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Technical Aspects of Immunizations

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General Information:
Vaccine administration is not difficult, but requires attention to detail.  Someone giving a vaccine must consider the age and size of the patient, the vaccine to be administered and the appropriate paperwork to be completed.  Infection control practices are also essential during vaccine preparation and administration, and include hand washing, using single-dose rather than multi-dose vials, and preventing needle-stick injuries.

The injection site depends on both the age of the patient and the specific vaccination being administered.  Vaccines injections are either intramuscular (IM) or subcutaneous (SC).  The site of vaccine injection for adults is generally the upper arm.  For infants up to one year of age, the most common site is the vastus lateralis (anterolateral thigh).  Administration of multiple injections during a single visit affects selection of injection site.  Needle size is also an important consideration, and is determined by type of injection and age and size of the patient.  IM needle size should be 5/8 inch for newborns, and 1 inch for children less than 12 months.  For adults, IM vaccinations should be administered via a 1-2 inch, 22-25 gauge needle.  For SC injections, a 5/8-3/4 inch, 23-25 gauge needle is used.  Almost all vaccines currently available are given by injection.  The exceptions are the oral rotavirus vaccine and a version of the influenza vaccine that is given intranasally.

When administering vaccinations, it is important for the healthcare provider to minimize the patient’s fear, anxiety, and pain by providing comfort measures.  Parental participation is important with young children, and the healthcare provider should advise parents regarding anxiety-reducing strategies and fever/pain medication.  Teaching and distraction are often effective techniques with adolescents and teenagers.

Specific paper work must accompany vaccination administration.  Vaccine Information Statements (VIS) are single page sheets of vaccine information produced and updated regularly by the CDC.  Health care providers are required by law to give a copy of the appropriate VIS to each person receiving a vaccine.  The federal government requires that specific information be documented at the time of vaccine administration.  A permanent immunization record card should be established for each newborn infant and maintained by the guardian.  An immunization record card should also be established for adolescents and adults.  Written and dated records, or serological tests are the only valid evidence of immunization history.  The federal government does not require an immunization signature page, but many practices utilize them to comply with local and state regulations.

Vaccine Adverse Events Reporting System (VAERS) is a national reporting system administered by the FDA and CDC, which registers adverse events that occur after receipt of vaccines.  The FDA monitors the reports to watch for trends specific to a particular vaccine.  Some vaccine ingredients such as preservatives, adjuvants, additives, or manufacturing residuals have been implicated in adverse events or hypersensitivity reactions. 

Vaccine formulations are all of the materials that are in a vial of vaccine.  In addition to the active ingredient, the vaccine may contain preservatives, adjuvants, and/or additives.  Preservatives prevent bacterial or fungal contamination and are necessary in multi-dose vials.  Thimerosal is a mercury-containing preservative previously used in many childhood vaccines which has been implicated as a cause of autism.  Scientific studies, however, do not support this concern.  Adjuvants enhance immune responses after immunization.  Additives are used to stabilize vaccines from adverse conditions such as freeze drying or heat.  They also prevent immunogens from adhering to the sides of the vial.  Types of additives used in vaccines include sugars, amino acids, and proteins.

Healthcare providers should refer to vaccination schedules for appropriate timing of vaccinations.  Contraindications are reasons why someone should NOT receive a certain vaccine.  These may include allergies to vaccine components, previous adverse reactions to a specific vaccine, and certain pre-existing health conditions.  Precautions are reasons to consider the relative risk versus benefit of giving a vaccine to an individual. 

The following specific populations should be given special consideration when determining whether or not to vaccinate:

  • premature infants,
  • patients with severe or acute illnesses,
  • patients with previous severe reactions to a vaccine,
  • immunosuppressed individuals,
  • pregnant women,
  • internationally adopted children, and
  • individuals planning international travel.

Internationally adopted children may have limited protection and documentation, and should receive vaccines according to recommended schedules for children in the United States.  Written documentation and serological tests are the only acceptable forms of evidence of vaccination history.  People planning international travel should schedule an appointment with a physician or travel clinic 4 to 6 weeks prior to their trip to receive required vaccinations.

Transportation and storage of vaccines must be done correctly to maintain the quality and efficiency of the vaccine.  Vaccines should be stored at recommended temperatures during transportation and immediately upon receipt.  Specific mode of transportation is determined by whether the vaccine must be refrigerated or frozen.  Likewise, once at their destination, vaccine storage conditions should be monitored.

To learn more about ideas covered in this section, visit the following:

General Recommendations on Immunization
http://www.cdc.gov/mmwr/indrr_2006.html
See issue dated December 1, 2006, Volume 55, No. RR-15

Immunization Techniques DVD
http://www.immunize.org/shop/toolkit_iztechdvd.asp

Administration of IM and SC Injections
http://www.aimtoolkit.org/children_immun.htm

Specific Information:

Administration of Vaccines:
Administration Safety:  It is important to protect patients and providers while administering vaccinations, and there are several infection control practices that should be utilized in doing so.  Important ways to reduce the chance of infection include the use of a sterile syringe and needle for each injection, prevention of contamination of the injection equipment and medication during preparation, and proper reconstitution if required. This can be accomplished through preparing injections in clean designated areas free of blood or bodily fluids.  The use of single-dose vials rather than multi-dose vials also reduces the risk of bacterial contamination.  Injection providers can avoid needle stick injuries by avoiding recapping of needles and using an enclosed sharps container to transport used needles for disposal.  Providers should also use pop-open ampoules rather than glass ampoules, which have the potential to lacerate the provider’s hand.  Hand hygiene and skin integrity are also of vital importance in the practice of administering injections.  Washing or disinfecting hands is a standard procedure that should be done prior to preparing injection materials.  Skin lesions and skin irritation are associated with bacterial contamination; therefore, it is necessary to avoid giving injections if skin integrity is compromised by local infection or other skin conditions, and to cover any cuts.  While swabbing the clean skin of a patient before giving an injection is unnecessary, skin that is visibly soiled or dirty must be washed using traditional skin-preparation protocols, such as wiping with 70% alcohol.  This practice may be insufficient to eliminate skin flora on otherwise clean skin because of limited contact time.  Bacteria from the skin flora that is introduced through skin piercing are non-pathogenic and the number introduced is usually lower than the minimal infectious dose.  While the benefit of skin preparation is unclear, unsafe skin preparation protocols may be harmful. Thus, if swabbing with an antiseptic is selected for use, a clean, single-use swab must be used and the product-specific recommended contact time should be followed. Swabbing should be done in a spiral motion from the injection site outward, so that dirt is not brushed onto the clean skin. Cotton balls stored wet in a multi-use container should not be used.

Different sites of injection: It is important to inject vaccines in the appropriate site on the patient’s body in order to have them work effectively.  Generally for adult vaccinations, the site for injection is the upper arm.  For infant vaccinations up to one year of age, the common injection site is the vastus lateralis (anterolateral thigh).  Vaccine injections are either intramuscular (IM) or subcutaneous (SC).  The reason for giving an IM injection versus an SC injection is that SC doses are absorbed more slowly than IM doses. 

Intramuscular injections (IM):
An intramuscular injection is given directly into the deltoid muscle, below the shoulder on the upper arm.  An IM needle is longer than an SC needle.  For injection of newborns, the needle length should be 5/8-inch and for other children less than 12 months, a 1-inch needle should be used. For almost all IM injections with adults, a 1-2 inch, 22-25 gauge needle should be used; however, clinical judgment should be used to assess the site.  To give an IM injection, use the part of the deltoid muscle just below the shoulder but above armpit-level in the upper arm.  Grasping the muscle between the thumb and fingers of the non-injecting hand, the needle is inserted at a 90 degree angle with a quick yet firm and steady insertion, slowly depressing the plunger.  Vaccines that are administered via the IM route are Hep A, Hep B, Td, Tdap, HPV, meningococcal conjugate, and inactivated Influenza.  The pneumococcal polysaccharide and inactivated polio vaccines can be given either IM or SC.

Subcutaneous injections (SC):
Subcutaneous injections are injected directly into the fatty tissue on the back of the upper arm, under the skin and overlying the muscle.  For SC injections, a 5/8-3/4 inch, 23-25 gauge needle is used.  To administer a vaccine with a subcutaneous injection, pinch up the subcutaneous tissue on the back of the upper arm with the non-injecting hand and inject the needle at a 45-degree angle.  Vaccines given via an SC route are MMR, varicella, meningococcal polysaccharide, and shingles. 

Diagrams are available to consult for further information and for specific needle sizes for specific age groups.  (See link at the end of this section for diagrams at “How to administer IM and SC injections”.)

Multiple Injections:  Administration of multiple vaccinations in a single visit is to avoid missed opportunities and late immunizations. In addition, it is often more convenient for families and practices to decrease the number of  visits required for immunizations.  It is important to check with the recommended schedules of each vaccine prior to administration to check for correct timing.  In terms of physically administering multiple injections into one patient, a ‘site map’ may be used to create consistency within the practice and aid in documenting the site of administration in the patient’s chart.  If the patient is receiving two injections, they may prefer to have one in each arm, but if they are receiving more than two, the patient will have to receive two in the same area.  Normally injections are administered about one inch apart in a given area. (See link at end of this section for “Sample site maps.”)

Comfort Measures: Vaccinations are often accompanied by fear and anxiety for the patient.  Part of the healthcare provider’s job is to decrease the fear and pain accompanied by vaccinations.  There are different methods and techniques for doing so, according to age group.  For younger children, health care providers may encourage the parents to participate in techniques for patient safety, proper administration, and to reduce their child’s anxiety during the vaccination process.  The provider should encourage the parent to talk softly and touch their child soothingly, make eye contact while smiling at their child, have the child sit on their lap, talk or sing to their child, encourage the child to take deep breaths and “blow out the pain”, use distraction techniques such as hand puppets or pointing out things in the room to look at, story telling, and allowing the child to cry if they need to.  The provider can use some of the same techniques.  After the shot, the health care provider should give the parent with information regarding the correct medication and dosage in case the child develops a fever, and other techniques to reduce any pain.  Fever-reducing medications include acetaminophen or ibuprofen; aspirin should not be administered.  During the injection process, a technique known as “comforting restraint” may be used as taught by the provider.  This method involves having the parent embrace their child and control all four limbs.  It avoids holding down the child but helps steady and control the limb of the injection site for the health care provider.  For infants and toddlers, have the parent hold the child on their lap.  One of the child’s arms embraces the parent’s back and is held under the parent’s arm, while the other arm is controlled by the parent’s arm and hand.  For infants, the parent can control both arms with one hand.  Both legs are anchored with the child’s feet firmly held between the parent’s thighs, and controlled by the parent’s other arm.  For kindergarten-aged and older children, the child is either held in the parent’s lap or stands in front of the seated parent.  The parent’s arms embrace the child during the injection process, and both of the child’s legs are held firmly between the parent’s legs.

For the adolescent and teen age group (ages 11 to 18 years), there are several ways to make them feel more comfortable about getting vaccines.  When the members of the health care staff are confident about their knowledge of the vaccines and have positive talking points about the importance of the vaccines, adolescents and teens will have reason to feel more comfortable. They will also be more relaxed if their parents support the need for immunizations. Talk about the small amount of pain that is associated with the injection relative to the gain and answer any questions the teen may have.  While administering the injection, have the teen sit in a chair and talk to them about their interests.  Have them remain seated in the chair a few minutes after the injection to make sure they are not dizzy or lightheaded.  For teens that are extremely nervous, be sure they look away from the needle and have them relax their muscles.  You can also have them lie down. Deep breathing may be encouraged during the injection in the form of three short breaths and three long breaths.  Rubbing an alcohol swab on their opposite wrist and having them blow on it during the shot will create a cooling sensation as the alcohol evaporates. This will mask the pain of the shot and act as a distraction.  Pretreatment numbing creams are available for use as superficial anesthesia, such as the EMLA patch.  The limitations of the patch are that it must be applied to the skin one hour prior to injection, and it only works to decrease pain caused by subcutaneous injections under the skin, not vaccines given in the muscle.

Vaccine Storage and Handling:  Transportation of vaccines must be done appropriately in order to maintain the quality and efficiency of the vaccine.  Failure to adhere to recommended specifications for storage and handling of immunobiologics can reduce potency, resulting in an inadequate immune response in the recipient.  The package insert will provide instructions regarding storage and handling of each vaccine.  All vaccines should be inspected upon delivery and monitored during storage to ensure that the cold chain has been maintained. Vaccines should continue to be stored at recommended temperatures immediately upon receipt.  It is important to keep a temperature log during transport, and record the storage temperature regularly to ensure that the vaccine continues to be stored within the recommended range.  When in doubt regarding the appropriate handling of a vaccine, vaccination providers should contact the manufacturer.

Refrigerators and freezers that store vaccines should be kept plugged in and at the appropriate temperatures; they should have separate, sealed refrigerator and freezer compartments, each with its own temperature controls.  Certified thermometers should be used to check and record temperatures twice daily.  Using a safety plug or a plug cover will prevent accidental disconnection.  Refrigerated vaccines include Tdap, Hib, Polio (IPV), Hep A, Hep B, HPV, inactivated influenza, and rotavirus.  Vaccines stored in the freezer include varicella, live influenza, and zoster.  The MMR vaccine can be stored in either refrigerator or freezer.  Vaccines should be protected from light, and individual vials should only be removed from their package when necessary.  Expiration dates of vaccines should be checked monthly.  Vaccines that are going to expire first should be used first, and only one to two months’ worth of vaccines should be stocked at a time.  Transportation of vaccines depends on whether the vaccine is refrigerated or frozen.  Refrigerated vaccines must be transported in an insulated cooler with a barrier separating the vaccines from the ice or cold packs.  Frozen vaccines can only be transported in an insulated cooler with dry ice.  (Storage and handling of specific vaccines may be found using the link at the end of this section.)

Vaccine Information Statements (VIS):  The National Childhood Vaccine Injury Act of 1986 requires that health-care providers in the United States give a copy of the current edition of these single page sheets of vaccine information to each person receiving a vaccine or their caregiver. The sheets are produced and updated regularly by the CDC.  There is a different VIS for each vaccine and the VIS addresses what disease the vaccine is protecting against, who should and should not get the vaccine, possible side effects of the vaccine, and what to do in the event of a serious side effect.

Documentation:  Documentation of patient vaccinations helps ensure that persons in need of a vaccine receive it.  Lack of adequate vaccination documentation is a common problem in health care.  A permanent immunization record card should be established for each newborn infant and maintained by the guardian; likewise, using immunization record cards for adolescents and adults is also encouraged.  Only written and dated records or serological tests are accepted as evidence of immunization history.  Self-reported doses of vaccines without written documentation should not be accepted.  If missing records cannot be found, the patient should be started on the age-appropriate schedule.  A federal requirement is that certain information be recorded about the vaccines administered: the date the vaccine was given; the vaccine manufacturer and lot number of the vaccine administered; the name, address, signature and title of the health care provider; the date of publication of the Vaccine Information Statement (VIS) administered to the patient; and the date that the information regarding the vaccine was given to the patient.  Properly documenting vaccinations is not complex, but it is important.

Consent:  The Vaccine Information Statements (VIS) must be provided to the legal guardian of any child or to the adult that is receiving the vaccine.  While the National Childhood Vaccine Injury Act of 1986 does not require that a signature be obtained. Many practices use an immunization signature page to comply with local or state requirements.

Adverse event:  A negative experience or reaction experienced by someone following receipt of a vaccine. Adverse events may or may not be caused by the vaccine, but they are related in time. Adverse events should be recorded in the patient’s medical record and reported to the Vaccine Adverse Events Reporting System, known as VAERS (see below).

Vaccine Adverse Events Reporting System (VAERS): A national reporting system in place to register adverse events that occur after receipt of vaccines. VAERS is co-administered by the FDA and the CDC and is the result of the National Childhood Vaccine Injury Act of 1986. Anyone can report an occurrence to VAERS and the FDA monitors the reports to watch for trends specific to a particular vaccine. If trends are established, studies are designed to determine whether the relationship between a vaccine and an adverse event are causal or coincidental.

Indications, Contraindications, and Special Populations:
Indications:  An indication is a reason to administer a vaccination to a specific individual.  Vaccination schedules for infants, children, adolescents, and adults can be referred to for appropriate timing of vaccinations. 

Contraindications:  Reasons why someone should NOT receive a certain vaccine. Contraindications are specific to each vaccine, but generally include things like allergies to vaccine components, previous adverse reactions following that vaccine, and certain pre-existing health conditions or current treatment for a particular condition.

Precautions:  Reasons to consider the relative risk versus benefit of giving a vaccine to a particular person. For example, a person with a moderate or severe illness should be evaluated for the relative risk versus benefit of getting a vaccine that they require.

Premature infants:
Premature infants, regardless of birth weight, should be vaccinated at the same chronological age and according to the same schedule and precautions as full-term infants and children.  Birth weight and size are not factors in deciding whether to postpone routine vaccination of a clinically stable premature infant, and the full recommended dose of each vaccine should be used.  Because hepatitis B vaccine is first given shortly after birth, the series should be restarted one month after birth in babies weighing less than 2,000 grams. (For more information, see link at end of this section titled “Premature infants”.)

Breastfeeding:
For breast-feeding mothers, both inactivated and live vaccines have shown to pose no threat to the safety of mother or baby.  Thus, breastfeeding is not a contraindication for any vaccine.  In addition, breast-fed infants should be vaccinated according to routine recommended schedules.
 
Moderate or severe illnesses:
Most studies support the safety and efficacy of vaccinating persons who have mild illness.  The decision to administer or delay vaccination because of a current or recent acute illness depends on the severity of symptoms and the etiology of the disease.  Persons with severe acute illness should be vaccinated after they have recovered from the acute phase of the illness to avoid additional discomfort to the underlying illness or mistakenly attributing a manifestation of the underlying illness to the vaccine.

Previous severe vaccine reactions:
Patients with a history of a severe, or anaphylactic, reaction to a vaccine or its constituents have to take special precautions for vaccines in the future.  Signs and symptoms of an anaphylactic reaction include sudden or gradual onset of generalized itching, erythema, hives, swelling of the lips, face, or throat, bronchospasm or wheezing, shortness of breath, shock, or cardiovascular collapse.  The patient’s airway, breathing, circulation, and level of consciousness should be continuously monitored, and aqueous epinephrine (1:1000 dilution) should be administered intramuscularly.  An extensive listing of vaccine components, their use, and the vaccines that contain each component has been published and is available through the CDC.  This list should be consulted if needed to determine if a vaccine is safe for a patient with a history of serious reactions to vaccines. 

Pregnant women:
While pregnant women should not receive live viral vaccines because of a theoretical risk to the fetus, they can be immunized with inactivated viral or bacterial vaccines or toxoids. In addition, benefits of vaccinating pregnant women usually outweigh potential risks when the likelihood of disease exposure is high, when infection would pose a risk to the mother or fetus, and when the vaccine is unlikely to cause harm.  For example, women who will be pregnant during flu season should be immunized with the inactivated flu vaccine since they have been demonstrated to be at increased risk for hospitalization from influenza.  Therefore, routine influenza vaccination is recommended for healthy women who will be pregnant during influenza season.  All pregnant women should be evaluated for immunity to rubella and be tested for the presence of HBsAg.  A woman known to be HBsAg-positive should be followed carefully to ensure that the infant receives HBIG and begins the hepatitis B vaccine series less than 12 hours after birth, and that the infant completes the recommended hepatitis B vaccine series. 

Travelers:
People preparing to travel should set up an appointment with a physician or travel clinic about 4 to 6 weeks prior to inquire about possible vaccine requirements.  There are specific vaccine recommendations depending upon destination, time of year of travel, and activities during travel. It is best to consult with a healthcare professional or the CDC regarding travel immunizations specific for each trip.

International adoptions:
Internationally adopted children may have limited protection and documentation, and should receive vaccines according to recommended schedules for children in the United States. Only written documentation should be accepted as evidence of prior vaccination as written records are more likely to predict protection if the vaccines, dates of administration, intervals between doses, and the child's age at the time of immunization are comparable to the current U.S. recommendations.  The majority of vaccines used worldwide are produced with sufficient quality control standards and are adequately potent, and if properly administered and documented may be accepted as complete by US standards.  However, if a question arises regarding whether vaccines administered to an adoptee were immunogenic, the health care provider can either repeat the vaccination, or use serologic testing to determine which immunizations are needed. 

Immuno-compromised individuals:
Severe immunosuppression can be a result of many conditions, including HIV infection, leukemia, lymphoma, radiation, or a prolonged course of corticosteroids.  For all immuno-compromised patients, a healthcare provider should evaluate the severity of their condition prior to vaccination administration.  Severely immuno-compromised persons should not receive live viral vaccines.  Generally speaking, there are always special considerations for those who are immuno-compromised, and should be considered case-specific. Patients should be evaluated based on relative risks and benefits. 

Vaccine Formulations: In addition to immunogens, vaccines often contain preservatives, adjuvants, additives, or manufacturing residuals.  Preservatives prevent bacterial or fungal contamination and are necessary in multi-dose vials.  Thimerosal is a mercury-containing preservative previously used in many childhood vaccines that has been questioned as a cause of autism. However, several scientific studies have not borne out this concern.  Aluminum salts are the only adjuvants currently licensed for use in the United States.  They were initially found to enhance immune responses after immunization, and their safety has been established after 70 years of experience inoculating people with aluminum-containing vaccines.  Additives are used to stabilize vaccines from adverse conditions such as freeze drying or heat.  They also prevent immunogens from adhering to the sides of the vial.  The types of additives used in vaccines include sugars, amino acids, and proteins.  Gelatin is a protein found in the MMR vaccine. It has been known to induce hypersensitivity reactions, and is thus a common identifiable cause of immediate-type hypersensitivity reaction.  This type of reaction can be easily avoided by inquiring about food allergies before vaccination with gelatin-containing vaccines.  Human serum albumin is another type of protein additive found in the MMR vaccine. To regulate the safety of serum albumin, this protein is taken only from screened blood donors, and manufactured specially to eliminate risk of transmission of any blood-borne viruses.  No viral diseases have ever been associated with its use.  In addition to the previously discussed substances, there are also reagents such as glycerol, enzymes, and amino acids. 

To learn more about ideas covered in this section, visit the following:

General Recommendations on Immunization

http://www.cdc.gov/mmwr/indrr_2006.html 

See issue dated December 1, 2006, Volume 55, No. RR-15

Immunization Techniques DVD

http://www.immunize.org/shop/toolkit_iztechdvd.asp

How to administer IM and SC injections:
http://www.immunize.org/catg.d/p2020.pdf
http://www.aimtoolkit.org/adult_immun.htm - “Injectable vaccine administration for adults”
http://www.aimtoolkit.org/adolescents_immun.htm - “Injectable vaccine administration for children ages 7-18 years”
http://www.aimtoolkit.org/children_immun.htm - “Injectable vaccine administration for children birth to 6 years” and “Injectable vaccine administration for selected populations”

Site Maps:
http://www.aimtoolkit.org/children_immun.htm - “Giving all the doses. . .” series of 4 PDFs
http://www.aimtoolkit.org/adolescents_immun.htm -“Giving all the doses. . .” – 1 PDF

Storage and Handling
http://www.immunize.org/catg.d/p3049.pdf
http://www.aimtoolkit.org/vaccine_vaccine.htm - Several useful resources

Comfort Measures for Use by Parents and Caregivers
www.vaccine.chop.edu/parents
http://www.cispimmunize.org/fam/Lessening_the_Pain.pdf
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/D/comforting-restraint.pdf

Contraindications
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5102a1.htm#tab5

Special Populations
Vaccination of Internationally Adopted Children
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5102a1.htm#tab6
http://www.cdc.gov/vaccines/spec-grps/default.htm

Travel
http://wwwn.cdc.gov/travel/default.aspx

Premature Infants
http://www.chop.edu/consumer/jsp/division/generic.jsp?id=84302

 

UPDATED: July 2009

 

 

 

©2006 Philadelphia Immunization Coalition