12.8.2020

The challenges and perils of transporting millions of COVID-19 vaccines with dry ice across the U.S.

By Elisabeth Buchwald

Transporting large quantities of dry ice, which can emit carbon dioxide, could pose a danger on airplanes, experts say

When you order a gift from Amazon (AMZN) the process of getting the item you purchased to your doorstep is fairly straightforward.

But transporting a coronavirus vaccine, if and/or when emergency-use authorization is granted in the U.S., requires arctic temperatures.

The government, through Operation Warp Speed, has begun the laborious process of modeling various distribution plans for coronavirus vaccines.

The Pfizer/BioNTech (PFE)(BNTX) vaccine candidate is one of three front runners currently working their way through trials. It has been developed in a record 10 months. It has already been granted emergency-use authorization in the U.K.

Moderna Inc. (MRNA) is also developing an mRNA vaccine, and has said it generated a 94.5% efficacy rate in its late-stage trial. Moderna is seeking U.S. and EU emergency-use authorizations (link) for its candidate.

A third vaccine being developed by AstraZeneca PLC (link) with (AZN.LN) Oxford University — a viral vector-based vaccine — recently produced some confusing results, with the vaccine appearing 62% effective when tested as originally planned, but 90% effective when a manufacturing error led to a reduced initial dose for some volunteers.

Pfizer expects to deliver 50 million doses of its vaccine worldwide by the end of the year, while Moderna expects to deliver 20 million in the U.S.

The U.S. Food and Drug Administration is scheduled to meet on Dec. 10 to review the Pfizer–BioNTech vaccine candidate and could also issue an emergency-use authorization.

Pfizer/BioNTech’s vaccine must be stored at -70deg C (-94degF) and there are two main ways to maintain that temperature: dry ice and temperature-controlled refrigeration units.

The Moderna vaccine, which is also being reviewed for an EUA, “remains stable at 2deg to 8degC (36deg to 46degF), the temperature of a standard home or medical refrigerator, for 30 days,” according to a Nov. 16 company statement (link). After 30 days, its vaccine can remain stable for up to six months at -20deg C (-4degF) for up to six months.

Dry ice has a financial advantage over refrigeration units.

That may explain why the Centers for Disease Control and Prevention urged health-care providers not to purchase the ultra-low temperature freezers in late August, saying it was working on solutions for Pfizer’s “very complex storage and handling requirements,” according to Reuters (link).

Additionally, “if you’re sending a batch of the vaccines up to northern Minnesota or to a small community where they’re going to get vaccinated, the likelihood of them having a refrigeration system is slim,” said Richard Gottwald, chief executive of the Compressed Gas Association, a trade group.

Constructing a refrigeration system for the vaccine “doesn’t make sense in the long term,” he added.

However there are safety concerns about transporting large quantities of dry ice, which can emit carbon dioxide, on airplanes. Packaging dry ice in a container that does not allow adequate release of the gas could cause the container to explode from the built-up levels of pressure, a process known as sublimation. Dry ice can also deprive a confined space of oxygen, making it difficult to breathe.

That’s why the U.S. Department of Transportation and the International Air Transport Association classify dry ice as hazardous when transported. Though under normal flight ventilation conditions, the risk of suffocation or an explosion from dry ice is minimal, according to the FAA.

“There have been very few reported incidents of carbon dioxide hazards aboard aircraft resulting from sublimation of dry ice,” a 2009 memo (link) circulated by the FAA states. “In the incidents that have been reported, the aircrew recognized symptoms that they considered to be related to potential air contamination and took appropriate procedures to avoid any serious problems.”

“The FAA is working with manufacturers, air carriers, and airport authorities to provide guidance on implementing current regulatory requirements for safely transporting large quantities of dry ice in air cargo,” an FAA spokesman told MarketWatch.

The FAA has said it would allow United Airlines (UAL) to carry 15,000 pounds of dry ice per flight — five times more than normally permitted, The Wall Street Journal reported (link).

The Department of Transportation released a statement (link)Dec. 1 saying that “The Department has established the appropriate safety requirements for all potential hazards involved in shipping the vaccine, including standards for dry ice and lithium batteries.” The agency did not share what the “appropriate safety requirements” are when MarketWatch inquired.

Earlier in the pandemic, Gottwald penned a letter (link) to Vice President Mike Pence warning that there could be a shortage of carbon dioxide, the frozen form of which is dry ice, due to the pandemic-fueled drop in industrial manufacturing (CO2 is a byproduct of manufacturing).

Given that more businesses have reopened their manufacturing plants, Gottwald has said he no longer anticipates a shortage even as more cities, including Los Angeles (link), reimpose stricter lockdown measures to curb the exponential growth in new cases of coronavirus.

On Thursday, New York Gov. Andrew Cuomo, a Democrat, revealed that the first 170,000 doses of the Pfizer/BioNtech vaccine, if approved, will be shipped in boxes that are equipped with dry ice and glass vials produced by Corning Glass (GLW) that were specially designed to withstand the extreme temperatures needed. Corning supplies glass for Apple’s (AAPL) iPhones.

The company, based in upstate New York, received a $204 million federal contract to produce glass vials for vaccines.

By the fourth quarter of next year, Corning expects to “ship enough vials to deliver over a 100 million vaccine doses,” Brendan Mosher, Corning’s head of pharmaceutical technologies, told MarketWatch in an emailed statement.

Pfizer’s distribution plan calls for using either ultra-low-temperature freezers that “can extend shelf life for up to six months” as well as dry-ice-equipped boxes for transporting its vaccine from its main distribution center located in Kalamazoo, Mich. Pfizer has a smaller distribution center located in Pleasant Prairie, Wis. as a base for shipping vaccines.

Unlike Moderna, Pfizer will not be working with McKesson Corp. (MCK), the company chosen to distribute the vaccine by the U.S. government as part of Operation Warp Speed, both Pfizer and McKesson confirmed with MarketWatch.

“McKesson built large-scale, custom freezers and refrigerators with the capacity to safely store and process tens of millions of vaccine doses at strategically located distribution centers,” the company told MarketWatch.

“For the frozen Moderna vaccine, one temperature indicator is packed inside each vaccine shipment to enable those receiving and administering the vaccine to have confidence that the cold chain was maintained during shipment,” it added.

“We have added more than 3.3 million square feet of distribution-center space, including storage, to our distribution network to manage the scale of this project. For comparison, that’s twice the size of New York City’s Grand Central Station,” McKesson’s memo states.

David Matthews, a senior spokesman for McKesson said, “We aren’t releasing the number or location of the additional distribution centers,” and declined to comment further.

This article appeared on the Morningstar website at https://www.morningstar.com/news/marketwatch/20201207412/the-challenges-and-perils-of-transporting-millions-of-covid-19-vaccines-with-dry-ice-across-the-us

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