The FDA approves a vaccine for use only if it is proven safe and effective, after clinical trials have been conducted with thousands of people, and when its benefits outweigh any risks. The COVID-19 vaccine builds on years of scientific research and an unprecedented level of scientific investment and cooperation. Every study and every phase of every trial was carefully reviewed and approved by a safety board and the FDA. The process was transparent and rigorous throughout, with continual oversight and expert approval. The Pfizer vaccine alone had a trial of over 40,000 people over a period of many months without any serious incidents.
Since vaccines became available in December, hundreds of millions of people across the country have received the vaccine with a relatively small number of reports of serious adverse reactions.
The Pfizer-BioNTech, Moderna, and Johnson & Johnson/Janssen COVID-19 vaccines will continue to undergo the most intensive safety monitoring in US history.
This includes both established and new safety monitoring systems to make sure that the COVID-19 vaccines are safe. Please visit the CDC’s website to learn more about the safety of COVID-19 vaccines.