tetano
Editor, Senior Moderator
JAMA Netw Open
. 2024 Apr 1;7(4):e248192.
doi: 10.1001/jamanetworkopen.2024.8192. Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years
Mao Hu[SUP] 1 [/SUP], Azadeh Shoaibi[SUP] 2 [/SUP], Yuhui Feng[SUP] 1 [/SUP], Patricia C Lloyd[SUP] 2 [/SUP], Hui Lee Wong[SUP] 2 [/SUP], Elizabeth R Smith[SUP] 1 [/SUP], Kandace L Amend[SUP] 3 [/SUP], Annemarie Kline[SUP] 4 [/SUP], Daniel C Beachler[SUP] 5 [/SUP], Joann F Gruber[SUP] 2 [/SUP], Mahasweta Mitra[SUP] 1 [/SUP], John D Seeger[SUP] 3 [/SUP], Charlalynn Harris[SUP] 4 [/SUP], Alex Secora[SUP] 6 [/SUP], Joyce Obidi[SUP] 2 [/SUP], Jing Wang[SUP] 1 [/SUP], Jennifer Song[SUP] 3 [/SUP], Cheryl N McMahill-Walraven[SUP] 4 [/SUP], Christian Reich[SUP] 6 [/SUP], Rowan McEvoy[SUP] 1 [/SUP], Rose Do[SUP] 1 [/SUP], Yoganand Chillarige[SUP] 1 [/SUP], Robin Clifford[SUP] 3 [/SUP], Danielle D Cooper[SUP] 4 [/SUP], Richard A Forshee[SUP] 2 [/SUP], Steven A Anderson[SUP] 2 [/SUP]
Affiliations
Importance: Active monitoring of health outcomes after COVID-19 vaccination provides early detection of rare outcomes that may not be identified in prelicensure trials.
Objective: To conduct near-real-time monitoring of health outcomes after COVID-19 vaccination in the US pediatric population.
Design, setting, and participants: This cohort study evaluated 21 prespecified health outcomes after exposure before early 2023 to BNT162b2, mRNA-1273, or NVX-CoV2373 ancestral monovalent COVID-19 vaccines in children aged 6 months to 17 years by applying a near-real-time monitoring framework using health care data from 3 commercial claims databases in the US (Optum [through April 2023], Carelon Research [through March 2023], and CVS Health [through February 2023]). Increased rates of each outcome after vaccination were compared with annual historical rates from January 1 to December 31, 2019, and January 1 to December 31, 2020, as well as between April 1 and December 31, 2020.
Exposure: Receipt of an ancestral monovalent BNT162b2, mRNA-1273, or NVX-CoV2373 COVID-19 vaccine dose identified through administrative claims data linked with Immunization Information Systems data.
Main outcomes and measures: Twenty-one prespecified health outcomes, of which 15 underwent sequential testing and 6 were only monitored descriptively due to lack of historical rates.
Results: Among 4 102 016 vaccinated enrollees aged 6 months to 17 years, 2 058 142 (50.2%) were male and 3 901 370 (95.1%) lived in an urban area. Thirteen of 15 sequentially tested outcomes did not meet the threshold for a statistical signal. Statistical signals were detected for myocarditis or pericarditis after BNT162b2 vaccination in children aged 12 to 17 years and seizure after vaccination with BNT162b2 and mRNA-1273 in children aged 2 to 4 or 5 years. However, in post hoc sensitivity analyses, a statistical signal for seizure was observed only after mRNA-1273 when 2019 background rates were selected; no statistical signal was observed when 2022 rates were selected.
Conclusions and relevance: In this cohort study of pediatric enrollees across 3 commercial health insurance databases, statistical signals detected for myocarditis or pericarditis after BNT162b2 (ages 12-17 years) were consistent with previous reports, and seizures after BNT162b2 (ages 2-4 years) and mRNA-1273 vaccinations (ages 2-5 years) should be further investigated in a robust epidemiologic study with confounding adjustment. The US Food and Drug Administration concludes that the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks of COVID-19 infection.
. 2024 Apr 1;7(4):e248192.
doi: 10.1001/jamanetworkopen.2024.8192. Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years
Mao Hu[SUP] 1 [/SUP], Azadeh Shoaibi[SUP] 2 [/SUP], Yuhui Feng[SUP] 1 [/SUP], Patricia C Lloyd[SUP] 2 [/SUP], Hui Lee Wong[SUP] 2 [/SUP], Elizabeth R Smith[SUP] 1 [/SUP], Kandace L Amend[SUP] 3 [/SUP], Annemarie Kline[SUP] 4 [/SUP], Daniel C Beachler[SUP] 5 [/SUP], Joann F Gruber[SUP] 2 [/SUP], Mahasweta Mitra[SUP] 1 [/SUP], John D Seeger[SUP] 3 [/SUP], Charlalynn Harris[SUP] 4 [/SUP], Alex Secora[SUP] 6 [/SUP], Joyce Obidi[SUP] 2 [/SUP], Jing Wang[SUP] 1 [/SUP], Jennifer Song[SUP] 3 [/SUP], Cheryl N McMahill-Walraven[SUP] 4 [/SUP], Christian Reich[SUP] 6 [/SUP], Rowan McEvoy[SUP] 1 [/SUP], Rose Do[SUP] 1 [/SUP], Yoganand Chillarige[SUP] 1 [/SUP], Robin Clifford[SUP] 3 [/SUP], Danielle D Cooper[SUP] 4 [/SUP], Richard A Forshee[SUP] 2 [/SUP], Steven A Anderson[SUP] 2 [/SUP]
Affiliations
- PMID: 38656578
- DOI: 10.1001/jamanetworkopen.2024.8192
Importance: Active monitoring of health outcomes after COVID-19 vaccination provides early detection of rare outcomes that may not be identified in prelicensure trials.
Objective: To conduct near-real-time monitoring of health outcomes after COVID-19 vaccination in the US pediatric population.
Design, setting, and participants: This cohort study evaluated 21 prespecified health outcomes after exposure before early 2023 to BNT162b2, mRNA-1273, or NVX-CoV2373 ancestral monovalent COVID-19 vaccines in children aged 6 months to 17 years by applying a near-real-time monitoring framework using health care data from 3 commercial claims databases in the US (Optum [through April 2023], Carelon Research [through March 2023], and CVS Health [through February 2023]). Increased rates of each outcome after vaccination were compared with annual historical rates from January 1 to December 31, 2019, and January 1 to December 31, 2020, as well as between April 1 and December 31, 2020.
Exposure: Receipt of an ancestral monovalent BNT162b2, mRNA-1273, or NVX-CoV2373 COVID-19 vaccine dose identified through administrative claims data linked with Immunization Information Systems data.
Main outcomes and measures: Twenty-one prespecified health outcomes, of which 15 underwent sequential testing and 6 were only monitored descriptively due to lack of historical rates.
Results: Among 4 102 016 vaccinated enrollees aged 6 months to 17 years, 2 058 142 (50.2%) were male and 3 901 370 (95.1%) lived in an urban area. Thirteen of 15 sequentially tested outcomes did not meet the threshold for a statistical signal. Statistical signals were detected for myocarditis or pericarditis after BNT162b2 vaccination in children aged 12 to 17 years and seizure after vaccination with BNT162b2 and mRNA-1273 in children aged 2 to 4 or 5 years. However, in post hoc sensitivity analyses, a statistical signal for seizure was observed only after mRNA-1273 when 2019 background rates were selected; no statistical signal was observed when 2022 rates were selected.
Conclusions and relevance: In this cohort study of pediatric enrollees across 3 commercial health insurance databases, statistical signals detected for myocarditis or pericarditis after BNT162b2 (ages 12-17 years) were consistent with previous reports, and seizures after BNT162b2 (ages 2-4 years) and mRNA-1273 vaccinations (ages 2-5 years) should be further investigated in a robust epidemiologic study with confounding adjustment. The US Food and Drug Administration concludes that the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks of COVID-19 infection.