Influenza A (H1N1) 2009 Monovalent Vaccine Storage, Preparation, Handling Q & A

March 5, 2010, 5:00 PM ET

Purpose and Target Audience

The purpose of this document is to provide information to vaccine planners, clinicians and health care providers on the storage, preparation, and handling of inactivated and live attenuated (LAIV) influenza A (H1N1) 2009 monovalent vaccine.

Background

Maintaining recommended temperatures and protecting against other environmental exposures during the vaccine storage, transport, handling and administration processes is critical to prevent damage to the vaccine.  Use of the appropriate vaccine cold chain management equipment and adherence to both manufacturer instructions and state/local immunization program procedures will ensure optimal vaccine administration results.

2009 H1N1 vaccines must be stored and transported within the recommended temperature range of 2°C to 8°C (35°F to 46°F).  These fragile biological substances can be rendered unusable if they are exposed to freezing conditions and if they are subjected to prolonged exposure in an environment that is too hot.  Vaccine that is stored or handled at temperatures below 2°C or above 8°C for any period of time, or that is not stored according to the manufacturer’s recommendations, is deemed to be exposed.

Proper vaccine storage, preparation, and handling are critical in maintaining the integrity of the vaccine. Vaccine quality is the shared responsibility of all parties, from the time vaccine is manufactured until it is administered.

Storage of Vaccines

How should 2009 H1N1 monovalent vaccine be stored during transport to vaccine administration locations?

When transporting vaccines, think about how each vaccine was packed when you first received it from the manufacturer or distributor. Use this as a model for how to repack the individual vaccines in order to transport them at their appropriate temperature. Keep a temperature log. Record the temperature during transport and periodically (e.g., at least once each hour) during the entire time the vaccine is kept in the transport container to ensure it remains within the recommended range.
Please access and view special instructions of the Immunization Action Coalition’s document entitled Maintaining the Cold Chain During Transport.

In addition, contact your state health department immunization program for details and refer to the “Maintaining the Cold Chain” section of the CDC Vaccine Storage and Handling Toolkit for general vaccine storage guidelines.

How should 2009 H1N1 monovalent vaccine be stored in health care provider/clinical settings?

Immediately upon arrival in a health care provider or clinical setting, vaccine (both inactivated and LAIV) should be removed from the transport cooler, inventoried, and stored inside a refrigerator (which does not share a door with a freezer, i.e. “non-dorm style”) in the center of the unit, away from the walls and the doors of the refrigerator.

Inactivated vaccines are sensitive to excessive heat, freezing and light. They should be protected from light at all times by being stored in their original packaging with the tops on until they are needed. Inactivated vaccines should be stored in a refrigerator at 35° to 46°F (2° to 8°C), with a desired average temperature of 40°F (5°C). Exposure to temperatures outside this range results in decreased vaccine potency and increased risk of vaccine-preventable diseases. Inactivated vaccines may tolerate limited exposure to elevated temperatures, but they are cold sensitive and are damaged rapidly by freezing temperatures.

Like inactivated influenza vaccine, LAIV should be stored in the refrigerator at 35° to 46°F (2° to 8°C). Unlike other live virus vaccines, LAIV should not be stored in the freezer.

How should 2009 H1N1 monovalent vaccine be stored in mass vaccination clinic settings?

If a properly functioning vaccine storage unit is not available at the administration site, then the 2009 H1N1 monovalent vaccine may be maintained in a properly conditioned insulated cooler during an off-site (mass vaccination) clinic. The vaccine should be stored in the cooler at 35° to 46°F (2° to 8°C), with a desired average temperature of 40°F (5°C). Providers should minimize the number of times that the cooler is opened. A calibrated thermometer must be kept in the cooler with the vaccines, and temperatures should be checked and recorded periodically to ensure that the cold chain is not broken. In addition, checking and recording the temperature in storage containers ensures that if temperatures are increasing or decreasing over time, providers can intervene before the vaccine is exposed and potentially wasted.

The Centers for Disease Control and Prevention (CDC)’s National Center for Immunization and Respiratory Diseases (NCIRD) recommends that, at a minimum, temperature readings in the insulated cooler should be recorded prior to leaving the provider’s main office, upon arrival at the vaccine administration clinic location, every hour during the vaccine administration clinic session, upon completion of the vaccine administration clinic session, and after return to the main office.

Preparation and Handling of Vaccines

What is the proper process for inspecting and handling multidose vials (MDVs) of inactivated 2009 H1N1 monovalent vaccine immediately prior to use?

Each MDV should be carefully inspected for damage or contamination just prior to use. Always check the label on the vial before removing the cap to make sure you have the correct vaccine type and check the expiration date. Remove the cap only when you are ready to draw up and administer the vaccine. Mark each opened MDV with the date it was first punctured.

If an unopened MDV looks damaged or contaminated, providers should isolate the vial, mark it as "DO NOT USE," and store it under appropriate conditions in a properly functioning vaccine storage unit until the integrity of the vaccine is determined. Providers should contact their state or local health department immunization program for further guidance.

How long can multidose vials (MDVs) of inactivated 2009 H1N1 monovalent vaccine be used after the cap has been removed and the vial has been punctured?

Inactivated 2009 H1N1 monovalent vaccine MDVs contain bacteriostatic agents that prevent the growth of bacteria. Once punctured, if the vials are stored properly at 35° to 46°F (2° to 8°C), they can be used until the last day of the month indicated by the expiration date, if not contaminated or unless otherwise stated in the manufacturer’s product information. Expired vaccine should never be used. Remove the cap only when you are ready to draw up and administer the vaccine.

Once punctured, mark each MDV with the date of first puncture. Dating punctured MDVs helps manage vaccine inventory by identifying vials that should be used first. Whenever possible, use all vaccine in one MDV before opening another vial.

What should providers do with partially used and unexpired MDVs of inactivated 2009 H1N1 monovalent vaccine?

MDVs of vaccine can be used until the expiration date on the vial as long as the vaccine is stored and handled properly and has a normal appearance. Between uses, return the MDV to the recommended storage conditions at 2° to 8°C (35° to 46°F).

What should providers do with excess (unopened) doses of 2009 H1N1 monovalent influenza vaccine?

Any excess, unopened, and viable doses of 2009 H1N1 vaccine should be made available for use to vaccinate other patients.

If providers have unused doses of 2009 H1N1 influenza vaccine at the end of the 2009-10 influenza season, they should contact their state or local health department immunization program for instructions and regulation on how to dispose of any excess vaccine.  Excess, opened vials that will not be used, should be discarded per manufacturers’ instructions. There is no federal excise tax for 2009 H1N1 monovalent vaccine; therefore, vaccine will not need to be returned to the manufacturer.

What should providers do if they suspect or know that the 2009 H1N1 monovalent vaccine was not stored or handled properly?

To determine the usability of vaccine that was stored or handled improperly (e.g., exposed to inappropriate temperatures because of a fault in the refrigerator or freezer), providers should set aside and label the vaccine “Not For Use”, and store it under appropriate conditions in a properly functioning vaccine storage unit until the usability of the vaccine is determined.  Do not assume that vaccine that has been inappropriately exposed to light or to excessive temperatures cannot be salvaged. Providers should contact the vaccine manufacturer and their state or local health department immunization program for further guidance.

What should providers do with expired or wasted doses of 2009 H1N1 monovalent vaccine?

Providers are encouraged to follow any reporting requirements that their state or local health department immunization programs have established with regard to expired or wasted doses. There is no federal excise tax for 2009 H1N1 monovalent vaccine; therefore, vaccine does not need to be returned to the manufacturer and should not be sent back to CDC’s centralized vaccine distributor if it was wasted or expired. Disposal of expired vaccine is primarily regulated at the state level. To determine what laws apply in your state, contact your state or local health department or refer to the links provided below for more information:

• State Medical Waste Programs and Regulations

How far in advance can 2009 H1N1 monovalent inactivated vaccine be pre-drawn into syringes?

CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), strongly recommends providers draw vaccine only at the time of administration to ensure that the cold chain is maintained and that vaccine is not inappropriately exposed to light.

CDC also strongly discourages pre-filling syringes because of the increased risk of administration errors. The vaccine manufacturers do not recommend that influenza vaccine be filled in advance of a mass influenza vaccination clinic because there are no data on the stability of vaccine stored in syringes filled by providers.

What is the rationale behind NCIRD’s recommendation to providers to not pre-draw 2009 H1N1 monovalent inactivated vaccine into syringes?

Once the vaccine is in the syringe it is difficult to identify the type or brand of vaccine. Other problems associated with this practice are vaccine wastage, possible bacterial growth, and the unknown stability of vaccine stored in a plastic syringe. Furthermore, medication administration guidelines state that the individual who administers a medication should be the one to draw up and prepare it. (This is a quality-control and patient-safety measure because if you do not draw up the vaccine yourself you cannot be sure of the composition and sterility of the dose you are administering).

Does guidance exist for prefilling syringes with inactivated 2009 H1N1 monovalent vaccine in a mass influenza vaccination clinic setting?

Although pre-filling vaccine is generally discouraged, a limited amount of vaccine may be filled in advance of a large-scale vaccination clinic if all the following procedures are followed:

• Only one vaccine type may be administered at the clinic. If more than one vaccine type is to be administered, separate vaccine administration stations must be set up for each vaccine type to prevent medication errors.
• Vaccine should not be drawn up in advance of arriving at the clinic site. Because of the lack of data on the stability of vaccine stored in plastic syringes, the practice of drawing up quantities of vaccine hours or even days before a clinic is not acceptable.
• Vaccine should be transported at the proper temperatures to the clinic site in the manufacturer-supplied packaging.
• Vaccine must be maintained at 35° to 46°F (2° to 8°C), either inside a refrigerator or inside a properly chilled insulated cooler. Providers should keep the cooler closed as much as possible. A calibrated thermometer must be kept in the cooler with the vaccines, and temperatures should be checked and recorded hourly to ensure that the cold chain is not broken.
• Prior to administering vaccine to patients, each healthcare worker (HCW) may draw up a small quantity of vaccine to meet the initial needs of the clinic—no more than 10 doses. This will limit the amount of time the vaccine is held in the syringe before administration and reduce vaccine wastage.
• Patient flow should be monitored to avoid drawing up unnecessary doses.
• At the end of the clinic day, any remaining vaccine in syringes should be discarded. Vaccine that has been drawn up and not administered may not be used on subsequent days.

If additional staff is available during the clinic, HCWs can alternate activities. One may stop vaccinating and fill additional syringes as needed; when this HCW resumes vaccinating, the other HCW may stop and draw up additional vaccine as needed. This minimally slows the patient flow and limits the amount of vaccine drawn up at any one time.

Does guidance exist for prefilling syringes with inactivated 2009 H1N1 monovalent vaccine in a hospital pharmacy or other inpatient clinical setting?

Pre-filling vaccine is also generally discouraged in inpatient settings, however a limited amount of vaccine may be pre-filled by a hospital pharmacy for use in an inpatient setting if all the following procedures are followed:

• Syringes are prepared by the pharmacy under conditions consistent with practice standards for compounding sterile pharmaceutical preparations.
• Syringes are clearly labeled with the:
  • Name and amount of vaccine,
  • Date the vaccine was prepared,
  • Instructions to discard vaccine by the end of the day.
• Vaccine is dispensed by the pharmacy directly to the administering nurse or clinician.

Refer to the United States Pharmacopeia and Joint Commission 2008 National Patient Safety Goals for additional guidance on proper storage, handling and labeling sterile pharmaceuticals in in-patient care settings.

Preparing Needles and Syringes for Vaccine Administration

What is the best way to prepare needles and syringes prior to administering the inactivated 2009 H1N1 monovalent vaccine?

Whether health care providers are attaching needles to pre-filled syringes or using integrated needle/syringe units (no assembly required), it is important to make sure that the needle is firmly attached to the hub of the syringe. Some brands of needles and syringes must be attached by twisting the needle into the syringe hub prior to drawing vaccine.  This will prevent vaccine from leaking during vaccine administration.

What are the appropriate needle sizes for children and adults when administering the inactivated 2009 H1N1 monovalent vaccine?

Vaccine providers should use a 23–25 gauge needle and choose the injection site and needle length appropriate to the person’s age and body mass. It is recommended that providers use 1 inch needles for children (ages 6 months to 18 years) and 1-1.5 inch needles for adults (19 + years).

Labeling Vaccine and Syringes

How should inactivated 2009 H1N1 monovalent vaccine be labeled once it is drawn up into a syringe?

Once vaccine is drawn into a syringe, the content should be indicated on the syringe. There are a variety of methods for identifying or labeling syringes (e.g. keep syringes with the appropriate vaccine vials, place the syringes in a labeled partitioned tray, and/or use color-coded labels or preprinted labels).

Labeling syringes avoids waste and confusion and helps to reduce the chance of a vaccine administration error.  Labeling syringes is also important in order for providers to differentiate between seasonal influenza and 2009 H1N1 monovalent influenza vaccines as well as between the adult formulation (.5 mL) and the pediatric formulation (.25 mL) of the vaccines.

Handling and Disposal of Used Vaccine, Needles, and Syringes

What is the best way to avoid accidental needle stick injuries when administering the vaccine?

When needles and syringes are used to draw vaccine from a multidose vial, use firm pressure when replacing the cap after drawing up vaccine.  A click should be heard.  When picking up a syringe, the nurse must use caution to ensure that the cap is firmly in place to avoid a possible needle stick injury.

Some of the needles/syringes that are supplied with the 2009 H1N1 monovalent vaccine can retract directly from the patient into the syringe as a built-in safety mechanism.  If health care providers experience difficulty retracting the needle after vaccine administration, remove the needle from the patient prior to attempting to retract.  Dispose the syringe into a sharps container.

Other needles supplied with the 2009 H1N1 monovalent vaccine are safety-engineered to cover the used needle after vaccine administration.  The needle safety shields should be activated immediately after vaccine administration.  Do not manually recap needles.

What are the procedures for proper disposal of used vials, syringes, and needles?

Needles and syringes are single-patient devices and should NEVER be used to administer vaccine to more than one patient.  Used needles should not be detached from syringes, recapped or cut before disposal. All used syringe/needle devices should be placed in puncture proof containers to prevent accidental needlesticks and reuse.

Empty or expired vaccine vials are considered medical waste and should be disposed of according to state regulations.  Medical waste disposal is primarily regulated at the state level. To determine what laws apply in your state, contact your state or local health department or refer to the links provided below for more information:

• State Medical Waste Programs and Regulations

How should used LAIV be discarded after vaccine is administered?

LAIV nasal sprayers are single-patient devices and should NEVER be used to administer vaccine to more than one patient. Once the vaccine has been administered, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container).