Various Temperature Requirements for the Covid-19 Vaccines

Various Temperature Requirements for the Covid-19 Vaccines

The COVID-19 vaccine efforts are well underway and possibly here to stay. Pharmacies, hospitals, private clinics, and other providers are actively setting up opportunities to get the public inoculated against the virus as soon as possible. With multiple FDA-approved vaccines in circulation, it is not uncommon for many vaccine providers to have one of the two major vaccines stored on their premises ready to go. In some cases, providers may be housing both approved Covid –19 vaccines (Moderna and Pfizer-BioNTech).

Avoiding Cold-Storage Storage Mistakes

With such a sense of urgency to organize the vaccines and administration details, there could be a common oversight in the temperature variance between the two vaccines. Accidental storage of the two vaccines at the same temperature will more than likely destroy the vaccine’s integrity.

  • Increased the chance of adverse reactions in patients.
  • Changes in potency.
  • Reduced patient confidence if additional doses must be administered.
  • Costly expenditures due to lost vaccine inventory.

What is the Main Storage Temperature Variance Between COVID-19 and Pfizer-BioNTech?

The biggest difference between the two storage requirements is their frozen state housing temperatures.

Moderna

Pfizer BioNTech

-20° C Frozen Temp

-80° C Frozen Temp

What is the most up-to-date guidance for storing the COVID-19 Pfizer-BioNTech Vaccine Product?

The U.S. Food and Drug Administration is authorizing undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.

This is an update from the previous guidance indicating that thawed, undiluted vaccine vials could be stored in the refrigerator for up to 5 days.

*Updated guidance excerpt issued from the CDC and Pfizer websites on 5-21/2021.

Frequently Asked Questions

Why do the COVID-19 vaccines need to be kept frozen?

The main reason is that they are a new class of vaccines described as mRNA vaccines. It is an innovation that has been fast-tracked to help fight the spread of the pandemic. The approach uses messenger RNA, or mRNA, to facilitate the body’s ability to make one coronavirus protein. That protein kicks off an immune response as if there was a real coronavirus infection.

What are the specifications for the Moderna COVID-19 Vaccine Cold Storage and Transportation?

The Moderna COVID-19 Vaccine should be transported in the frozen state. If transport at -50° to -15°C (-58° to 5°F) is not feasible, available data support transportation of one or more thawed vials for up to 12 hours at 2° to 8°C (35° to 46°F) when shipped using shipping containers which have been qualified to maintain 2° to 8°C (35° to 46°F) and under routine road and air transport conditions with shaking and vibration minimized. Once thawed and transported at 2° to 8°C (35° to 46°F), vials should not be refrozen and should be stored at 2° to 8°C (35° to 46°F) until use. *This represents updated guidance from the CDC website on 5-21-2021.

What are the frozen storage long-term requirements for the Moderna Vaccine before use?
The Moderna COVID-19 Vaccine multiple-dose vials are stored frozen between -50° to -15°C (-58° to 5°F).

What is the best temperature to thaw the Moderna Vaccine before use?
Thaw in refrigerated conditions between 2° to 8°C (36° to 46°F) for 2 hours and 30 minutes for the maximum 11-dose vial, or 3 hours for the maximum 15-dose vial. Let the vial stand at room temperature for 15 minutes before administering.

What is the required refrigeration temperature required for storing the Moderna Vaccine before use?
Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days before first use. Do not refreeze once thawed. Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 24 hours. Do not refreeze once thawed.

How do you store the Moderna Covid-19 vaccine following a first use (puncture)?
After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Discard the vial after 12 hours.
Do not refreeze.

How do you store unused Moderna COVID-19 Vaccine vials?

Unpunctured vials may be stored in the freezer between -50°C and -15°C (-58°F and 5°F). Store in the original carton. Do not allow light to shine inside the carton. Do not store with dry ice or below -50°C (-58°F).

How do you protect the Pfizer Vaccine during transportation?

Heavy-duty packaging tape should be used to reseal the outer carton after each entry. Store vaccine vials upright in the tray and they must be shielded from light exposure. Before mixing, the vaccine may be stored in an ultra-cold freezer between -80°C and -60°C (-112°F and -76°F) *updated by CDC on 5-21/2021.

How do you properly store a Pfizer Vaccine Vial following the first puncture?

Once it is punctured, you can’t refreeze the vial. The U.S. Food and Drug Administration is authorizing undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.

What temperature can you safely thaw the Pfizer vaccine?

Between 2°C and 8°C (36°F and 46°F)

Best Cold Storage Practice Recommendations for Both COVID-19 Vaccines

It is not recommended to store any vaccine in the mini-fridge/bar-styled units or that combined refrigerator/freezer unit under any circumstances. Often, these units only have a single exterior door and an evaporator plate/cooling coil usually located in an icemaker/freezer compartment. As a result, units such as these pose a significant risk of freezing vaccines, even when used for temporary storage.

(Note: Not all small storage units are built the same. Compact, purpose-built units for biologics can be used to store vaccines.

K2 Scientific values our scientific partnerships. We invite you to shop at k2sci.com for COVID-19 vaccine storage.

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