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...the vaccine has to be kept in ultra-cold storage at below minus 80C.

POLICY

Deep freezers and dry ice for Pfizer vaccine may face shortages

Vaccine must be stored at an average of 103 degrees below zero Fahrenheit

By Emily Kopp
Posted October 13, 2020 at 9:43am

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 adviser to the 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.

“That’s where you have the bottleneck,” she said.

The demand for dry ice has increased during the pandemic because of a spike in meal kit delivery memberships. There were 90 percent more new HelloFresh customers in the first quarter of 2020 compared to 2019, and Sun Basket experienced a doubling in orders, according to the business publication IndustryBrief.

Behlim says the potential for a dry ice shortage is among her top two concerns about the entire vaccination effort.

“When you look at the front runners for when a vaccine will be available the soonest, they’re the ones that require dry ice. That could potentially put the brakes on actually being able to get vaccines into people’s arms,” she said.

Alcorn said Pfizer is not anticipating a dry ice shortage “as of today.”

CQ Roll Call asked senior administration officials on a briefing call whether they were looking into the potential for a dry ice shortage, but did not get a reply.

Potential for waste

Spoiled doses would set back the administration’s timeline for vaccinating enough people to get back to normal.

The ultra-cold demands of the vaccines could make it difficult to vaccinate in pharmacies or stand up mass vaccination sites in parking lots. People in rural areas might find it difficult to go to a major hospital.

Messonnier acknowledged last month that Pfizer’s vaccine is unlikely to be administered at doctors’ offices because of its sensitivity.

“One of the early vaccine candidates needs to be transported at ultra-low cold chain. That means to me that it won't be given at a lot of providers’ offices because providers don’t have ultra-low cold chain freezers,” she said.

A preliminary planning document by CDC describes “vaccine A” — a vaccine meeting Pfizer’s description — as shippable only to large administration sites.

“We are looking and surveying what folks have for storage for a vaccine and what kind of freezers people have,” said Washington State Secretary of Health John Wiesman last week. “We’re just starting this but there aren’t a lot. … It’s probably just the large institutions that will have those.”

CDC’s Messonnier said on the call last month she was recommending against states investing in their own deep freezers, which cost as much as $15,000, because the CDC does not consider it “viable.”

Five dozen vaccination jurisdictions have received $200 million to prepare for the distribution of a vaccine, a small fraction of the billions experts estimate is needed.

More guidance from CDC to states on whether to purchase deep freezers is expected in the coming days, said Khatereh Calleja, head of the Healthcare Supply Chain Association.

Some states, including Wyoming, Delaware and Oregon, reported they’re waiting until they receive federal guidance. Others, including New Hampshire and Maine, say they’re moving ahead with purchasing plans.

The delicate storage concerns could also make it more difficult to share vaccines between public health departments and lead to waste. Pfizer’s cooler stores between 1,000 to 5,000 vaccine doses for a two-dose vaccine. Since the vaccine doses must be used between five and 15 days, that could make it difficult to distribute the vaccine nimbly.

“The Pfizer vaccine is good for 10 days in that dry ice package. So within those 10 days, you have to get your product to the right place and vaccinate as many people as possible within that timeframe,” Saha said. “In a situation where you have an excess of vaccine and want to help a neighbor out and ship it over, you’re losing a day or two in transport. And you’re not going to make that call on day six or seven; you’re going to make that call on day nine.”

“So wastage is a major concern for us,” she said.

Operation Warp Speed officials also called this a concern.

“We need to be very careful with the inventory, because we don’t want to put too much out there if it’s not going to be used pretty close to the time it gets out there,” said Paul Mango, Health and Human Services deputy chief of staff for policy.

Pfizer is working on a smaller suitcase that will be available “early next year” that holds fewer vaccines with the aim of making distribution easier.

The CDC has said it prefers these smaller shipping containers.

The administration says the first vaccines out of the gate are not expected to be the only ones developed, and that they hope to get more shelf-stable vaccines in 2021.

“I want to stress this is one or two vaccine products, and that as we progress particularly into 2021, there will be additional products with less restrictive cold chain requirements,” said Butler. “Assuming everything goes well, there will be more vaccines available and products that can be handled at routine immunization sites throughout the United States.”