Russia’s Covid vaccine faces global production hurdles

Russia’s coronavirus vaccine Sputnik V was designed in a state laboratory with backing from the Kremlin’s sovereign wealth fund. But if it is going to meet a target of vaccinating almost one tenth of the world’s population, Moscow must rely on factories in Brazil, India and South Korea.

With limited manufacturing capacity at home, the Russian Direct Investment Fund (RDIF), which is managing Sputnik V’s distribution, has turned to partner countries boasting large drugmaking capabilities.

In doing so it has entrusted the vaccine’s future to a vast network of outsourced private companies all operating under different national regulations — some of which told the Financial Times that they were months away from reaching full production.

“Each site is likely to face different kinds of problems . . . it takes time to get the production up and running and ensure quality, especially when the production is outsourced to third parties,” said Rasmus Bech Hansen, founder of Airfinity, a London-based science analytics company.

A shipment of 400,000 Sputnik V doses arriving at Buenos Aires airport in Argentina last week © Juan Mabromata/AFP via Getty Images

RDIF told the FT that it had signed contracts with 15 manufacturers in 10 countries to produce 1.4bn jabs, enough to vaccinate 700m people.

The agreements mean RDIF is relying on foreign plants to produce more than twice as many doses as Russian companies. Factories in China, South Korea, India and Iran will manufacture shots that could be exported to third countries, while plants in states such as Brazil and Serbia will primarily serve domestic demand.

“We have some players who are really big, and they will be producing for the whole world. And we have some who are smaller and they will be producing more for local demand,” said Kirill Dmitriev, RDIF’s head. “This is our approach: to solve the bigger production issue while also . . . providing local availability.”

RDIF is banking on that devolved approach to help it avoid the production shortfalls that have bedevilled other Covid-19 vaccine producers such as AstraZeneca, while also tapping a large market for jabs in poorer countries.

Russian state TV proclaimed in November last year that the two-shot adenovirus-based vaccine was “as simple and reliable as the Kalashnikov assault rifle”. Yet experts in many western countries were sceptical in the absence of peer-reviewed evidence.

But after a study published earlier this month said the vaccine was 91.6 per cent effective — on a par with mRNA vaccines from BioNTech/Pfizer and Moderna — Sputnik V is now seeking to emulate the Kalashnikov as one of Russia’s great exports. 

People wait to receive doses of the Sputnik V vaccine in Buenos Aires earlier this month
People wait to receive doses of the Sputnik V vaccine in Buenos Aires earlier this month © Matias Baglietto/Reuters

Whereas the mRNA vaccines require below-temperate storage, making them tricky and more expensive to transport, Sputnik V’s $10 cost and required storage temperature of between 2C and 8C has made it attractive for many lower-income countries. 

“It wins on every point,” said Dmitry Kulish, a professor at private Moscow science university Skoltech. “Sputnik V’s simplicity and sensitivity to temperature mean it can win just as the Kalashnikov did.”

Moscow has pitched the state-developed vaccine as both a statement of scientific prowess and a tool of diplomatic soft power. That has made Sputnik V particularly attractive to countries that have felt elbowed out of global pharmaceutical deals by richer states.

Global production of the Russian Sputnik V vaccine

But questions remain over how soon Sputnik V’s global production network will be able to meet demand from more than 50 countries. Contractors in India and Brazil, countries that account for more than half of RDIF’s global production forecast, told the FT that they were yet to begin mass production of the vaccine.

Hetero Drugs, an Indian manufacturer contracted to produce more than 100m doses a year, is waiting for approval from national regulators before it starts growing the bulk virus culture, a pre-production step that takes significant time, a source with knowledge of the company told the FT.

Uniao Química, RDIF’s Brazilian contractor, said it was in pilot production and would only reach full output of 8m doses per month from April — adding that it was also in talks to import 10m doses from Russia in the next six weeks.

South Korean manufacturer GL Rapha, which will produce purely for export, said it did not have capacity for the entire 150m doses a year agreed with RDIF so was subcontracting production to other companies and expanding its own facilities. 

Airfinity estimates that 8m doses of Sputnik V had been delivered so far. US drugmaker Pfizer said this month it had produced 65m doses. 

In reference to RDIF’s vaccination target, Hansen said that “700m is very high and unlikely given the current rate and also what we have seen from other vaccine producers”. He added: “We believe that 380m for total production for 2021 is more realistic, but it could be significantly lower than that if their production site in Hyderabad in India does not scale fast.”

Russian producers’ experience and the vaccine’s relative simplicity could, however, enable foreign participants to scale up quickly, Kulish said.

Dmitriev declined to comment on current production levels, but said RDIF would announce the full details of overseas production sites next month.

“Some of [the foreign factories] are already producing. And most of them have produced high-quality trial batches,” he said. “In some of those countries, [vaccines] are ready to be shipped, in others it is going through approval processes.”

In Russia, six pharmaceutical companies are manufacturing the vaccine, while a further two are reportedly in discussions to join them. That production was “almost 100 per cent” for domestic use, Dmitriev said, but would start to be redirected to export markets after June, when Russian needs had been met.

Russian production has not been without hiccups. The country initially planned to manufacture 30m doses by the end of 2020, but scaled back the plans to just 2.5m after local producers encountered problems with acquiring equipment and production of the vaccine’s second dose. Dmitriev said these issues had now been resolved. Russia plans to make 33m doses by the end of March.

Dmitriev rejected suggestions that supply was already showing signs of strain, after Hungary, the first EU member state to unilaterally approve Sputnik V, said it would receive only 100,000 doses this month, down from the 300,000 it had earlier said it expected.

“Hungary is on plan . . . We are delivering to Hungary exactly as per schedule,” Dmitriev said, adding that he expected another EU country to begin buying the vaccine “soon”.

RDIF has said it is ready to supply the EU directly and has begun filing information to the European Medicines Agency (EMA), which approves drugs for use in the bloc. Josep Borrell, the EU’s foreign policy chief, said during a recent visit to Moscow that he hoped the EMA would approve the jab “because we are facing a shortage of vaccines”.

German chancellor Angela Merkel said last month that the country was interested in “joint production” of Sputnik V if it was approved by the EMA. Dmitriev declined to comment on whether that interest had progressed into concrete agreements, adding: “We have several EU plants willing to work with us ready to go as soon as there is an approval.”

Additional reporting by Edward White and Kang Buseong in Seoul and Stephanie Findlay in New Delhi

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