By Dr. Carol Hoban
Faculty Member, School of Health Sciences
As COVID-19 vaccinations have been made available to the public, questions have come up about providing these vaccinations to children. Some concerns that parents have include:
- Are these vaccinations safe for children?
- Do the vaccinations have potential side effects?
- What are the long-term effects?
It’s not surprising that parents have concerns over the safety of COVID-19 vaccinations, since these vaccines are new and some of them have not been fully approved by the Food and Drug Administration (FDA). However, there are online resources out there to assist in answering the questions that parents, guardians and caretakers might have regarding the safety of the COVID-19 vaccinations for their kids.
The Pfizer BioNTech Vaccine Now Has the FDA’s Full Approval
According to the Centers for Disease Control and Prevention (CDC), children age 5 years and older can receive the Pfizer-BioNTech coronavirus vaccination. The Pfizer BioNTech vaccine received the FDA’s full approval on August 23, 2021, for use in individuals age 16 years and older.
That approval means the vaccine is no longer being distributed under the FDA emergency use authorization. It also indicates that the Pfizer BioNTech vaccine, now known as Comirnaty, has met all of the FDA standards for safety, effectiveness and manufacturing quality as an approved product in the prevention of COVID-19.
CDC Recommends That Children Receive COVID-19 Vaccines to Prevent Illness, Death and New Infections
The CDC recommends COVID-19 vaccinations for children age 5 years and older to prevent infection, hospitalization, and in some circumstances, death. Although children who contract COVID-19 tend to have a milder case of the disease, this illness can still lead to short- and long-term complications, as well as the risk of those children spreading the disease to others.
In addition, children with underlying medical conditions – such as heart conditions, Type I or Type II diabetes, cancer, and chronic lung diseases, to name a few – can have more severe health complications caused by the virus, just as in adults with underlying medical conditions. One serious complication that may result from COVID-19 infection is multi-system inflammatory syndrome (MIS-C), which results in the inflammation of different body parts such as the heart, lungs, kidney, brain, skin, eyes or gastrointestinal organs.
Related link: 5 Habits to Improve Your Physical and Mental Health
All Drugs and Treatments, Even for Emergency Use, Must Undergo the FDA’s Clinical Trials
Before any drug or treatment is approved by the FDA, even in an emergency use authorization, it must undergo a series of clinical trials. The steps in the process involve vaccine development and then a series of three clinical trials to ensure the drug is safe and effective for use.
During the clinical trials, volunteers from different ages, races and ethnicities are given a vaccine. They are then monitored for side effects and efficacy (how many vaccinated people versus unvaccinated people contracted the virus).
With the COVID-19 vaccines, these clinical trials were expedited to get the vaccines out to the public as soon as possible. However, this speed in getting the vaccines to the public does not mean that the clinical trials were not fully completed to the standards outlined by the FDA.
Furthermore, the side effects reported from each of the COVID-19 vaccines are closely monitored and tracked in the Vaccine Adverse Event Reporting System. This information is available to the public.
Ideally, parents, guardians, and caretakers who have questions about the safety of the COVID-19 vaccine for their children should always speak to their physician. That doctor can recommend the best course of action for those children and their family.