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FDA Advisory Board Recommends Approving Pfizer COVID-19 for Children 5 to 11
As expected, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended to amend the emergency use authorization for Comirnaty, Pfizer's COVID-19 vaccine, for use by children of ages 5 to 11. The vote was 17-0 with one committee member abstaining [nbcnews.com]. The committee was concerned about the possible side effect of myocarditis in children and the lack of data about its frequency. However, the committee decided the benefits from vaccination outweighed possible safety risks. This is based on a clinical trial involving 2,268 children, of which two-thirds were given the vaccine while the other third was given a placebo [nytimes.com]. During the clinical trial, 16 children who received the placebo developed COVID-19 compared with three children who were vaccined and became symptomatic with COVID-19, which is an efficacy of 91% at preventing symptomatic COVID-19.
Some committee members expressed concern that the clinical trial was too small to properly quantify the risks of myocarditis, which is an inflammation of the heart. Children will receive two doses spaced three weeks apart, each containing 10 micrograms of mRNA, which is a third of the dosage given to adults. Here is the briefing document [fda.gov] submitted to VRBPAC by Pfizer containing results of the clinical trials of Comirnaty in young children. The document specifically notes that myocarditis is associated with COVID-19 in children:
Myocarditis is an important complication of COVID-19 illness in children. CDC studied a US cohort of patients with at least one inpatient or hospital-based outpatient encounter during March 2020 to January 2021 and reported that among patients with COVID-19 the adjusted risk ratio (aRR) for myocarditis was highest in the <16 and ≥75 age groups, with more than a 30-fold greater risk of myocarditis in COVID-19 illness compared with patients without COVID-19 (aRR: <16 years = 36.8 [95% CI: 25.0 to 48.6]; 16 to 24 years = 7.4 [95% CI: 5.5 to 9.2]; 25 to 39 years = 6.7 [95% CI 5.5 to 8.0]).
Although no cases of myocarditis were observed in children who received the vaccine during the clinical trial, the briefing states that the trial was not large enough to determine the frequency of myocarditis:
The size of the safety database is not large enough to detect any potential risks of myocarditis associated with vaccination. For this reason, long-term safety of the COVID-19 vaccine in participants 5 to <12 years of age will be studied in 5 post-authorization safety studies, including a 5-year follow-up study to evaluate long term sequelae of post-vaccination myocarditis/pericarditis.
Following VRBPAC's recommendation to approve Pfizer's COVID-19 vaccine for children of ages 5 to 11, the FDA will need to amend the emergency use authorization. Following this step, the an advisory panel at the CDC will make recommendations about how to administer the vaccine to children of this age and who should receive it. Former FDA commissioner Scott Gottlieb predicted that the vaccine will start being administered to children around November 4.
