FDA authorizes emergency use of Pfizer COVID-19 vaccine for adolescents 12 to 15

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The U.S. Food and Drug Administration (FDA) announced on Monday the expansion of the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020, for administration in individuals 16 years of age and older.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. 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.”

From March 1, 2020, through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC). Children and adolescents generally have a milder COVID-19 disease course as compared to adults. The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older.

The FDA has determined that Pfizer-BioNTech COVID-19 vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population. 

The FDA has updated the fact sheets for healthcare providers administering the vaccine (Vaccination Providers) and for recipients and caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine.

Calling the announcement an “extraordinary development,” Gov. Tim Walz applauded the news in a statement released Monday evening. “This is an extraordinary development on our path back to normalcy,” said Gov. Walz. “We have been planning and preparing for this moment and are ready to begin vaccinating teens 12 and older. Start making your plan, Minnesota — let’s get our kids their shot as soon as possible so they are fully vaccinated and protected in time for a fun, safe summer.”

“I am so excited to get our kids back to all the things they love this summer — camps, sports, activities, vacations, and more,” said Lieutenant Governor Peggy Flanagan. “And now, with the ability to get vaccinated, our teens 12 and older can have a significant level of extra protection to keep themselves, their families, and their communities safe. This is a great day for progress and I hope Minnesotans take advantage of this life-saving opportunity and get their shot as soon as possible.”

“The Pfizer vaccine has gone through rigorous clinical trials on children in this age group and has proven to be a highly safe and effective preventative measure against the deadly coronavirus,” said Department of Health Commissioner Jan Malcolm. “Minnesota parents can feel confident in the science, medical experts, and federal guidelines expanding authorization to 12-to-15-year-olds, and I hope they get their children vaccinated as soon as possible. Every person who gets vaccinated helps us slow the spread of this disease and protect those who cannot get vaccinated.”

Final federal guidance is expected to be issued from the Centers for Disease Control and Prevention (CDC) later this week following a meeting of the Advisory Committee on Immunization Practices scheduled for Wednesday.

Once CDC immunization guidance is issued, Minnesotans age 12 to 15 can receive vaccinated at locations where Pfizer vaccines are available. Parent or guardian consent is required for COVID-19 vaccination for people younger than 18 years old.

There are a number of ways to get a Pfizer vaccine: 

  • Vaccine Connector: You can directly sign up for an appointment at one of the state Community Vaccination Program locations at VaccineConnector.mn.gov
    • Walk-ins for Minnesotans 12+ will be accepted at state community vaccination sites administering Pfizer vaccines in Bloomington (Mall of America), Saint Paul (Roy Wilkins Auditorium), Lino Lakes and Oakdale. 
  • Vaccine Locator Map: You can use the Vaccine Locator Map to search for providers who are offering COVID-19 vaccine to Minnesotans ages 12 and older at https://mn.gov/covid19/vaccine/find-vaccine/locations/index.jsp.  
  • Vaccine Finder: You can also find COVID-19 vaccine appointments at Vaccines.gov, which allows you to filter by vaccine manufacturer and search for only Pfizer vaccine appointments. 
  • Health Care Provider: You can also contact your child’s primary health care provider, local public health department, or a local pharmacy.  

—Information provided by FDA and the Office of Gov. Tim Walz and the Office of Lt. Gov. Peggy Flanagan.