CDC’s Vaccine Toolkit: COVID-19 Addendum

May 2021 - Vol.18 No. 5 - Page #22
Category: Vaccines

Efforts to implement COVID-19 vaccination programs have invigorated a focus on the processes of receiving, handling, storing, and transporting vaccines to maximize efficiency, safety, and effectiveness. The urgency of this vaccine rollout behests the sharing of tips and tools so vaccine providers at every level are benefitting from best practices.

The Centers for Disease Control and Prevention (CDC) provides comprehensive information about vaccine storage and handling in its Vaccine Storage and Handling Toolkit, which includes the COVID-19 vaccine storage and handling information addendum that is continually updated as new information becomes available. Implementing best practices and recommendations from this addendum will help protect patients, safeguard the vaccine supply, and avoid unnecessary costs of revaccinating patients and replacing expensive vaccines.

The information provided herein is from the CDC Vaccine Storage and Handling Toolkit as of April 14th, 2021. As the toolkit is continually updated, it is important to check the source regularly to get the most current information. The toolkit is available in its entirety at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html.

COVID-19 Vaccine Deliveries and Inventory Management

The first step in vaccine inventory management is maintaining the cold chain. Vaccine deliveries must only be scheduled at times when staff is guaranteed to be present as vaccines can never be left unattended. To support the efficient distribution of the vaccine, full-day receiving hours should be available. When that is not possible, locations receiving the vaccine and ancillary supply shipments must be available during a four-hour window on a weekday other than Monday. All COVID-19 vaccine and ancillary kit deliveries will require a signature. As COVID-19 vaccine shipments will include the following ancillary supplies, ensure the staff members responsible for receiving are prepared to appropriately store these items as well as the vaccines:

  • Needles (various sizes for the population served)
  • Syringes
  • Alcohol prep pads
  • Surgical masks and face shields for vaccinators
  • COVID-19 vaccination record cards for vaccine recipients
  • Vaccine needle and length guide
  • Diluent and mixing supplies (based on vaccine product)

Upon arrival, shipments of refrigerated and frozen vaccine must be immediately examined for three issues:

  • Any signs of damage
  • An indication of a temperature excursion during transit
  • To confirm receipt of the appropriate vaccine types and quantities

Before opening ultra-cold vaccine shipments, make sure the vaccine can be quickly placed in an ultra-cold freezer or that dry ice is available for re-icing the shipping container to ensure the vaccine remains at the appropriate ultra-cold temperature. Following careful examination, store vaccines and diluents at recommended temperatures and document them using your facility’s vaccine inventory management process immediately.

Never leave a vaccine shipping container unpacked and unattended. If vaccines and diluents get too warm, they cannot be used. Be sure all staff is aware that vaccine deliveries require immediate attention.

Vaccine inventory accounting includes keeping records to determine the type and amount of COVID-19 vaccine that should be stocked to meet the needs of your patients. Check expiration dates regularly and rotate stock to ensure doses with earlier expiration dates are continually moved in front of those with later dates.

Vaccine Storage

When storing vaccines, a foundational requirement is to never store any vaccine in a dormitory-style or bar-style combined refrigerator/freezer unit under any circumstances. Dormitory-style or bar-style refrigerator/freezer units have a single exterior door and an evaporator plate/cooling coil, usually located in an icemaker/freezer compartment, which poses a significant risk of freezing vaccines, even when used for temporary storage.

When organizing vaccines for storage, note that neither food nor beverages should be stored in the same unit as vaccines. If other biologics are stored in the unit, vaccines should be stored on the shelf above them. Vaccines and diluents with earlier expiration dates should be placed in front of those with later expiration dates.

It is important to note that EUA vaccine labels may not include expiration dates. To help providers track expiration dates and beyond use dates (BUDs), the CDC provides a COVID-19 Vaccine Expiration Date Tracking Tool on its website (See TABLE 1). Also, note that expiration dates may change as additional stability data become available.

Vaccine Preparation

Different COVID-19 vaccine products have different preparation requirements. Some vaccine products cannot be shaken, or the vaccine will be compromised and cannot be used. Carefully follow the manufacturer’s vaccine preparation guidance for each COVID-19 vaccine product.

Often, vaccines need to be mixed with a liquid product before administration, as is the case for the Pfizer/BioNtech COVID-19 vaccine. Always follow the COVID-19 vaccine manufacturer’s guidance for use of the diluent. Diluents are not interchangeable and can only be used with the product for which they are provided. A vaccine mixed with the wrong diluent should never be administered.

Expired Vaccine

Critical to proper vaccine storage and handling is identifying when the cold chain has been broken and determining if a vaccine or diluent has expired.

After a temperature excursion, certain steps must be followed so the manufacturer can determine whether a vaccine is likely to still be viable. It is important to note that the vaccine manufacturer’s responses to temperature excursion reports are dependent on the information given by the provider to the manufacturer. Reporting different information about the same event can lead to different recommendations from the manufacturer as to whether the vaccine can or cannot be used, or if patients need to be revaccinated.

Once identified as expired, the vaccines and diluents must be removed immediately from storage units to avoid inadvertent administration. Vials that have been opened or broken, as well as vaccines predrawn by providers, cannot be returned to the manufacturer and must be discarded according to your jurisdiction’s requirements.

Vaccine Disposal

Medical waste disposal requirements vary by state environmental agencies. Your jurisdiction’s immunization program or environmental agency can guide your facility’s vaccine disposal procedures to ensure compliance with both state and federal regulations. Vaccine manufacturers should also provide guidance on the proper disposal of their products, including any unused vaccine. In some instances, the unused vaccine may be returned to the manufacturer. Empty vaccine vials are usually not considered hazardous or pharmaceutical waste and therefore do not require disposal in a biomedical waste container. However, check and comply with your jurisdiction’s requirements for disposal.

COVID-19 Vaccine Transport Requirements

In the event that transportation is required, the vaccines must be transported in a stable storage unit and monitored with a digital data logger. If this is not possible, keep vaccines in the portable storage unit and record the unit temperature every time the portable unit is opened. In most instances, the packing materials that the vaccines were initially shipped in are not meant for reuse (the most common exception is ultra-cold vaccine shipping materials). Transport equal amounts of vaccines, diluents, and ancillary supplies (including vaccination record cards and PPE). At the beginning of transport and immediately upon arrival at the destination, record the time and minimum/maximum temperature of the vaccines.

The CDC recommends transporting vaccines in vials. However, in instances in which the only option is to transport vaccine in a predrawn syringe, US Pharmacopeia includes guidance for the transportation of predrawn vaccines in syringes in the USP COVID-19 Vaccine Toolkit: Operational Considerations for Healthcare Practitioners, which is available at www.usp.org/covid-19/vaccine-handling-toolkit.

To view the CDC’s guidance on specific vaccine information concerning the Pfizer/BioNTech, Moderna, and Johnson & Johnson/Janssen vaccines visit www.cdc.gov/vaccines/covid-19/info-by-product/index.html.


References

  1. Vaccine Storage and Handling Toolkit. Centers for Disease Control and Prevention. Published 2021. www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. Accessed April 14, 2021. 

Samantha Halvorsen is the associate editor at Pharmacy Purchasing & Products magazine. She can be reached via email at the address skhalvorsen@ridgewoodmedia.com.

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