has been modified to carry genes for the “spike” protein that coats the coronavirus, in order to prime the body to recognize if a real COVID-19 infection strikes. The vaccine, developed jointly by the Gamaleya Research Institute and the Russian Defense Ministry, requires an initial injection and a booster shot 21 days later to confer one- to two-year immunity.

According to details provided on a new website launched by the Russia Direct Investment Fund (RDIF) to share the details of the vaccine with the public and scientists around the world, Sputnik V has gone through all stages of pre-clinical trials with experiments on different types of animals, including two types of primates. The Phase 1 and 2 clinical trials of the vaccine were completed on August 1, 2020. All the volunteers were feeling well, and no unforeseen or unwanted side effects were observed. The vaccine induced strong antibody and cellular immune responses and not a single participant of the current clinical trials was infected with COVID-19 after being administered the vaccine.

The Sputnik V website states that the vaccine’s efficacy was confirmed by high precision tests for antibodies in the blood serum of volunteers (including an analysis for antibodies that neutralize the coronavirus), as well as the ability of the immune cells of the volunteers to activate in response to the spike S protein of the coronavirus, which indicates the formation of both antibody and cellular immune vaccine response. Sputnik V’s Phase 3 clinical trial involving more than 2,000 people has now begun in Russia, and a number of Middle Eastern (UAE and Saudi Arabia), and Latin American countries (Brazil and Mexico).