Russia expects to produce mostly freeze-dried Sputnik-V coronavirus vaccine doses by spring, a top official said, eliminating ultra-low temperature transportation as part of an ambitious plan to vaccinate its population.
Vaccine developers around the world are trying to figure out how to ship and store their vials. Some of them need to be kept in special freezers at extremely low temperatures.
The logistical challenge has come to the fore following promising interim trial data for the vaccine developed by BioNTech and Pfizer, a major breakthrough in the race to contain the pandemic.
This vaccine has to be shipped and stored at minus 70 degrees Celsius, which corresponds to an Antarctic winter. This poses a challenge to even the most demanding hospitals in the United States.
It is currently inaccessible to many poor countries.
Transportation is an urgent problem for Russia, which has many extremely remote settlements and has already started rolling out a mass vaccination program for frontline medical professionals across the country, although the human Sputnik V trials are ongoing.
Regardless of whether they are transported through Siberia or flown into the distant Arctic, the vials must be stored at minus 18 degrees Celsius or below, according to the Gamaleya Institute, which developed the shot.
But Russia has also tested a version that has undergone freeze-drying, turning the liquid vaccine into a dry, white mass that can be stored at normal refrigerator temperatures of 2 to 8 degrees Celsius. It is then diluted before injection.
Russia has not yet disclosed how many doses of freeze-dried vaccine it will produce. However, Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which supports and markets the vaccine, told Reuters that this will soon be the focus.
“We expect to switch mainly to the lyophilized form around February,” he said. “Much, if not the majority, of the doses will be specifically in this form.
“We have conducted studies confirming that the immune response to the lyophilized form is the same as to the standard form of the vaccine.”
Preliminary results for the vaccine in liquid form showed the shot was 92% effective.
The lead scientist at the Gamaleya Institute, Alexander Gintsburg, said in an interview with Reuters earlier this year that freeze drying is not yet a main focus, as lyophilisate is more expensive and takes longer to produce.
However, Dmitriev said the process is not significantly more expensive and that the main limitation is the time it takes to acquire additional equipment.
Russia plans to produce around 2 million cans of Sputnik V this year, which is set to increase to 15 million per month by spring.
Reuters contracts in the state tendering register indicate that the Gamaleya Institute has placed an order for materials for packaging 2.9 million cans of the shot in liquid form and 720,000 freeze-dried cans from laboratory supplier Dia-M. The order must be fulfilled by December 21st.
The Ministry of Health, which oversees the Gamaleya Institute, did not comment on the contracts. Dia-M also did not respond to a request for comment.
Widespread freeze drying could give Russia an advantage in some export markets.
The health minister of the Brazilian state of Bahia told Reuters that he had ruled out the purchase of the vaccine, made by Pfizer and BioNTech, because ultra-cold freezers were required to transport it.
Bahia signed a contract with Russia in September for 50 million cans of Sputnik V.
Russia is not the only one looking into freeze drying.
In Japan, Daiichi Sankyo Co is making what is known as a messenger RNA (mRNA) -based candidate, which he hopes will provide 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, creating immunity.
“We believe we can offer a much, much better condition (for storage),” said Masayuki Yabuta, director of the company’s biologics division. “Freeze-dried is the best formulation.”
The technique would be particularly useful for mRNA vaccines such as those developed by Pfizer and BioNTech, as they require storage at extremely low temperatures, said Anna Blakney, a research fellow 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 hasn’t gotten into these big drug companies yet,” she said.
More tests may be needed to see if freeze-drying is affecting the effectiveness of a vaccine.
“You need to demonstrate equivalence between the formulations. Someone vaccinated with the original formulation will get the same immune response as someone vaccinated with the freeze-dried formulation,” she said.
In late September, the Russian authorities carried out a supply chain test and sent small quantities of the vaccine in liquid form to all regions of the country.
At the Moscow headquarters of the logistics and courier company Biocard, employees followed the movements and received real-time updates on the temperature in the special containers.
Containers can maintain a constant temperature of minus 18.5 degrees for up to four days.
“The challenge is that … you can’t change the temperature even half a degree, not even for a minute or a second,” said Oleg Baykov, director of Biocard. “So you have very little time,” said Baykov. “We are like the Spetsnaz (rapid response forces) in the world of medical distribution.”
Outside temperatures can also affect the functionality of the containers. Due to the winter weather in remote Russian cities, many of which have been built around oil or gas reserves, Biocard is preparing to use helicopters to haul some cans.
Russia has so far exported the vaccine to four destinations: Belarus, Venezuela, India and the United Arab Emirates. The delivery to Venezuela was handled by the delivery company DHL, said Baykov, who also placed an order with Biocard for their temperature-controlled containers for the trip.
(Except for the headline, this story was not edited by GossipMantri staff and posted from a syndicated feed.)