About CDC’s Vaccine Safety Monitoring Program

Overview

As science continues to advance, scientists, healthcare providers and public health workers strive to continue developing safer vaccines, to improve vaccine delivery and to ensure the United States is better protected from diseases. CDC's Immunization Safety Office (ISO) helps monitor vaccine safety in the United States, including during public health emergency responses and for many new vaccines.

Impact

ISO regularly shares vaccine safety monitoring findings through presentations at scientific meetings and publication in peer-reviewed journals. Safety data are shared with multiple stakeholders, including both domestic and international partners such as the Advisory Committee on Immunization Practices (ACIP). ACIP develops the recommended vaccination schedule for children and adults in the United States. Factors ACIP considers in its recommendations include:

• Age, health conditions and disease prevalence to determine best vaccination practices.
• Scientific evidence, research studies and data on vaccine safety and effectiveness.
• Vaccine safety perspectives from other expert groups, such as medical associations and public health agencies.
• The benefits of vaccines in preventing diseases, potential side effects and how well vaccines work at different ages.

Priorities

• Performing high-quality vaccine safety surveillance and research.
• Identifying vaccine adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) through public health surveillance, and better understanding those adverse events, including if there is a potential association with vaccination.
• Contributing vaccine safety data to stakeholders, including advisory committees, to keep the public informed and to inform vaccine recommendations.

Strategies

CDC and FDA monitor the safety of vaccines after their approval or authorization. If they find a problem with a vaccine, CDC and FDA inform health officials, healthcare providers and the public.

CDC monitors the safety of vaccines through four complementary systems:

Strategic partners

Other government partners

• FDA Center for Biologics Evaluation and Research regulates vaccine clinical trials, licenses vaccines, and monitors vaccine safety after the public begins using a vaccine.
• Health Resources and Services Administration (HRSA) runs the National Vaccine Injury Compensation Program and the Countermeasures Injury Compensation Program.
• National Institutes of Health (NIH) Clinical Trials maintains ClinicalTrials.gov, a database of clinical studies involving people. These include vaccine studies.
• National Vaccine Program Office (NVPO) coordinates and ensures collaboration among the many Federal agencies involved in vaccine and immunization activities.
• Vaccine Safety Coordinators (VSCs) help CDC and local, state and territorial public health jurisdictions stay informed by supporting communication and sharing useful information.

Non-government partners

• Immunization Action Coalition (IAC) creates and distributes immunization educational materials for health professionals and the public. The IAC also facilitates communication about vaccines among patients, parents, healthcare organizations and government health agencies.
• Institute for Safe Medication Practices (ISMP) provides resources and tools for preventing medication errors and promoting safe medication use.

Policy

The National Childhood Vaccine Injury Act (NCVIA)

During the mid-1970s, there was an increased focus on personal health, and more people became concerned about vaccine safety. People who believed they had been injured by the diphtheria, tetanus, pertussis (DTP) vaccine filed several lawsuits against vaccine manufacturers and healthcare providers. (DTP is no longer used in the United States; a safer acellular pertussis vaccine [DTaP] replaced DTP.) Damages were awarded despite the lack of scientific evidence to support vaccine injury claims. As a result of these decisions, liability and prices soared, and several vaccine manufacturers halted production. A vaccine shortage resulted, and public health officials became concerned about the return of epidemic disease.

To reduce liability and respond to public health concerns, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986.

Results

• Established the National Vaccine Program Office (NVPO). The NVPO coordinates immunization-related activities among all Department of Health and Human Services (DHHS) agencies. These include the FDA, CDC, National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA).
• Requires healthcare providers who administer vaccines to provide a vaccine information statement (VIS) to the person getting the vaccine or to their guardian.
  • A VIS must be given with every vaccination, including for each dose in a multi-dose series.
  • Each VIS contains a brief description of the disease as well as the risks and benefits of the vaccine.
  • CDC develops VISs and distributes them to state and local health departments and to individual providers.
• Requires healthcare providers to report certain adverse events (health effects occurring after immunization that may or may not be related to the vaccine) following vaccination to VAERS.
• Created the National Vaccine Injury Compensation Program (VICP) to compensate those injured by vaccines on a "no fault" basis.
• Established a committee from the Institute of Medicine (IOM) to review the literature on vaccine reactions.