Who Approved Vaccines

Vaccines are a critical part of modern medical care, providing protection from a range of diseases, from measles to tuberculosis. So, who examines and approves vaccines to ensure that the safety, efficacy, and quality are in line with established standards?

The main body responsible for the approval of vaccines in the United States is the United States Food and Drug Administration (FDA). The FDA is charged with evaluating the safety and efficacy of all vaccines before they are licensed and made available to the public.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is an independent body of experts appointed by the FDA to monitor and evaluate the safety, efficacy and quality of vaccines. The VRBPAC reviews data from clinical trials and other studies to evaluate the safety and effectiveness of each vaccine. The committee then makes a recommendation to the FDA on the safety, efficacy, and quality of the vaccine, which the FDA can accept or reject.

In addition to the FDA and VRBPAC, the Centers for Disease Control and Prevention (CDC) has a role in the approval process. As the leading public health agency in the United States, the CDC monitors disease outbreaks and sets guidelines for healthcare providers. The CDC also offers guidance on the timing, dosage and a general recommendation for using vaccines, which are known as “recommended immunization schedules”.

In some cases, researchers can skip the FDA and use a process called Emergency Use Authorization (EUA) if there is an immediate threat to public health. This allows the clinical testing and commercialization of a vaccine to be expedited while continuing to carefully evaluate the safety and effectiveness.

Vaccines go through a rigorous testing and approval process before they are available to the public to ensure that they are safe and effective. Vaccines are one of the most successful public health endeavors in our lifetime, responsible for the eradication or near eradication of countless diseases.