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Russia begins distributing vaccine -- despite not showing safety or effectiveness in large-scale trials

While you're living in 2020, Russia is already living in a risky 2021.

Mihai Andrei
December 7, 2020 @ 1:26 pm

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Thousands of people have already registered for coronavirus vaccination in the US, as President Putin says 2 million doses of the Sputnik V vaccine will become available in the following days.

However, the vaccine developed by the Gamaleya Research Institute still hasn’t been tested in large scale trials.

The likes of Pfizer, Moderna, and AstraZeneca have announced effective, safe COVID-19 vaccines which will be ready by the end of the year, marking a groundbreaking achievement. After all, a ten year development period was considered pretty short for a vaccine, and here we have not one, but three vaccines ready to go in less than a year. So at first glance, Russia’s vaccine, which has received approval in August, is even more impressive.

But there’s a big difference: the state-backed Sputnik V vaccine isn’t really tried and tested. Pfizer’s large-scale trials included over 43,000 participants. The Russian trial after which the vaccine received approval had 76, plus (allegedly) “the members of the Gamaleya Research Institute who worked on the vaccine and, confident in its effectiveness, voluntarily injected themselves with it.” Ironically, large-scale trials started after the vaccine received approval.

Experts have repeatedly cautioned that introducing a vaccine without proper tasting can do more harm than good, from unexpected side effects to simply undermining public trust in their efficacy. AstraZeneca stopped their entire trial on over 30,000 participants because of a single adverse reaction (which later proved to be unrelated to the vaccine). Meanwhile, Russia is already starting mass vaccination campaigns.

The two-shot Sputnik V is offered to people aged 18-60 who don’t suffer from any chronic illnesses and aren’t pregnant or breastfeeding. The vaccine is mainly aimed at key workers, not the at-risk population.

Health Minister Mikhail Murashko said that more than 100,000 people in Russia have received the shots, although no scientific data has been published to document this. Developers of the vaccine said the vaccine is 91.4% effective based on interim data from 18,794 study participants — but again, published data is still lacking.

Many see the vaccine race as a competition between rival global powers, and having the first vaccination campaign would bolster Russia’s international prestige, even as experts have expressed a healthy dose of skepticism against this approach. So far, however, the campaign is proceeding smoothly. People lined up in Moscow to take the vaccine voluntarily, although reactions have been mixed. Opting against a second major lockdown, Russia has pinned its pandemic hopes on this vaccine.

The good news, researchers say, is that it’s no longer a question of ‘will we have a vaccine?’, but rather of ‘when?’. Three other vaccines are very close to completing large-scale trials: one each from the U.S., U.K./Sweden, and China. Production, storing, and distribution will be a whole different challenge, but we can have some hopes of bringing some normalcy back to our lives already.

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