2.5.3: Vaccines

Centers for Disease Control and Prevention (CDC)

The Centers for Disease Control and Prevention (CDC) in the United States plays a central role in managing and coordinating vaccination programs to protect the public from vaccine-preventable diseases.

The CDC's vaccination program encompasses various aspects, including vaccine research, development, regulation, distribution, education, and monitoring. The CDC researches to develop new vaccines and improve existing ones. They collaborate with other organizations, such as the National Institutes of Health (NIH) and pharmaceutical companies, to advance vaccine science. The CDC also conducts studies to determine the safety and effectiveness of vaccines.

The CDC works closely with manufacturers, healthcare providers, and public health agencies to ensure an adequate supply of vaccines. They maintain the Vaccines for Children (VFC) program, which provides vaccines at no cost to eligible children who might not otherwise have access to immunizations.

The CDC plays a crucial role in educating healthcare professionals, the public, and community leaders about the importance of vaccines. They develop educational materials, host webinars, and engage in public awareness campaigns to promote vaccination.

The CDC monitors vaccine safety through the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD). These systems track and investigate potential adverse events following vaccination. Timely surveillance helps identify rare or unexpected side effects, contributing to vaccine safety. In the event of vaccine-preventable disease outbreaks, the CDC provides guidance and support to contain the spread of the disease and increase vaccination coverage in affected communities.

Vaccine Schedules

The CDC's Advisory Committee on Immunization Practices (ACIP) provides expert recommendations on vaccine use in the United States. ACIP develops guidelines for vaccination schedules, including those for infants, children, adolescents, and adults. These recommendations serve as a basis for vaccination policies and guidelines at the state and local levels. The CDC’s vaccine schedules are comprehensive and evidence-based plans that outline the recommended vaccinations for individuals of all ages in the United States. The CDC vaccine schedules are divided into age-specific categories, including vaccines for infants, children, adolescents, and adults. The schedules outline the recommended vaccines for each age group and the recommended timing for vaccination.

The Infant and Childhood Vaccination Schedule covers vaccines recommended for children from birth to 18 years old, including vaccines against diseases like measles, mumps, rubella, diphtheria, tetanus, pertussis, and more. The Adolescent Vaccination Schedule includes vaccines recommended for adolescents, such as those protecting against meningitis, human papillomavirus (HPV), and annual influenza vaccination. The adult schedule guides vaccines for adults based on age, medical conditions, and risk factors. It includes vaccines like influenza, shingles, and pneumococcal vaccines. The Catch-up Vaccination Schedule helps individuals who may have missed or fallen behind on their vaccinations catch up to the recommended vaccine series. The schedules also address vaccinations for specific populations, such as pregnant women and travelers, and provide recommendations for healthcare workers. The CDC updates the vaccine schedules annually to reflect the latest scientific research, vaccine approvals, and changes in vaccine recommendations.

Vaccine Information Statement (VIS)

CDC Vaccine Information Statements (VISs) are essential educational materials provided by the Centers for Disease Control and Prevention (CDC) to inform vaccine recipients, their parents, or legal representatives about the benefits and risks associated with vaccines. VISs facilitate informed decision-making regarding vaccinations and promote vaccine safety and public health. VISs serve as a crucial communication tool to ensure that individuals receiving vaccines have access to clear and comprehensive information about the vaccine, its potential side effects, and the importance of vaccination. The goal is to help recipients make informed decisions about vaccination based on their personal circumstances and medical history.

Healthcare providers are required by law in the United States to provide a copy of the appropriate VIS to vaccine recipients or their parents/legal representatives before administering specific vaccines. This requirement is mandated by the National Childhood Vaccine Injury Act (NCVIA) to enhance vaccine safety and the informed consent process.

Each VIS contains specific information related to a particular vaccine, including:

• The name of the vaccine.
• Why the vaccine is recommended.
• A description of the disease(s) the vaccine prevents.
• The recommended vaccination schedule.
• Possible side effects or adverse reactions.
• Who should or should not receive the vaccine.
• What to do in case of an adverse event.

VISs are available in multiple languages to accommodate diverse populations in the United States. Healthcare providers should offer the appropriate language version to ensure that individuals can fully understand the information provided. Healthcare providers typically provide a copy of the relevant VIS to the vaccine recipient, parent, or legal representative before vaccination. Depending on their practice's policies and patient preferences, they may use printed copies, electronic versions, or both. After reviewing the VIS, healthcare providers should address any questions or concerns the recipient or their representative may have.

The medical assistant is responsible for ensuring that the most current issue of the VIS is presented to the patient. Presentation of the VIS to the patient must be documented along with the publication date of the VIS. The date can be found at the bottom of the VIS PDF form available from the website CDC Vaccine Information Statements [www.cdc.gov].

CDC Pink Book

The CDC Pink Book is a reliable resource for the medical assistant to use when administering vaccines. It provides the most comprehensive information on routinely used vaccines and the diseases they prevent. It includes general immunization recommendations, vaccine safety, storage and handling instructions, and detailed information about vaccine-preventable diseases and the vaccines administered to avoid them (National Center for Immunization and Respiratory Diseases, 2021).

Vaccine Administration Documentation

In addition to documenting the presentation of the VIS to the patient or the patient’s guardian, there are other items that the MA must legally enter into the patient’s health record.

The National Childhood Vaccine Injury Act mandates that the following must be documented in the patient’s health record:

• Date of administration
• Vaccine manufacturer
• Vaccine lot number
• Name and title of the person who administered the vaccine and address of the facility where the permanent record will reside
• Vaccine information statement (VIS)
• Date printed on the VIS
• Date the VIS was given to the patient or parent/guardian

Most facilities also require the MA to document the site of vaccine administration and the patient’s response (National Center for Immunization and Respiratory Diseases, 2019).

Immunization Information Systems

Immunization information systems (IISs) are confidential, computerized databases that record information on all vaccine doses administered.

In Illinois, this allows patients to access Vax Verify from the Illinois Department of Public Health to view their personal vaccination history. This can help the patient and the provider keep patients up to date with the CDC vaccine schedules (Illinois Department of Public Health, 2024).

In California, the California Immunization Registry (CAIR) is used to maintain vaccination history.[1]

The Vaccine Adverse Event Reporting System (VAERS)

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program for reporting adverse events after administering any vaccine in the United States.

VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). Anyone can report an adverse event to VAERS, but healthcare professionals must report certain adverse events, and vaccine manufacturers must report all adverse events that come to their attention. Adverse events should be reported even if the cause of the adverse event is uncertain (U.S. Department of Health and Human Services, n.d.)

References

1. California Immunization Registry. Accessed January 17, 2026.

Attributions

Pharmacology-Principles and Application for Medical Assistants by Anna Jannak (Consortium of Academic and Research Libraries in Illinois (CARLI)(opens in new window)) is licensed CC BY 4.0(opens in new window)