Any temperature reading outside the recommended range for vaccine storage is a temperature excursion. However, it is generally the total amount of time, or cumulative time, out of range that affects the viability of vaccine. Any time appropriate vaccine storage temperatures are in question, stop giving vaccinations and contact your state immunization program and/or the vaccine manufacturer for further guidance about whether or not a vaccine may be used. The CDC Storage and Handling Toolkit contains detailed guidance on the management of a temperature excursion. See www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf, pages 12–15. Additional information for COVID-19 and mpox vaccine temperature excursions is available in the addendum at the end of the toolkit.
Ask the Experts: Storage & Handling: Vaccine Viability and Expiration
Disposable syringes are meant for administration of vaccines, not for storage. CDC recommends that vaccines that have been drawn into syringes by the provider be discarded at the end of the clinic day if unused. Manufacturer-filled syringes that have not been activated (i.e., have not had the needle guard removed or a needle attached) may be kept and used until their expiration date. A manufacturer-filled syringe does not contain a preservative to help prevent the growth of microorganisms. Once the sterile seal has been broken, the vaccine should be used or discarded by the end of the workday.
With the exception of COVID-19 vaccines, vaccines in multidose vials (MDVs) that do not require reconstitution contain preservatives and can be used through the expiration date printed on the label as long as the vaccine is not contaminated, unless indicated otherwise by the manufacturer. For example, inactivated polio vaccine in an MDV can be used through the expiration date on the vial. For some vaccines, the manufacturer specifies that once the MDV has been entered or the rubber stopper punctured, the vaccine must be used within a certain number of days. This is commonly referred to as the “beyond-use date” (BUD). Any vaccine not used within the BUD should be discarded. Specific information regarding the BUD can be found in the product information. For example, the package insert for some inactivated influenza vaccine indicates once the stopper of the MDV has been pierced, the vial must be discarded within 28 days. Package inserts for vaccines can be found at www.immunize.org/fda.
Be careful to follow current guidance from the manufacturer and CDC for how long an MDV of COVID-19 vaccine may be used after puncturing the vial. The COVID-19 vaccine MDVs do not contain preservatives and must be used within hours; specific times vary by product.
No. Only the number of doses indicated in the manufacturer’s package insert should be withdrawn from the vial. For some vaccines, the package insert also may indicate the maximum recommended number of punctures of the vial stopper. After the maximum number of doses has been withdrawn or the number of punctures of the stopper has met the recommended limit, the vial should be discarded, even if there is vaccine remaining in the vial and the expiration date has not been reached. Never use partial doses from two or more vials to obtain a dose of vaccine.
Vaccine may be used through the last day of the month indicated on the expiration date. After that, do not use it. Monitor your vaccine supply carefully so that vaccines do not expire.
The expiration date is the date by which the vaccine should be used. Vaccines may be used up to and including this date unless otherwise stated in the manufacturer’s product information. The expiration date is based on the assumption that the vaccine has been properly handled and that it has not become contaminated.
Some vaccines expire within a certain time after opening or after reconstitution. Multidose vials that contain bacteriostatic agents that prevent the growth of bacteria and may be used until the expiration date printed on the vial unless they become contaminated. Single-dose vials, COVID-19 vaccine multidose vials, and manufacturer-filled syringes do not contain bacteriostatic agents. Once the cap has been removed or the sterile seal has been broken on these vaccines, they should be administered. Lyophilized (freeze-dried) vaccine must be used within a specified time frame after it has been reconstituted. You may find an educational piece from Immunize.org titled Vaccines with Diluents: How to Use Them helpful. It’s available at www.immunize.org/catg.d/p3040.pdf.
First and foremost, rotate your vaccine supply so expensive vaccine does not expire in your refrigerator. If you discover expired vaccine, remove it from the refrigerator or freezer so that it is not inadvertently given to a patient. Expired vaccines and diluents should NEVER be administered, even if it is only 1 day past the expiration date. Contact your immunization program, vaccine supplier, or vaccine manufacturer for specific policies about disposing expired vaccines.
It is acceptable to put the Beyond Use Date (BUD) on the packaging; this may help when reviewing inventory. But a provider should always read the label on the vial before administering a vaccine. It is possible for a vial to be placed in the wrong box. So, the vial label is the safest place to put the BUD. Vial labels are small, and it may require putting an extra sticky label on the vial.
The dose should be repeated. If the error was detected on the same clinic day, you can repeat the dose that day. If the error is detected more than one day later and if the expired dose is a live virus vaccine, you must wait at least 28 days after the previous (expired) dose was given before repeating it. If the expired dose is not a live vaccine, the dose should be repeated as soon as possible. An exception to this is for recombinant zoster vaccine (Shingrix, GSK); the repeat dose should be given 4 weeks after the invalid dose, to reduce the risk of side effects caused by the adjuvant used to enhance the effectiveness of this vaccine. If you prefer, you can perform serologic testing to check for immunity for certain vaccinations (e.g., measles, rubella, hepatitis A, diphtheria, varicella, and tetanus).
There are various requirements for the use of vaccines after reconstitution. Some manufacturers’ package inserts require that the vaccine be used or discarded in varying time frames ranging from 24 hours after reconstitution to “immediately” after reconstitution. While the specific timeframes are simple to interpret, there can be some confusion as to what the requirement of “immediately” actually means.
CDC considers “immediately” to be the reasonable time it takes to prepare and transport the vaccine to the patient to be administered. This would include any limited documentation that may be related to this process. It is up to the judgment of a provider to determine if a vaccine has not been used in the appropriate time. Some manufacturers have indicated to providers that “immediately” can be up to 30 minutes. The definition of “immediately” varies from manufacturer to manufacturer. Some do not have the data to put forth a general timeframe as to what “immediately” means. CDC recommends that the provider contact the manufacturer if any question arises about whether or not a vaccine dose has been used in the appropriate timeframe.
Most empty vaccine vials are not considered hazardous or pharmaceutical waste and do not require disposal in a biomedical waste container. Check and comply with your state requirements for disposal. Medical waste disposal requirements may vary from state to state because they are set by state environmental agencies. Contact your immunization program or state environmental agency for guidance to ensure your facility’s vaccine disposal procedures comply with state and federal regulations.
An exception to this principle is that an empty rotavirus vaccine dispensing tube or oral applicator is considered medical waste and should be disposed of in a medical waste container.
The amount of time in which a dose of vaccine must be used after reconstitution varies by vaccine and is usually outlined in the vaccine’s package insert. MMR must be used within 8 hours of reconstitution. MMRV must be used within 30 minutes; other vaccines must be used immediately. Immunize.org has a staff education piece that outlines the time allowed between reconstitution and use, as stated in the package inserts for a number of vaccines. This handout can be found at the following link: www.immunize.org/catg.d/p3040.pdf.