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Russian coronavirus vaccine rollout plans hit production speed bumps

  • Moscow is dialing down production forecasts as scientists encounter challenges in ramping up manufacturing

Russia’s plan to roll out its coronavirus vaccine to the wider population is progressing at a slower pace than expected as policy makers encounter challenges in ramping up production.

Russia in August became the first country to approve a Covid-19 vaccine, called Sputnik V, despite skepticism in the West over the speed with which it was developed and the fact that trials were still ongoing. Moscow has since registered a second vaccine and authorities say a third could be approved next month.

Since mass production of Sputnik V began in September, attempts to scale it up have proved difficult as scientists struggle with fine-tuning the technical processes and encounter issues with the equipment, officials and experts say.

Russian officials have dialed back their earlier forecasts that up to 30 million doses of Sputnik V could be produced this year. They now expect between two million and 10 million doses by the end of the year, and a large-scale vaccination campaign is now set to begin late November or early December, having previously been anticipated in October.

President Vladimir Putin acknowledged last month that there was “only one issue to resolve now—the necessary production volumes."

Russia, one of the world’s worst-affected countries with over 1.8 million infections, has recently seen new daily cases hit records, stretching the health-care system to the limit. Daily deaths have also reached new highs, with a total of 31,161 officially recorded fatalities.

The challenges Russia is facing are typical with many vaccines, experts say, and involve the key technical aspects of the production process. Sputnik V uses a genetically altered form of a virus that causes the common cold, known as the adenovirus, to serve as a vehicle for a fragment of genetic material from the new virus. The modified virus is then fed into a so-called bioreactor, where it goes through fermentation, growth and multiplication.

The production specifications differ for every bioreactor, depending on size, yield and other characteristics, experts say. Scientists then need to tweak production methods as they go, based on variables such as temperature and air pressure.

“It’s a bit of trial and error in finding the right method and it can’t be done in advance," said Anton Gopka, dean of the School of Technology Management and Innovations at St. Petersburg’s ITMO University and general partner of health-care investment firm ATEM Capital.

Mr. Gopka said that scaling production is an unpredictable process that takes time and is “just impossible to do in a few weeks."

To speed up the process of manufacturing the shot, Russia has employed most of its vaccine-production facilities, including five pharmaceutical companies as well as a production site run by the state-run Gamaleya Institute for Epidemiology and Microbiology, which developed the vaccine, according to a person close to the process. Experts from the companies have met daily in recent weeks to come up with solutions for increasing production, the person said.

“It’s one thing to make a few thousand doses in small flasks in a lab and quite another to manufacture tens or hundreds of millions of doses," said Konstantin Chumakov, a U.S.-based Russian virologist and member of the Global Virus Network, an international scientific collaboration.

On Monday, Health Minister Mikhail Murashko said a first large-scale batch of the vaccine would be supplied to medical establishments from the production sites this week, without specifying the number of doses.

“These are the initial supplies, which are growing on a daily basis," Mr. Murashko said.

Russia’s health ministry and ministry of industry and trade didn’t respond to requests for comment on the production issues and planned vaccine volumes.

The latest production estimates vary. Industry Minister Denis Manturov said last month that Russia could produce 1.5 million doses in December, 3.5 million doses in January and then 15 million each month by spring.

Kirill Dmitriev, the head of the Russian Direct Investment Fund, the country’s sovereign-wealth fund, which has spearheaded the vaccine effort, said that Russia may reach a production volume of 7 million to 10 million a month in December or January at the latest.

Western companies are also facing challenges with vaccine rollouts, such as with lining up the raw materials, factory capacity and equipment needed to transport many millions of doses.

On Monday, Pfizer Inc. and BioNTech SE said that their vaccine—which is based on a different technology than Russia’s, known as mRNA—proved to be more than 90% effective. The vaccine could go into distribution this month or next, depending on a regulatory review.

Following Pfizer’s announcement, the Russian health ministry said that Sputnik V is also more than 90% effective, though the claim was based on the ministry’s observations from those inoculated so far rather than on data from a clinical trial.

Russian scientists are currently still testing Sputnik V in a so-called Phase 3 trial with over 40,000 volunteers. Officials expect to publish preliminary results this month. People in high-risk groups, including doctors and teachers, are already being given the jab as part of an emergency approval.

Several nations are banking on Sputnik V’s promise to curb the pandemic. Moscow has struck deals to sell the vaccine to Brazil, India and Mexico, among others. The production setbacks aren’t expected to affect these agreements since the doses won’t be manufactured in Russia but in production hubs in Brazil, China, India and South Korea.

This story has been published from a wire agency feed without modifications to the text

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