Page 8: Canadian Immunization Guide: Part 1 - Key Immunization Information
Vaccine Administration Practices
Updated: September 2014
- General considerations
- Pre-vaccination counselling
- Vaccine administration
- Post-vaccination counselling and observation
- Infection prevention and control
- Selected References
Appropriate vaccine administration is essential to 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 jurisdictional policies and procedures (if available) also guide vaccination practices.
All vaccine providers 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. For detailed information about the required immunization competencies, refer to the Public Health Agency of Canada's Immunization Competencies for Health Professionals.
The following information provides general guidance regarding vaccine administration practices for use in conjunction with vaccine manufacturers' instructions, outlined in: product leaflets and product monographs; professional standards of practice; and jurisdictional policies and procedures.
Prior to vaccination, the vaccine provider should:
- assess that the vaccine recipient is capable of consenting to the procedure or that, when required, an appropriate guardian or substitute decision-maker gives consent;
- provide information regarding the risks and benefits of receiving or not receiving the vaccine;
- assess the vaccine recipient's current state of health;
- assess contraindications and precautions to receiving the vaccine, including any history of potential immediate or anaphylactic hypersensitivity to a previous dose of the vaccine or to any of the vaccine components; refer to Contraindications, Precautions and Concerns in Part 2 for additional information;
- evaluate reactions to previous vaccinations;
- discuss frequently occurring minor adverse events and potential rare severe adverse events;
- provide an opportunity for the vaccine recipient or guardian to ask questions.
After informed consent is obtained, the vaccine provider should outline the process of vaccine administration and explain positioning procedures. The parent or guardian should hold a child in a position as instructed by the vaccine provider. Failed positioning can result in loss of part or all of the dose, inappropriate depth of injection, or injury to the vaccine recipient or vaccine provider. Refer to Table 4 for additional information. Table 1 provides an example pre-vaccine administration checklist.
|Screening questions for all vaccines||Yes||No|
|Additional screening questions if immunizing with live vaccines||YesTable 1 - Footnote 2||No|
Administer vaccines to the right person using the correct vaccine, correct dose, correct route of administration, correct injection site (if applicable) and correct time (schedule), to optimize vaccine effectiveness and to reduce the risk of local reactions or other adverse events. Table 2 provides an example of a checklist for vaccine administration. Refer to Storage and Handling of Immunizing Agents in Part 1 and vaccine specific chapters in Part 4 for additional information.
Before vaccine administration, the vaccine identification label must be checked to ensure that the correct vaccine selection of the correct vaccine and the expiry date on the vaccine vial and vaccine diluent (if applicable) must be verified to ensure that they have not expired. Vaccines or diluents should not be used beyond their expiration date. Before use, vaccine vials must be inspected for any irregularities, such as particulate matter in the contents, or damage to or contamination of the vial or its contents. Vaccines should be mixed with a careful swirling motion until a uniform suspension is achieved prior to administration. Unless otherwise instructed by the manufacturer, the vaccine should not be shanken before use. Refer to Storage and Handling of Immunizing Agents in Part 1 for additional information about expiration dates and multi-dose vials.
Vaccines should be reconstituted according to the manufacturers' guidelines, using only the diluent provided by the manufacturer for that purpose, and adhering to local policies and procedures. The diluent should be introduced down the side of the vaccine vial and not directly into the vaccine powder, to avoid foaming or potential denaturing of the vaccine protein. The reconstituted vaccine should be mixed with a careful swirling motion until a uniform suspension is achieved prior to administration, unless otherwise instructed by the manufacturer. Once reconstituted, the vaccine should be administered within the time frame specified in the manufacturer's product information. Refer to Storage and Handling of Immunizing Agents in Part 1 for additional information about vaccine reconstitution.
In immunization clinics in which only a single vaccine is being administered, the contents of more than one multi-dose vial may be combined to prevent wastage if the vials have the same lot number. Vaccine providers should observe strict aseptic technique when using multi-dose vials. Injecting air into a multi-dose vial prior to withdrawing a vaccine dose is not necessary.
Pre-loading vaccine in syringes
Ideally, a vaccine should be withdrawn from the vial by the vaccine provider who is administering the vaccine. Pre-loading syringes with vaccine is strongly 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 may be considered in the hospital setting if vaccines are drawn up and labelled in the pharmacy or in an immunization clinic, to facilitate timely and efficient administration of a single vaccine to a large number of people. If the practice of pre-loading of syringes is implemented, it should be limited to hospital or immunization clinics and should include:
- prior agreement on professional accountability if different people pre-load and administer the vaccine,
- review of the data on stability of pre-loaded product for a specified time period, and
- maintenance of the cold chain.
Refer to Storage and Handling of Immunizing Agents in Part 1 for additional information.
Syringe and needle selection for parenteral vaccines
A separate, sterile needle and syringe should be used for each injection. Different vaccines must never be mixed in the same syringe, unless specified by the manufacturer. The use of safety-engineered needles and syringes is preferred and, in many jurisdictions, mandated by law to reduce risk of injury. However, vaccines packaged by the manufacturer in pre-filled syringes should not be transferred to safety-engineered injection devices.
Use a 1 mL or 3 mL syringe, depending on the volume of the vaccine dose.
Appropriate needle selection is important because the immunizing agent must reach the appropriate tissue site (dermis, subcutaneous tissue or muscle) to optimize the immune response and to reduce the risk of injection site reactions.
When considering needle length, select a needle that is long enough to reach the tissue site, but not so long as to hit underlying bone. The use of longer needles for intramuscular injection of vaccine is associated with less injection site redness and swelling than occurs with shorter needles. When needles are too short to reach muscle, vaccine may be inadvertently injected into more superficial tissue (i.e., dermis and subcutaneous tissue), resulting in increased inflammation, induration or granuloma formation. The selection of the right needle should be based on the: route of administration, vaccine recipient's age and size of muscle mass, and the viscosity of the vaccine or passive immunizing agent. Table 3 provides guidelines for needle selection.
|Route of administration||Age of vaccine recipient||Recommended needle gauge||Recommended needle length|
|Intradermal (ID)||All ages||26-27||1.0 cm|
|Subcutaneous (SC)||All ages||25||1.6 cm (⅝ inch)|
|Intramuscular (IM)Table 3 - Footnote 1||Infants, toddlers and older children||22-25Table 3 - Footnote 2||2.2 cm - 2.5 cm
(⅞ inch - 1 inch)
|Adolescents and adults||22-25Table 3 - Footnote 2||2.5 cm - 3.8 cm
(1 inch - 1½ inch)
Route, site and technique for vaccine administration
Refer to Contents of Immunizing Agents Available for Use in Canada in Part 1 for information about the recommended route of administration for vaccines and passive immunizing agents authorized and available for use in Canada.
Vaccines are injected via the intradermal (ID), subcutaneous (SC), or intramuscular (IM) routes.
Intradermal (ID) injections
Intradermal vaccine administration technique is product-specific and should be applied according to the vaccine's product monograph. ID vaccines available in Canada include:
- Bacillus Calmette-Guérin (BCG) vaccine
- Trivalent inactivated influenza vaccine, Intanza®.
- Smallpox vaccine.
- Rabies vaccine for pre-exposure immunization protection only.
Subcutaneous (SC) injections
For infants younger than 12 months of age, the usual site for SC administration of vaccine is the subcutaneous tissue of the anterolateral thigh; if necessary, the upper triceps area of the arm may be used. SC injections for vaccine recipients 12 months of age and older are usually given into the subcutaneous tissue of the upper triceps area of the arm. SC injections should be administered at a 45° angle.
Intramuscular (IM) injections
IM injections of vaccine are administered at a 90° angle into the vastus lateralis muscle (anterolateral thigh) in infants less than 12 months of age and into the deltoid muscle of persons 12 months of age and older (unless the muscle mass is not adequate, in which case the anterolateral thigh can be used). For the injection of diphtheria, tetanus, acellular pertussis (DTaP) vaccine in children 12 to 35 months of age, the deltoid muscle or anterolateral thigh can be used. A large retrospective cohort study of children 12 to 35 months of age demonstrated a lower risk of medically- attended local reactions when DTaP vaccine was given into the thigh compared to vaccination into the arm.
Appropriate site selection is important to avoid inadvertent injection into a blood vessel or injury to a nerve. Vaccines containing adjuvants must be injected intramuscularly. If a vaccines containing an adjuvant is inadvertently injected subcutaneously or intradermally, increased inflammation, induration or granuloma formation may occur. Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional information about IM administration of vaccines to people with bleeding disorders.
Active immunizing agents should not be administered into the buttock (gluteal muscle). 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 absorbed. The buttock is an acceptable site for administration of immune globulin when large volumes are administered, and activation of the immune system is not required, but appropriate site selection of the gluteal muscle is necessary to avoid injury to the sciatic nerve.
All opportunities to immunize should be used and giving multiple vaccines at the same clinic visit is encouraged. Giving multiple injections at one visit helps to ensure that individuals are up to date with the vaccines required for their age and risk factors. 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 vaccines used in the past, because of changes in the vaccine products.
Practice considerations for multiple injections include the following:
- Label syringes to identify which vaccine each syringe contains.
- Record the site of administration of each vaccine, so that if an injection site reaction occurs, the associated vaccine can be identified.
- Use separate limbs if two IM injections are required. If more than two injections in the same limb are required, administer the two injections into the same muscle, separated by at least 2.5 cm (1 inch). In cases where there is insufficient deltoid muscle mass, the anterolateral thigh can be used.
- Administer vaccines that are known to cause more stinging or pain after other vaccines (e.g., Prevnar®13; M-M-R®II, human papillomavirus vaccines [HPV]).
- If a vaccine and an immune globulin preparation are administered simultaneously (e.g., tetanus toxoid-containing vaccine and tetanus immune globulin), use separate anatomic sites (different limbs) for each injection.
Techniques to decrease immunization injection pain
Vaccine injections can be a source of distress for individuals of any age, as well as for the immunization provider. If not addressed, the pain and anxiety associated with immunization can increase fear leading to avoidance of future medical procedures and lack of adherence to immunization schedules. It is estimated that up to 25% of adults have needle fears and 10% have needle phobias, defined as a marked and persistent fear that is excessive or unreasonable, cued by the presence of needles or anticipation of vaccination. The majority of people with needle fears develop them in childhood. Efforts aimed at minimizing pain in childhood have the potential to prevent the development of needle fears and to promote satisfaction and trust in health care providers because of more positive experiences for children and their families.
Research has shown that there are many effective pharmacologic, physical, and psychological interventions available for use during the immunization procedure. Combining strategies has been shown to improve pain relief. The most effective strategies for infants, in order of effectiveness, are breastfeeding or administration of a sucrose solution, topical anesthetics, and distraction. The most effective strategies for older children, in order of effectiveness, are topical anesthetics and distraction.
Refer to Table 4 for a listing of pain management strategies for children by age groups.
|Age of child||Pain management strategiesTable 4 - Footnote 1|
|2 to 12 months||
|12 months to 2 years||
|3 to 6 years||
Mothers can breastfeed their infants before, during, and after the immunization. Research indicates that breastfeeding during immunization may reduce pain and distress through:
- presence of a comforting person
- diversion of attention (sucking and distraction)
- physical sensation of skin to skin contact with mother
- sweet taste of breast milk and other chemicals in the milk (e.g., tryptophan [a precursor of melatonin] which has been reported to increase the concentration of ß-endorphins, thereby producing analgesia and relaxation).
Administration of a sucrose solution
For infants up to and including 12 months of age who cannot be breastfed during immunizations, a sucrose solution may be administered to the infant one to two minutes before the immunization. By activating the sweet taste receptors, a sucrose solution stimulates the release of endogenous opioids and acts as a distraction.
The analgesic effect of a sucrose solution has been demonstrated to last for up to10 minutes following its administration. Due to the duration of its effect, it is expected to mitigate immunization injection pain when multiple injections are administered. The analgesic effect may be enhanced by having the infant suck on a pacifier following administration of the sucrose solution.
Parents should be informed that sucrose solutions should not be used at home as a comfort measure for their infant. A sucrose solution is specifically recommended for the management of painful medical interventions.
Application of topical local anesthetics
Topical local anesthetics act by inhibiting the generation and transmission of pain impulses across nerve endings located in the dermis. They decrease the pain as the needle penetrates the skin and reduce the underlying muscle spasm associated with this pain. Given that there is a cumulative effect when infants or children are exposed to sequential painful stimuli, prevention of the initial painful stimulus (needle puncture through the skin) decreases the overall pain experience.
Topical anesthetics are effective in reducing vaccine injection pain in individuals of all ages and are available without prescription. There is no evidence that the application of a topical local anesthetic poses a risk of decreased immune response to vaccines if the topical anesthetic is used as directed in the product leaflet and only for the ages recommended by the manufacturer. There have been reports of serious adverse events with excessive topical application of local anesthetics in adults and children. During and after use of topical anesthetics, children should be observed, as they may be at greater risk than adults for serious adverse events. For additional information refer to Health Canada's advisory Safety information regarding topical anesthetics and serious adverse events - For Health Professionals.
There is no demonstrated benefit of administering oral analgesics (such as acetaminophen or ibuprofen) to children to reduce pain at the time of injection.
Studies have demonstrated that having parents hold a child in a seated or semi-seated position (for infants) and sitting up (for all other ages) are associated with reduced pain during immunization, when compared to the supine position. This difference may be because parental holding and sitting up are associated with a greater sense of personal control and reduced anxiety, which in turn reduces the perception of pain.
Rapid injection without aspiration
Ideally, injections should be done using the technique of rapid injection without aspiration. Aspiration is not recommended, as there are no data demonstrating that it is necessary prior to IM or SC injection of vaccines. There are no large blood vessels at the recommended immunization sites. Not aspirating before injection has been demonstrated to reduce pain at the injection site because there is less contact time between the needle and tissue and less lateral movement of the needle.
Inject the most painful vaccine last
When administering multiple vaccine injections sequentially, the most painful vaccine should be injected last. Studies have indicated that when two vaccines were injected sequentially, injection of the least painful vaccine first not only reduced pain from the less painful vaccine, but also reduced pain from the more painful one.
Rubbing or stroking the skin near the injection site
Rubbing the area near the injection site prior to and during immunization may decrease pain perception by stimulating large diameter (touch) neurons that compete with small diameter (pain) neurons, activated during painful procedures, resulting in reduced pain stimulation transmitted to the brain. This pain management strategy has been studied only in children 4 years of age and older. Rubbing should be tailored according to the request and comfort level of the individual child. In adults, pressure applied to the injection site prior to injection has been demonstrated to reduce pain during injections. Rubbing the injection site after immunization is not recommended.
Distraction during immunization can be used as a pain management strategy with all age groups. There are many theories about why distraction is effective (e.g., the parts of the brain that process painful stimuli are less active when the person is distracted; or when attention is directed to a distracting task, there are fewer resources available within the brain to pay attention to the pain).
Studies have demonstrated that distraction is most effective when it is interactive and when the person being vaccinated is actively engaged in the distraction strategy. Parents can be engaged in selecting a distraction strategy for their child. Distraction led by a parent has been found to be less effective than distraction led by the immunization provider or the child. This may be because the parent finds it difficult to provide distraction when he or she is also concerned about the immunization.
Examples of distraction include the use of toys, stories, bubbles, singing, pinwheels, pop-up books, conversation about things other than the immunization, hand-held games, and directing the individual's attention to something in the environment. Most children 3 years of age and older are able to participate in distraction activities without adult assistance. For example, children in this age group can engage in slow deep breathing or blowing out during immunizations. Simple breathing exercises are effective at significantly reducing immunization pain and distress.
Do not tell children that "it won't hurt"
Telling a child that the immunization won't hurt has been found to be ineffective at reducing pain during immunization and may lead to a relationship of distrust between the child and health care provider. Honest statements such as "you may feel it a bit, but I think you can handle it" can be used, as well as words that are explanatory without evoking anxiety (e.g., such as pressure and squeezing, and avoid words such as shot, pain, and hurt).
Preventing anxiety and fainting
Techniques to decrease anxiety in adolescents and adults are important to minimize the risk of fainting. These techniques include ensuring comfortable room temperature and short waiting times, preparation of vaccines out of the view of recipients, providing privacy during the procedure, and administering the vaccine while the person is seated. Pain reduction techniques such as applying topical local anesthetics and tactile stimulation will also help reduce anxiety. People who appear very anxious should be observed while seated until anxiety has resolved post-immunization.
In Canada, oral vaccines include rotavirus, oral typhoid capsules, and oral vaccine for cholera and travellers' diarrhea. Oral vaccines should be administered as directed in the product leaflet. In general, oral vaccines should be given prior to injectable vaccines.
All doses of rotavirus vaccine should be given in a clinic or office setting under the direction of a health care provider. If an infant spits or regurgitates the vaccine, a replacement dose should not be administered.
Live attenuated influenza vaccine (LAIV) is the only vaccine in Canada administered by the intranasal route. LAIV should be administered by a health care provider following the instructions in the product leaflet. If the vaccine recipient sneezes immediately after administration, there is no need to repeat the dose.
Post-vaccination counselling and observation
Vaccine recipients should be counselled about the reporting and management of common adverse events following immunization. Individuals who are particularly anxious about receiving the vaccine should be identified and observed. Syncope can occur after immunization and is most common among adolescents and young adults. Individuals with pre-syncopal symptoms, such as pallor or sweating, should sit or lie down until symptoms resolve. If they need to stand up, they should be supported to a sitting position and then to a gradual stand. Once standing, the vaccine recipient should continue to be supported in order to prevent injury if they do faint.
Vaccinees should remain in the clinic, or be advised to stay with someone else if outside of the clinic area, for at least 15 minutes post-immunization, as most syncopal events occur within 15 minutes of vaccination (63% within 5 minutes of vaccination and 89% within 15 minutes). They should be advised to avoid stairs so that injury from a significant fall does not occur if they faint.
Vaccine recipients should be kept under observation for at least 15 minutes when there is a specific concern about possible vaccine allergy; 30 minutes is a safer interval since the majority of cases of anaphylaxis will occur within 30 minutes following vaccine administration. In low-risk situations, observation can include having vaccinees remain within a short distance of the vaccinator (e.g., within a school where an immunization clinic is being held) in the company of another person and so that they can return immediately for assessment if they feel unwell. Every vaccine provider should be familiar with the signs and symptoms of anaphylaxis and be prepared to act quickly. Refer to Early Vaccine Reactions Including Anaphylaxis in Part 2. Refer to Immunization Records in Part 1 for information which is to be recorded post-vaccine administration.
Oral analgesics and antipyretics
Oral analgesics and antipyretics (such as acetaminophen or ibuprofen) can be used for treatment of minor adverse reactions such as fever or injection site discomfort that might occur following vaccination. There is no evidence that antipyretics prevent febrile seizures.
Infection prevention and control
Immunization providers should incorporate routine infection control practices into all immunization procedures as follows:
- Prior to withdrawal of vaccine into the syringe, uncap the vaccine vial, wipe the stopper with a suitable disinfectant (e.g., isopropyl alcohol) and allow the stopper to dry.
- Before injection, cleanse the skin with a suitable antiseptic and allow it to dry. Skin cleaning prior to vaccination is under review by the National Advisory Committee on Immunization (NACI).
- Use a separate, sterile needle and syringe for each injection.
- Perform hand hygiene 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 when hands are not visibly soiled. Perform hand hygiene after removing gloves.
- Glove use during immunization is not routinely recommended unless the skin on the vaccine provider's hands is not intact or when administering BCG or smallpox vaccine. If gloves are worn, they should be changed between patients.
- Develop and implement policies and procedures regarding accidental exposure to blood or body fluids, including needle stick injuries, and educate vaccine providers about these policies and procedures. Refer to Immunization of workers in Part 3 for more information about recommended immunization schedules for vaccine providers.
In addition to the provisions recommended above, the following practices should be observed:
- Do not change the needle between withdrawing vaccine from the vial and administering the vaccine, unless the needle is contaminated or damaged.
- Do not recap needles after use.
- Immediately and carefully dispose of used syringes and needles in a container designed for this purpose; used syringes and needles should never be placed on the work surface.
- Dispose empty or expired vaccine vials according to local waste management legislation or guidelines.
Additional information on infection prevention and control guidelines is available in Infection Prevention and Control Best Practices for Long Term Care, Home and Community Care including Health Care Offices and Ambulatory Clinics
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