Thursday 15 July 2021
Sputnik V is the Russian vaccine against Covid. The world isn’t sure it’s getting the whole truth about it
Hi, I’m Claudia – and this is Sensemaker – from Tortoise Media.
One story every day to make sense of the world.
Russia stunned the world when it announced a successful Covid vaccine earlier than anyone else. Today: why the Sputnik V has now run into trouble.
“Russia has become first country to give regulatory approval to a Covid-19 vaccine and will begin a mass immunisation programme in October.”BBC News
When President Vladimir Putin announced in August 2020 that a team of scientists had developed the world’s first vaccine for the coronavirus, heads turned.
It was called Sputnik V. A provocative name, a throwback to the space race of the 1950s, and the first satellite ever launched into space by the Soviets.
The announcement came four months before Oxford/AstraZeneca, Pfizer or Moderna had declared success.
Sputnik V had been funded by the “Russian Direct Investment Fund” or RDIF, the country’s sovereign wealth fund. And Vladimir Putin claimed it was as “reliable as an assault rifle”.
[Clip of Vladimir Putin speaking about Sputnik V]
In fact, his own daughter was jabbed with it.
It also had an extraordinary efficacy rate – that’s how well a vaccine works against a virus – and it was much higher than any of the results that came out of the Pfizer or AstraZeneca trials.
“The efficacy of the vaccine in preventing someone from contracting Covid-19 is 91.6. Now that is absolutely excellent.”Dr John Campbell speaking on his YouTube channel
Soon, Sputnik V was being used in more than 60 countries – including Argentina, Mexico and Hungary – and according to the RDIF there have been, and I quote, “no reported serious adverse events” – so, no worrying side effects.
But some people wondered if it had been rushed through – it got approval for use by the government before the phase three trial had even begun – that’s the large-scale testing phase.
Like its namesake, people wondered if this was a way for Russia to show off, to beat the rest of the world in the vaccine race.
And now, nearly a whole year on, international watchdogs, including the World Health Organisation, are delaying its approval for emergency use, meaning it can’t yet be used in the COVAX initiative which provides doses to lower income nations.
So what’s happening? Is this a plot to undermine the vaccine, as the Russians suggest, or is Sputnik V not what it seems?
“Scientists and regulators are raising questions about Russia’s Sputnik V vaccine… while the vaccine is already being used in multiple countries around the world such as Argentina, Turkey and Serbia, it has still yet to win EU regulator approval.”CBSN News
The European Medicines Agency, or EMA for short, is the European Union’s medicines watchdog. They evaluate and supervise medicines being used in Europe, to make sure citizens stay safe.
And last month, the EMA’s review of Sputnik V’s safety and efficacy was delayed because the Russian team missed a deadline to submit data.
Now, it’s standard practice for developers to submit all kinds of data, including case report forms.
“A case report form or CRF is defined as a set of printed paper or electronic documents designed to record all information necessary about a subject that has been enrolled in a clinical investigation.”World Medical Device Organisation
They show how each patient involved in a trial responded, a pretty important thing to consider for vaccines.
And other bits of data are missing too. A body of French scientists found they couldn’t be certain that the initial building block of Sputnik V fitted with EU regulations.
And the concern doesn’t stop there.
“Now Brazil’s health regulator, Anvisa, rejects the importation of Sputnik V vaccine after state governors there asked that the Russian drug be used to battle their second deadly wave of the coronavirus.”ANC News
Brazilian regulators rejected imports of Sputnik V because of missing data around safety, quality and effectiveness. They’ve since given “conditional approval” if the information gaps are met.
Slovakia’s drug agency took a similar stance.
So, what does Russia make of all this?
“We are very modest in our expectations for all of Sputnik in Europe because we already have great obligations to 66 other nations to Russia. But if the vaccine is registered of course we’ll be happy to provide some quantities to Europe.”Kirill Dmitriev, CEO, Russian Direct Investment Fund
That’s the CEO of the Russian Direct Investment Fund speaking to reporters in St Petersburg.
But behind the scenes, the RDIF has been taking a different stance.
They claim their vaccine could be under attack by the “Western pharmaceutical lobby,” that there is a “major information warfare” against its vaccine and they even threatened to sue Brazil’s health regulator for defamation.
Their worry is that the delay in approval by watchdogs like the EMA will allow rival vaccine makers to monopolise key markets. And so they’ll miss out.
But Russia still has a big job to do at home.
The country has high hesitancy rates for Covid vaccines… and at the end of June, only around 15 percent of Russia’s population – which is around 144 million – had received one dose of a vaccine.
So, things look tricky for Sputnik V.
Russia is keen to get greater international approval as quickly as possible and they’re hoping that the studies already underway in countries like Argentina and Turkey – where their vaccine is currently being used – will help prove that Sputnik V is both safe and effective.
Today’s story was written and produced by Imy Harper.
Book, listen, read
Genesis: The mystery of where Covid began
The truth of an origin story has never mattered more: did Covid cross to humans from an animal, or did it escape from a laboratory? The arguments between science, politics and, now, the intelligence services have only grown fiercer. And in the fog of war, the World Health Organisation lost its way