From the U.S. Food & Drug Administration
From babies to teenagers, people need vaccines throughout childhood to provide them with immunity from potentially dangerous infectious diseases. If individuals choose not to vaccinate themselves or their children, some diseases that are now rare or nonexistent in the United States may resurface.
The FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine for emergency use to prevent COVID-19 in people 12 and older. The Centers for Disease Control and Prevention (CDC) recommends COVID-19 vaccination for everyone 12 and older.
1. Is the Pfizer-BioNTech COVID-19 Vaccine for adolescents 12 through 15 the same vaccine authorized for emergency use in people 16 and older?
Yes. Pfizer, Inc. tested its COVID-19 vaccine in a clinical trial in adolescents 12 through 15. Based on this data, the FDA determined that the known and potential benefits of Pfizer-BioNTech COVID19 Vaccine outweigh the known and potential risks of the vaccine for the prevention of COVID-19 in adolescents 12 through 15.
2. Were the side effects reported during the clinical trial in adolescents 12 through 15 consistent with side effects reported by people 16 and older?
Yes. The most commonly reported side effects were:
• pain at the injection site
• muscle pain
• joint pain
Like people 16 and older, adolescents 12 through 15 are more likely to experience side effects after the second dose of the vaccine.
While some people experience side effects following any vaccination, not everyone’s experience will be the same and some people may not experience side effects.
3. Is the FDA continuing to monitor the safety of COVID-19 vaccines? What about reports of heart inflammation following vaccination with Pfizer-BioNTech and Moderna COVID-19 Vaccines?
Yes, the FDA is monitoring the safety of all vaccines, including COVID-19 vaccines, which has and always will be a top priority for the FDA. COVID-19 vaccines are undergoing intensive safety monitoring in the U.S.
The FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety. These systems, called “passive surveillance” and “active surveillance” systems, rapidly detect and investigate potential safety problems. Systems such as the Vaccine Adverse Event Reporting System (VAERS) and CDC’s text-based v-safe system, which receive reports of adverse events following vaccination, are examples of passive surveillance systems. The FDA’s BEST Initiative is an example of an active surveillance system, which can analyze information occurring in millions of individuals recorded in large data systems to investigate any safety signals that are identified by VAERS or v-safe. Given the risk of COVID-19 disease and related, potentially severe, complications, the data continue to show that the known and potential benefits of each of the three authorized COVID-19 vaccines outweigh their known and potential risks.
Reports to VAERS suggest an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with both Pfizer-BioNTech and Moderna COVID-19 vaccines, particularly following the second dose. (Moderna COVID-19 Vaccine is authorized for emergency use in individuals 18 and older). Typically, onset of symptoms has been several days to a week following vaccination.
The FDA required both manufacturers to revise the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to include a Warning pertaining to the risk of myocarditis and pericarditis, as well as the Fact Sheet for Recipients and Caregivers to include information about myocarditis and pericarditis. The FDA will provide updates to the public as additional details become available.
4. Can my adolescent get other vaccines with the Pfizer-BioNTech COVID-19 vaccine?
Yes. According to the CDC, if an adolescent 12 through 17 is receiving the Pfizer-BioNTech COVID-19 Vaccine, they can receive routinely recommended vaccines at the same time as the COVID-19 vaccine.
5. Why should I get my adolescent vaccinated to prevent COVID-19?
Vaccination is one of the best ways to protect people 12 and older from COVID-19.
The most recent studies show that currently authorized COVID-19 vaccines prevent COVID-19, including potential serious health consequences of hospitalization and death. The U.S. is currently experiencing a surge of COVID-19 cases and more adolescents are becoming ill and being hospitalized with COVID-19 during this surge.