The Rigorous Voyage of Vaccine Safety

When presented with a patient or a parent that is concerned about the use of vaccines, clinicians have many choices about what to do. One approach worthy of consideration is to explain the rigorous and scientific process that vaccines go through before being approved, and recommended, by the Centers for Disease Control (CDC).

Healthcare professionals can play an important role in educating patients on the vaccine approval process that has led to what the CDC reports as the safest vaccine supply in U.S. history.

Journey to Approval

A new vaccine must pass through three phases of clinical trials approved by the Food and Drug Administration (FDA) before it earns a place in the CDC-approved vaccine rotation. The phases include the following:

  • Phase 1: Between 20 and 100 healthy individuals volunteer to receive the vaccine for researchers to measure the safety and efficacy of the vaccine, and check for potential side effects.
  • Phase 2: Testing is expanded to include several hundred volunteers to determine the most common side effects of the vaccine, which also allows researchers to monitor how volunteers’ immune systems respond.
  • Phase 3: Even more volunteers are enlisted for further testing of the vaccine. Control groups are used to compare differences in those who receive and do not receive the vaccine, and researchers conduct their final analysis.

Once the vaccine completes these three phases, the FDA will determine if it is safe and effective, and whether the benefits of the vaccine outweigh the potential risks of the side effects. Only then will the FDA license the vaccine.

In a post-manufacturing phase, the FDA will test the vaccines again and inspect all manufacturing facilities. Despite this thorough process, the vaccine still has more hurdles to jump before reaching the doctor’s office.

Approval and Recommendation

The next step in the journey of a new vaccine is determining proper applications to the public. The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts responsible for determining appropriate ages to administer vaccines, number of doses required, recommended time between doses, and any precautions for administration. Among the experts invited to develop the vaccine schedules are stakeholders from the following organizations:

  • American Academy of Pediatrics (AAP)
  • American Academy of Family Physicians (AAFP),
  • American Colleges of Obstetricians and Gynecologists (ACOG)
  • And, the American Academy of Physicians (ACP).

Finally, once a consensus is reached, the group submits their recommendations to the Director of the CDC for approval. After review and approval, the submission is published in the CDC’s Morbidity and Mortality Report (MMWR), making it an official CDC recommendation. Only then can a vaccine be considered for the schedule recommended to families.

Continuous Monitoring

Even after a new vaccine meets the standards of the FDA, the ACIP, the CDC and the US Department of Health and Human Services, these agencies and organizations continue to take precautions. For example, the FDA and CDC both closely monitor the vaccine after it is worked into the immunization rotation using a surveillance program called VAERS (Vaccine Adverse Event Reporting System). This program collects reports of adverse effects and potential side effects caused by the vaccine that parents and guardians, healthcare providers, manufacturers, and others can access anytime. And, researchers continue to use these insights to improve the vaccines in use today.

A view into the process of bringing a new vaccine to the public highlights the level of care that researchers and public health agencies take to ensure new vaccines are as safe and effective as possible. Knowing this, clinicians and other healthcare professionals can confidently educate patients about vaccines and continue to recommend them as a safe, preventative health measure.