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'Notably clever': If Russia's vaccine is so good, why isn't it more widely used?

A quick guide to Russia's world first COVID vaccine - and why it's still controversial.

Even before Russia's brand-new COVID-19 vaccine was tested on monkeys, the director of the institute that made it had injected himself. So had his staff. Fortunately, the shot has proven both safe and effective, boasting one of the highest efficacy rates of any COVID vaccine on the market. "Australia could have done worse than ordering it," says epidemiologist Mike Toole. "But politics are what they are, and Russia hasn't done itself any favours by being secretive."

Indeed, as questions linger over how closely Russia is monitoring for rare side effects and export supply fails to live up to the Kremlin's big promises, Russia's new tool of influence on the world stage is proving volatile. It's already brought down the prime minister of Slovakia, spawned both propaganda and anti-vax misinformation campaigns and triggered a defamation suit between Russia and Brazil. So, what is the Sputnik V vaccine and does it live up to the scientific heights of the satellite it was named after?

Russia named its vaccine after the world-first satellite it put into space in 1957. Credit:Joe Benke

What is Sputnik V?

That's right, it's named after the satellite. Russia stunned the world when they became the first to launch into space in 1957, and the vaccine shares the name for again coming first. In late August 2020, when President Vladimir Putin announced the Sputnik V vaccine had been granted emergency approval, data from its phase one and two clinical trials was not yet published. (One of Putin's own daughters had already had the vaccine, though, and was "feeling fine".) As China did with its own vaccines, Russia leapfrogged the final phase of clinical testing into a "live trial" rollout of sorts, offering assurances via press conference rather than the standard rigorous data.

But, come February, when Sputnik's results were at last peer-reviewed and published in leading medical journal The Lancet, much of the scepticism around the world evaporated. "It's an excellent vaccine," Toole says, more than 91 per cent effective at stopping a symptomatic case of COVID. That puts it almost on par with the Western vaccines using new mRNA technology by Pfizer and Moderna.

Sputnik V is now authorised in 69 countries, and, because it doesn't require the deep-freeze storage of the mRNA vaccines and is about 73 per cent effective at stopping COVID even after just one dose, it's proving an attractive option for developing nations and those needing to move fast in the face of outbreaks (as well as countries at odds with the West such as Iran).

It's "good business": Russian President Vladimir Putin stunned the world when he announced Russia had already approved the Sputnik V vaccine in August 2020. Credit:AP

How does it work?

Vaccines train your body to kill a virus without you ever having to catch it. In the case of COVID, the vaccines introduce your immune system to a tiny piece of the coronavirus (the signature spike protein it uses to hack into our cells). This won't make you sick but it will help your body hunt down the virus if it shows up for real. The Sputnik vaccine, as with AstraZeneca and Johnson & Johnson, uses another harmless virus, known as an adenovirus vector, to deliver the spike. The Pfizer and Moderna vaccines use new mRNA technology to insert a segment of the coronavirus' genetic code, while China's Sinovac and Sinopharm vaccines use a dead version of the coronavirus itself to build immunity.

Sputnik's design is "notably clever", Toole says, for using one type of adenovirus in the first shot and another in the second. This reduces the chance that, by the second shot, the immune system will remember the adenovirus used as the Trojan horse to package the vaccine, and so start attacking it instead of the coronavirus. It's the same reason scientists think pairing an AstraZeneca shot with different kinds of vaccines, such as Pfizer for the second dose, has proven so effective in mixed trials overseas. The first dose of Sputnik (known as Sputnik Light) has itself been paired with AstraZeneca, Moderna and Sinopharm in a large trial in Argentina. Results are still to come but the agency that markets Sputnik V, the Russian Direct Investment Fund (RDIF) says so far all combinations appear safe.

There is a long tradition of medical researchers experimenting on themselves, one that has not declined in Russia as fast as it has in the West. (Just as American Jonas Salk tested his polio vaccine on himself and his family, the Russian researchers who developed the first oral inoculation for polio tested it first on their own children, who, as it happens, have now grown up to be virologists working on COVID vaccines themselves.) At the well-respected Gamaleya Institute in Moscow where Sputnik V was made (and which Toole has visited), the 100-odd scientists who injected themselves with the vaccine back in April 2020 reported no ill effects. That included institute director Alexander Ginzburg who said the team did it to reduce the chance that they themselves would fall sick. They made the vaccine so fast, he said, by tweaking one they were already working on for MERS, another dangerous coronavirus cousin of both COVID and SARS.

What about these side effects?

Sputnik can cause the same mild cold and flu symptoms sometimes brought on by the other vaccines but no adverse complications have been linked to it so far. Gary Grohmann a virologist who consults for the World Health Organisation, says he has no doubt Sputnik is a very good vaccine, based on both its trial and real-world data so far. But given it uses the same kind of technology as AstraZeneca and J&J, both of which have recorded rare clotting cases (AstraZeneca more prominently), Grohmann says it makes sense to be searching for cases in Sputnik, too.

"The fact there is nothing immediately raises a flag for me," says Grohmann, who previously worked at Australia's regulator the Therapeutic Goods Administration. "Either they are not doing the monitoring and deaths are being attributed to other causes, or the vaccine is marvellous. And if it's that good, then we should look at it closer to understand the difference with the other vector vaccines."

Toole agrees Russia's monitoring is dubious but notes none of the other 60-odd countries using the vaccine have reported a link to clotting either, including during trials in Argentina, Italy and the tiny republic of San Marino (which has been almost entirely vaccinated with Sputnik).

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Deakin University epidemiologist Catherine Bennett notes that Sputnik is mostly being used in less affluent countries with poorer monitoring. "That's part of the inequality of the [global vaccine rollout]," she says. "We all have an obligation to understand these vaccines or you can have this kind of closed shop. That doesn't mean it's a bad choice to roll out those vaccines, they could be the thing that saves a population, but it makes it harder to make decisions, how well they last or stand up against Delta, whether to use them as boosters."

What countries are using Sputnik?

Many eastern European countries such as Serbia and Hungary are already using Sputnik, though it is yet to be approved by the European Union's regulator, the EMA, while places such as India and South Korea have signed deals to make it. But there are cautionary tales, too. Countries such as Iran and Mexico are still waiting for many of the millions of doses promised by Russian suppliers, weeks or months behind schedule. And Slovakia's prime minister, Igor Matovic, was forced to step down in March after it was revealed he had secretly arranged to import 200,000 doses of Sputnik V without informing his coalition partners in government.

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Russia's big push at "vaccine diplomacy" has also been hampered by disputes with international regulators who say it has not been forthcoming with all its paperwork. The EMA has reportedly faced repeated delays in its review of Sputnik due to a lack of data, and a separate delegation of French scientists encountered similar roadblocks, despite hopes Sputnik would speed up Europe's initially-slow vaccination campaign. The RDIF, which has previously said it is co-operating with regulators, did not respond to requests for comment before deadline.

Meanwhile, in Brazil, the country's regulator has been hit by a defamation lawsuit from the Sputnik team at RDIF. Brazilian authorities had cited concerns that the inactivated viral vector in the vaccine might still be replicating, saying Russia did not appear to have a zero-tolerance policy for such a possibility in its regulation back home, as other countries do. But RDIF and most scientists say this claim appears to have been a misunderstanding of the paperwork by Brazil, not evidence of replication. When the vaccine batches were independently tested, there was no replication found; the shots safe, Science reported.

Still the WHO is also yet to approve the shot, recently citing some issues with a production facility filling Sputnik vials in India."I'm not sure why the WHO is taking so long," Toole says. "They've already approved China's Sinovac and that's not as effective and has its own [data] transparency issues."

Like Grohmann, Toole thinks that politics are playing a role in resistance to Sputnik too, perhaps nowhere so much as in Russia itself, where vaccine hesitancy is among the highest in the world. (About a year after Sputnik was approved for emergency use in Russia, fewer than 20 per cent of Russians are vaccinated, despite a deadly new outbreak). "They should never have authorised it before the data was in, that alienated a lot of Russians," Toole says. "They already don't trust the government."

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The Kremlin, having spent most of the pandemic so far playing down its toll in Russia, has launched an urgent push to get more people vaccinated. Suddenly, there are local COVID patients on state television, not just horror stories from Europe. In some cities, bars and restaurants, even workplaces, are open only to those with the QR codes to prove they have been vaccinated.

But the U-turn is up against conspiracy theories with long tentacles, not unlike the misinformation the Kremlin itself has been accused of spreading against rival Western vaccines.

Putin, usually not shy about taking off his shirt for the camera, was only vaccinated in recent months behind closed doors, fuelling speculation he didn't really get the jab, or at least not Sputnik V. And already, a black market in these coveted vaccination QR codes has sprung up – for people happy to pay for a vaccine certificate, there are reports some doctors will tip your dose of Sputnik V straight down the sink.

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Source: https://www.smh.com.au/national/notably-clever-if-russia-s-vaccine-is-so-good-why-isn-t-it-more-widely-used-20210802-p58f0i.html

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