How will we know if the vaccine is safe?

The FDA requires that vaccines undergo a rigorous scientific process, including three phases of clinical trials, before they authorize or approve the vaccine. The COVID-19 vaccines are subject to the same safety standards as other vaccine trials.  To date, the independent Data and Safety Monitoring Board overseeing Phase 3 trials of the Pfizer and Moderna vaccines has not identified or reported any serious safety concerns.

All phase 3 studies have Data Safety and Monitoring Boards. The boards are made up of independent scientists hired by the company to look at the safety data and check at regular intervals whether the company should cancel or continue with the study. Additionally, two independent advisory committees will review a vaccine’s safety data before it is made available to the public. These committees are the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which advises the FDA, and the Advisory Committee on Immunization Practices (ACIP), which advises the CDC.  Learn more about the Vaccine safety and development process.

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