As COVID-19 vaccination rates gradually rise across the globe and the number of COVID cases begin to decline, immunization brings a glimmer of hope for the public that their daily lives might return to what was considered normal before the pandemic. However, as vaccination campaigns gain speed, it is becoming increasingly important to prevent the loss of the vaccine’s potency via proper vaccine storage and handling practices.
Starting from the minute the vaccine is manufactured to the time it is administered, it is imperative to maintain the quality of the vaccine. All COVID-19 vaccination providers must follow proper vaccination storage and handling procedures under suitable conditions as dictated by the Centers for Disease Control and Prevention (CDC) to ensure that the vaccine’s potency is not compromised. This article will address the most significant elements of vaccine storage and handling: guidelines to maintain the cold chain in a provider’s facility and the components of the COVID-19 vaccine storage and handling standard operation procedures.
Vaccine Storage and Handling SOPs
The CDC has designed certain protocols that outline the proper vaccine storage and handling methods.
The first and most crucial step in the vaccine storage and handling process is maintaining an effective uninterrupted cold chain. A cold chain is a temperature-controlled supply chain that entails a set of protocols that ensure the vaccine is stored and distributed properly. Exposure to any unsuitable condition such as heat or light at any point in the cold chain could significantly reduce the potency of the vaccine.
The cold chain begins at the manufacturing site of the vaccine inside a cold storage unit. It then progresses to the transport and delivery of the vaccine with portable storage units to the provider’s facility. This is the point at which the vaccine becomes the responsibility of the provider. The cold chain ends with the successful administration of the vaccine to the patient.
From its manufacture to administration, several people are responsible for maintaining the cold chain of a vaccine including manufacturers, health staff, and healthcare providers. To ensure patient safety and maintenance of vaccine potency, it is essential that all staff members who are responsible for the delivery as well as administration of the vaccine are thoroughly trained and familiar with the COVID-19 vaccine storage and handling standard operating procedures.
For this purpose, the CDC recommends that providers train their staff routinely and keep detailed and clearly written vaccine storage and handling SOPs within their facility to ensure that proper procedures are followed so that the staff knows what to do in case of any emergencies.
CDC’s vaccine storage and handling guidelines recommend that the storage unit for any vaccine be kept in a well-ventilated space with plenty of air circulation outside the unit. Research has shown that storage units for vaccines work best when kept in rooms with a temperature of 20-25 °C.
Remember to also monitor and document the minimum and maximum temperatures of a storage unit such as a refrigerator or freezer over a period of two to seven days to make sure that the unit is stable and ready to use. Freezers should maintain a temperature of -15 °C to -50 °C while refrigerators should maintain temperatures between 2°C to 8°C.
Every storage unit must also have a temperature monitoring device (TMD) such as a digital data logger which provides accurate and extensive details about all the temperatures recorded in the unit and measures and documents the storage unit’s minimum and maximum temperatures daily.
The following details should also be documented in addition to recording vaccine temperatures:
- Name of the person recording details;
- Any course of action taken if a temperature excursion was measured.
This temperature data is stored by the TMD and reviewed to assess the viability of the vaccine. Different vaccines must be stored at different temperatures both before and after a puncture is made in the vial. The following are the details of the temperatures at which each type of vaccine has to be stored as well as how long they can be stored depending on the temperature at which they are stored before they need to be discarded.
|Type of Vaccine||Storage Temperature Before Puncture||Storage Temperature After Puncture|
|Pfizer||-80°C to -60°C (store until expiration date)-25°C to -15°C (store for up to 2 weeks)2°C to 8°C (store for up to 5 days)||2°C to 25°C (store for up to 6 hours)|
|Moderna||-25°C to -15°C (store until expiration date)2°C to 8°C (store for up to 30 days)||2°C to 25°C (store for up to 12 hours)|
|Janssen||2°C to 8°C (store until expiration date)||2°C to 8°C (store for up to 6 hours)9°C to 25°C (store for up to 2 hours)|
COVID-19 vaccination standard operating procedures also recommend that frequent routine checks should be carried out to inspect the vaccine monitoring and storage equipment to spot any temperature excursions in time. By doing this, quick action can be taken to correct the temperature excursions before the vaccine has to be discarded, thus safeguarding the integrity of the vaccine.
According to vaccine storage and handling guidelines, vaccines or diluents should be stored in their original packaging and in separate containers to protect them from light until they are ready to be administered. Loose vials have a greater chance of being exposed to unsuitable conditions.
When transporting a vaccine between providers and their destinations, it is essential that the vaccine is transported in a stable storage unit or packing container. Each portable storage unit should also have a TMD to monitor the temperatures at the beginning and end of the journey as well as the times at which the vaccine was removed from the storage unit and placed in the portable containers.
Diluents should only be transported with their corresponding vaccines but in suitable packing containers that provide appropriate protection and should not be transported more than once. Make sure to never freeze diluents or use dry ice for storage. Use a portable vaccine freezer that maintains temperatures between -50°C and -15°C to transport frozen vaccines.
When transporting, ensure that the containers are adequately secured to avoid any unnecessary movement that could potentially damage the vaccines. CDC vaccine storage and handling guidelines state that the total time for transport or transport plus provider facility hours should not exceed 8 hours. The vaccine is to be immediately shifted to an appropriate storage unit upon arrival at the final location. The following are the temperatures at which different vaccines should be transported:
|Vaccine Type||Transport Temperature Before Puncture||Transport Temperature After Puncture|
|Pfizer||-80°C to -60°C-25°C to -15°C2°C to 8°C||2°C to 25°C (for up to 6 hours)|
|Moderna||-25°C to -15°C2°C to 8°C||2 °C to 25°C (for up to 6 hours)|
|Janssen||2°C to 8°C||2°C to 8°C (for up to 6 hours)|
Improper implementation of the necessary protocols due to errors in the vaccine storage and handling process could lead to reduced potency of the vaccination, which ultimately could result in financial loss for vaccination companies due to the wastage of vaccines. Once potency is lost, it cannot be restored to its original form. Additionally, several patients would have to be revaccinated, undermining their confidence in both vaccines and providers. Hence, it is vital to follow the CDC-recommended COVID-19 vaccine storage and handling standard operating procedures to ensure that the public’s trust in the healthcare and immunization system remains intact and that they receive uncompromised high-quality vaccines.