Key points
- The United States currently has the safest, most effective vaccines in its history.
- As an immunization provider, you also play a key role in helping to ensure the safety and efficacy of vaccines.
Recommendations and guidelines
The United States currently has the safest, most effective vaccines in its history. Federal regulations require that vaccines undergo years of testing before they can be licensed. Once in use, vaccines are monitored continually for safety and efficacy. As an immunization provider, you also play a key role in helping to ensure the safety and efficacy of vaccines through proper:
- Vaccine storage and handling
- Vaccine administration
- Timing and spacing of vaccine doses
- Observation of precautions and contraindications
- Management of vaccine side effects
- Reporting of suspected side effects
- Communication about vaccine benefits and risks
- Standards for Immunization Practices for children and adolescents and adults
Vaccine storage and administration
To achieve the best possible results from vaccines, carefully follow the recommendations for storage, handling, and administration found in each vaccine’s package insert. Here are other steps you can take to help ensure vaccine safety:
Storage
- Carefully select and use the proper vaccine storage units to store vaccines.
- Have a properly calibrated thermometer or temperature recording device inside each storage compartment.
- Evaluate your cold chain procedures to ensure that vaccine storage and handling guidelines are being followed.
- Inspect vaccines upon delivery and monitor refrigerator and freezer temperatures to assure maintenance of the cold chain.
- Rotate vaccine stock so the oldest vaccines are used first.
- If errors in vaccine storage and administration occur, take corrective action immediately to prevent them from happening again and notify public health authorities.
Consult the vaccine storage and handling page that has many resources along with the learning tool: Storage and Handling Toolkit.
Administration
- Never administer a vaccine later than the expiration date.
- Administer vaccines within the prescribed time periods following reconstitution.
- Wait to draw vaccines into syringes until immediately prior to administration.
- Never mix vaccines in the same syringe unless they are specifically approved for mixing by the Food and Drug Administration (FDA).
- Record vaccine and administration information, including lot numbers and injection sites, in the patient's record.
Consult the vaccine administration page for more resources.
Timing and spacing
The timing and spacing of vaccine doses are two of the most important issues in the appropriate use of vaccines. To ensure optimal results from each immunization, follow the currently recommended immunization schedules for adults, children and adolescents, and catch-up schedules.
Please note:
- Administering all needed vaccines at the recommended ages, even if it means giving multiple doses during the same visit, is important because it increases the likelihood that children will be fully immunized as recommended. Studies have shown that vaccines are as effective when administered simultaneously as they are individually and carry no greater risk for adverse side effects.
- The use of a combination vaccine is generally preferred over separate injections of its equivalent component vaccines. Considerations should include provider assessment, patient preference, and the potential for adverse events. Administration of separate vaccines when combinations are available results in more discomfort for the patient.
- Some vaccines, like pediatric diphtheria and tetanus, produce increased rates of side effects when given too frequently. Good record keeping, maintaining careful patient histories, and adherence to recommended schedules can decrease the chances that patients receive extra doses of vaccines.
Observe valid contraindications and precautions
Contraindications and precautions to vaccination indicate when vaccines should not be given. A contraindication is a condition in a patient that increases the chance of a serious, adverse reaction. In general, a vaccine should not be administered when a contraindication is present. A precaution is a condition in a patient that may increase the chance of a serious side effect or render a vaccine less effective. Normally, vaccination is deferred when a precaution is present. However, situations may arise when the benefits of vaccination outweigh the risk of a side effect, and the provider may decide to vaccinate the patient. Most precautions and some contraindications are temporary and the vaccine may be given at a later time. For details, consult the CDC Guide to Contraindications to Childhood Vaccinations.
One key to preventing serious adverse reactions to vaccines is screening for contraindications and precautions. Every provider who administers vaccines should screen every patient before giving a vaccine dose. Sample screening questionnaires are available from the Immunization Action Coalition site.
Many conditions are often inappropriately regarded as contraindications to vaccination. In most cases, the following are not contraindications:
- Mild acute illness (e.g., diarrhea and minor upper-respiratory tract illnesses, including otitis media) with or without low grade fever
- Mild to moderate local reactions and/or low grade or moderate fever following a prior dose of the vaccine
- Current antimicrobial therapy
- Convalescent phase of illness
- Recent exposure to an infectious disease
- Preterm birth
- Breastfeeding
Communicate about vaccine benefits and risks
While you can do a number of things to help make vaccines as safe and effective as possible, providing patients or parents/guardians with information about vaccines and immunization is equally important.
Before you administer each dose of certain vaccines, you are required by law to provide a copy of the most current Vaccine Information Statement (VIS) to either the adult being vaccinated or to the child's parent/legal representative. VISs are developed by the CDC and discuss the benefits and risks associated with specific vaccines. You must also record the date that the VIS was given and the publication date of the VIS in the patient's chart. Current VISs are available on CDC's Vaccine Information Statements page. Translations in over 40 languages are available on the Immunization Action Coalitions site.
Other materials can assist you in communicating with parents or patients about vaccine benefits and risks. Parents can also be referred to credible Internet and hotline resources, such as CDC-INFO at 1-800-CDC-INFO or 1-800-232-4636 (English and Español).
Be prepared to manage vaccine side effects
Most people experience no side effects, or only mild ones, following immunization. Mild side effects may include soreness, swelling, or redness at the injection site or mild fever. Severe side effects, such as severe allergic reactions, following vaccination are extremely rare. However, any provider who administers vaccines should have procedures in place for the emergency care of a person who experiences an anaphylactic reaction. Epinephrine and equipment for maintaining an airway should be available for immediate use. All vaccine providers should be familiar with the office emergency plan and should be certified in cardiopulmonary resuscitation.
Report suspected side effects to VAERS
The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety monitoring program. VAERS collects information about adverse events (possible side effects) that occur after administration of U.S. licensed vaccines.
The National Childhood Vaccine Injury Act requires healthcare providers to report selected events occurring after vaccination to VAERS. However, VAERS encourages reporting of any clinically significant adverse event that occurs after administration of any vaccine licensed in the United States, even if it is not certain that the vaccine caused the event.
By reporting possible vaccine side effects to VAERS, you provide valuable information that is needed for the ongoing evaluation of vaccine safety. The CDC and FDA use VAERS information to ensure the safest strategies of vaccine use and to further reduce the rare risks associated with vaccines.
For more information about VAERS, including reporting forms, visit VAERS or call VAERS at 800-822-7967.