ROME — The stress test devised by engineers at an industrial facility in southern Italy had a clear objective: How would the ultracold freezers, their interior temperatures plunged to an Antarctic minus-94 degrees Fahrenheit, perform under a sweltering and humid 95 degrees?
With the first doses of coronavirus vaccines expected to become available in the United States and globally within weeks, keeping things extremely cold has assumed a burning urgency.
One of the vaccines on the horizon, made by Pfizer and German firm BioNTech, must be transported and stored at extremely low temperatures — minus-94 degrees — much colder than most medicines and vaccines. Hence the parameters of the tests conducted by the engineers at Desmon, a producer of commercial refrigeration equipment, late last month.
“For instance, what you need to find out is how the device responds, how long the compressor has to work to keep the temperature,” said Corrado De Santis, Desmon’s chief executive and founder. “The more the compressor works, the more there’s power consumption. It’s also aimed at checking if/and for how long the compressor can ensure those performances.”
On Wednesday, Britain became the first country to grant emergency approval to the Pfizer vaccine, with the distribution of the first doses in a mass immunization program expected to begin next week. The Food and Drug Administration is expected to approve the Pfizer vaccine for emergency use by mid- to late December. Biotechnology company Moderna also announced last month that it was filing for regulatory clearance.
The European Union regulator said it plans to give an opinion on the Pfizer vaccine at a meeting on Dec. 29, followed by individual member states.
For Italy, that is expected to occur later in January, with about 300 distribution points across the country geared to the temperatures required for the Pfizer vaccine, according to Domenico Arcuri, the country’s coronavirus emergency commissioner.
“I think we may get the approval of these two first vaccines within the end of the year/beginning of 2021 as a sort of Christmas gift,” said Franco Locatelli, president of the Higher Health Council (CSS). “From January 15, we could be in the position of starting vaccination of the most exposed categories … to be followed by frail patients.”
Before the pandemic, ultracold freezers were a relatively niche market, supplying pharmaceutical companies, hospital labs and universities with the specialized and extremely costly cooling units.
Now, with the challenge of international vaccine distribution looming, ULT freezers are becoming much sought after, much like personal protective equipment and ventilators in the early months of the pandemic.
Ford has announced it is acquiring its own ultracold freezers to supply employees with Pfizer’s vaccine. Hospital systems, logistics and delivery companies are also gearing up.
Desmon is hoping it can meet some of that surge in demand.
The family-run firm, established in 1994, specializes in making industrial-scale freezer and refrigeration equipment, although not, until now, ultracold freezers. It was acquired by Illinois-based Middleby Corp. six years ago,
“My understanding is that the U.S. would need at least 50,000 of these deep freezers to distribute [the vaccine] on a vast scale,” De Santis said.
Such units can sell for between 10,000 and 18,000 euros, or about $12,000 to $21,000. But Desmon is hoping to beat those prices, he said.
Pfizer said it has created its own GPS-tracked coolers filled with dry ice to distribute the frozen vials of vaccine on a “just in time” basis. Packing shipments with dry ice can allow for 15 days of storage, Pfizer said.
Ultra-low-temperature freezers can extend shelf life for up to six months, provided the units can withstand environmental conditions. But existing manufacturers may have to scramble to ramp up production in time for rapid distribution of the vaccine.
“Everybody wants the vaccine, but many companies will only ever roll out a few hundred units per year,” De Santis said.
Paul Knight, a life sciences analyst and managing director at KeyBanc Capital Markets, noted that the market for ultra-low-temperature freezers has been growing recently with the development of cell and gene therapies that require far lower temperatures than the Pfizer vaccine.
He said supply chain pressures would be limited to distribution of the vaccination, not its storage.
“The test will be the shipping and distribution for air and freight carriers. The second challenge will be point of vaccination with many doses administered by doctors and clinics,” Knight said in an email.
Engineers at Desmon’s facility, nestled among the hills east of Naples, have been hard at work for months developing a freezer for the vaccine, said Corrado’s brother, Ciriaco De Santis, who heads the company’s research and development department.
Desmon’s sister company in the United States, K2 Scientific, said it has received preorders from major health-care systems and expressions of interest from retail pharmacy chains including CVS, Walgreens and Rite Aid.
Production is scheduled to start early in 2021, with the firm producing 50 to 100 units per day. The freezers will use GPS-tracking and send alerts should temperatures stray outside the necessary range, the company said.
According to both brothers, Desmon’s freezers have an edge when it comes to insulation, which helps maintain those ultralow temperatures. The larger model — a chest freezer designed to store 180,000 doses of the vaccine — can retain the necessary cold for up to 40 hours, even when removed from a power source.
That model, which the company said will be priced around $54,000, is meant to solve one of the toughest supply-chain hurdles confronting the Pfizer vaccine: transporting the vials to countries and regions that are prone to power outages, or may have trouble acquiring and storing dry ice.
The freezer was based on freezers used by fishing fleets off Italy and North Africa that were developed to keep the catch at a chilly 32 degrees Fahrenheit for 72 hours.
“Every hour matters,” said Corrado De Santis.