WASHINGTON – States are getting little federal assistance as they scramble to find medical-grade deep freezers or dry ice for one of the COVID-19 vaccines furthest along in development, which requires storage at much colder temperatures than found on an average winter day on the South Pole.
The Trump administration has earmarked billions in taxpayer dollars to vaccines by Moderna and Pfizer, but these vaccines require ultra-low temperatures – particularly Pfizer’s, housed at an average of 103 degrees below zero Fahrenheit.
Nancy Messonnier, Centers for Disease Control and Prevention director of immunization and respiratory diseases, candidly acknowledged the challenge on a late September call with industry.
“If you were looking at these vaccines and you had all the time in the world because you weren’t in the middle of the pandemic, you might say, ‘Well, gee, that particular vaccine is not optimized for delivery,’” she said.
The number of medical grade ultra-cold deep freezers in the United States is unknown. And it’s up to states to locate them.
“Not all of those (vaccination sites) will have the ultra-cold deep freezers to be able to store vaccines, particularly the Pfizer product,” said Jay Butler, CDC deputy director for infectious diseases, during a media briefing Friday. “So that is an important part of the state planning effort to determine where that capacity is.”
President Donald Trump has promised a vaccine by the Nov. 3 election. Pfizer CEO Albert Bourla, the only pharmaceutical executive to lay out a timeline similar to the president’s, said the company could have safety and efficacy data this month.
Federal officials – including the CDC and those with Operation Warp Speed, the administration’s vaccine and therapeutics initiative – are not working with hospital associations or medical supply chain experts on a national plan. Instead, officials made clear that it’s up to each of 64 vaccination jurisdictions to identify these freezers, according to an American Hospital Association spokesman.
The hodgepodge approach could lead to a national competition for freezers or dry ice.
“Those freezers are like unicorns. They are few and far between in health care settings today,” said Soumi Saha, senior director of advocacy at Premier Inc., which assists hospitals with medical supplies.
There are fewer than 10 national suppliers of medical grade deep freezers, experts say. A recent market report identified nine major suppliers.
“When you’re going to buy a medical grade freezer, it’s not like walking into Best Buy to buy a refrigerator and freezer for your home,” said Azra Behlim, a medical supply chain expert who leads a COVID-19 task force at Vizient Inc. and who led vaccination planning for Walgreens during the H1N1 pandemic.
The time it takes to manufacture and distribute a freezer under normal circumstances varies from 10 days to six weeks. One supplier, Helmer Scientific, announced last week that it’s experiencing a delay in fulfilling orders.
Luckily, some hospitals have these specialized freezers even if they don’t realize it, Belhim said, although their sizes vary widely “from the size of a table top or the top of a desk to the size of a TV tray.”
Some concern about the freezers’ availability was relieved recently after Pfizer announced it designed a special short-term cooler for keeping its COVID-19 vaccine in dry ice. Dry ice is a little colder than the vaccine must be: -109.3 degrees Fahrenheit.
Pfizer’s cooler or “thermal shipper,” which is the size of a carry-on suitcase, is capable of storing unopened vaccines for 10 days, said Tanya Alcorn, Pfizer’s vice president of biopharma global supply chain.
The Food and Drug Administration requires any vaccine it reviews to be stable on the shelf for at least 10 days.
Once opened, the vials can be stored at a more common 36 to 46 degrees Fahrenheit for five days, Alcorn said. Most pharmacies have these refrigerators, she said.
The cooler can also store the vaccine for up to 15 days after opening if the cooler is replenished with more dry ice. To do that, the cooler could be opened no more than once every five days and for no longer than one minute.
“There’s no historical precedent for us maintaining vaccines on dry ice in the United States. That’s never happened,” testified Paul Offit, an advisor to FDA on vaccines and director of vaccine education at the Children’s Hospital of Philadelphia, before Congress last month. “We’ve always shipped in the United States at most at freezer temperatures. ... I do worry about that. I think it’s going to be an enormous challenge.”
Pfizer will make its own dry ice for its manufacturing sites and distribution centers, but it’s again up to states, territories and major cities to track down their own supply once Pfizer’s suitcases arrive, Alcorn said.
Behlim is unclear on whether the nation’s supply of dry ice will be enough. According to her research, there are fewer than half a dozen national suppliers. A recent market report lists five major companies.