Vaccines are some of the most rigorously tested and tirelessly researched products in American life. Questions of safety and effectiveness are scrutinized through a number of channels before they are approved for us.
All vaccines are meticulously tested in clinical trials that include tens of thousands of participants from varying age groups, racial and ethnic backgrounds and with a variety of underlying medical conditions. Vaccines must be proven to be safe and effective before being released to the public. The COVID-19 vaccines are not any different in this regard.
Sharon Wright, MD, MPH, Infection Control Lead at Beth Israel Lahey Health, is confident in the FDA’s approval and authorization processes. “[The FDA] is committed to safety, quality, and high reliability. The FDA is required to make decisions that are guided by science and data regarding the authorization or approval of all COVID-19 vaccines.”
Sometimes, in emergency situations like the COVID-19 pandemic, a vaccine is considered under a more rapid process called an Emergency Use Authorization (EUA). This still requires at least six months of results to be reviewed.
After looking at all the data, the FDA only authorizes a vaccine under an EUA if it is proven to be both safe and effective AND the benefits outweigh the risks.
Once a vaccine is authorized, the FDA and Centers for Disease Control and Prevention (CDC) continue to monitor its safety and effectiveness as more people receive it.