RALEIGH — The Food and Drug Administration has approved the Pfizer-BioNTech COVID-19 vaccine, which will Pfizer is calling Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.

"Vaccines are our most important tool in the fight against COVID-19," said NC Department of Health and Human Services Secretary Mandy K. Cohen, M.D. "All authorized vaccines have met rigorous testing and scientific standards. Millions of North Carolinians have been safely vaccinated, but for some people full FDA approval provides additional confidence. If you are not vaccinated, we urge you: please don’t wait to vaccinate."

The Pfizer vaccine will continue to be available under emergency use authorization for teens 12-15. FDA approval for this age group will require additional time as the vaccine was not authorized for younger teens until May 2021, six months after it was granted EUA for people 16 and older. All available vaccines in the United States have been under an EUA. Rigorous clinical trials among thousands of people have proven that vaccines are safe and effective. More than 170 million Americans have been safely vaccinated against COVID-19.

Vaccines are widely available in North Carolina. Through Aug. 31, anyone 18 and older who gets their first dose of a COVID-19 vaccine at a participating location will receive a $100 Summer Card* in the form of a Prepaid Mastercard® while supplies last.

Last week, the Centers for Disease Control and Prevention shared new data showing vaccines continue to be remarkably effective in reducing risk of severe disease, hospitalization and death, even against the widely circulating Delta variant. There is urgency to get vaccinated now. North Carolina is experiencing the fastest acceleration in cases since the pandemic started. Earlier this month, the state had the largest single-day jump in ICU admissions since the beginning of the pandemic.

Anyone who has symptoms of or has been exposed to COVID-19 should get tested as soon as possible. To find a testing site in your community, go to www.ncdhhs.gov/GetTested. People who are not experiencing serious symptoms should not go to the emergency department for routine COVID-19 testing. People should seek medical attention immediately for serious symptoms such as trouble breathing, persistent pain or pressure in the chest, new confusion or inability to arouse, or bluish lips or face.

While vaccines are the best protection against serious illness, hospitalization and death, monoclonal antibody therapy can reduce the severity of COVID-19 symptoms and decrease the likelihood of hospitalization, especially in high-risk patients. If you test positive for COVID-19, monoclonal antibody therapy must be administered within 10 days of your first COVID-19 symptoms, so it is crucial to get tested early.

Visit MySpot.nc.gov for accurate information about the COVID-19 vaccine and to find a vaccine location near you. We need to layer up our protection to fight this more contagious Delta variant and weather the storm: Vax up, Mask up and urge others to do the same.

Read the FDA’s press release regarding the approval of the Pfizer vaccine here.