FDA Approves Vaccine for Kids 12 to 15
The CDC still has to review the authorization and make recommendations for its use with this age group.
The U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNtech COVID-19 vaccine for emergency use in adolescents aged 12 to 15 Monday.
While the FDA has given approval for emergency use, this does not mean that the vaccine can be administered to children in this age group yet, said Elizabeth Goodsitt, communications officer for the state Department of Health Services.
The CDC’s Advisory Committee on Immunization Practices is meeting Wednesday to review the vaccine for expanded authorization and will vote on recommendations and guidance for its use with this age group. CDC director Rochelle Walensky will then decide whether to adopt the recommendations of the committee.
Dr. Janet Woodcock, acting FDA commissioner, said the new authorization is a “significant step in the fight against the COVID-19 pandemic,” in a statement released Monday. She also said, “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.”
The data supporting the decision, according to the FDA, comes from a placebo-controlled study with 2,260 participants, 50% of whom were given the saline-placebo.
The vaccine proved 100% effective at preventing COVID-19 among the group of adolescents who received the vaccine. The most common side effects from the study lasted one to three days and were also the same as those that occurred among people 16 years and older. They included pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain.
In the FDA’s announcement of the expanded use, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said “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.”
The FDA said approximately 1.5 million cases of COVID-19 have been reported to the Centers for Disease and Control and Prevention among children aged 11 to 17. In Milwaukee County, cases have been rising sharply for teenagers aged 15 to 17 in recent weeks, with most of the transmission occurring in the city of Milwaukee.
If you think stories like this are important, become a member of Urban Milwaukee and help support real, independent journalism. Plus you get some cool added benefits, all detailed here.
More about the Coronavirus Pandemic
- State Begins Vaccines For Youngest People - Erik Gunn - Jun 22nd, 2022
- DHS Recommends COVID-19 Vaccines for Everyone Age 6 Months and Older - Wisconsin Department of Health Services - Jun 21st, 2022
- Wisconsin Department of Health Services Secretary-designee Karen Timberlake’s Statement on CDC’s COVID-19 Pediatric Vaccine Recommendations and Expansion to Children Under Age 5 - Wisconsin Department of Health Services - Jun 18th, 2022
- MKE County: New COVID-19 Cases Down Slightly This Past Week - Graham Kilmer - Jun 17th, 2022
- City of Milwaukee Weekly COVID-19 Update - City of Milwaukee Health Department - Jun 17th, 2022
- MKE County: County Sees “Plateau” In New COVID-19 Cases - Graham Kilmer - Jun 10th, 2022
- City of Milwaukee Weekly COVID-19 Update - City of Milwaukee Health Department - Jun 10th, 2022
- High Court Okays Release of COVID-19 Workplace Data - Erik Gunn - Jun 8th, 2022
- MKE County: COVID-19 Cases Show Slight Decrease - Graham Kilmer - Jun 3rd, 2022
- Ivermectin Lawsuits Create New Challenge For Health Care Providers - Erik Gunn - Jun 2nd, 2022
Read more about Coronavirus Pandemic here