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Coronavirus: Sputnik V Vaccine Rushed Out To Wary Russians

Sarah Rainsford

BBC News, Moscow

Sputnik V is the country's leading vaccine against Covid-19

Its name alone speaks of Russia's ambition: Sputnik V, the country's leading vaccine against Covid-19, is meant to be a world-beater just like its cosmic namesake.

Back in August, it was the first to be registered for emergency use although it had only been tested on a few dozen people.

Now doctors, teachers and social workers are being offered Sputnik V in a mass inoculation campaign ordered by President Vladimir Putin. Its timing, just ahead of a similar launch in the UK, is unlikely to be a coincidence.

But Sputnik V is still in the midst of trials to check that it's safe and actually works, making some Russians wary of receiving it yet.

And despite a fanfare over the vaccine's grand rollout, there are still problems scaling up production.

In December the BBC's Sarah Rainsford went to a Moscow clinic where the Sputnik V vaccine was being given to patients

In a sense, this is no "launch" at all. Russian health workers have been getting vaccinated in tandem with the official trials for several months. Teachers have been eligible too, and VIPs including President Putin's own daughter have had the jab. The list is said to total more than 100,000 people.

Bold claims

"All of the staff here have been vaccinated," nurse Oksana Konstantinova confirms, as she removes a tiny glass bottle of vaccine from the deep freeze at a Moscow clinic.

Sputnik V has to be stored at -18C at least in its liquid form. There are plans for a more practical, powder version of the vaccine but it's not yet being made in large amounts.

Why did she accept an experimental jab? "We have to be able to say that the vaccine is safe and necessary in the current situation," the nurse explains. "I was worried a bit. I am human! But I realised it was a fuss about nothing."

Sputnik's backers claim it offers 95% protection against the coronavirus, putting Russia's offering right up alongside the vaccines of teams in the US and Europe. But here, the data released so far is based on interim results only - after just 39 trial volunteers caught Covid. That haste - coupled with such bold claims - has raised eyebrows.

"We hope the vaccine is effective, but it's difficult to trust some of the figures," argues Svetlana Zavidova, whose organisation monitors clinical trials in Russia.

She also lists concerns that Sputnik's developers injected themselves with their own vaccine and that the product was registered for use after such limited trials.

Svetlana Zavidova says some of the data is difficult to trust

"We don't see the point of such a rush, other than announcing how we beat the rest of the world," Zavidova says. "I think there's a struggle between scientists and politicians, and the latter are winning."

Limited issue

Like other countries, Russia presents its trial results to an external panel of experts for analysis. "I heard the interim reports and can say for sure that Sputnik is safe and can produce a short-term immune response," oncologist Dr Alexander Rumyantsev told the BBC.

He had the vaccine himself in September and now boasts a large number of antibodies, though he said it was impossible to tell from the trial data how long any protection would last.

"We need more observation. I think we will only know that in spring." Around 24% of volunteers experience side effects, the doctor said. "They were not pronounced, and they didn't create any serious problems."

But there have been problems for Sputnik of another kind. Its developers used to boast that tens of millions of doses of their vaccine would be rolling off conveyer belts this year, but they've had to scale-back expectations.

Even President Putin now expects a modest two million doses of Sputnik this month.

Many Russians are deciding to wait to have the vaccine

The Russian vaccine comprises two entirely different injections - using different "vectors" or carriers for the coronavirus each time. Its backers insist that makes it more effective, but it also piles extra pressure on producers.

"Russia has taken on a crazy task," Dmitry Morozov says, arguing that biotech firms like his should have been consulted on the practicalities at the very start.

"They basically doubled the work for us. It's like you need to make two cars to actually move forward, but they're both completely different: a Jeep and a mini bus," he explains. "That's a serious challenge. It means we have a far tougher task than most other manufacturers."

Even so, Morozov is confident his firm, Biocad, can produce "millions" of doses of Sputnik. Its test batches are in Moscow now, waiting to be quality-cleared.

Dmitry Morozov says biotech firms should have been consulted at the start

Another source told the BBC that producers have struggled with the second Sputnik jab in particular.

"The first component is the most stable, we can produce more of it," the source said. "The second is less so and we have to keep strict temperature controls. I think it will soon be resolved."

Tough sell

But even when production lines are up and running, there could be another issue to contend with.

We only saw a handful of people getting injected on the first day of "mass" vaccination. On Monday, a reporter for Novaya Gazeta described similar scenes at another Moscow clinic.

According to the paper, a nurse had to throw some Sputnik V away when she defrosted it and no-one turned up.

That's a worry when the country is being hit hard by Covid, reporting close to 30,000 new cases a day. But it seems many Russians may have decided to wait.

"A lot of people don't believe in the vaccine at this point," Svetlana Zavidova believes. "I hope if there's real scientific data, they will change their minds."

A tour of one of Russia's temporary Covid hospitals

Russia begins Covid vaccinations in Moscow

Russia pins hopes on own vaccines and huge hospitals

Russian Sputnik COVID-19 Vaccine 'will Cost Less Than $10 A Dose'

The developer of Russia's COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose course – on the same day as revealing new clinical data with the shot.

Sputnik V's efficacy has remained high at 91.4% according to the latest analysis, which comes from almost 19,000 subjects who were assessed seven days after the second dose of the vaccine, administered 28 days after the first.

Preliminary data from a smaller group of patients 21 days after the second shot suggests an efficacy of 95%, according to a press release from the Gamaleya Institute and Russian Direct Investment Fund (RDIF).

That puts the efficacy of the adenovirus-based vaccine ahead the 70% overall efficacy seen with AstraZeneca/University of Oxford's AZD1222 jab – also based on an adenoviral vector – although AZ said yesterday there was a protective efficacy of 90% among patients receiving the vaccine as a half dose, followed by a full dose at least one month later.

AZ's trial also had a higher number of confirmed cases of COVID-19 to power the analysis, at 131 cases, while there were 39 cases in the Russian study by the latest data cutoff. The next analysis for Sputnik V will be made when there are 78 confirmed coronavirus cases.

Sputnik V's developers say its high level of efficacy comes from the use of two different adenoviral vectors which "allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses."

At the moment scientists only have the top-line data from press releases to go on so it is impossible to make any judgments about the relative efficacy of the two vaccines, or indeed the two mRNA-based shots from Pfizer/BioNTech and Moderna that have also shown efficacy rates above 90% in clinical trials.

The RDIF has echoed the position voiced by AZ that its adenoviral vaccine will be cheaper than the mRNA shots – by two to three times – and also has the advantage of being stored using regular refrigeration temperature of +2 to +8 degrees Celsius.

Pfizer and Moderna's vaccines require much lower temperatures to prevent their active ingredients from breaking down.

"Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates," it said.

Russia will provide Sputnik V to its domestic population free of charge, so the $10 per dose price applies to international markets.

Capacity to make the vaccine is currently enough to immunise 500 million people per year, and the first international deliveries will be made to customers in January. Other orders will start to be fulfilled from March.

Russia approved Sputnik V in August, making it the first coronavirus vaccine worldwide to be licensed worldwide.

So far it has accepted orders for 1.2 billion doses from more than 50 countries, including Brazil, India, Mexico and Hungary – the latter deal reportedly putting the EU member state at odds with the European Commission as Sputnik V hasn't yet been approved by the EMA.

Why Many In Russia Are Reluctant To Have Sputnik Vaccine

Sarah Rainsford

BBC News, Moscow

Local official Galina Bordadymova is proud of Russia's scientific breakthrough

When officials in Sputnik village announced recently that they would be offering Russia's Sputnik V vaccine at the local clinic, just 28 pensioners signed up for a Covid jab.

That endorsement was a political success, as well as a scientific one, for a prestige project loudly trumpeted by Moscow and openly doubted by many in the West.

But while countries from Latin America to Europe are now ordering batches of Sputnik, the rollout in Russia itself has been slow, as people prove deeply reluctant to be injected.

Sputnik for Sputnik

"Everyone scared me that it would hurt, but I didn't feel a thing!" an old-aged pensioner exclaimed, tugging his jumper on after a Sputnik jab in Sputnik village.

Behind him, a nurse leaned in to shout in another pensioner's ear that he should stay off alcohol for a while after his injection.

A couple of hours' drive from Moscow, Sputnik village has a cattle farm, a few identical apartment blocks and no indication at all why it was named after a triumph of the Soviet space race.

The cosmic link to the vaccine is clearer.

"The Sputnik satellite [in 1957] was a breakthrough and this vaccine is one too!" village official Galina Bordadymova laughed, fur-coated but gloveless in the bitterly cold street.

"We planned for 25 people to come but we got 28, so we're pleased," she insisted, dismissing the suggestion that interest was worryingly low in a population of over 1,000, given the high risk of Covid-19.

Her team had called around older residents, prioritising those most vulnerable to the virus. "Anyone who wanted the vaccine could get it," Ms Bordadymova said.

International interest

Western commentators were initially dismissive, even scornful, of Sputnik V as officials made bold claims on what was then scant evidence. Data from Phase III trials has since shown the vaccine to be effective, with side-effects similar to jabs made in Europe and the US, and interest abroad has surged.

"Even our critics have run out of arguments," Kirill Dmitriev said last month, the head of the RDIF state investment fund that's backing Sputnik.

The RDIF says 39 countries have already registered its vaccine and, to Russia's delight, it's even being called upon to help the vaccine-strapped EU.

Hungary was first to approve the Russian vaccine for emergency use and Slovakia has just received 200,000 doses, shrugging off talk of Sputnik as a "tool" of Russian influence.

Covid-19 doesn't care about geopolitics, Slovak Prime Minister Igor Matovic argued.

"You can say it's Russian weaponisation, or the vaccine is just a victim of the political background, but definitely politics is more explicitly represented in the case of the Russian vaccine than any other produced in the world today," Andrei Kortunov of the Russian International Affairs Council notes.

Still, Russia now has so many requests for Sputnik the Kremlin says it cannot handle them all with current production capacity.

The RDIF says it will supply foreign markets from plants abroad, not with doses meant for Russians, but it has given no details yet, nor a timetable.

"For Putin, creating the vaccine was a way to prove to the world that Russia is a developed, major country able to achieve great success in spheres which demand a lot of skill and technology," Tatiana Stanovaya of the R.Politik analysis firm argues.

But EU-wide approval of Sputnik remains a difficult goal as a result.

"When you decide to buy the Russian vaccine, it seems like you invest in or approve of the achievements of Putin's regime or Putin himself," she says.

Russian caution

In Sputnik village, there is no such discussion of vaccine politics.

Some residents are nervous of catching Covid: two locals in their 50s died of the virus in the first wave of the pandemic. But villagers seem warier still of getting a vaccine.

A poll by sociologists at the Levada Centre this week found only 30% of Russians willing to receive Sputnik V - down 8% since rollout began, and despite safety data now being public.

Adverts promoting the vaccine have been placed in the Moscow Metro

"People are afraid; there's all sorts of rumours about complications," Lidia Nikolaevna reasoned, shovelling thick snow away from her garage door.

She was in hospital with Covid only recently, so her doctor says she doesn't need a jab yet herself.

"Maybe later," Lidia ventured, echoing other villagers. "People say it's fine, but let's see. If everything goes ok, then I think more people will get vaccinated."

"Russians are conservative: they don't trust their own state and they don't trust whatever can come out of this state," Andrei Kortunov says, explaining people's hesitation.

With no new national lockdown, and minimal mention of Covid deaths by officials, they could be forgiven for thinking the danger had passed.

State TV has not been deployed with its full, persuasive force and President Vladimir Putin himself still has not been vaccinated.

The BBC's Sarah Rainsford went to one central Moscow clinic when vaccinations began in December

So despite remote rollouts like in Sputnik and pop-up vaccination points in city shopping centres, only four million Russians have so far had a Covid jab - far below the health ministry target of 60% of all adults in six months.

The Kremlin insists there is no deficit of vaccine for domestic use.

But its description of production and domestic demand as "in harmony" for "this stage" suggests a reluctance to promote the vaccination campaign too hard, until more phials are rolling down factory conveyer belts.

Heading home from Sputnik village clinic, pensioner Anatoly says getting his injection was no big deal.

"Wham! It was over in a moment," he says, miming a jab in the arm, but he doubts he really needed vaccinating at all.

"I'm healthy! You just have to drink samogon," Anatoly insists, referring to home-distilled, high-strength alcohol.

"I think that'll protect me from Covid too," the 74-year-old laughs, then wanders off across the snow.

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Sputnik V vaccine rushed out to wary Russians

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