What to know
Vaccine preparation is the next-to-last step in the cold chain. Handling vaccines with care is equally as important as storing them properly. Preparation and administration guidance depends on the type of vaccine presentation.
Types of Vaccine Presentations
Single-Dose Vials
A single-dose vial (SDV) contains one dose and should be used one time for one patient. SDVs typically do not contain antimicrobial preservatives, making them susceptible to contamination and potential sources of infection when used improperly. Never combine leftover vaccine from one SDV with another. Open an SDV only when you are ready to use it. Before removing the protective cap, always check the vial to verify it's the correct vaccine. Once the cap is removed, the vaccine must be used because it may not be possible to determine if the rubber seal has been punctured. At the end of the workday, discard all unused SDVs without a protective cap.
Multidose Vials
A multidose vial (MDV) contains more than one dose of vaccine. Because MDVs typically contain a preservative to help prevent microorganism growth, they can be entered or punctured more than once. Only the number of doses indicated in the manufacturer's package insert should be withdrawn from the vial. After the maximum number of doses has been withdrawn, the vial should be discarded, even if there is vaccine left and the expiration date has not been reached.
MDVs can be used through the expiration date printed on the vial, unless the vaccine is contaminated or compromised in some way, or there is a BUD noted in the package insert. The BUD should be noted on the vaccine vial along with the initials of the person making the calculation. Never use partial doses from two or more vials to obtain a dose of vaccine.
Based on safe injection practices, CDC does not recommend using vial adapters, spikes, or other vial access devices when withdrawing vaccine from a multidose vial. Leaving a vial access device inserted into a vial septum provides a direct route for microorganisms to contaminate the vaccine.
Manufacturer-Filled Syringes
A manufacturer-filled syringe (MFS) is prepared and sealed under sterile conditions by the manufacturer. Activate an MFS by removing the syringe cap or attaching the needle only when ready to use it. An MFS 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.
Manufacturer-Filled Nasal Sprayer
Live, attenuated influenza vaccine (LAIV [FluMist]) is administered by the intranasal route using a manufacturer-filled nasal sprayer. A dose-divider clip, located on the plunger, separates the total vaccine dose of 0.2 mL into two equal parts of 0.1 mL each.
Oral Applicator
Because oral vaccines are prepared differently and may have different types of oral applicators, providers should be familiar with how to prepare and administer the brand stocked in their facility.
Vaccine Reconstitution
Before being administered, lyophilized (freeze-dried) vaccines such as MMR or recombinant zoster vaccine (Shingrix) are in either powder or pellet form and must be mixed with a liquid (diluent) in a process known as "reconstitution." Diluents vary in volume and composition and are specifically designed to meet volume, pH balance, and chemical requirements of their corresponding vaccines. Some diluents contain a vaccine component or an adjuvant needed for vaccine effectiveness.
☑ Establish a process to keep diluents and their corresponding vaccines together if storage requirements do not differ. Sometimes all vaccine components are packaged together; other times the diluent is separate.
☑ Never freeze diluents. All diluents can be stored at refrigerated temperatures, and some can also be stored at room temperature. Always refer to the manufacturer's package insert for product-specific guidance on storage and handling.
☑ Before reconstitution, always check the expiration date of both the vaccine and diluent.
- Each vaccine component has a separate lot number and expiration date.
- Never use an expired diluent or vaccine.
- VFC or other providers who have vaccines purchased with public funds and must transfer vaccine to another facility so it can be used before it expires, should contact their immunization program for guidance on vaccine transport.
☑ Use only the diluent provided with the vaccine.
- Diluents are not interchangeable unless specified by the manufacturer.
- Using the wrong diluent is a serious vaccine administration error that may result in incorrect doses and possible contamination.
☑ Never use a stock vial of sterile water or normal saline to reconstitute vaccines. Even if the diluent is composed of sterile water or saline, use only the specific diluent supplied with the vaccine.
☑ Never administer vaccine reconstituted with the wrong diluent. If an incorrectly reconstituted vaccine is administered, contact the immunization program or the vaccine manufacturer for revaccination and safety guidance.
Predrawing Vaccine
Use Manufacturer-Filled Syringes
Draw up vaccines only at the time of administration.
Predrawing vaccines is discouraged for many reasons, including
- Risk of compromising the stability of the vaccine. Disposable syringes are meant for administering vaccines, not for storing them.
- Increased risk for vaccination errors if predrawn syringes are labeled improperly, or if one person draws up vaccine doses while others administer them.
- Vaccine wastage if predrawn doses do not match the number of vaccine recipients.
In rare circumstances, such as during large off-site vaccination clinics, predrawing vaccine doses might be the only option. If vaccines must be predrawn, adhere to the following best practices:
- Set up a separate administration station for each vaccine type.
- Draw up vaccines only after arriving at the vaccination site.
- Once each predrawn dose is prepared, label the syringe with the vaccine name and dosage, the beyond-use date and time, lot number, and the preparer's initials. Additional pertinent information can be added, such as age range or if the dose is intended for use as primary or booster dose.
- Each vaccinator should draw up only one MDV at a time, regardless of whether it contains 2 or 10 doses. For SDVs and MFSs, no more than 10 doses may be predrawn or activated.
- Predraw reconstituted vaccine into a syringe only when ready to administer, as it has limited beyond-use time. If not used within 30 minutes, follow the manufacturer's guidance for storage and time limits.
- Monitor patient flow to avoid drawing up unnecessary doses.
- Store predrawn syringes at manufacturer-recommended temperatures. Discard any doses that were stored improperly.
- Discard all remaining predrawn syringes no later than the end of the workday. Never transfer predrawn reconstituted vaccine back into a vial.