This is the year that the COVID-19 vaccines will reach mass distribution. It will be a massive undertaking that will require several checks and balances to ensure that the vaccines arrive at their destination safely. One of the major considerations during this process will be temperature control and monitoring. In this article, we will take a closer look at elements of this process that will be crucial in the delivery of the COVID-19 vaccine.
The Vaccine Cold Chain
A temperature-controlled supply chain is the foundation of a cold chain. The cold chain, which includes vaccine-related equipment and procedures, begins at the manufacturing plant where the vaccines are kept in cold storage. The cold chain includes the transportation and delivery of the vaccine as well as proper storage and temperature control every step of the way, all the way to when it’s administered to the people who need it. The vaccine cold chain is the responsibility of many different people ranging from the manufacturers and distributors to the public health staff and healthcare providers.
According to the Centers for Disease Control and Prevention (CDC), facilities should have written, detailed and current storage and handling procedures in place. These Standard Operating Procedures (SOPs) are to be reviewed and updated annually. The SOPs should cover three main concerns. General Information - details on contacts for manufacturers of vaccines, equipment service providers, identities of key personnel, job descriptions, training requirements, etc. - Routine Storage/Handling which outlines all information dealing with vaccine management - and Emergency Vaccine Storage/Handling/Transport which will detail steps to follow in case of equipment failure, malfunction or natural disaster or other emergency arises.
Anyone who comes in contact with vaccines anywhere along the cold chain should have proper training. The training must focus on the correct storage and handling of vaccines as outlined in the facility’s SOPs. The CDC recommends that SOPs be located near the storage location of the vaccines and that management ensure that staff members are aware of where the SOPs are located. As for training, the CDC suggests that training programs be included as part of new employee orientation, offered annually to refresh all staff members, whenever new vaccines are added to the existing inventory and when vaccine recommendations are updated.
Vaccine Storage/Temperature Monitoring
Any facility that stores vaccines requires proper storage and temperature monitoring equipment. That temperature monitoring equipment must be set up correctly and operating properly, as well as be maintained and repaired when required. Vaccines require cold storage that is constant and does not include exposure to variations in temperature. Depending on the vaccine, specialized refrigerators or freezers may be required to provide proper storage temperatures. Monitoring equipment such as a data logger will help ensure quality. Data loggers are the main method of conducting temperature monitoring for vaccines. Dickson’s explanation is a good resource for the role data loggers play in environmental monitoring in general.
Vaccine Inventory Management
This category includes several subcategories that have an impact on the quality and integrity of the vaccines.
1. Inventory Tracking
A good practice is to conduct a complete vaccine inventory once a month. This assists with vaccine orders so that you do not end up missing vital vaccines that are low in the inventory totals.
2. Expiration Dates
Proper vaccine handling and storage hinges on knowing when vaccines have passed their expiration date and are removed from inventory. Those vaccines labelled with a month and year expiration date are said to be good until the final day of the month noted. If the expiration date includes a day with the month and year, that vaccine is good to the end of the day noted.
3. Vaccine Preparation
Preparation of the vaccine just before administering it is the final step of the cold chain. Preparation steps are as follows:
- adhere to strict aseptic medication preparation procedures.
- follow hand hygiene practices before preparing the vaccine.
- prepare vaccines in a clean medication preparation area.
- prepare vaccines for one patient at a time, and just before they are to be administered.
- confirm expiration dates and that the correct vaccine has been prepared.
- the person preparing the vaccine should be the person administering it to the patient.
- follow instructions provided by the vaccine manufacturer.
The Different Types of Vaccines
There are many different vaccines, and each has a specific purpose and temperature requirement. For example, refrigerated vaccines should be stored at +35F to +46F with an average temperature of +41F. Frozen vaccines must remain in a continuously frozen state at +5F or colder. Diluents do not require refrigeration and can be stored at room temperature. Here is a closer look at the different types of vaccines.
1. Single Dose Vials (SDVs)
An SDV is just as the name suggests. It has a single dose and is used just once for one patient.
2. Manufacturer-Filled Syringes (MFS)
This is similar to the SDV but is a syringe that has been prepared and sealed under sterile conditions by the manufacturer. It is intended for single use with one patient. However, once the seal has been broken, an MFS must be used by the end of that day.
3. Multidose Vials (MDV)
An MDV is also as the name implies. It contains more than a single dose of the vaccine. The manufacturer will have indicated with the packaging how many doses a vial contains and once that limit is reached, the MDV is spent.
4. Reconstitution with Diluents
Frozen vaccines are typically in a powder form and require liquid diluents to reconstitute them before administration. Details on what diluents and how much diluent is required will be noted in the packaging that came with the vaccines. The requirement varies from vaccine to vaccine.
5 - Predrawing Vaccines
These are vaccines that are meant for immediate administration and are not meant to be stored for any length of time.
Thanks to the vaccine rollout in 2021 to combat COVID-19, we are going to be hearing a lot about temperature-controlled atmospheres and cold chains. As long as these vaccines are properly stored, there should be no problems. Fortunately, the technology exists to monitor temperatures to ensure that vaccines remain safe and secure as they travel through the cold chain from manufacturer to user.