FDA approval
Frequently Asked Questions about FDA approval
Emergency use authorization (EUA) allows the FDA to authorize the use of yet to be approved drugs, or unapproved uses of approved drugs, for life-threatening conditions when there are no other adequate, approved, and available options and other conditions are met. In the case of COVID-19, the FDA issued EUAs for the Pfizer, Moderna, and Johnson & Johnson vaccines, and has now issued full approval for the Pfizer and Moderna COVID-19 vaccines.
In an emergency when lives are at risk, like a pandemic, it may not be possible to have all the evidence that the FDA would usually have before approving a vaccine or drug. If there’s evidence that strongly suggests that patients have benefited from a treatment, the agency can issue an EUA to make it available. For the COVID-19 vaccines, FDA required two months of safety and efficacy data before the EUA was granted. That included clinical trials with tens of thousands of people and rigorous testing and review, and all the vaccines continue to be closely monitored. Compared to emergency use authorization, FDA approval of vaccines requires even more data on safety, manufacturing, and effectiveness over longer periods of time and includes real-world data.
The CDC recommends that most people get a Pfizer or Moderna COVID-19 vaccine over the Johnson & Johnson vaccine, but there is no preference between the Pfizer or Moderna vaccine. These two vaccines are widely available, and for most people, getting the first available COVID vaccine is the best thing you can do to safeguard your health. If you have additional questions about which vaccine is best for you, check with your doctor.
The Pfizer and Moderna COVID-19 vaccines have both received full FDA approval. Before receiving EUA, all three vaccines underwent rigorous testing and review—including clinical trials with tens of thousands of people, and the FDA evaluated comprehensive data on their safety and effectiveness. All three showed excellent safety and effectiveness profiles, and now, hundreds of millions of vaccine doses in the U.S. and billions worldwide have been safely administered. The Johnson & Johnson vaccines will continue to be safely administered through emergency use authorization as the FDA reviews data about their real-world use.
