The Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee voted in favor (17 yes with 1 abstention) of amending the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include use in children 5 to 11 years of age.
The specific question the panel was asked was whether the benefits of the Pfizer-BioNTech COVID-19 vaccine when administered as a 2-dose series (10mcg each dose; 3 weeks apart) outweigh its risks for use in children 5 to 11 years of age based on the totality of scientific evidence available.
The panel reviewed safety and efficacy data from a phase 2/3 study (ClinicalTrials.gov Identifier: NCT04816643) that included 2268 participants who received a 2-dose regimen of 10mcg administered 21 days apart. 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 solicited adverse reactions were pain at the injection site, fatigue, and headache; lymphadenopathy was the most frequently reported unsolicited adverse event. No reports of myocarditis or pericarditis were observed in the study population.
Study results in children under 5 years of age are expected later this year. A 2-dose series of 3mcg each is being investigated for this age group.
While not bound to the panel’s recommendations, the FDA will take them into consideration when making the final decision on authorization.
In August 2021, the FDA approved the Pfizer-BioNTech COVID-19 vaccine under the brand name Comirnaty for the prevention of COVID-19 in individuals 16 years of age and older.
The vaccine is also authorized for use under an EUA for individuals 12 to 15 years of age; for administration as a third dose in certain immunocompromised individuals; and as a booster dose administered at least 6 months after completion of the primary series to individuals 65 years of age and older; people 18 to 64 years old at high risk of severe COVID-19; and people 18 to 64 years old with frequent institutional or occupational exposure to SARS-CoV-2.
FDA Briefing Document. EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age. October 26, 2021. https://www.fda.gov/media/153447/download.