Vaccin Sputnik

In August 2020, Russia’s President Vladimir Putin surprised the world by approving its first domestically developed covid-19 vaccine.

Russia’s first approved vaccine was developed and produced entirely domestically. In early March 2020, the Gamaleya National Center of Epidemiology and Microbiology was already working on a prototype of Sputnik V, funded by the country’s sovereign wealth fund. Gamaleya researchers opted for two different adenovirus vectors delivered separately in a first and second dose, 21 days apart. Two different vectors reduce the chance of this. To make the vaccine, the adenoviruses are combined with the SARS-CoV-2 spike protein, which prompts the body to make an immune response to it.

Phase I and II results, on 76 participants of an open, non-randomized trial, were published in the Lancet. All participants developed SARS-CoV-2 antibodies. No serious adverse events were detected. Most adverse effects were mild. Interim phase III data were published in early February 2021. The randomized, double blind, placebo controlled trial included nearly 22 000 adults aged 18 years or older. Interim results indicate that the vaccine is 91.6% effective. There were no cases of in the vaccinated group at least 21 days following the first dose. Some 94% of reported side effects were very mild.

President Putin surprised the world by announcing Russian approval for emergency use of Sputnik V as early as August 2020, before phase I or II data had been published. The early approval provoked skepticism among scientists. 30 scientists worldwide criticized inconsistencies in the phase I and II study paper. The team behind Sputnik V dismissed the concerns in a letter published in the Lancet, pointing out that some of the alleged irregularities were likely coincidences. Phase III data have been met more warmly. Some commentators have pointed out that the original protocol for the trial has not been published so it is not possible to know whether this was decided before or during the trial. But others argue the phase III data published to date have vindicated Russia’s decision to go ahead with Sputnik V vaccinations.

Putin declared that mass vaccination using Sputnik V, provided free to citizens, was to begin within days. Employees of Gamaleya were among the first people to receive prototype doses in the spring of 2020. The first members of the public to receive a dose of Sputnik V were school and healthcare workers. However, drop-in hubs offering jabs have also opened. As of 10 February, Russia had inoculated more than two million people with at least one dose of Sputnik V.  That’s nearly three vaccine doses per 100 people according to the latest available data. The rollout may be hampered by skepticism about Sputnik V among the Russian public.

Russia has gone to great lengths to promote Sputnik V promising that it will cost less than $10The RDIF says it has signed contracts with more than a dozen manufacturers to produce a total of 1.4 billion doses. Ursula von der Leyen, president of the European Commission, has publicly questioned why Russia is “offering theoretically millions and millions of doses while not sufficiently progressing in vaccinating their own people.” Indeed, hundreds of thousands of doses have been shipped to several countries.

Source: BMJ (British Medical Journal)

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