The dry ice will go into a box developed by Pfizer, which the company calls a "thermal shipper."
Pfizer will use that box to ship the vaccine, opting out of the government's plan to use McKesson, a third-party distributor, which is expected to handle other coronavirus vaccines when they become available.
Clinics can then use the shipper to store the vaccine until it's ready to thaw, dilute and inject into arms. Health care workers, essential workers, and those at high risk for Covid-19 complications, such as the elderly, are expected to be among the first to get vaccinated.
States will administer the vaccination programs. Public health nurses, as well as private doctors, nurses, and pharmacists will give the shots.
At Pfizer's webinar with state health officials last month, the company laid out its specific requirements. Once sites receive their thermal shippers filled with vaccine, they're supposed to replenish the dry ice within 24 hours. If they don't use the vaccine within five days, they're supposed to replenish the dry ice again, and then again five days later.
Clinic staff must act fast when removing vaccine from the shippers. According to Pfizer's instructions, the boxes can be opened only twice a day, and each time for no more than a minute.
At any point, the vaccine can be removed from the shipper and put in the refrigerator, where it is good for only five days — any longer than that and the vaccines have to be thrown away. When ready to use, nurses dilute the vaccine, making five doses with one vial. Those five shots have to be given within six hours. If more than six hours pass, the vaccines have to be thrown out.
There's another potential problem. Doctors and nurses overtaxed with Covid-19 patients and other responsibilities will be challenged to follow directions perfectly — directions where mere minutes matter.
"They're all so insanely busy," said Moore, the doctor who's helping doctors and nurses get ready.
"I know they were astonished when they got their first glimpse from Pfizer on all of the steps in this process, on the thermal shipper and how it worked," she said. "You could see all of the brains spinning."
"I could start to smell fumes from the gears turning in their minds about — 'oh my — how are we going to keep up with all of this? This is not what we expected.'"
An Unconventional Method for Keeping Vaccine Frozen
The thermal shippers are essential to the success of the vaccine, but it's not clear that they work. CNN asked Pfizer what tests they've done to show the thermal shippers are capable of keeping the vaccine at minus 75 degrees. The company didn't respond.
A spokesperson for the US Food and Drug Administration said before authorizing any vaccine, "the FDA will review vaccine stability information for each particular vaccine candidate. This information reflects anticipated distribution and storage conditions for a specific vaccine candidate, and our review is provided to ensure that the vaccine's quality, safety and efficacy is not compromised prior to its administration."
CNN asked the CDC, HHS and Pfizer how they know the thermal shippers work. They did not answer.
"When they don't answer questions, that's when I begin to get nervous," said Schaffner, a member of the CDC's Advisory Committee on Immunization Practices.
There are other questions, too. At the August CDC meeting, Pfizer said the shipper could be used for 10 days, and it could be replenished with dry ice for an extended period, but it did not say how long that period was. In
September, the group president of Pfizer's Biopharmaceuticals Group, Angela Hwang,
said the vaccine can be stored in the shipper for 15 days. In November, a Pfizer spokesperson told CNN that unopened, the shipper can maintain its temperature for 10 days, which allows for extended shipping times, and once opened upon arrival, can be used as temporary storage for up to 15 days with dry ice being replenished every five days.
Such comments have caused confusion among state health officers. In addition, it's unclear where they will get dry ice.
HHS has told state governors they will need to obtain the dry ice from local suppliers but has also acknowledged there could be difficulty obtaining dry ice in some parts of the country. The agency says it's exploring options to resolve this, including solutions to provide increased access to dry ice, but it has not yet said what those solutions will ultimately be.
Pfizer has told states that if they can't source dry ice locally, they can use the company's dry ice suppliers. But it has given few details on what that process will look like. That's prompted at least one state, North Dakota, to buy its own dry ice machine — an expensive proposition at $48,000, plus another $40,000 for three months' worth of liquid carbon dioxide, a necessary ingredient to make the ice, according to according to George Gerhardt at the North Dakota Department of Health.
Some states are disregarding the CDC's directive not to purchase ultra-low temperature freezers. North Dakota, for example, has spent $100,000 to purchase 13 ultra-low temperature freezers, according to Nicole Peske, a spokeswoman for the state health department.
Fears of Finger-Pointing
As state health workers hurry to put their plans in place to distribute the Pfizer vaccine, they know three things are true.
One, if there are glitches in getting the vaccine out to the public, the blame will likely fall on them.
"I think that there's going to be a level of finger pointing," said Wood, the public health consultant who's helping states with their immunization plans. "People are going to turn around and say, 'well, public health just wasn't ready. This didn't happen the way that it should have, and these are unprofessional bureaucrats.'"
Second, if the distribution of Pfizer's vaccine doesn't go well, an already skeptical public could mistrust distribution of other coronavirus vaccines down the road.
"If we lose confidence in the very early, in the first stages, then the downstream ramifications I think are pretty profound," Wood said.
The third is that no matter how hard state officials work to plan out the details, no matter how many webinars they attend or CDC playbooks they read, everything right now is theoretical.
"There are definitely a lot of opportunities for errors to occur," Moore said. "You don't figure out where the bugs are until you turn the system on — so far this entire system has just been on paper."
State public health officials are resourceful and innovative, Moore said, and right now they're forging ahead.
"It's going to be hard. Mistakes will be made, but we will learn from them, and we will get better and better," she said.
They try to be optimistic about the prospect of rolling out such an unprecedented immunization plan.
"It's a very big deal," said Howell, the North Dakota program manager. "I think we can do it."
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