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 Vaccine developers globally are scrambling to work out how to ship
and store their vials, some of which must be kept in specialised
freezers at extremely low temperatures.
The logistical challenge was brought into sharp focus after
promising interim trial data for the vaccine developed by BioNTech <BNTX.O>
and Pfizer <PFE.N>, a major breakthrough in the race to curb the
pandemic.
This vaccine needs to be shipped and stored at minus 70 degrees
Celsius, equivalent to an Antarctic winter, posing a challenge for
even the most sophisticated hospitals in the United States.
It also puts it out of reach for the moment for many poor countries.
Transportation is a pressing issue for Russia, which has many
extremely remote settlements and has already begun rolling out a
programme of mass inoculation of frontline medical workers across
the country, though human trials of Sputnik V are not yet complete.
Whether being trucked across Siberia or flown to the far reaches of
the Arctic, its vials must be stored at minus 18 degrees Celsius or
below, according to the Gamaleya Institute which developed the shot.
But Russia has also been testing a version that has undergone
lyophilisation, turning the liquid vaccine into a dry, white mass
that can be stored at normal fridge temperatures of 2 to 8 degrees
Celsius (35.6-46.4°F). It is then diluted before injection.
Russia has not previously disclosed how many doses of freeze-dried
vaccine it is planning to produce. But Kirill Dmitriev, head of the
Russian Direct Investment Fund (RDIF), which is backing and
marketing the vaccine, told Reuters it would soon be the main focus.
"We expect that, starting roughly from February, we will switch
mainly to the lyophilised form," he said. "A large proportion of
doses, if not a majority, will be specifically in this form.
"We have conducted trials that confirm that the immune response to
the lyophilised form is the same as to the standard form of the
vaccine."
Interim results for the vaccine in liquid form showed the shot to be
92% effective.
Lead scientist at the Gamaleya Institute, Alexander Gintsburg, said
in an interview with Reuters earlier this year that freeze-drying
was not yet a primary focus, as lyophilisate is more expensive and
takes longer to produce.
However, Dmitriev said that the process was not significantly more
expensive, and that the main limitation is the time needed to
acquire additional equipment.
Russia plans to produce around 2 million doses of Sputnik V this
year, ramping up to 15 million per month by the spring.
Contracts seen by Reuters in the state tender register show that the
Gamaleya Institute placed an order for materials from laboratory
supplier Dia-M to be used for packaging 2.9 million doses of the
shot in liquid form, and 720,000 doses freeze-dried. The order must
be fulfilled by Dec. 21.
The health ministry, which supervises the Gamaleya Institute, did
not comment on the contracts. Dia-M also did not respond to a
request for comment. Freeze-drying, if applied widely, could give
Russia an advantage in some export markets. The health secretary of
the Brazilian state of Bahia told Reuters he had ruled out buying
the vaccine produced by Pfizer and BioNTech as they required
ultra-cold freezers for transportation. Bahia signed a deal with
Russia for 50 million doses of Sputnik V in September.
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Russia is not alone in looking at freeze-drying.
In Japan, Daiichi Sankyo Co <4568.T> is making a so-called messenger RNA
(mRNA)-based candidate which it hopes will give it an edge for storing 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 believe we can offer a much, much better condition (for storage),"
said Masayuki Yabuta, head of the company's biologics division. "Freeze-dried is
the best formulation." VACCINE SPETSNAZ
The technique would be particularly useful for mRNA vaccines, such as the one
developed by Pfizer and BioNTech, because of the ultra-low temperature storage
needs, Anna Blakney, research fellow at Imperial College, said.
But it could also be used for other types of vaccines, including ones based on
an adenovirus vector like in Russia.
"I think it just hasn't permeated into these big pharma companies yet," she
said.
More testing may still be needed to check if freeze-drying affects a vaccine's
efficacy.
"You have to show equivalency between the formulation. So someone that's
vaccinated with the original formulation gets the same immune response as
somebody vaccinated with the freeze-dried formulation," she said. In late
September, Russian authorities ran a test of the supply chain, sending small
quantities of the vaccine in liquid form to every region of the country. At the
Moscow headquarters of logistics and courier firm Biocard, staff tracked the
movements, receiving real-time updates on the temperature inside the special
containers. Containers are able to maintain a consistent temperature of minus
18.5 degrees for up to four days. "The challenge is that ... you can't change
the temperature by even half a degree, not even for a minute or a second," Oleg
Baykov, Biocard director, said. "So you have very little time," Baykov said.
"We're like the Spetsnaz (rapid deployment forces) of the world of medical
distribution." Outside temperatures can also affect how long the containers are
able to function. Winter weather in remote Russian towns, many built around oil
or gas deposits, mean Biocard is gearing up to use helicopters for transporting
some doses. Russia has so far exported the vaccine to four destinations:
Belarus, Venezuela, India and the United Arab Emirates. The Venezuela delivery
was handled by delivery firm DHL, Baykov said, which also placed an order with
Biocard for its temperature-controlled containers for the trip.
(Reporting by Polina Ivanova, Rinat Sagdiev and Polina Nikolskaya; additional
reporting by Rocky Swift in Tokyo and Alistair Smout in London; Editing by
Josephine Mason and Nick Macfie)
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