How do you store the COVID-19 vaccine? Now that the COVID-19 vaccines are available, facilities are starting to vaccinate. Part of any vaccination process requires planning for handling and storage. Do you have a policy for vaccine storage? The COVID-19 vaccines have specific requirements, does your policy specifically address COVID-19?

Safe medication management also applies to vaccines. Vaccine storage is not complex but requires precision and compliance to ensure patient safety and positive outcomes. The Centers for Disease Control and Prevention (CDC) provides a lot of guidance on this topic and is a key resource for storing vaccines correctly. In addition to ensuring patient safety, meeting CDC guidelines is also an expectation of licensing and accrediting agencies such as the Centers for Medicare and Medicaid Services (CMS), Accreditation Association for Ambulatory Health Care (AAAHC), The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) and The Joint Commission (TJC).

Let’s start with the basics: Do you have a vaccine storage policy? If not, you should, and your consultant pharmacist can help. What should that policy include? We recommend starting with the CDC recommendations, which include “Do’s” and “Don’ts”.

CDC Recommended Vaccine Storage

Carefully select and use the appropriate vaccine storage units to store vaccines.
Have a properly calibrated thermometer or temperature recording device inside each storage compartment. We recommend a traceable thermometer.
Evaluate your cold chain procedures to ensure vaccine storage and handling guidelines are being followed. Store vaccines at the ideal temperature of 40° F (applies to most, but not all vaccines).
Upon delivery, inspect vaccines; monitor refrigerator and freezer temperatures to ensure cold chain storage was maintained all along.
Rotate vaccine stock so that the oldest vaccines are used first.
Should errors in vaccine storage and administration occur, take corrective action immediately to prevent them from happening again — and notify public health authorities.

CDC Vaccine Storage Do’s

Do make sure the refrigerator door is closed!
Do leave 2 to 3 inches between vaccine containers and refrigerator walls.
Do post “Do Not Unplug” signs on the refrigerator and near the electrical outlet.

CDC Vaccine Storage Don’ts:

Don’t use a dormitory-style refrigerator.
Don’t use the top shelf for vaccine storage.
Don’t allow food or beverages in the refrigerator.
Don’t store vaccines on door shelves or on the floor of the refrigerator.

For more details on the basic of vaccine storage, read my previous post: “Tips from a Consultant Pharmacist: How to Properly Store Vaccines”. Additional guidance from the CDC can be found on the CDCs website for Vaccine Storage and Handling.

Now that you have the essentials of vaccine storage, let’s look at the currently available COVID-19 vaccines, summarize some similarities and differences and then focus on storage. As of today, there are two vaccines authorized by Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) for use in the United States, the Pfizer-BioNTech vaccine and the Moderna vaccine.

What age groups are the COVID-19 vaccines authorized for?

Pfizer-BioNTech: ages ≥16 years
Moderna: ages ≥18 years

How are the COVID-19 vaccines administered?

They are both administered intramuscularly. Each vaccine series consists of two doses.

Pfizer-BioNTech: Administer (30 µg, 0.3 ml) today and the second dose in 3 weeks (21 days apart).

Moderna: Administer (100 µg, 0.5 ml) today and the second dose in 1 month (28 days apart).

At this time, the CDC does not recommend additional booster doses, but the need for boosters has not been established.

What are the contraindications for the COVID-19 vaccine?

If you have a history of one of the following conditions, the CDC considers vaccination with either COVID-19 vaccine to be contraindicated:

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG])
Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)

What are the precautions for the COVID-19 vaccines?

If you have a history of any immediate allergic reaction to any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies not related to a component of mRNA COVID-19 vaccines or polysorbate), be aware that the risk of developing a severe allergic reaction to the vaccine is unknown and that risk should be weighed against the benefits of getting vaccinated.

How to handle and store the COVID-19 vaccines:

Pfizer-BioNTech:

Vaccine will arrive in thermal containers with dry ice. Remove the vaccine and place in an ultracold freezer (-70^oC±10^oC) until ready to use; ≤6 months (undiluted).

Thawing is required before diluting. May take two to three hours in the refrigerator, or 30 minutes at room temperature. Allow vial to reach room temperature before diluting. Once thawed, do not refreeze.

Refrigerator (2^oC to 8^oC): 5 days undiluted; 6 hours once diluted.

Room Temp (up to 25^oC): 2 hours, undiluted, 6 hours once diluted, minimizing light exposure, direct sunlight and ultraviolet light.

For more details, please refer to the fact sheet for healthcare providers.

Moderna:

Shipping and long-term storage: -25^oC to -15^oC for ≤6 months. Store in the original carton to protect from light.

Once thawed, do not refreeze.

Refrigerator (2^oC to 8^oC): 30 days after thawing (prior to first use), within the 6-month shelf-life.

Room temperature: 12 hours (6 hours after the first dose is withdrawn).

For more details, please refer to the fact sheet for healthcare providers.

Now that the COVID-19 vaccines are available, the process of immunizing has begun and will evolve over the coming months. For the vaccines to be as effective as possible, proper storage and handling will be required. As we continue to learn more, guidelines will evolve. We suggest working closely with your state authorities as well as your pharmacy consultant for up-to-date information. If you have questions or need guidance, please reach out to us and we will ensure you are prepared.

The Consultant Pharmacists at OctariusRx provide guidance on safe medication management, survey readiness and cost savings to ambulatory healthcare facilities/surgery centers, senior care facilities and pharmacies. We also help individual patients optimize their medications to improve their quality of life and save money. Contact us for assistance.