The U.S. Food and Drug Administration (FDA) makes sure all food and drugs are safe. The COVID-19 vaccines must pass clinical trials like other drugs and vaccines. The FDA checks the work and approves vaccines only if they are safe and effective. The FDA can get them to people faster through an Emergency Use Authorization. Like all vaccines, the FDA keeps checking safety through the Vaccine Adverse Events Reporting System (VAERS). Healthcare providers are required to report serious side effects, or if someone gets seriously ill with COVID-19. There is also a smartphone-based health checker called V-SAFE that uses text messaging and web surveys to do health check-ins after people receive a COVID-19 vaccination.
More than 70,000 people volunteered in clinical trials for two vaccines (Pfizer and Moderna) to see if they are safe and work to prevent COVID illness. Volunteers included Black/African American, Hispanic/LatinX, Asians and others. To date, the vaccines are 95% effective in preventing COVID-19 with no serious safety concerns noted in the clinical trials. The U.S. Food and Drug Administration (FDA) makes sure the vaccines are safe and can prevent people from getting COVID-19. Like all drugs, vaccine safety continues to be monitored after they are in use.