Practice Support Update Blog

Pfizer - BioNTech COVID-19 Vaccine EUA Expanded to 12-15 Years Old

May 18, 2021 3:19:28 PM / by Practice Support Team

On Monday May 10, 2021, the FDA amended the December 11, 2020 emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in adolescents 16 or older to include adolescents 12 -15 years of age.   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.  

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The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The issuance of an EUA is not an FDA approval (licensure) of a vaccine. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance or to protect public health or safety. 

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. 

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.  

Learn more in the May 10, 2021 FDA press release  and the May 13, 2021 NCDHHS Press Release. COVID-19 vaccines are available in North Carolina to everyone ages 12 and older. 

 

What you should know: 

The vaccine is free everywhere in North Carolina. Everyone 18 and over can receive any of the three approved vaccines. 

Those aged 12-17 may only receive the Pfizer vaccine. Use My Spot to find locations that carry the Pfizer vaccine. 

No government-issued ID or insurance is needed. 

Depending on where you get your vaccine, you may need to make an appointment. 

Everyone can be vaccinated, regardless of their immigration status. Getting vaccinated will not affect your immigration status. 

Read our frequently asked questions to learn more about vaccinations and what you can do after you’re vaccinated. 

 

Interim Provider Guidance for Vaccinating North Carolinians 

Following a thorough safety review, the Centers for Disease Control and Prevention and the Food and Drug Administration have confidence that the Johnson & Johnson vaccine is safe and effective in preventing COVID-19 and recommend its use to prevent serious illness, hospitalization and death from COVID-19. More information. 

Interim Provider Guidance for Vaccinating North Carolinians provides administrative guidance on vaccinating eligible North Carolinians (updated May 17, 2021) 

Summary of Interim Provider Guidance for Vaccinating North Carolinians (updated May 17, 2021) 

COVID-19 Vaccine Provider Guidance Appendix (updated May 17, 2021) 

 

More detailed information for providers can be found on the Vaccination Information for Health Care Providers page. 

 

 

Tags: COVID-19, Vaccines, fda

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