FDA approves Pfizer vaccine for ages 12 and up

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DENVER (KDVR) — The Food and Drug Administration approved emergency use of the Pfizer COVID-19 vaccine for children age 12 and up on Monday. The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices could give final approval later in the week.

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D.

“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. 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.”

Local hospitals and families are already gearing up. Rocky Mountain Hospital for Children in Denver already had vaccination clinics planned for Saturday and Sunday for kids ages 16 and up, and their parents. Doctors say they are ready if the Pfizer vaccine is opened up to kids ages 12 to 15. 

“Once that announcement is made we are prepared in a matter of an hour or so to change all of our registrations to include that age group,” said Dr. Reginald Washington, the Chief Medical Officer at Rocky Mountain Hospital for Children. 

A study on the younger age group was conducted by Pfizer and the FDA determined the benefits outweighed the risks.

“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

“With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”

The Advisory Committee on Immunization Practices is the next step in getting shots in kids’ arms. They need to make a formal recommendation for health care providers to use the vaccine in the age group and are expected meet on May 12.

As Colorado pushes to achieve herd immunity, Governor Jared Polis was pleased to receive news of the FDA approval. There are approximately 300,000 Coloradans that fall into this age group.

“I am thrilled that, thanks to the FDA’s decision, all Coloradans ages 12-15 are one step closer to being eligible to receive the COVID-19 vaccine. For younger Coloradans, this doesn’t just mean getting much-needed protection from this disease, it also means even safer classrooms and after-school activities, the opportunity to visit with friends and family without guilt, and the chance to get closer to life as we knew it. This last year hasn’t been easy for Colorado students, and I’m glad to see that even more will now be able to live without fear as they head into the summer and this next school year. We are hopeful that final approval will be granted as soon as Wednesday and 12-15 year olds can start getting protected by the end of this week.”

Gov. Jared Polis

An email from a state spokesperson said:

“We are proud of the actions Coloradans have taken in the past year to help suppress the virus by following public health protocols. 

Vaccination is our ticket out of this pandemic. To get there, we need people to choose to get the vaccine. Children ages 12-15 make up approximately 300,000 Coloradans. Once the vaccine is approved for this age group, vaccine uptake among this age group will be a key to helping us achieve our goals.

Our goal is to get all eligible Coloradans vaccinated as quickly as possible to put an end to the crisis caused by this pandemic. Our Joint Vaccine Task Force is nimble, and we will update our vaccine protocols as quickly as possible pending approval by the Advisory Committee on Immunization Practices.

Pending approval by the Advisory Committee on Immunization Practices, any vaccine provider that receives a Pfizer allocation will be able to administer the vaccine to that age group. Our community vaccination sites also will be able to administer the vaccine to individuals 12-15 when the time comes. We are working with our providers to prepare for this potentially as early as this week.”

If you would like to attend the vaccination Clinic at Rocky Mountain Hospital for Children, here are the details:

First doses: Saturday, May 15 and Sunday, May 16 (10AM – 4PM)
Second doses: Saturday, June 5 and Sunday, June 6 (10AM – 4PM)

Register at: RockyMountainHospitalforChildren.com/vaccine

  • If child is under 18 years old, parent or legal guardian must be present
  • Vaccines will be given by pediatric nurses in the lobby of the hospital (2001 N. High Street at 20th and High Street)
  • Parents are welcome to register alongside their children for a vaccine

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