November marks a monumental milestone in the battle against COVID-19. The U.S. Food and Drug Administration (FDA) expanded its emergency use authorization (EUA) for the Pfizer-BioNTech vaccine to children ages 5 to 11.
This means, all children over the age of 5 are eligible to receive a COVID-19 vaccination. Pfizer is the only COVID-19 vaccine maker with full Food and Drug Administration (FDA) approval for people ages 16 and older.
Is the COVID-19 vaccine safe for children?
Clinical trials have shown the Pfizer vaccine to be both safe and effective when used to prevent COVID-19 in children ages 5 to 11.
Were COVID-19 vaccine clinical trials rushed?
The clinical trials for the COVID-19 vaccines have all been done with the same care and requirements applied to any previous FDA approved vaccine. Under the emergency circumstances of the pandemic, the review processes were made more efficient. This in no way means that any shortcuts were taken or that any data collection or safety monitoring was shortened. The trials for the 5-11-year age group included a large number of patients covering multiple backgrounds that provide excellent data.
As of October 2021, more than 6.55 billion doses have been administered across 184 countries, but most importantly, the vaccines have been shown time and again to be safe and effective in people ages 18 and over.
Another factor that should be reassuring for parents is the robust reporting system, VAERS, the U.S. has put in place to detect vaccine safety issues and side effects.
“The VAERS (Vaccine Adverse Event Reporting System) has long been an extra layer of protection and monitoring that should bring a sense of comfort to all patients receiving any vaccine,” Dr. Horton said. “Through VAERS any vaccine adverse event can be reported and monitored. This means that should a troubling previously unknown side effect begin to emerge, it would be quickly recognized and acted upon.” A report can be made to VAERS by anyone and all health care providers are required to make a report if an event occurs.
[For more information about COVID-19 vaccinations, read “Everything You Need to Know About COVID-19 Vaccinations.”]
Parents have been eagerly awaiting this news, especially since many kids are back to in-person learning this past fall. Coincidentally, this summer and fall, the U.S. saw its largest surge in COVID-19 cases and hospitalizations among children—more than at any time during the pandemic.