Cryopak, A Leader in Temperature Assurance Packaging Supports North American and European Distribution Efforts

vial hand

By now Pfizer and Moderna have become household names in North America. Other vaccine suppliers (i.e., Johnson & Johnson, AstraZeneca, Novavax to name a few) have introduced their versions. We now take for granted that vaccines arrive and can be dispensed without incident. In this article we look back at the early days of COVID-19 vaccine packaging distribution, provide references to articles you may find interesting, and share a couple of thoughts from the Cryopak perspective.

Temperature Requirements for Vaccine Shipping

Initially, the Pfizer vaccine needed to be stored at ultra-low temperatures of -70° C. The reason for this is because it is built through RNA rather than DNA; this makes it less stable in standard refrigeration temperatures[i]. Modifications have been made so that the Pfizer vaccine can be stored at -25° to -15° C, which is standard of most pharmaceutical freezers; however, the ultra-low requirements must be kept for transportation[ii].

The temperature requirements for the Moderna vaccine are less extreme, despite that fact it is also an RNA product. This is due to its different nanoparticle structure, which allows it to be kept at -20° C. This is a requirement that many facilities already have in place.[iii]

The Johnson & Johnson vaccine differs as it is made of DNA instead of RNA. This means it can be kept at normal refrigeration temperatures of 2°-8° C, making cold chain requirements less complicated[iv].

 

Requirements for Shipping Vaccines Without Damage

All vaccines are kept in glass vials. To ship these at required temperatures and without damage, it is best to use hard-sided insulated containers or EPS foam (expanded polystyrene) material (more commonly referred to as Styrofoam™[v]). Additional shipping materials include insulators like bubble wrap and corrugated cardboard[vi].

What Size or Duration Is Needed for Vaccine Shipping?

The Pfizer vaccine can be stored at temperatures of -25° to -15° C for up to 2 weeks; keeping it at refrigerated temperatures of 2°to 8° C will keep it viable for 30 days[vii]. The Moderna vaccine can be stored at refrigerated temperatures for up to 30 days as well[viii].

When identifying a cold chain packaging partner, it can also be important to evaluate the packaging sizes offered. “Off the shelf” solutions may be available that are qualified and ready to be used. Custom sizes may require validation (of temperature and duration), but this can serve to elongate the process. The amount of refrigerant (gel packs, phase change bottles, dry ice) will take up space within the box and can cut down on the payload size. Work with your cold chain partner to determine the appropriate packaging size and type as they can range from very small on up to pallet-sized shippers.

Are Vaccine Shippers Single or Multiple Use?

The overall design of the containers used to ship vaccines is in line with the idea of overall sustainability. These containers are reusable and can act as a temporary storage container if they are replenished with dry ice[ix].

Cryopak’s Role in Supporting Vaccine Shipment

With such a high demand for temperature-controlled shipping of vaccines, Cryopak has been a major stakeholder in North America and Europe and has stepped up to do its part in support of vaccine shipment.

Brent Begley, Vice President of Sales at Cryopak commented, “We have been working closely with both the Canadian government agencies and the major distribution partners for vaccines in Canada to insure that from the very start that our supply could meet their demand – both in volume and in the robust nature of the packaging requirements. Our engineering and production teams have met the challenges associated with producing quality products in large volumes that have helped our distribution partners keep their supply one step ahead of the demand.” Begley went on to say, “The very nature of the standard supply chain was knocked off its axis by COVID-19. The demand for corrugate spiked due to the change in consumption (everyone was shopping from home). In addition, staffing challenges due to COVID-19 impacted suppliers up and down the supply chain line. I am very pleased that Cryopak has been able to make its contribution in support of fighting the pandemic. Our team has really stepped up to meet the challenge, and the positive comments we have received from our distribution partners on our participation in helping to fight the pandemic has been rewarding.”

Cryopak provides a full line of vaccine shippers that are designed to handle all the temperature ranges that the existing vaccines require.

Learn More

To meet the many needs for shipping vaccines, Cryopak offers several solutions. These includes ultracold shippers, refrigerated shippers, control room temperature shippers, as well as temperature loggers that monitor the thermal status of a vaccine shipment. To learn more, visit www.cryopak.com.

 

 

 

[i] DiPietro, Gina. “Why COVID-19 vaccine needs to be stored at super cold temperatures.” Novant Health, 18 December 2020, https://www.novanthealth.org/healthy-headlines/why-covid-19-vaccine-needs-to-be-stored-at-super-cold-temperatures#:~:text=While%20most%20flu%20vaccines%20are,temperature%20of%20%2D94%20degrees%20Fahrenheit.

 

[ii] Arthur, Rachel. “EMA approves new storage conditions for Pfizer/BioNTech COVID-19 vaccine.” BioPharma Reporter, 30 March 2021, https://www.biopharma-reporter.com/Article/2021/03/30/EMA-approves-new-storage-conditions-for-Pfizer-BioNTech-COVID-19-vaccine.

 

[iii] Simmons-Duffin, Selena. “Why Does Pfizer’s COVID-19 Vaccine Need to Be Kept Colder Than Antarctica?” National Public Radio, 17 November 2020, https://www.npr.org/sections/health-shots/2020/11/17/935563377/why-does-pfizers-covid-19-vaccine-need-to-be-kept-colder-than-antarctica.

 

[iv] Feldman, Nina & Zoe Read. “What you need to know about the new Johnson & Johnson vaccine.” WHYY, 8 March 2021, https://whyy.org/articles/what-you-need-to-know-about-the-new-johnson-johnson-vaccine/.

 

[v] Styrofoam is a trademark of the Dow Chemical Company.

 

[vi] Vaccine Storage and Handling Toolkit. Center for Disease Control and Prevention, 4 March 2021, https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf.

 

[vii] FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available. U.S. Food & Drug Administration, 19 May 2021, https://www.fda.gov/news-events/press-announcements/fda-brief-fda-authorizes-longer-time-refrigerator-storage-thawed-pfizer-biontech-covid-19-vaccine.

 

[viii] Moderna COVID-19 Vaccine. Center for Disease Control and Prevention, 20 December 2020, https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/storage-summary.pdf.

 

[ix] COVID-19 vaccination: supply and logistics guidance. World Health Organization, 12 February 2021,

https://www.who.int/publications/i/item/who-2019-ncov-vaccine-deployment-logistics-2021-1.