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That booster shot is a doozy Production problems involving Sputnik V’s second dose complicate Russia’s plans for mass coronavirus vaccinations

Source: Meduza

Earlier this week, Vladimir Putin vowed that Russia will produce 2 million doses of its coronavirus vaccine, known as “Sputnik V,” in the coming days. Under his orders, the nation will launch a mass vaccination campaign, beginning on Saturday in Moscow. Meduza has learned, however, that Russian pharmaceutical companies are struggling to build a stable supply chain for Sputnik V’s required booster shots. In other words, Russia can start its mass vaccinations, but it can’t currently complete them. 

Russia has stockpiled about 500,000 doses of Sputnik V

According to Moscow Deputy Mayor Anastasia Rakova, Moscow is opening 70 vaccination centers across the city today. Beginning tomorrow, on December 5, the capital will start offering Sputnik V to Muscovites from designated risk groups: teachers, medical staff, and social workers. Rakova says she hopes Moscow will have 170 such centers by early next year. 

Though President Putin stated publicly on December 2 that Russia will imminently produce 2 million doses of Sputnik V, a federal government official with knowledge of the vaccine and a source in Russia’s pharmaceutical industry told Meduza that the country currently has just 500,000 complete doses (500,000 boxes containing both injections of Sputnik V that patients must receive several weeks apart). Meduza’s sources say the manufacture of the vaccine’s first component is going smoothly, but technical problems have plagued the production of the booster shot. 

Two Russian companies — Pharmstandard’s “Generium” and AFK Sistema’s “Binnopharm” — are currently manufacturing Sputnik V on an industrial scale. They’ll soon be joined by the St. Petersburg company “Biocad,” which recently announced that it will produce roughly 1 million doses of the vaccine in December. 

“All manufacturers are currently able to produce the vaccine’s first dose and there are already several million stockpiled, and at least 10 million can be produced,” an executive at one of Russia’s Sputnik V manufacturers told Meduza. “But there’s not enough of the second dose and nobody will say how much of it is available.”

Production of the vaccine’s second component has proved to be “more finicky”

In Sputnik V’s clinical trials, volunteers received their second injections 21 days after their first. Doctors were careful to administer the second dose within no more than one or two days of this three-week window. According to an executive at one of the vaccine’s manufacturers, however, Russian health officials have now changed this approach. It remains unclear why.

“It turns out that it’s unnecessary to do the second one after exactly 21 days and the interval can be anywhere from 21 to 50 days,” says Meduza’s source. “Meaning you can get the first dose within two or three months without any problems, and then get the second one later because it’s a booster. [...] So the president wasn’t joking when he announced the start of mass vaccinations: we have sufficient quantities of the first dose. Vaccinating 2 million people with the first dose before the end of the year is entirely possible.”

Meduza’s source says Sputnik V’s second component has proved to be “more finicky,” and Russian manufacturers are now focusing all their efforts on developing the processes and additional equipment needed to ramp up production in the next six weeks, though the supply might not reach the same volume already achieved with the vaccine’s first-stage dose. 

A source in Russia’s federal government explained to Meduza that the manufacturing setback is “natural,” given the unchartered territory of mass-producing an all-new biological agent. The same state official vowed that the country’s pharmaceutical companies will resolve the manufacturing problems before the year’s end, reaching President Putin’s promise of 2 million vaccinations by January 2021.

Meduza asked Sputnik V’s suppliers — Generium, Binnopharm, and Biocad — to comment on their reported manufacturing difficulties with the vaccine’s second dose. At the time of this writing, the companies have not responded. 

Manufactured and boxed, the vaccine still needs to be quality-checked

Another hurdle in Russia’s race to mass immunizations is the fact that regulators must verify the vaccine’s quality even after manufacturers have figured out how to make it in large quantities. Before this review process is complete, doses of Sputnik V remain unavailable to the general public.

Since the beginning of the year, Meduza’s sources in the pharmaceutical industry and the federal government say regulators have approved as many as 200,000 doses of Sputnik V for release to the general public, while the total supply of the vaccine is somewhere between 500,000 and 1 million doses. So far, Russia’s Food and Drug Administration has approved only the supplies manufactured by Generium and Sputnik V’s original developer, the Gamaleya Research Institute. 

A pharmaceutical executive told Meduza that another 500,000 doses of the coronavirus vaccine should reach civilian circulation this month, though he warns that talk of “millions of doses in December” is premature. Russia won’t reach that level of production until January, he says. 

Another four COVID-19 vaccines are now undergoing clinical trials in Russia: two Russian-made products (“EpiVacCrown,” developed by the Vektor Center, and a vaccine created by the Chumakov Research Center), as well as two foreign-made immunizations developed by CanSino Biological and AstraZeneca. It’s unclear, however, when any of these vaccines will be approved and available in mass quantities. 

In October, Health and Consumer Rights Agency head Anna Popova said Russia had 10 different COVID-19 vaccines in development. 

“We’ve got the equipment but no vaccine”

As Moscow readies for mass coronavirus vaccinations (albeit without enough second doses), other regions across Russia have found themselves without the information or even the first doses needed to begin the campaign.

“We’ve heard nothing except what’s been said in public. Only Moscow got anything. They’ve given us nothing,” a senior state official in one of Russia’s northern regions told Meduza. “We won’t hear anything until Monday, December 7, when there’s supposed to be a meeting with the Health Ministry, where they’ve promised to tell us something.” The same source implied that federal officials rushed Sputnik V’s rollout in order to score a publicity victory as the world’s leader in the fight against the coronavirus pandemic. He says his region received 40 trial doses of Sputnik V to vaccinate local doctors. Federal officials promised to send another 500 doses in November, but nothing arrived. “We know how to store it. We bought the equipment, but there’s no vaccine,” he told Meduza.

A senior official in Novosibirsk also told Meduza that his office doesn’t know how much Sputnik V to expect in December. A source in Nizhny Novgorod’s government says the region has inoculated 240 people, so far, and more vaccine supplies should arrive on December 7. It’s unclear, however, how many doses that shipment will contain.