The Centers for Disease Control and Prevention (CDC) considers all approved vaccines to be generally safe for most people. In fact, on its website, the CDC simply states, “Vaccines are safe and effective.” However, all vaccines have known side effects, and getting vaccinated can lead to serious medical issues in some cases. With this in mind, when does the CDC consider a vaccine to be “safe”?

Three Stages of Vaccine Safety Evaluation

The CDC uses a three-stage approach to evaluate vaccine safety. Of course, this oversimplifies the process a bit. Within each of these stages, there are numerous intermediate steps, and multiple agencies and clinical researchers are involved in determining whether a vaccine should be released for widespread use in the United States.

Stage 1: Pre-Approval Testing

When a drug manufacturer develops a new vaccine, it must first go through an approval process with the U.S. Food and Drug Administration (FDA). The FDA approval process involves multiple phases, including clinical trials and then long-term testing using human volunteers. As the CDC notes, “[t]hese tests take several years,” and they are subject to strict rules and requirements administered by the FDA.

In addition to receiving FDA approval, new vaccines must also receive recommendation from the CDC. If the CDC recommends a new FDA-approved vaccine, then the vaccine will be put into use with the general population.

Stage 2: Continued Testing During Use

Once a vaccine is in use, testing continues. According to the CDC, “[e]very batch of vaccines is tested for quality and safety.” This testing focuses on ensuring that (i) the vaccine is working as intended, (ii) the vaccine does not contain any contaminants or impurities, and (iii) all doses of the vaccine are completely sterile.

Stage 3: Ongoing Monitoring for Safety and Effectiveness

Finally, the CDC, FDA and other agencies continue to monitor vaccines’ safety and effectiveness as they are used within the general population. There are various systems in place that work together to, “help provide a full picture of vaccine safety.” The vaccine monitoring systems in the U.S. include:

  • Vaccine Adverse Events Reporting System (VAERS)
  • The Vaccine Safety Datalink (VSD)
  • Post-licensure Rapid Immunization Safety Monitoring System (PRISM)
  • Clinical Immunization Safety Assessment Project (CISA)
  • Additional Research and Testing Conducted by the Department of Defense (DoD), U.S. Department of Veterans Affairs (VA), National Institutes of Health (NIH) and the Office of Infectious Disease and HIV/AIDS Policy (OIDP)

Another important tool for monitoring vaccine safety is the National Vaccine Injury Compensation Program (VICP). The VICP is a federal government program that provides financial compensation to individuals who have been diagnosed with vaccine-related illnesses and injuries. For individuals who are harmed by vaccines, filing a VICP claim not only ensures that the costs of your illness or injury are covered, but it also provides important information about the safety of the CDC’s recommended vaccines.

Contact Vaccine Injury Lawyer Leah V. Durant

The Law Offices of Leah V. Durant & Associates is a vaccine injury law firm that represents individuals in VICP claims nationwide. If you have questions and would like to speak with an attorney about your legal rights, we encourage you to call 202-775-9200 or contact us online for a free initial consultation.