COVID-19 Vaccination Storage and Supply Chain Strategies


February 2021 - Vol.18 No. 2 - Page #8

At long last, the arrival of vaccines for COVID-19 is cause for celebration. And yet, consistent with management of the COVID-19 pandemic itself, managing the supply chain for the currently available vaccines does pose logistical challenges that must be addressed promptly. As both Pfizer-BioNTech’s and Moderna’s COVID-19 vaccines have logistical challenges that are unique to each vaccine, health systems must have a detailed plan in place to manage the storage and supply chain of this valuable inventory. (see TABLE 1 for a comparison of product requirements).

 

Vaccine Storage Requirements

The Moderna vaccine arrives on site with the vials in a manufacturer specific carton within the shipping container. The vaccine is a multiple-dose vial that can be stored as follows:

  • At -25˚ to -15˚C in the manufacturer’s original carton to protect the product from light, for up to 6 months
  • Refrigerated between 2˚ to 8˚C for 30 days
  • At 8˚ to 25˚C for up to 12 hours1
  • Once punctured, the product must be used within 6 hours

Conversely, Pfizer-BioNTech’s vaccine arrives on site in a thermal container with dry ice packaging. The vaccine may be stored in an ultra-low freezer with temperatures between -80˚ to -60˚C for up to 6 months, or kept in the thermal shipping container for up to 30 days if proper precautions are taken.2 If the administering site decides to store their vaccine in the thermal shipping container, the dry ice in which the vaccine is packaged must be replenished within 24 hours of receiving the shipment and every 5 days thereafter.3 Note that these replenishments are the responsibility of the administering site. Utilizing the thermal container for primary storage poses additional logistical challenges as the container is designed to be used only for short periods of time; it cannot be opened more than twice daily and each opening cannot exceed a 3-minute interval. This severely limits access to the thermal cooler for restocking or to take out additional inventory as vaccination volumes fluctuate throughout the day.

Pfizer-BioNTech’s vaccine must be thawed before dilution, an additional step that is not needed for the Moderna Vaccine. Undiluted Pfizer-BioNTech vaccine can be stored between 2˚ and 8˚C for up to 120 hours to allow for thawing, or they can be thawed at room temperature, up to 25˚C for 30 minutes but no more than 2 hours. Once the vaccine is thawed, it must be diluted per Pfizer-BioNTech’s instructions with 1.8 mL of 0.9% Sodium Chloride Injection, USP. Following dilution, the vaccine can be stored between 2˚ to 25˚C and must be used within 6 hours.

 

Supply Chain

The COVID-19 vaccines are provided to administration sites via one of two shipping models: central distributor or direct from the manufacturer. Due to the possibility of fluctuating vaccine availability, healthcare systems must be prepared to manage both distribution models.

  • Central Distributor – The product is provided by the manufacturer to a third-party distributor that utilizes existing shipping networks to deliver to customers. For the Moderna vaccine, McKesson functions as a central distributor, shipping all product. The major benefit of this approach is the increased efficiencies gained by utilizing a shipping infrastructure already in use by the distributor, instead of the manufacturer having to design a distribution channel to move their vaccine to each individual vaccination site. A challenge that pharmacies should be aware of with this approach is the potential delay in information regarding drug supply as notices come second hand from the central distributor instead of directly from the manufacturer.
  • Direct from Manufacturer – The product is provided directly from the manufacturer; no third-party is involved. This model requires the manufacturer to coordinate logistics directly with each customer. In some cases, this may be a new relationship between the two parties or it may require new processes, such as coordinating times that the shipping docks are able to receive new shipments. This model minimizes external variables and allows vaccines to be shipped per the manufacturer’s exact specifications. Pfizer-BioNTech ships directly to customers from their manufacturing site in Michigan via their distribution center in Wisconsin.

Conclusion

 

Coordinating vaccination logistics is time intensive and complex. Each vaccine has shipping, storage, and preparation nuances that must be executed with perfection in order to ensure that mass vaccination efforts are timely and seamless. Fortunately, pharmacies are well positioned to play a major role in coordination efforts given their extensive experience in managing mediation distribution systems. Additional COVID-19 vaccines are anticipated to enter the market. Hopefully, at that time, vaccine supply will be sufficient to allow health-systems to select which brand to source to better align with their existing medication management infrastructure. If not, pharmacy must remain agile in lending their expertise to vaccination efforts.


References

  1. Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-providers.pdf. Updated December, 2020. Accessed January 8, 2021.
  2. Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). www.fda.gov/media/144413/download. Updated January, 2021. Accessed January 8, 2021.
  3. Cdc.gov. Vaccines & Immunizations Pfizer-BioNTech Vaccine. www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/. Updated January 4, 2021. Accessed January 8, 2021.
  4. United States Pharmacopeial Convention. (2008). USP <797>: Guidebook to pharmaceutical compounding: sterile preparations. Rockville, MD: United States Pharmacopeia Convention.

Brock Dantuma, PharmD, BCPS, is a PGY2 Health System Pharmacy Administration and Leadership resident at the University of Iowa Hospitals & Clinics in Iowa City, Iowa. He earned his doctor of pharmacy degree from the University of Wisconsin-Madison School of Pharmacy. Brock is currently pursuing his MHA at the University of Iowa College of Public Health.

Camryn Froerer, PharmD, MS, BCPS, is an adult pharmacy operations manager for University of Iowa Hospitals & Clinics in Iowa City, Iowa. He earned his doctor of pharmacy degree from the University of Utah College of Pharmacy. Camryn completed his MS in pharmacy administration at the University of Utah while completing a combined PGY1/PGY2 in Health-System Pharmacy Administration at the University of Utah Health.

Jonathan Wilson, PharmD, MHA, BCPS, BCSCP, is an adult pharmacy operations manager for University of Iowa Hospitals & Clinics in Iowa City, Iowa. He earned his doctor of pharmacy degree from the University of Minnesota College of Pharmacy. Jonathan completed his MHA at the University of Iowa College of Public Health while completing a combined PGY1/PGY2 in Health-System Pharmacy Administration at UIHC.

Felix Lam, PharmD, MBA, BCPS, is the pediatric pharmacy operations manager for University of Iowa Hospitals & Clinics in Iowa City, Iowa. He earned his doctor of pharmacy from the University of North Carolina Eshelman School of Pharmacy and his MBA with an emphasis on health care management from the Johns Hopkins Carey Business School while completing a combined PGY1/PGY2 in health-system pharmacy administration at The Johns Hopkins Hospital.


University of Iowa Health Care (UIHC) is a non-profit, academic medical center comprising 845 beds within two tertiary care hospitals: UI Hospital and UI Stead Family Children’s Hospital. With more than 16,000 employees, UIHC has more than 36,000 inpatient admissions and over one million clinic visits annually. To manage the COVID-19 vaccine logistics, UIHC collaborated with local vaccine research experts. In addition, the pharmacy department played a central role in the development of our COVID-19 vaccine preparedness strategies. For each of the two vaccines, detailed processes had to be developed in three key areas: storage, temperature tracking, and vaccine preparation.

UIHC considered all options for the storage of COVID-19 vaccines. The organization was comfortable with managing the supply chain process for the Moderna vaccine due to our experience handling frozen medication shipments on a nearly daily basis. The supply chain process for the Pfizer-BioNTech vaccine was one the organization manages less frequently, thus it required additional analysis.

Moderna

Pfizer-BioNTech

Constant and consistent temperature surveillance of storage areas is critical to ensuring vaccine stability. Systems must be designed to ensure monitoring is occurring and prompt action is taken to correct any irregularities. Both vaccines are shipped with temperature tracking devices. Once the vaccines are received at UIHC, pharmacy assumes monitoring responsibility.

All vaccines and their related supplies are stored in a secured area outside of the pharmacy. Both the freezers’ and the immediate room’s ambient temperature are monitored via the hospital’s temperature tracking system. With this system, out of range temperatures are escalated in step-wise fashion until the issue is resolved, starting with the frontline staff, then escalating to the area manager, followed by the administrator on call. However, the alert system has been modified for vaccine management to ensure both a prompt response and the application of adequate resources (see FIGURE 1). The following staff are notified simultaneously in the event of a temperature deviance:

These staff members are tasked with responding to the alarm and coordinating the appropriate response as a team.

Click here to view a larger version of this Figure

Pfizer-BioNTech

The preparation workflow evolved as daily administration volumes increased. The initial process is described in FIGURE 2. At the outset, nursing planned to manage diluting the vaccine vials, as this was similar to their standard workflows of reconstituting select vaccines prior to administration. While the 0.9% Sodium Chloride for Injection, USP, and supplies needed for diluting were supplied by Pfizer-BioNTech, pharmacy provided pre-drawn diluent syringes to simplify the process.

Click here to view a larger version of this Figure

Just before the vaccination effort started, the request was made for pharmacy to assist with dilution in the clinic in order to allow nurses to focus on administration. To repackage the diluent syringes, pharmacy technicians in a cleanroom drew up the diluent, removed the needle, and replaced it with a luer lock cap. When placing a new needle on the syringe, volume lost in the needle’s dead space (ie, needle fill) must be accounted for. To ensure the full manufacturer specified 1.8 mL of diluent was instilled into the vaccine vial, the syringes were drawn up with overfill to 1.85 mL to account for the 0.05 mL of lost volume. These syringes were made in bulk, stored in the same refrigerator as the thawing vaccine, and given a 9-day expiration date based on USP <797> (last revised in 2008) medium-risk dating criteria.4 It is important to note that caution should be used with this method as additional needles are not included in the supplies provided by Pfizer-BioNTech, and it is reasonable to dilute vials utilizing needles of varying gauge and length, which may result in different volumes of loss in the attached needle.

As vaccination workflows were optimized and patient volumes became more predictable, pharmacy’s involvement evolved. Dilution moved from the clinics to the pharmacy as part of standard sterile compounding workflows. Each evening, a pharmacist removes sufficient vials for thawing based on the number of scheduled patients for the next day. In the morning, a designated pharmacy technician dilutes the thawed vials stored in the refrigerator and assigns a 6-hour expiration date. Additional vials are thawed and diluted throughout the day as requested.

Moderna

The process for preparing the Moderna vaccine is relatively simple as the product does not require dilution.

Similar to the Pfizer-BioNTech vaccine, this process was directly overseen by the supply chain and automation manager, and the director of pharmacy business and support (see FIGURE 3).

Click here to view a larger version of this Figure



Where to Find Refrigeration/Freezers
 
For a full list of vendors offering refrigeration/freezers go to:

Key Refrigeration/Freezers Suppliers

Login

Like what you've read? Please log in or create a free account to enjoy more of what www.pppmag.com has to offer.

Current Issue

Enter our Sweepstakes now for your chance to win the following prizes:

Just answer the following quick question for your chance to win:

To continue, you must either login or register: