Vaccines and freezers

The Pfizer vaccine must be stored in an ultra-cold freezer. Many hospitals can't afford it, and there are already shortages.

This week, Pfizer handed all of us extremely good news—their vaccine is much more effective against the novel coronavirus than many scientists expected.

But nothing is that easy. The vaccine comes with its own unique logistical challenges that are—as per usual in health care—going to exacerbate existing social ills.

The Pfizer vaccine, namely, must be stored at -70 degrees Celsius (-94 degrees Fahrenheit). Seeing as the typical freezer maintains temperatures of around -18 Celsius, the vaccine will require some extra work beyond sticking it in the office freezer.

These logistical challenges aren’t limited to the Pfizer vaccine—the Moderna vaccine will probably also require very low temperatures (and be administered in two doses per person). But because the Pfizer vaccine will likely be the first available, the question of who can solve the freezer problem determines who can get the vaccine earliest. The freezer problem, of course, is complicated by rural hospitals’ budgets, a lack of guidance from the CDC, and shortages already popping up.

Ultra-cold freezers

The easiest solution to the Pfizer vaccine storage problem is an ultra-cold freezer, one that dips to temperatures below that of even pharmaceutical grade freezers. But these are expensive. As Olivia Goldhill of STAT News reported Wednesday, ultra-cold freezers cost between $10,000 and $15,000 each, putting them beyond the reach of many rural or struggling hospitals that don’t have that much cash to spare (especially as COVID-19 still rages).

Exacerbating inequities

As a result, only the wealthiest hospitals (and some states) are able to purchase these freezers—meaning populations in wealthy service areas are likely to have access to the vaccine fastest, even though it is Black and Hispanic patients who are more at risk of getting and dying of COVID-19.

To supply hospitals that can’t afford ultra-cold freezers, Pfizer is preparing to ship its vaccine in boxes the size of carry-on suitcases, filled with dry ice.

Shipping with dry ice is apparently novel for the U.S., and it means that there will be tightly constrained timelines for vaccine distribution. It will be most difficult to get the vaccine to isolated, rural areas; the dry ice may evaporate before the vaccine can be put in the arms of willing patients.

In September, Paul Offit, a vaccine expert, testified before Congress that “[t]here's no historical precedent for us maintaining vaccines on dry ice in the United States. That's never happened. 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."

Even in other countries typically thought of as less medically developed than the U.S., it appears that vaccine distribution has moved beyond dry ice. Amy Maxmen, a journalist for Nature, noted on Twitter that Ebola vaccines distributed in the Democratic Republic of the Congo could be distributed via a combination of freezers, special canisters, and dry ice boxes. But as the tweet notes, that requires a capital infusion. And the CDC and larger federal government, at least at the time of this writing, seems unprepared to offer that.

If anything, available CDC guidance has only sowed further confusion.

CDC guidelines

The CDC has, so far, urged states and hospitals not to invest in ultra-cold freezers, using the logic that more vaccine candidates (with less challenging storage requirements) will soon be available. This guidance has led to no small amount of confusion; if the Pfizer vaccine is released first (as is almost certain), there will probably be a rush to the hospitals that could afford the ultra-cold freezers and thus have access to the vaccine. Further, the Moderna vaccine, another option in the pipeline, also requires very cold storage (although for the Moderna vaccine, the average pharmaceutical freezer may be enough).

The CDC’s guidance is also creating some confusion between states and hospitals located within those states.

Pennsylvania, for example, decided to obey the CDC’s guidance and not invest in the ultra-cold freezers, nor to help hospitals located within the state.

Philadelphia’s Jefferson Health, meanwhile, decided to lease freezers on its own. The system’s chief pharmacy officer told STAT News: “I didn’t ever want to be stuck in a situation where products were available but we couldn’t receive them because we can’t store it. That would be a tragedy as far as I’m concerned.”

Supply chain challenges

Even for hospitals with the money, the purchase of ultra-cold freezers may soon become difficult.

The demand for ultra-cold freezers—and the supply chain distortions of vaccine distribution in general—will severely test the already-shaky medical supply chain situation. (As I wrote in March, group purchasing organizations are more than a little responsible for the current fragility of the supply chain.)

The ultra-cold freezer supply chain seems to be U.S.-based, meaning there’s less global competition for the freezers and that the shipping time is reduced. This, combined with the fact that several nations are pursuing their own vaccine candidates, means that the ultra-cold freezer supply probably won’t be as constrained as PPE was in March.

But there are still only 9 suppliers of ultra-cold freezers nationally. And each ultra-cold freezer takes 10 days to 6 weeks to build. At least one supplier has already announced that it’s experiencing shortages.

“Those freezers are like unicorns. They are few and far between in health care settings today," a senior director at Premier told the New Hampshire Union Leader.

A Vizient employee also offered a vivid analogy: "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.”

In other words, there’s probably going to be a big crunch for these freezers, even among hospitals that can afford them.

Other logistical challenges

The ultra-cold freezers are just the latest in a long string of massive logistical problems that must be overcome before the vaccine can be distributed. In a Radio Advisory podcast episode from August, Dr. Zeke Emanuel (now of President-elect Biden’s coronavirus task force) discussed the challenges inherent in distributing more vaccine at one time than has ever been attempted.

One of the first challenges is mass-producing a COVID-19 vaccine after it’s been approved. The Serum Institute of India (SII) is the largest global producer of vaccines, and they may or may not be up to the task. As Dr. Emanuel noted during the podcast:

I would say that they produce so many vaccines, I often wonder if what's happening is they're a little like the musical, The Producers. They got capacity. And they're selling the capacity over and over and over again, in part because they don't expect everyone to pan out. So SII might be thinking, AstraZeneca bought a bunch of capacity, but if that doesn't work, we'll shift capacity to Pfizer or whomever.

In other words, if multiple COVID-19 vaccines need to be produced simultaneously, SII might find itself unable to meet all of the demand.

Next, the vaccine has to be placed in specially produced glass vials. Corning is the only producer of this glass in the U.S.

Dry ice itself (a solid form of carbon dioxide) might run into shortages as Pfizer begins shipping its vaccine in the packages containing dry ice. A shipping executive told the Wall Street Journal that “demand for dry ice, for sure, will spike next year.”

And then, unless they can use up all the vaccine before the dry ice evaporates, hospitals and provider offices will need ultra-cold freezers.

Conclusion

In short, the logistics of handing out this vaccine are a huge problem, and the CDC’s guidance has done little to actually assist hospitals in pushing the vaccine to their service areas. The Biden team seems prepared to take over—but it’ll take genuine government effort (and probably funding) to get over these hurdles. Longer term, the COVID-19 crisis should show us that supply chain resiliency is a national security issue and a public health issue (and that having just one producer of special vaccine storage glass is a dangerous monopoly); it’s essential for the FTC to examine these failure points after the COVID-19 crisis has passed.

The vaccine reveals real shortcomings in the American supply chain and health care system, with failures falling most heavily on those already vulnerable to COVID-19.