The expanded emergency use authorization (EUA) was granted because Pfizer has demonstrated that its vaccine is well-tolerated and 100% effective in the 2,260 clinical trial participants in this younger age group.
Pfizer’s clinical trials involving kids are ongoing and more data is to come. For now, the FDA has ruled that there’s enough data to safely authorize vaccines for ages 12 and up—an important step forward ahead of the next school year.
“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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “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.”
Prior to the FDA’s decision, the Pfizer COVID-19 vaccine was authorized for use in people 16 and older. The Advisory Committee on Immunization Practices (ACIP) will meet on May 12 to make official recommendations on the use of the Pfizer COVID-19 vaccine in this younger age group. Currently, the COVID vaccines from Moderna and Johnson & Johnson are still only authorized for use in people over the age of 18.
Is the Vaccine Any Different For Kids?
Under the expanded authorization, kids ages 12 through 15 will receive the same version and the same 30-microgram dose of the Pfizer vaccine that adults receive. Like adults, they will need two doses spaced 21 days apart.
Clinical trials are actively exploring the use of smaller dose sizes for younger age groups. For example, one Pfizer-BioNTech trial is currently testing low, medium, and high doses of 10, 20, and 30 micrograms in kids under age 12.
Will Kids Experience Vaccine Side Effects?
Pfizer’s clinical trial data showed that kids in the 12 to 15 age group had an even stronger antibody response to the vaccine than people in the 16 to 25 age group. But this did not make side effects any worse. According to the FDA, “the side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older.”
The most common side effects reported among 12 to 15-year-olds lasted one to three days, and were more prevalent after the second shot. They included:
Pain at the injection siteTirednessHeadacheChillsMuscle painFeverJoint pain
Where Can Kids Get Vaccinated?
Adolescents will be eligible to get a COVID shot at any vaccination site that carries Pfizer. But in the coming weeks, they’ll also be able to get a vaccine from their pediatrician. Currently, adults cannot get the vaccine at a primary care checkup because of the challenges it would pose for scheduling appointments and storing vaccines.
At a press briefing hosted by the Association of State and Territorial Health Officials (ASTHO) on May 11, state public health leaders explained the main reason kids will be able to get vaccines at their pediatrician’s office: parents will have lots of questions.
“We’re working to get the Pfizer vaccine to more pediatric and primary care providers, especially, because we want to make it easy for parents to get information, talk to the provider, and ultimately vaccinate their children,” Umair A. Shah, MD, MPH, Secretary of Health at Washington State Department of Health, said during the briefing. “This is the first time that we are not just speaking to the individual who’s getting vaccinated, but also the parent or guardian of the individual who is going to be eligible for vaccination. It’s absolutely critical that they hear our messages.”
The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.
