Canadian Immunization Guide
Seventh Edition - 2006

[Previous] [Table of Contents] [Next]

Part 1
General Guidelines

Vaccine Administration Practices

Appropriate vaccine administration is a key element to ensuring the optimal safety and efficacy of vaccines. Vaccine administration practices are based on clinical trials that determine the dose, route and schedule for each vaccine. Professional standards for medication and vaccine administration and federal/provincial/territorial policies and procedures, where these exist, also guide vaccination practices. All providers of vaccines should receive education and competency-based training on vaccine administration before providing vaccines to the public. Programs should be in place to monitor the quality of immunization services. The following information provides general guidance for vaccine administration practices.

Pre-vaccination counselling

Prior to vaccination, the vaccine provider should ensure that the vaccine recipient is capable of consenting to the procedure or that, when required, an appropriate guardian or substitute decision maker is present to give consent. Information regarding the risks and benefits of both receiving and not receiving the vaccination should be provided, along with the opportunity to ask questions. Minor side effects that occur frequently and any adverse effects that are severe should be discussed with the individual, guardian or substitute decision maker. This person should be asked about all relevant contraindications and precautions to receiving the vaccine. Care should be taken to determine whether there is a risk of anaphylaxis, such as previous anaphylaxis or severe allergy to any of the vaccine components or latex, if contained in the vaccine products. For more information, please refer to the General Contraindications and Precautions chapter.

Vaccine administration

Vaccines should be administered using the recommended dose, route, site and schedule to optimize vaccine effectiveness and reduce the risk of local reactions or other adverse events.

Vaccine preparation

• Vaccine inspection: The vaccine identification label and expiry date on the vaccine vial or package should be checked by the vaccine provider before administration. Vaccines should not be used beyond their expiry date. If only the month and year are provided for the expiry date, the vaccine can be used to the end of that month. Multi-dose vials should be labelled with the date of first entry into the vial and, unless otherwise specified by the manufacturer, should be discarded after 30 days of the date of first entry. Before use, vaccine vials should be inspected for any irregularities, e.g., particulate matter, damage or contamination. Vaccines should be mixed with a careful swirling motion until a uniform suspension is achieved prior to administration.
• Vaccine reconstitution: Vaccines requiring reconstitution, i.e., a lyophilized product that is mixed with a diluent, should be mixed only with the diluent supplied for the vaccine unless otherwise permitted by the manufacturer.
• Pre-loading vaccines in syringes: Ideally, a vaccine should be withdrawn from the vial by the vaccine provider administering the vaccine. Pre-loading syringes with vaccine is discouraged because of the uncertainty of vaccine stability in syringes, risk of contamination, increased potential for vaccine administration errors and vaccine wastage. Pre-loading of syringes in the hospital setting where vaccines are drawn up and labeled in the pharmacy may be considered. In addition, to facilitate timely and efficient administration of a single vaccine to a large number of people in an immunization clinic setting, pre-loading of syringes may be considered. However, if implemented, this practice should be limited to these settings and should include the following:
  
  
  1. Prior agreement on how professional accountability can be ensured if different people pre-load and administer the vaccine
  2. Data on stability of pre-loaded product for a specified time period
  3. Maintenance of the cold chain

Syringe and needle selection

• Syringe selection: A separate, sterile syringe should be used for each injection, and different vaccines should not be mixed in the same syringe unless specified by the manufacturer as part of the reconstitution and administration procedure. Depending on the dosage, a 3 mL or 1 mL syringe should be selected.
• Needle selection: Needle selection should be based on the route of administration, individual's age, size of the muscle mass and viscosity of the vaccine:
  
  
  • For intradermal (ID) injections, a 26-27 gauge needle is recommended.
  • For subcutaneous (SC) injections, a 25 gauge, 1.6 cm (5/8") needle is recommended.
  • For intramuscular injections (IM) a 22-25 gauge needle that is long enough to reach muscle is recommended:
    
    
    • 2.2 cm (7/8"') to 2.5 cm (1") for infants
    • 2.2 cm (7/8") to 2.5 cm (1") for toddlers and older children
    • 2.5 cm (1") to 3.8 cm (1½") for adolescents and adult

The needle should be inserted as far as possible into the muscle. A larger bore needle (e.g., 22 gauge) may be required when administering viscous or larger volume products such as immune globulin.

Restraint

After informed consent, the process of vaccine administration should be shared with the individual, and restraint procedures should be explained. The parent or guardian should hold a child with specific instructions on restraint positioning. Failed restraint can result in inaccurate dose, inappropriate depth of injection or injury to the individual being immunized and/or vaccine provider.

Injection site, route and technique

Vaccines and other biologic products are injected via ID, SC or IM routes.

• ID injections:
  
  
  • ID injections are usually administered on the flexor surface of the forearm.
  • The bevel of the needle should be turned upwards and at an angle parallel to the forearm.
  • The needle is inserted so that the bevel penetrates the skin. If done correctly, a small bleb should be observed at the injection site upon injection of the vaccine.
• SC injections: SC injections are usually given at a 45^o angle into subcutaneous tissue of the upper triceps area of the arm.
• IM injections:
  
  
  • IM injections are administered at a 90^o angle into the vastus lateralis muscle (anterolateral thigh) in infants < 1 year of age and the deltoid muscle of anyone ≥ 1 year of age (unless the muscle mass is not adequate). Appropriate site selection is important to avoid inadvertent injection into a blood vessel or injury to a nerve. Some vaccine providers prefer to pull back on the plunger (aspiration) to determine whether the needle has entered a blood vessel. There are no studies that have assessed the need for aspiration prior to IM injection of vaccines in relation to vaccine safety. As well, the syringes provided for immunization may not allow aspiration.
  • The buttock should not be used for active immunization.Immunogenicity is lower to hepatitis B and rabies vaccines if given in the buttock, probably because of injection into adipose tissue where the vaccine is not well mobilized. The buttock is an acceptable site for administration of immune globulin when large volumes are administered, but appropriate site selection of the gluteal muscle is necessary to avoid injury to the sciatic nerve.
  • Vaccines containing adjuvants are to be injected intramuscularly. If inadvertently injected subcutaneously or intradermally, increased inflammation, induration or granuloma formation may occur

Please see Table 1, which outlines the route of administration of all vaccines approved for use in Canada, in the General Considerations chapter.

Multiple injections

There are no contraindications to giving multiple vaccines at the same clinic visit, and all opportunities to immunize should be utilized. Giving multiple injections at one visit helps to ensure that children are up to date with the vaccines required for their age. Generally, infants and children have similar immune responses whether vaccines are given at the same time or at different visits. Although children are now receiving more vaccines, they are exposed to fewer antigenic proteins in today's vaccines than in the past because of changes in the vaccine products. Practice considerations for multiple injections include the following:

• Vaccines prepared in separate syringes should be labelled in order to identify which vaccine each syringe contains. The site of administration of each vaccine should be recorded.
• Separate limbs should be used if two IM injections are required. If more than two injections are required, two injections may be administered into the same muscle separated by at least 2.5 cm (1").
• Vaccines that are known to cause more stinging and/or pain should be given last.

Techniques to decrease pain and anxiety

Pain associated with immunizations is generally described as mild and short-lived, and no specific pain reduction strategies are recommended for routine use. However, the following strategies can be considered for individuals who are particularly concerned about immunization pain.

• Swaddling, holding or sucking on a pacifier.
• Breastfeeding infants or offering sweet-tasting solutions such as oral sucrose or glucose.
• Distraction techniques, such as books, video games, cartoons, movies, bubble and party blowers for older children; children can be instructed to "blow away the pain" using party blowers, windmills or bubbles.
• Pharmacologic agents such as EMLA (eutectic mixture of local anesthesia, consisting of 2.5% lidocaine and 2.5% prilocaine), Ametop^® gel (4% amethocaine) and vapocoolants (e.g., Fluori-Methane). Studies have demonstrated that EMLA does not affect the immunologic response to MMR, DTaP-IPV-Hib (Pentacel^®), hepatitis B (Recombivax^®) or Bacille Calmett-Guérin (BCG) vaccinations. EMLA needs to be applied approximately 60 minutes before the injection. Ametop^® gel produces anesthesia within 30 to 40 minutes and has been shown not to interfere with the immunologic response to MMR vaccine. Vapocoolants are effective immediately after application.

Techniques to decrease anxiety in adolescents and adults are important to minimize the risk of fainting. These techniques include ensuring that the temperature in the room is comfortable, avoiding long line-ups in mass immunization clinics and administering the vaccine while the person is seated. Patients who appear very anxious should be observed while seated until anxiety has resolved after the immunization.

After the vaccination

After vaccination, vaccine recipients should be counselled on common side effects and the reporting and management of these reactions. Vaccine providers should identify and observe individuals who are particularly anxious about receiving the vaccine. Individuals with presyncopal symptoms such as pallor or sweating should sit or lie down until symptoms resolve. A study using the American Vaccine Adverse Reporting System found that 63% of syncopal events occurred within 5 minutes of vaccination, and 89% occurred within 15 minutes. It is therefore prudent to keep the person in the clinic for 15 minutes after vaccination. This will also facilitate the management of the rare anaphylactic event. All vaccination providers should have the necessary training and equipment to manage anaphylactic events Please refer to the Anaphylaxis: Initial Management in Non-Hospital Settings chapter.

Infection prevention and control (IPC)

Immunization providers should incorporate routine infection control practices into all immunization procedures:

• The vaccine vial should be uncapped, wiped with a suitable disinfectant (e.g., isopropyl alcohol) and allowed to dry prior to withdrawal of vaccine into the syringe.
• Before injection, the skin should be cleansed with a suitable antiseptic and allowed to dry.
• A separate, sterile needle and syringe should be used for each injection.
• Hand hygiene should be performed before vaccine preparation, between vaccine recipients, and whenever the hands are soiled. Alcohol-based hand sanitizers are an alternative to hand washing with soap and water. Glove use during immunization is not routinely recommended, unless the skin on the vaccine provider's hands is not intact. The Health Canada (now the Public Health Agency of Canada) document on Infection Control Guidelines, Routine Practices and Additional Precautions for Preventing the Transmission of Infection in Health Care, provides information on IPC precautions.
• Additional practices recommended during immunization include the following:
  
  
  • Needles used during immunization should not be recapped after use.
  • Used syringes and needles should be immediately and carefully disposed of in a container designed for this purpose and should never be laid down on the work surface.
  • Used syringes with attached needles and empty or expired vaccine vials should be disposed of according to local waste management legislation or guidelines.

Occupational health

• All vaccine providers should be offered hepatitis B vaccine. Post-immunization serologic testing should be obtained to ensure that there is an adequate antibody response. Please refer to the Hepatitis B Vaccine chapter for more information.
• Procedures for accidental exposure to blood or body fluids should be in place and understood by vaccine providers.

 

Vaccine administration check list Is the vaccine indicated according to the recommended immunization schedule and the individual's immunization history? Has the appropriate consent been obtained? Are there any contraindications to vaccination? Has the expiry date been checked? Has the vaccine provider washed his or her hands or used an alcohol-based hand sanitizer? Has the vaccine been appropriately reconstituted and/or mixed? Are the dose and route of administration correct? Is the appropriate needle gauge and length being used in the correct site? Has the appropriate documentation been completed? Have post-vaccination instructions been given to the vaccine recipient?

Selected references

Alberta Health and Wellness. Multiple injections workbook. 2004. (A participant workbook for use in conjunction with the Multiple Injections video to provide the rationale and evidence-based nursing practice guidelines for administration of multiple injections from an Alberta perspective.)

American Academy of Pediatrics. Red book 2003: report of the Committee on Infectious Diseases, 26^th edition. Elk Grove Village, Illinois: AAP, 2003.

Atkinson W, Hamborsky J, Wolfe S eds. Epidemiology and prevention of vaccine-preventable diseases, 8^th edition. Washington DC: Public Health Foundation, 2004;G1-G19.

Braun MM, Patriarca PA, Ellenberg SS. Syncope after immunization. Archives of Pediatrics and Adolescent Medicine 1997;151(3):255-59.

Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices and the American Academy of Family Physicians. Morbidity and Mortality Weekly Report 2002;51(RR-2):1-35.

Centers for Disease Control and Prevention. Suboptimal response to hepatitis B vaccine given by injection into the buttock. Morbidity and Mortality Weekly Report 1985;34(8):105-108.

Halperin BA, Halperin SA, McGrath P et al. Use of lidocaine-prilocaine patch to decrease intramuscular injection pain does not adversely affect the antibody response to diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b conjugate and hepatitis B vaccines in infants from birth to six months of age. Pediatric Infectious Disease Journal 2002;21(5):399-405.

Halperin SA, McGrath P, Smith B et al. Lidocaine-prilocaine patch decreases the pain associated with subcutaneous administration of measles-mumps-rubella vaccine but does not adversely affect the antibody response. Journal of Pediatrics 2000;136(6):789-94.

Health Canada. Routine practices and additional precautions for preventing the transmission of infection in health care. Canada Communicable Disease Report 1999;25(S4). URL: <http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/99pdf/cdr25s4e.pdf>.

Jacobson RM, Swan A, Adegbenro A et al., Vaccine Research Group. Making vaccines more acceptable - methods to prevent and minimize pain and other common adverse events associated with vaccines. Vaccine 2001;19:2418-27.

O'Brien L, Taddio A, Ipp M et al. Topical 4% amethocaine gel reduces the pain of subcutaneous measles-mumps-rubella vaccination. Pediatrics 2004;114(6):720-24.

Offit PA, Quarles J, Gerber MA et al. Addressing parents' concerns: Do multiple vaccines overwhelm or weaken the infant's immune system? Pediatrics 2002;109(1):124-29.

Reis EC, Holubkov R. Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children. Pediatrics 1997;100(6). URL: <http://pediatrics.aappublications.org/cgi/reprint/100/6/e5?maxtoshow=&HITS=10&hits
=10&RESULTFORMAT=&author1=Holubkov%2C+R&fulltext=EMLA&searchid
=1130332254570_349&stored_search=&FIRSTINDEX=0&sortspec=relevance&journalcode=pediatrics>.

[Previous] [Table of Contents] [Next]