After initial development, vaccines go through three phases of clinical trials to make sure they are safe and effective. For other vaccines routinely used in the United States, the three phases of clinical trials are performed one at a time. During the development of COVID-19 vaccines, these phases overlapped to speed up the process so the vaccines could be used as quickly as possible to control the pandemic. No trial phases have been skipped.
The clinical trials for COVID-19 vaccines have involved tens of thousands of volunteers of different ages, races, and ethnicities. Clinical trials for vaccines compare outcomes (such as how many people get sick) between people who are vaccinated and people who are not. Because COVID-19 continues to be widespread, the vaccine clinical trials have been conducted more quickly than if the disease were less common. Results from these trials have shown that COVID-19 vaccines are effective, especially against severe illness, hospitalization, and death.
The clinical trials showed no serious safety concerns within 8 weeks following vaccination. This is an important milestone, as it is unusual for adverse effects caused by vaccines to appear after this amount of time. Now that COVID-19 vaccines are available to the public, CDC and FDA continue to monitor their safety and alert the public about health problems that are reported after vaccination.