The U.S. vaccine safety system ensures that all vaccines are as safe as possible. Safety is a top priority while federal partners work to make this and other COVID-19 vaccines available.
FDA Approves First COVID-19 Vaccine
On August 23, the U.S. Food and Drug Administration (FDA) approved the first ever COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty, in individuals 16 years of age and older. The vaccine continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for a third dose in certain immunocompromised individuals.
About the Vaccines
The available COVID-19 vaccines may work in slightly different ways, but all types of the vaccine will help protect you. The vaccines have been shown to be safe and effective in reducing the risk of severe illness, hospitalizations and death as caused by the virus.
After the vaccination you may have some side effects, which are normal signs that your body is building protection. These side effects may affect your ability to do daily activities, but usually go away in a few days.
Read more about common side effects, helpful tips, when to call the doctor, and adverse events.
Fully vaccinated people (at least 2 weeks after receiving the second dose in a 2-dose series or at least 2 weeks after receiving a single-dose vaccine):
- Visit with other fully vaccinated people indoors without wearing masks or physical distancing. However, to maximize protection from the Delta variant and prevent possibly spreading it to others, wear a mask indoors in public if in an area of substantial or high transmission.
- Refrain from quarantine (unless they have symptoms), but should get tested 3-5 days after their exposure – even if they don’t have symptoms – and wear a mask indoors in public for 14 days following exposure or until their test result is negative.
Read more about public health recommendations for fully vaccinated people.
Keep in Mind
It’s important for everyone to continue using all the tools available to help stop this pandemic as we learn more about how COVID-19 vaccines work in real-world conditions. Cover your mouth and nose with a mask when around others, stay at least 6 feet away from others, avoid crowds, and wash your hands often.
- Read more about the safety of COVID-19 vaccines in the United States
- Read more about the V-safe After Vaccination Health Checker