In a recent press release, the FDA announced its Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 in pediatric patients aged 5 years through 11 years. The authorization was based on the FDA's thorough and transparent assessment of the data, including input from independent advisory-committee experts who overwhelmingly voted in favor of making the vaccine available to pediatric patients in this age group.

The FDA indicated three key points that they wanted to convey to parents and caregivers: 1) Effectiveness: Immune responses of children aged 5 through 11 years were comparable to those of individuals aged 16 through 25 years. Moreover, the vaccine was 90.7% effective in preventing COVID-19 in children aged 5 through 11 years. 2) Safety: The vaccine's safety was studied in approximately 3,100 children aged 5 through 11 years who received the vaccine, and no serious adverse effects have been identified in the ongoing study. 3) The CDC's Advisory Committee on Immunization Practices will meet again soon to discuss further clinical recommendations.   

The effectiveness data supporting the EUA in children as young as age 5 years is based on an ongoing randomized, placebo-controlled study that has enrolled approximately 4,700 children aged 5 through 11 years. The study is being conducted in the United States, Finland, Poland, and Spain. Pediatric patients in the vaccine group received two doses of the Pfizer-BioNTech COVID-19 vaccine containing 10 micrograms of messenger RNA per dose. The FDA analyzed data that compared the immune response of 264 participants from this study to 253 participants aged 16 through 25 years who had two higher doses of the vaccine in a previous study that determined the vaccine to be effective in preventing COVID-19. The immune responses of the younger participants were comparable to those in the older participants.

The FDA also conducted a preliminary analysis of cases of COVID-19 occurring 7 days after the second dose. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, three cases of COVID-19 occurred among 1,305 vaccine recipients and 16 cases of COVID-19 occurred among 663 placebo recipients; the vaccine was 90.7% effective in preventing COVID-19.

The available safety data supporting the EUA involve more than 4,600 participants (3,100 vaccine, 1,538 placebo) aged 5 through 11 years enrolled in the ongoing study. In this trial, 1,444 vaccine recipients were followed for safety for at least 2 months after the second dose.

In the clinical trial, commonly reported adverse effects included injection-site pain, redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea, and decreased appetite. More patients reported adverse effects after the second dose than after the first dose. Adverse effects were generally mild to moderate in severity and occurred within 2 days after vaccination, and the majority resolved within 1 to 2 days.

The FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis and pericarditis following vaccination with the Pfizer-BioNTech COVID-19 vaccine, particularly following the second dose, with the observed risk highest in males aged 12 through 17 years. Consequently, the FDA conducted its own benefit-risk assessment using modeling to predict how many symptomatic COVID-19 cases, hospitalizations, ICU admissions, and COVID-19 deaths the vaccine would prevent in pediatric patients aged 5 through 11 years versus the number of potential myocarditis cases, hospitalizations, ICU admissions, and deaths that the vaccine might cause. The FDA's model predicts that overall, the benefits of the vaccine would outweigh its risks in children aged 5 through 11 years.

Acting FDA Commissioner Janet Woodcock, MD, stated, "As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy. Our comprehensive and rigorous evaluation of the data pertaining to the vaccine's safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards."

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

 « Click here to return to Pediatrics Update.