The FDA has approved Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) for ages 16 and older. The vaccine continues to be available under emergency use authorization (EUA) for adolescents ages 12 to 15.
Vaccines are essential to getting children off to a healthy start in life.
Because immunization programs of the 20th and 21st century have been so successful, many parents today have never seen the many vaccine-preventable diseases that were once common. They don’t realize that those infectious diseases could reemerge. If individuals choose not to vaccinate themselves or their children, some diseases that are now rare or nonexistent in the United States may resurface.
Infectious diseases that used to be common in children in the United States – including polio, diphtheria, pertussis (whooping cough), rubella (German measles), and chickenpox – are preventable with vaccines approved by the U.S. Food and Drug Administration (FDA). Vaccines can prevent contagious diseases that once killed or harmed many infants, children, and adults. The FDA ensures that the vaccines children receive are safe and effective.
From babies to teenagers, people need vaccines throughout childhood to provide them with immunity from potentially dangerous infectious diseases. Without vaccines, children would be at risk for serious illness and even disability, or death, from diseases such as meningitis due to Haemophilus influenzae type b (Hib), measles, and whooping cough, among others.
A vaccine is a medical product. Like any medicine, vaccines can cause side effects, but most are minor and short-lived, such as a low-grade fever, or pain and redness at the injection site. Severe, long-lasting side effects of vaccines are extremely rare. The risk of being harmed by vaccines is much smaller than the risk of serious illness from the diseases they prevent. Ensuring the safety and effectiveness of vaccines is one of the FDA’s top priorities.
The FDA ensures that vaccines undergo a rigorous and extensive development program. The development programs for vaccines include studies conducted by the manufacturers to meet FDA standards for safety and effectiveness in the target population. Manufacturers conduct clinical trials according to plans that have been evaluated by the FDA and reflect the FDA’s considerable expertise in clinical trial design and methods. The FDA approves a vaccine only if it determines that the vaccine’s benefits outweigh its risks.
If you have questions about vaccines, visit the FDA’s guide for parents and caregivers. It describes in more detail the routinely administered vaccines for children and provides answers to commonly asked questions. Also, your health care provider is the best resource for information about vaccines.
In the meantime, here are some tips to keep in mind when your child is vaccinated.
Review the vaccine information sheets.
These sheets explain both the benefits and risks of a vaccine. Your health care provider is required by law to provide them to you.
Talk to your health care provider about the benefits and risks of vaccines.
Learn the facts about the benefits and risks of vaccines, along with the potential consequences of not vaccinating against diseases. Some people are surprised to learn that children can be harmed by or even die of measles, diphtheria, pertussis, and other infectious diseases that can be prevented by vaccines.
Before vaccination, tell your health care provider about certain conditions and allergies.
Your health care provider should be informed if your child is sick, or if they have a history of certain allergic or other adverse reactions to previous vaccinations or their components. For example, eggs are used to produce some influenza (flu) vaccines. Tell your health care provider if your child has a severe allergy to eggs.
Some vaccines are supplied in vials or prefilled syringes that may contain natural rubber latex, which can cause allergic reactions in people who are sensitive to latex. Let your health care professional know about an allergy to latex.
It is also important to discuss with your health care provider which vaccines should or should not be given to children who have a weakened immune system.
Report problems and side effects.
If you have any concerns after receiving a vaccine, contact your health care provider. Adverse events should be reported to the Vaccine Adverse Event Reporting System (VAERS). The FDA and the Centers for Disease Control and Prevention (CDC) maintain this national vaccine safety surveillance program. Your health care provider will usually file this report, or you can do it yourself.
Visit the VAERS website at www.vaers.hhs.gov to report possible side effects or other problems related to vaccines. You can report a problem online, download a form, or call them 1-800-822-7967 for more information.