Estimating pediatric cases of COVID-19 over time in the United States: Filling in a gap in public use data

Wiemken, Timothy; Niemotka, Samson L.; Clarke, Jacob A; Prener, Christopher; Rutschman, Ana Santos

doi:10.1016/j.ajic.2021.10.018

American Journal of Infection Control

2022

DOI: 10.1016/j.ajic.2021.10.018

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Estimating pediatric cases of COVID-19 over time in the United States: Filling in a gap in public use data

Timothy Wiemken

Samson L. Niemotka

Jacob A Clarke

et al.

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2023

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“…6 While it is true that COVID-19 is far less devastating in children than older adults, children are still at risk of serious and rarely fatal infections. When Pfizer presented the results of its phase 3 study to the FDA in October 2021, approximately 1.3 million children between 5 and 11 years of age had experienced COVID-19, 7 and 8600 had been hospitalized. 8 A few days later, during deliberations by the Advisory Committee for Immunization Practices, Sarah Oliver, MD, MSPH, from the Centers for Disease Control and Prevention, compared deaths from COVID-19 to deaths from other vaccine-preventable diseases that had vaccines that were licensed within the past 30 years.…”

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COVID-19 Vaccines in Young Children—Reassuring Evidence for Parents

Offit

2023

JAMA Pediatr

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In this issue of JAMA Pediatrics, Watanabe and coauthors 1 evaluated the safety and efficacy of 2 doses of Pfizer's messenger RNA (mRNA) vaccine in children aged 5 to 11 years during both the delta and omicron waves of COVID-19. In a systematic review and meta-analysis that included 17 published studies of 10 935 541 vaccinated and 2 635 251 unvaccinated children, they found that the mRNA vaccine was effective at preventing SARS-CoV-2 infection, symptomatic infection, hospitalization, and multisystem inflammatory syndrome in children (MIS-C). The vaccine was also safe; myocarditis occurred in only 1.8 per million vaccinees. This analysis offers 2 important advances over previous, smaller studies. First, during both the delta and omicron waves, mRNA vaccines consistently protected against serious illness, including MIS-C. Second, the risk of myocarditis was minuscule.More than 1 year ago, on October 26, 2021, researchers from Pfizer presented results of a prospective, placebo-controlled, phase 3 trial of their mRNA vaccine in 5-to 11-year-old children to the US Food and Drug Administration (FDA) Vaccine and Related Biological Products Advisory Committee. 2 About 1500 children were inoculated with 2 doses of 10 μg of mRNA vaccine administered 3 weeks apart; 750 were inoculated with placebo. At least 1 week after the second dose, 16 cases of symptomatic COVID-19 occurred in the placebo group and 3 in the vaccine group for a calculated efficacy of 90.9% (95% CI, 68.3%-98.3%). Although the FDA later authorized the use of Pfizer's mRNA vaccine for young children, several questions remained unanswered. Because Pfizer's phase 3 study was small, no cases of serious illness or MIS-C were included. Also, whereas those 12 years and older had received 30 ug of Pfizer's mRNA vaccine per dose, children aged 5 to 11 years would now be receiving 10 μg, one-third the dose with which we had had the most experience.One week later, on November 2, 2021, the US Centers for Disease Control and Prevention recommended Pfizer's mRNA vaccine for all 5-to 11-year-old children. Two months later, the omicron variant entered the US. Because omicron contained 15 sequence variations in the receptor-binding domain of the spike protein, it evaded recognition by neutralizing antibodies. Would protection against severe disease, which is the only reasonable and attainable goal of this vaccine, hold up when millions of 5-to 11-year-old children were vaccinated?Between November 2021 and March 2022, 2 studies evaluated the efficacy of 2 doses of Pfizer's mRNA vaccine in children aged 5 to 11 years. 3,4 The numbers of children studied ranged from 1000 to 9000, and confidence intervals were large. Researchers found that protective efficacy against asymptomatic

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COVID-19 Vaccines in Young Children—Reassuring Evidence for Parents

Offit

2023

JAMA Pediatr

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Estimating pediatric cases of COVID-19 over time in the United States: Filling in a gap in public use data

Cited by 1 publication

References 8 publications

COVID-19 Vaccines in Young Children—Reassuring Evidence for Parents

COVID-19 Vaccines in Young Children—Reassuring Evidence for Parents

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