Russia has not disclosed how many doses of freeze-dried vaccine it plans to produce. (File)
Moscow:
Russia expects to produce mainly freeze-dried doses of the Sputnik V coronavirus vaccine by spring, a senior official said, eliminating the need for ultra-low temperature transport as part of an ambitious plan to inoculation of its population.
Vaccine developers around the world are scrambling to figure out how to ship and store their vials, some of which must be kept in specialized freezers at extremely low temperatures.
The logistical challenge was highlighted after promising interim trial data for the vaccine developed by BioNTech and Pfizer, a major breakthrough in the race to fight the pandemic.
This vaccine must be shipped and stored at minus 70 degrees Celsius, which equates to an Antarctic winter, which poses a challenge for even the most sophisticated hospitals in the United States.
It also puts it out of reach for many poor countries at the moment.
Transportation is a pressing issue for Russia, which has many extremely remote settlements and has already started rolling out a massive inoculation program of frontline medical workers across the country, although human trials for Sputnik V are not yet complete. not yet completed.
Whether they’re trucked across Siberia or flown to the far reaches of the Arctic, its vials should be stored at minus 18 degrees Celsius or less, according to the Gamaleya Institute that developed the shot.
But Russia also tested a version that underwent freeze-drying, turning the liquid vaccine into a dry, white mass that can be stored at normal refrigerator temperatures of 2-8 degrees Celsius (35.6-46.4 F). . It is then diluted before injection.
Russia has yet to reveal how many doses of freeze-dried vaccine it plans to produce. But Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which supports and markets the vaccine, told Reuters that would soon be the main focus.
“We expect that from around February we will mainly switch to the freeze-dried form,” he said. “A lot of the doses, if not a majority, will be in this form specifically.
“We have conducted trials which confirm that the immune response to the lyophilized form is the same as to the standard form of the vaccine.”
Interim results for the vaccine in liquid form showed that the injection was 92% effective.
Gamaleya Institute lead scientist Alexander Gintsburg said in an interview with Reuters earlier this year that freeze-drying was not yet a main focus because freeze-dried is more expensive and takes longer to produce.
However, Dmitriev said the process is not much more expensive, and the main limitation is the time it takes to acquire additional equipment.
Russia plans to produce around 2 million doses of Sputnik V this year, rising to 15 million per month in the spring.
Contracts seen by Reuters in the state’s bidding register show that the Gamaleya Institute has placed an order for materials with laboratory supplier Dia-M to be used to package 2.9 million doses of the shot in liquid form and 720,000 lyophilized doses. The order must be filled before December 21.
The Ministry of Health, which oversees the Gamaleya Institute, has not commented on the contracts. Dia-M also did not respond to a request for comment.
Freeze-drying, if widely applied, could give Russia an advantage in some export markets.
Bahia’s Brazilian state health secretary told Reuters he had ruled out buying the vaccine produced by Pfizer and BioNTech because they needed ultra-cold freezers for transport.
Bahia signed an agreement with Russia for 50 million doses of Sputnik V in September.
Russia is not the only one interested in freeze drying.
In Japan, Daiichi Sankyo Co is making a messenger RNA (mRNA) candidate that she hopes will give her an advantage for storage at higher temperatures. The technology uses a chemical messenger to instruct cells to make proteins that mimic the outer surface of the coronavirus, thereby creating immunity.
“We think we can offer much better conditions (for storage),” said Masayuki Yabuta, head of the company’s organic products division. “Lyophilization is the best formulation.”
SPETSNAZ VACCINE
The technique would be particularly useful for mRNA vaccines, such as the one developed by Pfizer and BioNTech, due to the need for very low temperature storage, said Anna Blakney, a researcher at Imperial College.
But it could also be used for other types of vaccines, including those based on an adenovirus vector like in Russia.
“I think it just hasn’t penetrated these big pharmaceutical companies yet,” she said.
Further tests may still be necessary to verify whether freeze-drying affects the effectiveness of a vaccine.
“You have to show the equivalence between the formulations. So a person vaccinated with the original formulation gets the same immune response as a person vaccinated with the lyophilized formulation, ”she says.
At the end of September, Russian authorities carried out a supply chain test, sending small amounts of the vaccine in liquid form to all parts of the country.
At the Moscow headquarters of logistics and courier company Biocard, staff tracked movements, receiving real-time updates on the temperature inside special containers.
The containers are able to maintain a constant temperature of minus 18.5 degrees for up to four days.
“The challenge is … you can’t change the temperature by half a degree, not even a minute or a second,” said Oleg Baykov, director of Biocard. “So you have very little time,” Baykov said. “We are like the Spetsnaz (rapid deployment forces) of the medical distribution world.”
Outdoor temperatures can also affect the operating time of containers. Winter weather in remote Russian cities, many of which are built around oil or gas fields, means Biocard is preparing to use helicopters to carry certain doses.
Russia has so far exported the vaccine to four destinations: Belarus, Venezuela, India and the United Arab Emirates. Delivery to Venezuela was made by the delivery company DHL, said Baykov, who also placed an order with Biocard for its temperature-controlled containers for the trip.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
