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Posted on November 30, 2020 at 12:07 PM by Kari Bray
FDA Approval: The Center for Biologics Evaluation and Research within the Food and Drug Administration (FDA) regulates vaccines in the U.S. Vetting vaccines is a multi-step process. After clinical development of the vaccine, the vaccine’s sponsor must submit an application to the FDA prior to any human studies. Then vaccine clinical trials are done, typically in three phases. The first includes safety and immune response studies on a small number of closely monitored participants. More participants are added in the second phase, and by the third phase, the studies involve potentially thousands of individuals to document safety and effectiveness in preventing disease.
If all three rounds of trials are successful, an application for a biologics license may be submitted. The application must include efficacy and safety information, and a pre-manufacturing inspection is done at the facility where the vaccines would be made. The application is reviewed by a multidisciplinary FDA team that includes medical officers, microbiologists, chemists, and more. The team’s findings also may be reviewed by an additional advisory committee, the Vaccines and Related Biological Products Advisory Committee.
Monitoring by the FDA continues after an approved vaccine is in production, as well. Many vaccines also undergo a fourth phase of studies documenting efficacy and safety in the general population after approval, since extremely rare side effects may not be detected in phase 3 trials. There is a system in place to report any adverse reactions, called the Vaccine Adverse Event Reporting System (VAERS).
Emergency Use Authorization (EUA): This authorization by the FDA, when granted, allows for a vaccine or medicine to be used in the event of an emergency even if it has not yet gone through the full approval process. It can also allow an existing product to be used in a way other than its previously approved uses. This doesn’t mean the vaccine isn’t vetted – it still must go through the FDA and an independent panel of experts who advise the FDA on safety and efficacy. For example, all currently available tests and new treatments for COVID-19 are operating under an EUA.
Advisory Committee on Immunization Practices (ACIP): This is a panel of scientists and health care providers convened by the Centers for Disease Control and Prevention (CDC). The members all have expertise in various aspects of immunizations. They review the data for any FDA-approved vaccine and make the final recommendations for use of the vaccine. State and local health departments then promote those recommendations and health care providers implement them. ACIP provides such guidance on virtually all vaccines and has done so with great integrity for decades.
COVID Vaccine Scientific Safety Review Workgroup: In coordination with California, Oregon and Nevada, Washington is participating in this multi-state workgroup to review the safety and efficacy of COVID-19 vaccines once they have been approved by the FDA and recommended by ACIP. This is an added layer of independent expert review including local and regional experts who are nationally-recognized scientists with expertise in immunization and public health.