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Russia’s ‘Sputnik V’ Vaccine Registration and Deployment

Russian President Vladimir Putin announced today, on a televised video conference with his ministers, that the Russian vaccine for Covid-19 has passed “all needed checks” and provides “sustainable immunity.” He further said that his daughter had gone through the vaccine and its booster, raising her temperature each time by 1 degree for one day before returning to normal. Russia’s Health Minister Mikhail Murashko also announced today that it was a big step towards “humankind’s victory” over Covid-19. Tomorrow, Aug. 12, they begin Phase 3 levels of the vaccine, but directed first toward those most at risk: healthcare workers, and then the elderly. Industrial production levels begin in September. At this point, they have arranged production capacity for 500 million doses per year, set up in five countries. The vaccine will be generally available for Russians, for free, beginning in October.

Twenty countries have already made “preliminary applications for over 1 billion doses,” according to Kirill Dmitriev, the head of the Russian Direct Investment Fund. He will market the vaccine under the name “Sputnik V” — evoking the memory of the Soviet crash program that shocked the world with the 1957 Sputnik satellite.

Sputnik V uses not one but two human adenoviruses as vectors for bringing into human cells the genetic code required for human cells to produce the SARS-CoV-2 spike protein, which the immune system will find and learn how to defeat. One adenovirus is used for the first shot, and the other for the second. Since the body is confronted with a different adenovirus than the one it just experienced, the second one will better get past the immune system and into human cells to produce additional coronavirus spike protein to train the immune system.

According to Kirill Dmitriev, this approach is unique to Sputnik V: https://sputnikvaccine.com/newsroom/forbidden-op-ed-the-sputnik-vaccine-as-a-lifesaving-global-partnership-eng/

Other nations are eager to benefit from the potentials of this Russian research. The state of Parana in Brazil is arranging to sign an agreement with Russia to produce the new vaccine, according to an announcement Aug. 11 by the head of the Parana Technology Institute. Philippines President Rodrigo Duterte announced on Monday evening that his nation will be deploying Russia’s vaccine: “When the vaccine arrives, I will have myself injected In public.” He wants to arrange for production of the vaccine in his country. The Philippines’ presently has a total of 136,638 confirmed cases, the highest in Southeast Asia, although the real level, with adequate testing, would be significantly higher.

The Russian development has been met with skepticism in the West, partly for political reasons and partly based on the reasoning that the Russians are skipping Phase 3 trials. It is true that the Russian trials regimen differs from that of the United States. Although the results look extremely promising so far, the effectiveness of the vaccine in preventing infection is not known for certain.

It could be said that they are now doing phase 3 trials, but choosing to carry that out with their healthcare workforce. However, since there will be no placebo arm when the healthcare workers are vaccinated, the effectiveness of the vaccine will be more difficult to gauge.

These frontline responders in the war against Covid-19 are already taking much greater risks without the vaccine, which raises the dilemma of potentially withholding a useful treatment in order to compare it to placebo.

Russia may be rushing to win the title of world’s first vaccine, and their vaccine may indeed be effective. Time will tell.