The Food and Drug Administration (FDA) has authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 in children 5 to 11 years of age.
The FDA’s Vaccines and Related Biological Products Advisory Committee recently voted in favor (17 yes with 1 abstention) of amending the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine in this patient population.
For children 5 to 11 years of age, the vaccine is administered as a 2-dose series (10mcg each dose), separated by 3 weeks. Additional administration information is available in the health care provider fact sheet.
The authorization was based on data from an ongoing randomized, placebo-controlled study that enrolled approximately 4700 children 5 to 11 years of age. Results showed that the 10mcg dose level vaccine elicited strong neutralizing antibody responses, similar to those observed in individuals 16 to 25 years of age who received a 2-dose regimen of 30mcg.
Among participants 5 to 11 years old without evidence of prior SARS-CoV-2 infection, vaccine efficacy against symptomatic COVID-19 seven days after the second dose was reported to be 90.7% (95% CI, 67.4-98.3). At the time of data cutoff (October 8, 2021), there were 3 cases of COVID-19 in the vaccine group and 16 cases in the placebo group (most of which occurred during the height of the Delta variant in the US); none of these cases were considered to be severe.
The most frequently reported adverse reactions were injection site pain, redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite. There were no reports of myocarditis or pericarditis observed in the study population. Pfizer has updated the safety monitoring plan for the vaccine to include evaluation of myocarditis, pericarditis and other events of interest in children 5 to 11 years of age.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization,” said Acting FDA Commissioner Janet Woodcock, MD. “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 Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations in children 5 to 11 years of age.
A manufacturing change for the Pfizer-BioNTech COVID-19 vaccine has also been authorized to allow for use of a different buffer (Tris buffer). The new formulation is more stable at refrigerated temperatures for longer periods of time. Tris buffer is commonly used in other FDA-approved vaccines and other biologics.
FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age. News release. US Food and Drug Administration. Accessed October 29, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age.