Effectiveness of BNT162b2 (Pfizer-BioNTech) mRNA Vaccination Against Multisystem Inflammatory Syndrome in Children Among Persons Aged 12–18 Years — United States, July–December 2021

Abstract

On January 7, 2022, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr).Multisystem inflammatory syndrome in children (MIS-C) is a severe postinfectious hyperinflammatory condition, which generally occurs 2-6 weeks after a typically mild or asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19 (1-3). In the United States, the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine is currently authorized for use in children and adolescents aged 5-15 years under an Emergency Use Authorization and is fully licensed by the Food and Drug Administration for persons aged ≥16 years (4). Prelicensure randomized trials in persons aged ≥5 years documented high vaccine efficacy and immunogenicity (5), § and real-world studies in persons aged 12-18 years demonstrated high vaccine effectiveness (VE) against severe . Recent evidence suggests that COVID-19 vaccination is associated with lower MIS-C incidence among adolescents (7); however, VE of the 2-dose Pfizer-BioNTech regimen against MIS-C has not been evaluated. The effectiveness of 2 doses of Pfizer-BioNTech vaccine received ≥28 days before hospital admission in preventing MIS-C was assessed using a test-negative case-control design ¶ among hospitalized patients aged 12-18 years at 24 pediatric hospitals in 20 states** during July 1-December 9, 2021, the period when most MIS-C patients could be temporally linked to * These authors contributed equally to this report.† These senior authors contributed equally to this report. § https://www.fda.gov/emergency-preparedness-and-response/coronavirusdisease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine ¶ In this context, the test-negative case-control design was used to compare the odds of previous Pfizer-BioNTech vaccine receipt among inpatients without evidence of SARS-CoV-2 infection with case-patients hospitalized for MIS-C. These control patients included those with respiratory virus infection who received a negative test result for SARS-CoV-2 infection (test-negative) or patients without symptoms compatible with COVID-19 (syndrome-negative), including fever, cough, shortness of breath, loss of taste, loss of smell, gastrointestinal symptoms, use of respiratory support for the acute illness, or new pulmonary findings on chest imaging consistent with pneumonia. ** This investigation included patients enrolled from 24 pediatric hospitals in 20 states: Alabama,

Reported cases of multisystem inflammatory syndrome in children aged 12–20 years in the USA who received a COVID-19 vaccine, December, 2020, through August, 2021: a surveillance investigation

“…Multisystem inflammatory syndrome in adults was not reported in clinical trials of COVID-19 vaccines used in the USA, and MIS-C was not observed in the 46 000 individuals aged 16 years or older who participated in safety clinical trials for BNT162b2. 10 , 25 Globally, MIS-C in individuals who had received a COVID-19 vaccine has been described in detail in the literature for eight individuals younger than 21 years, 22 , 26 , 27 , 28 , 29 , 30 , 31 excluding aggregate counts from larger analyses assessing the effect of vaccination on preventing MIS-C. 32 , 33 From the USA, two reports included three cases that are also in our surveillance results, 22 , 26 and one report described a 14-year-old child with evidence of previous SARS-CoV-2 infection (positive anti-nucleocapsid antibody test) with MIS-C onset 2 months after a second dose with BNT162b2. 31 From outside the USA, we found reports of two individuals without evidence of previous or recent SARS-CoV-2 infection and who tested negative for anti-nucleocapsid antibodies: from Denmark, a 17-year-old with MIS-C onset 5 days after dose two of BNT162b2; 28 and from Turkey, a 12-year-old with onset 27 days after dose one of BNT162b2.…”

When vaccine adverse event reporting generates hope, not fear

“…Indeed, a recent report estimated that two doses of BNT162b2 were 91% effective against the development of MIS-C among adolescents aged 12–18 years when the delta (B.1.617.2) variant was predominant. 9 Together with the report by Yousaf and colleagues, these data offer hope that vaccination will reduce morbidity and mortality due to MIS-C.…”

Tracing and vaccinating: how to REACT to COVID-19 pandemic

“…First, a third booster vaccination is recommended after two doses of vaccine to restore protection against SARS-CoV-2 infection. Second, children need to be vaccinated to protect them from severe COVID-19 and MIS-C, 9 and to control the spread of COVID-19 in the community. Third, the REACT-1 study clearly shows the importance of tracing infections to understand the epidemiological evolution of the pandemic, www.thelancet.com/respiratory Published online January 24, 2022 https://doi.org/10.1016/S2213-2600(22)00016-9 which is even more important now that we are facing the challenge of the omicron variant.…”