COVID-19

While COVID-19 vaccines were developed rapidly, all steps were taken to make sure they are safe and effective:

Approach to Development – Scientists have been working for many years to develop vaccines against viruses like the one that causes COVID-19. This knowledge helped speed up the initial development of the current COVID-19 vaccines.

Clinical Trials – All vaccines in the United States must go through three phases of clinical trials to make sure they are safe and effective. During the development of COVID-19 vaccines, phases overlapped to speed up the process, but all phases were completed.

Authorization or Approval – Before vaccines are available to people, the U.S. Food and Drug Administration (FDA) assesses the findings from clinical trials. FDA determined that three COVID-19 vaccines met FDA’s safety and effectiveness standards and granted those vaccines Emergency Use Authorizations (EUAs)external icon. This allowed the vaccines to be quickly distributed to control the pandemic. Before recommending COVID-19 vaccination for children, scientists conducted clinical trials. The FDA gave the Pfizer-BioNTech COVID-19 vaccine emergency authorization to use in children ages 5 years through 15 years old and full approval to use in people ages 16 years and older. Read more about the first COVID-19 vaccine to receive FDA approvalexternal icon.

Manufacturing and Distribution – The U.S. government has invested substantial resources to manufacture and distribute COVID-19 vaccines. This allowed vaccine distribution to begin as soon as FDA authorized each vaccine.

Tracking Safety Using Vaccine Monitoring Systems – COVID-19 vaccine safety monitoring has been the most intense and comprehensive in U.S. history. Hundreds of millions of people in the United States have received COVID-19 vaccines. Through several monitoring systems, CDC and FDA continue to provide updated information on the safety of these vaccines.