On October 29th, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to the Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11 years old.
This authorization was based on robust safety and efficacy data of the vaccine in children. The results from pediatric studies demonstrate:
- 7% effectiveness in those 5 through 11 years of age in preventing COVID-19
- No serious safety concerns in 3,100 children who were administered the vaccine
Administration of the Pfizer vaccine in children is slightly different than it is in adults. For example, children are to receive a lower dose (10 micrograms) than those who are over the age of 12 who receive a 30 microgram dose1.
Studies in children indicated that vaccine side effects in children were mild and transient. Effects were like what one may see with other pediatric vaccines, with the most prevalent side effect being injection site pain2. Other common side effects from pediatric studies included:
- Swelling and redness
- Muscle and/or joint pain
- Decreased appetite
- Swollen lymph nodes
Most side effects seen in children lasted only one or two days. Other adverse effects of interest may include pericarditis (inflammation in the tissue around the heart) and myocarditis (heart muscle inflammation).
The FDA and CDC will continue to monitor the development of myocarditis, pericarditis, and other potential adverse effects in this new age group.
Vaccinators are required to report all adverse effects of the vaccine through the Vaccine Adverse Event Reporting System (VAERS) portal. Pfizer is also mandated to communicate any safety signals from vaccine surveillance to the FDA1.
The FDA’s authorization of the vaccine in children is a major step towards defeating the COVID-19 pandemic. Over the past 19 months, children and families have suffered from school shutdowns and illness due to coronavirus.
In fact, since the start of COVID-19, there have been 8,300 hospitalizations of children due to COVID-19. As of October 17th, 2021, there have been 146 reported COVID-19-related deaths in children 5 through 11 years of age1.
Children experiencing COVID-19 are at risk for multisystem inflammatory syndrome (MIS-C)2. In MIS-C, an individual’s organs become inflamed. Organs such as the lungs, heart, brain, kidneys, eyes, and skin can be affected by MIS-C. Children are also at risk for hospitalization, long-term complications, and death due to COVID-193.
The CDC followed suit in lieu of the authorization by the FDA. On November 2nd, 2021, the CDC endorsed the use of the Pfizer vaccine in children over the age of five years old, expanding vaccine access to up to 28 million children within the United States.
Vaccination will ensure a child’s protection against COVID-19, lessening the chances of developing serious disease, long-term complications, hospitalization, and death. Pediatric vaccination will also ensure a safe return to in-person school and activities2.
Pediatric vaccinations have started to be distributed throughout the U.S. as of last week. Starting the week of November 8th, low-dose vaccines for children will be widely available at doctors’ offices and pharmacies2.
Written by: Emmanuel J. Osemota
- FDA authorizes Pfizer-BioNtech COVID-19 vaccine for emergency use in children 5 through 11 years of age. (2021, October 29). FDA. https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age
- Coronavirus Disease 2019. (2021, November 3). Centers for Disease Control and Prevention. https://www.cdc.gov/media/releases/2021/s1102-PediatricCOVID-19Vaccine.html
- Multisystem inflammatory syndrome (MIS). (2020, February 11). Centers for Disease Control and Prevention. https://www.cdc.gov/mis/mis-c.html