Cold storage:
Hospitals buying special equipment to aid with distribution
Bay Area health officials are buying ultra- cold freezers and dry ice in anticipation of a coronavirus vaccine that must be kept at minus 94 degrees Fahrenheit.
After a group of scientists met to discuss coronavirus vaccines in August, one Northern California pharmacy executive foresaw potential problems.
The vaccine made by Pfizer and BioNTech, which is expected to be one of the first to get authorization from the Food and Drug Administration, must be stored at minus 94 degrees Fahrenheit — much colder than what most medicines and vaccines require. That’s when Ryan Stice, who oversees pharmacy services at Sutter Health, jumped into action.
It was “the starting gun,” Stice said, signaling the beginning of a complicated and monthslong planning effort to distribute vaccines. One critical component could be how to store and transport the Pfizer vaccine, which must be kept very cold because it contains fragile genetic material.
“We could see right away the cold chain logistics were going to be a challenge,” Stice said. “Like many systems, we didn’t have the infrastructure in place to handle this type of temperature.”
Health care providers and local health departments have long had systems in place to vaccinate large numbers of people against the flu and other illnesses. But most of those vaccines — such as the vaccine for the H1N1 influenza outbreak in 2009 — could be stored in refrigerators.
The prospect of building a cold chain infrastructure poses new challenges. While research labs and hospitals affiliated with research institutions often have these ultracold freezers, many community hospitals and clinics do not.
The August meeting was held virtually by the CDC’s Advisory Committee on Immunization Practices, which develops vaccine recommendations. It was closely monitored by doctors, health officials and health industry leaders across the country, including Stice and his colleagues.
Sutter, which runs 24 hospitals and dozens of outpatient centers in Northern California, does not typically use ultra-low-temperature freezers except to store specimens in its research institutes, because it does not have medications that need to be stored at such cold temperatures.
Now, like many other health care providers and local health departments, Sutter is moving quickly to buy ultra-freezers and place them strategically to facilitate the distribution of the Pfizer vaccine, should it gain FDA authorization soon.
Stice and Sutter’s vaccine planning group has acquired about a dozen large freezers, at $ 10,000 apiece, that can each store about 30,000 doses of vaccines at temperatures as cold as minus 112 degrees
Fahrenheit. It also bought three smaller portable freezers, which cost roughly $ 8,000 each, that will be used to transport doses from one location to another.
The portable freezers can potentially store up to 12,000 doses each. The freezers can accommodate a range of temperatures. So if it turns out they won’t need to store vaccines at that low of a temperature, they could also store, for example, the Moderna vaccine, which must be kept at minus 4 degrees Fahrenheit.
The portable freezers may also be used as mobile or “popup” vaccination units, similar to the mobile testing units that health care providers and local health departments have set up for diagnostic testing for the virus.
Sutter is still finalizing the exact locations to put the large freezers, Stice said. Those decisions will be shaped by many factors, including how many Sutter patients and employees are in each area, and how long it would take to transport vaccines a certain distance — which can vary greatly depending on whether it’s an urban or rural area.
The rollout of vaccines will start as a trickle, with a small number of highest priority people first, most likely health care workers who work with COVID19 patients. During that first phase, just 20 million people in the entire U. S. are estimated to be eligible for vaccination. For that reason, it’s possible the cold chain infrastructure will make up only a small, or initial, part of the eventual overall vaccine distribution.
The other leading vaccines under development do not require ultracold storage. By the time the broader public is able to get vaccinated, which will likely be midor late2021, there may several other vaccines available that don’t require ultracold storage.
“The question is whether we’re going to try to buy new ones or reconfigure where storage is,” said Stanford infectious disease specialist Dr.
Yvonne Maldonado, who estimates her lab has about five ultrafreezers to store research specimens. “We’re not talking about hundreds of thousands of doses, we’re talking about thousands of doses, so I suspect we won’t need more than some number, a reasonable number of freezers at places like Stanford. The problem will be what happens in a rural county or hospital. Where are they going to store their vaccine?”
State health officials are building out an ultralowtemperature storage system, though the number of sites and locations that will have the ultrafreezers is still being finalized, the California Department of Public Health said in a written statement.
Pfizer has said it will ship doses of its vaccine in specially designed, temperaturecontrolled containers cooled by dry ice that, if unopened, can maintain minus 94 degrees for up to 10 days. This means that ultralowtemperature trucks, trailers and trains won’t be needed, CDPH said.
But once health care providers and health departments receive the vaccines, they will have to store them in ultralowtemperature freezers, put them on dry ice, or refrigerate them at 35 to 46 degrees Fahrenheit, where they can last no more than five days. If thawed and kept at room temperature, they can last no more than two days.
The vaccine must be brought up to refrigerated temperatures, 35 to 46 degrees Fahrenheit, before it can be administered to patients.
Some Bay Area public health departments, which will likely allocate vaccines to health care providers, are also ordering freezers. Contra Costa County in late September bought an ultralowtemperature freezer for $ 15,000, and is negotiating with a local research firm to use freezer storage at their facility; combined, they would be able to store tens of thousands of doses. San Mateo County has ordered two ultracold freezers and four shuttle freezers for transport, and are evaluating sourcing options for dry ice.
Kaiser Permanente, Northern California’s largest health care provider, has already laid out some of the foundation for cold chain storage because it has been administering the Pfizer vaccine to volunteers as part of the drug company’s Phase 3 clinical trial. It involved buying some small freezers and dry ice.
“We’re using that knowledge to put together plans to expand our capacity to our other medical centers to the volume that’ll be needed when there’s more mass administration of this vaccine,” said Dr. Randy Bergen, who leads Kaiser’s Northern California flu vaccine program and serves on a stateassembled group that is drafting guidelines for coronavirus vaccine distribution in California. “I’m confident we can put in place the steps necessary to move from smallscale operation as part of a Phase 3 study, to a larger program.”