Cold Chain Break Management
If vaccines are exposed to temperatures outside the recommended range or other inappropriate storage conditions, immediate action should be taken in order to avoid product loss. It should not be assumed that vaccine inappropriately exposed to light or to temperatures outside the recommended range cannot be salvaged.
Maintenance Of Vaccine Storage Equipment
In order to protect the vaccine cold chain, regular maintenance is important as it helps to ensure optimal functionality of cold chain equipment. This ensures that vaccines will continue to be stored at the required temperatures, and also helps to extend the useful life of the CCE. Two main types of maintenance are required as described below:
Routine maintenance of CCE must be carried out at different frequencies daily, monthly and quarterly by the end-user at all levels of the cold chain. This is usually a do-it-yourself type of maintenance involving the use of simple instructional guides to complete outlined maintenance activities as scheduled. Routine maintenance also enables the identification of issues such as equipment breakdown or malfunctions that may require an expert-led repair response. Please see detailed the guidance on routine maintenance of CCE on pages 36-38 of the National Vaccine Storage and Handling Guidelines for Immunization Providers 2015.
Planned preventive and corrective maintenance
Requirements For Vaccine Refrigeration
Many vaccines must be stored at low temperatures, some below -15 °C, and others between 2 and 8 °C. as in an Ice Lined Refrigerator . If vaccines are not stored correctly they can lose their effectiveness.
According to the Center for Disease Control, failure to adhere to recommended specifications for storage and handling of immunobiologics can reduce or destroy their potency, resulting in inadequate or no immune response in the recipient. Maintenance of vaccine quality is the shared responsibility of all handlers of vaccines from the time a vaccine is manufactured until administration.
According to the Immunization Action Coalition, all vaccines should be stored in a refrigerator or freezer that is designed specifically for the storage of biologics or, alternatively, in a separate dedicated unit. A dorm-style combination refrigerator-freezer unit with just one exterior door has been shown to be unacceptable no matter where the vaccine was placed inside the unit. Stand-alone refrigerator or freezer units are best for storage needs. With retail pharmacies now playing a major role in pneumonia, influenza and shingles immunization programs, the value of critical vaccines being stored in pharmacy refrigerators has reached a new high. In fact, it is not uncommon for many pharmacies to now have over $100,000 of product in a single refrigerator during peak seasons.
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Vaccine And Equipment Disposal
Sometimes unused vaccine and diluent doses, unopened vials, expired vials, and potentially compromised vaccine may be returned for credit, even if they must be discarded. The state or local immunization program or the vaccine manufacturer can provide vaccine-specific information.
Open and broken vials and syringes, manufacturer-filled syringes that have been activated, and vaccines predrawn by providers cannot be returned and should be discarded according to state requirements.
Immediately after use, all syringe/needle devices should be placed in biohazard containers that are closable, puncture-resistant, leakproof on sides and bottom, and labeled or color-coded. This practice helps prevent accidental needlesticks and reuse. Used needles should not be recapped, cut, or detached from syringes before disposal.
Empty, expired, or compromised vaccine vials are usually not considered hazardous or pharmaceutical waste and do not require disposal in a biomedical waste container. However, state requirements regarding disposal should be followed. Medical waste disposal requirements are set by state environmental agencies.
Storage Of Frozen Temperature Covid
The storage conditions of the product have been specified by the manufacturer, including minimum and maximum temperature conditions for the safe storage of the product based on clinical and stability studies data provided by the manufacturer.
Frozen temperature COVID-19 vaccines must be stored in appropriate cold chain equipment that can ensure maintenance of the vaccine cold chain. Frozen temperature COVID-19 vaccines can be stored in active and passive CCE these types of equipment and when they should be used are described below.
Figure 3. Stand-up freezer
Copyright: ThermoFisher Scientific
Left to right: A stand-up freezer, closed and open.
Qualified transport containers
Figure 4. Qualified transport containers for frozen state transportation
Copyright: Pelican Biothermal
Left to right: A qualified transport container for frozen state transportation, put together and in pieces.
Active refrigerated devices
Walk-in cold and freezer rooms
C. Number of Doses in Question D. Manufacturer Recommendations E. Wastage F. Impact on FPT
Subject: FPT Temp Excursion Wastage Report A. Date of Incident
Refer to pages 82-83 of the National Vaccine Storage and Handling Guidelines for Immunization Providers 2015 for more guidance on managing temperature excursions.
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Reconstitution Of Lyophilized Vaccines
For optimal potency, lyophilized vaccines should be reconstituted immediately before use with the diluent provided by the manufacturer for that purpose. Refer to the product leaflet, product monograph, or jurisdictional guidelines for vaccine-specific recommendations regarding storage requirements for lyophilized vaccines and diluents, and the time frame for use following reconstitution. If not otherwise instructed by the manufacturer or jurisdictional guidelines, diluents that do not contain vaccine components and that are packaged separately from the vaccine may be stored at room temperature to conserve refrigerator space. The vaccine for which the diluent should be used must be marked clearly to avoid using the wrong diluent.
Reconstituted vaccines should be discarded if not used within the time frame specified for use by the manufacturer or jurisdictional guidelines.
Outdated Or Improperly Stored Vaccines Won’t Protect Patients
Updated 1/19Vaccine Storage Guide: Two-page illustrated guide to vaccine storage temperatures and where and how to store vaccine in a refrigerator-only unit, freezer-only unit, and combination refrigerator/freezer unit. Includes tips for proper storage and management of vaccines.
Download PDF version formatted for print: Vaccine Storage Guide
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The uracil problem can be dealt with by adding a modified version of the nucleotide, which Toll-like receptors overlook, sparing the RNA from an initial immune system attack so that the vaccine has a better chance of making the protein that will build immune defenses against the virus. Exactly which modified version of uracil the companies may have introduced into the vaccine could also affect RNA stability, and thus the temperature at which each vaccine needs to be stored.
Finally, by itself, an RNA molecule is beneath a cells notice because its just too small, Mishra says. So the companies coat the mRNA with an emulsion of lipids, creating little bubbles known as lipid nanoparticles. Those nanoparticles need to big enough that cells will grab them, bring them inside and break open the particle to release the RNA.
Some types of lipids stand up to heat better than others. Its like regular oil versus fat. You know how lard is solid at room temperature while oil is liquid, Mishra says. For nanoparticles, what theyre made of makes a giant difference in how stable they will be in general to the things inside. The lipids the companies used could make a big difference in the vaccines ability to stand heat.
Questions or comments on this article? E-mail us at
Solar Powered Vaccine Refrigerators
In developing countries the electricity grid often does not reach rural areas, and is not always reliable. As keeping vaccines at the appropriate temperature is vital, Solar powered refrigerators are a cost-effective alternative that can be highly reliable. A typical system will use a solar panel to generate electricity from sunlight, and a deep cycle battery to store energy for operation overnight, although newer fridges which have revolutionary Sure Chill Technology or Direct Drive technology do not need batteries to maintain temperatures for many days without sunlight.
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Vaccine Storage And Handling Standard Operating Procedures
Facilities should develop and maintain clearly written, detailed, and up-to-date storage and handling standard operating procedures . SOPs should be reviewed by all staff and updated by the vaccine coordinator annually.
SOPs should contain plans and information for three major areas:
- General information include contact information for vaccine manufacturers, equipment service providers, and important facility staff, as well as job descriptions, regularly used forms, and staff training requirements.
- Routine storage and handling include information for all aspects of vaccine inventory management, from ordering to monitoring storage conditions.
- Emergency vaccine storage, handling, and transport outline steps to be taken in the event of equipment malfunctions, power failures, natural disasters, or other emergencies that might compromise vaccine storage conditions.
VFC providers or those who have vaccines purchased with public funds should contact their immunization program for guidance regarding routine and emergency SOPs.
People In Riverside County Got Covid Vaccine Doses Stored In Freezer Longer Than Recommended: Officials
This file photo shows vials of the Pfizer COVID-19 vaccine in Hanoi on Oct. 12, 2021.
Officials said there is no danger to the recipients.
Even though these vaccines may have had improper storage from freezer to refrigeration to administration, they do not pose a danger to patients, but may have lost their potency which may impact the vaccine ability to protect against COVID-19, the health system said in a news release.
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Fda In Brief: Fda Authorizes Longer Time For Refrigerator Storage Of Thawed Pfizer
- For Immediate Release:
- May 19, 2021
The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research
Making COVID-19 vaccines widely available is key to getting people vaccinated and bringing the pandemic to an end. Pfizer Inc. submitted data to the FDA to support storage of undiluted, thawed vials of its COVID-19 vaccine for up to one month at refrigerator temperatures. This change should make this vaccine more widely available to the American public by facilitating the ability of vaccine providers, such as community doctors offices, to receive, store and administer the vaccine.
How Will Novant Health Ensure The Vaccines Are Stable While Theyre Being Prepared
Maki: Each COVID-19 vaccine has its own parameters for moving it from a storage temperature, allowing it to warm up and reconstituting it. Once the vial is open, or punctured, we have six hours to use it. So, if there are five doses per vial, once we take one dose out, we must administer the next four doses within six hours.
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Us To Require Vaccines For All Land Border Crossers In January
The vaccinations were given out at two community health center sites in Riverside County and the error was discovered on Tuesday after staff reviewed their logs.
Patients were given the shots at Jurupa Valley on 8876 Mission Blvd. in Jurupa Valley between Oct. 8 and Nov. 23, and at the Riverside Neighborhood Clinic on 7140 Indiana Avenue in Riverside between Oct. 23 and Nov. 23
Since the vaccines may have lost their potency due to the extended storage, it is recommended that the affected recipients get a repeat dose, officials said.
Riverside University Health staff started reaching out to the vaccine recipients involved, according to the news release.
Those who received the Pfizer COVID-19 vaccine at either of the locations during the same time frame can call 951-782-2976 before 5 p.m. if they are not contacted by CHC staff by Thursday. If calling after the Thanksgiving holiday, contact 800-945-6171.
Riverside officials said they have implemented measures to prevent this from happening again.
‘good News For The World’ Chief Science Adviser Responds To Vaccine Advances
Vaccines made from mRNA can be made much faster than older vaccines could, explains Margaret Liu, a vaccine researcher who chairs the board of the International Society for Vaccines and specializes in genetic vaccines. The problem, says Liu, is that mRNA is “really easily destroyed, and that’s because there are many, many enzymes that will just break it apart.”
Here’s an analogy: Think of the vaccine as a chocolate bar that melts easily. Just as there are ways to keep the chocolate from melting into goo, there are things the drugmakers did to protect their COVID-19 vaccines.
The first step, Liu says, was to modify the mRNA nucleosides the “building blocks” of the RNA vaccine. “They’ve used modified versions because those are more stable,” she says. This would be like changing the chocolate recipe so it’s not quite so melty.
The next step was to use lipid nanoparticles, which, Liu explains, “is kind of like putting your chocolate inside a candy coating you have an M& M, so the chocolate doesn’t melt.”
But even with the stabilized building blocks and lipid coating, the mRNA could still fall apart easily, which is why the vaccine is frozen.
“Everything happens more slowly as you lower the temperature,” Liu says. “So your chemical reactions the enzymes that break down RNA are going to happen more slowly.” It’s the same idea as freezing food to keep it from spoiling.
“Stress testing” to tease out these temperatures
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Information Management System For Covid
A hallmark of effective supply chains is the end-to-end visibility of supply data, its triangulation with demand information and its use in making decisions and taking effective action. A new information management system known as VaccineConnect will be deployed to support the COVID-19 vaccine rollout in Canada. VaccineConnect encompasses three key sets of functional capabilities, including the Intelligent Supply Chain module, which will support the NOC in terms of executing all the functions associated with managing and distributing the Government of Canada procured vaccines. This comprises transportation and distribution, warehousing and handling, inventory control, logistics information management, security, reporting, and integration with other systems.
To ensure full visibility on the tracking and aggregation of essential information, the ISC modules capabilities will coalesce data at each stage of the distribution, including vaccine ordering, processing and approval of orders, order fulfillment, distribution of order, and end user reporting. ISC capabilities will:
Vaccine Storage And Temperature Monitoring Equipment
It is important for a facility to have proper storage and monitoring equipment that is set up correctly, maintained appropriately, and repaired as needed. This equipment protects patients from inadvertently receiving compromised vaccine and protects facilities against costs of revaccinating patients, replacing expensive vaccines, and losing patient confidence.
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How Phononic Can Prevent Frozen Vaccines
Phononic is working to improve the pharmaceutical cold chain. Our solution is medical-grade solid-state refrigeration. Phononic refrigerators deliver unprecedented temperature stability and uniformity. Traditional compressor-based refrigerators experience temperature fluctuations as much as 5°C, which can damage or destroy products. Our technology is constantly monitoring and adjusting temperatures, so fluctuations are minimized to only 0.5° C. We also offer automated data logging, monitoring and alarm notification management that meets CDC data logging guidelines. With our technology, an efficient and safe cold chain is achievable, reducing the risk of inadvertent freezing.
Managing Vaccine Storage Equipment Breakdown
In order to ensure that COVID-19 vaccines maintain their efficacy, it is important to address cold chain breaks when they occur. If vaccine storage equipment stops working, first protect the vaccines and then check the cause of the problem. Guidance outlined by the jurisdiction/local public health office or immunization program for protecting the vaccines and addressing the equipment problem must be followed when cold chain breaks occur. It is advised that local public health units have a storage equipment breakdown plan in place so as to ensure that vaccine that might still be viable can either be safely moved to a suitable alternate storage location or administered to as many individuals as possible to minimize wastage, if feasible . Guidance has been provided on page 81 of the National Vaccine Storage and Handling Guidelines for Immunization Providers 2015 to support the response to cold chain breaks in the event that jurisdictional guidance is not available.
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What Is A Cold Chain
Maki: A cold chain is a temperature-controlled supply chain that maintains the quality and efficacy of a vaccine from the time its manufactured until the moment a patient receives it. While most flu vaccines are refrigerated between 35 and 46 degrees Fahrenheit, Pfizers COVID-19 vaccine must be stored at an ultracold temperature of -94 degrees Fahrenheit. Thats colder than winter in Antarctica.
Primary care means front line care
How Will People Know Which Vaccine They Received
Reed: While medical records will track which vaccine people receive, anyone who gets a COVID-19 vaccine at Novant Health will also receive a card that indicates the manufacturer. Its also suggested they take a picture of that card should they lose it. This is important because people must receive two doses of the vaccine to get to the greater than 90% efficacy the manufacturers were able to achieve. Future manufacturers such as Johnson & Johnson may not require two doses.
We are not suggesting one manufacturer to our communities, and instead, view our role as a partner to help people make an informed decision.
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I Hear Dry Ice Is Involved In The Process As Well
Maki: Our supply chain has worked with a dry ice vendor to secure 500 pounds of dry ice each week. This will help us with a couple of things. The vaccines come in a thermal shipper, which looks like a suitcase. We can use the dry ice to replenish the thermal shippers, allowing us to use them as storage, if needed. Well also use dry ice if we transport vaccines between our facilities. Overall, it gives us more flexibility to use temporary storage and move things around.