FDA and CDC Authorize Pfizer COVID-19 Vaccine for Children Age 12 and Older

RALEIGH — Based on a review of safety and effectiveness data from clinical trials in the United States and the expanded emergency authorization by the U.S. Food and Drug Administration, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) and the CDC today recommended use of Pfizer’s COVID-19 vaccine for children ages 12 through 15.

"Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations," said Acting FDA Commissioner Janet Woodcock, M.D, when announcing the authorization.

With the CDC recommendation, North Carolina teens ages 12 and older can now get vaccinated with the Pfizer COVID-19 vaccine to protect themselves from COVID-19, including preventing virus-related hospitalizations and deaths. The NC Department of Health and Human Services' State Health Director has amended the Standing Order authorizing health care providers to administer COVID-19 vaccines through an Emergency Use Authorization to include the use of the Pfizer vaccine for adolescents ages 12 through 15.

"Having a vaccine for our younger teens brings us that much closer to being able to end the pandemic," said NCDHHS Secretary Mandy K. Cohen, M.D. "By getting more teens vaccinated they are protecting themselves from the impact of COVID, and they are protecting their families and their communities by stopping the spread of the virus."

Young people are vulnerable to the COVID-19 virus, just like everyone else. In North Carolina, close to 123,000 children 0 to 17 years old have tested positive for COVID-19. With new variants, some parts of the country are seeing increased rates of COVID-19 in children and teens. In North Carolina, the percent of COVID-19 cases in children 17 and under has been increasing.

In the clinical trials, the vaccines were found to be very effective in the 12-15-year-old age group. The most commonly reported temporary reactions among teens were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. These typically lasted between one and three days and were similar to those reported in clinical trial participants 16 years of age and older.

Currently, North Carolina has close to 800,000 Pfizer first and second doses. NCDHHS is working with pediatricians and family medicine doctors to make the Pfizer vaccine accessible across the state, including connecting larger vaccine providers who have the capacity to store the vaccine to smaller practices needing a more limited quantity. In addition, the department is helping interested schools connect with vaccine partners to hosted onsite and offsite vaccine events for students and their families.

To find providers with the Pfizer vaccine, go to MySpot.nc.gov and filter for Pfizer.