https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-approves-required-updated-warning-labeling-mrna-covid-19-vaccines-regarding-myocarditis-and Purpose: To inform the public and healthcare providers that FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA) manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines. Specifically, FDA has required each manufacturer to update the warning about the risks of myocarditis and pericarditis to include information about (1) the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines and (2) the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 vaccine. FDA also required each manufacturer to describe the new safety information in the Adverse Reactions section of the Prescribing Information and in the Information for Recipients and Caregivers. 目的：告知公众和医疗保健提供者，FDA 已要求并批准更新辉瑞公司生产的 Comirnaty（COVID-19 疫苗，mRNA）和 ModernaTX, Inc. 生产的 Spikevax（COVID-19 疫苗，mRNA）的处方信息，以包含有关接种 mRNA COVID-19 疫苗后心肌炎和心包炎风险的新安全信息。具体而言，FDA 要求各制造商更新有关心肌炎和心包炎风险的警告，以包含以下信息：(1) 接种 2023-2024 年配方 mRNA COVID-19 疫苗后心肌炎和/或心包炎的估计未调整发病率，以及 (2) 一项研究的结果，该研究收集了接种 mRNA COVID-19 疫苗后患上心肌炎的人群的心脏磁共振成像 (cardiac MRI) 信息。 FDA 还要求每个制造商在处方信息的不良反应部分以及接受者和护理人员的信息中描述新的安全信息。 The Fact Sheets for Healthcare Providers and for Recipients and Caregivers for Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19, which are authorized for emergency use in individuals 6 months through 11 years of age, have also been updated to include the new safety information in alignment with the Comirnaty and Spikevax Prescribing Information and Information for Recipients and Caregivers. Moderna COVID-19 疫苗和 Pfizer-BioNTech COVID-19 疫苗的医疗保健提供者、接种者和护理人员情况说明书也已更新，包含与 Comirnaty 和 Spikevax 处方信息及接种者和护理人员信息一致的新安全信息，这两种疫苗均获准在 6 个月至 11 岁的个人中紧急使用。
The warning on myocarditis and pericarditis in the Prescribing Information for Comirnaty and Spikevax has been updated to convey that the observed risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines has been highest in males 12 through 24 years of age and to include the following new language: Comirnaty 和 Spikevax 处方信息中关于心肌炎和心包炎的警告已更新，以表明接种 mRNA COVID-19 疫苗后观察到的心肌炎和心包炎风险在 12 至 24 岁男性中最高，并包括以下新语言： Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age. 根据对住院和门诊商业健康保险索赔数据的分析，在接种 2023-2024 年配方 mRNA COVID-19 疫苗后 1 至 7 天内，6 个月至 64 岁人群中心肌炎和/或心包炎的未调整发病率估计为每百万剂约 8 例，12 至 24 岁男性中每百万剂约 27 例。 Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known. 一项纵向回顾性观察研究提供了关于确诊为COVID-19疫苗相关心肌炎的住院患者的心血管结局的随访信息。这些患者大多数在确诊前已接种两剂mRNA COVID-19疫苗基础免疫。在本研究中，在接种疫苗后约5个月的中位随访中，持续存在异常的心脏磁共振成像(CMR)结果（这是心肌损伤的标志）的情况很常见。这些CMR结果的临床和预后意义尚不清楚。
Purpose: To inform the public and healthcare providers that FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA) manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines. Specifically, FDA has required each manufacturer to update the warning about the risks of myocarditis and pericarditis to include information about (1) the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines and (2) the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 vaccine. FDA also required each manufacturer to describe the new safety information in the Adverse Reactions section of the Prescribing Information and in the Information for Recipients and Caregivers.
目的：告知公众和医疗保健提供者，FDA 已要求并批准更新辉瑞公司生产的 Comirnaty（COVID-19 疫苗，mRNA）和 ModernaTX, Inc. 生产的 Spikevax（COVID-19 疫苗，mRNA）的处方信息，以包含有关接种 mRNA COVID-19 疫苗后心肌炎和心包炎风险的新安全信息。具体而言，FDA 要求各制造商更新有关心肌炎和心包炎风险的警告，以包含以下信息：(1) 接种 2023-2024 年配方 mRNA COVID-19 疫苗后心肌炎和/或心包炎的估计未调整发病率，以及 (2) 一项研究的结果，该研究收集了接种 mRNA COVID-19 疫苗后患上心肌炎的人群的心脏磁共振成像 (cardiac MRI) 信息。 FDA 还要求每个制造商在处方信息的不良反应部分以及接受者和护理人员的信息中描述新的安全信息。
The Fact Sheets for Healthcare Providers and for Recipients and Caregivers for Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19, which are authorized for emergency use in individuals 6 months through 11 years of age, have also been updated to include the new safety information in alignment with the Comirnaty and Spikevax Prescribing Information and Information for Recipients and Caregivers.
Moderna COVID-19 疫苗和 Pfizer-BioNTech COVID-19 疫苗的医疗保健提供者、接种者和护理人员情况说明书也已更新，包含与 Comirnaty 和 Spikevax 处方信息及接种者和护理人员信息一致的新安全信息，这两种疫苗均获准在 6 个月至 11 岁的个人中紧急使用。
Comirnaty 和 Spikevax 处方信息中关于心肌炎和心包炎的警告已更新，以表明接种 mRNA COVID-19 疫苗后观察到的心肌炎和心包炎风险在 12 至 24 岁男性中最高，并包括以下新语言：
Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age. 根据对住院和门诊商业健康保险索赔数据的分析，在接种 2023-2024 年配方 mRNA COVID-19 疫苗后 1 至 7 天内，6 个月至 64 岁人群中心肌炎和/或心包炎的未调整发病率估计为每百万剂约 8 例，12 至 24 岁男性中每百万剂约 27 例。
Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known.
一项纵向回顾性观察研究提供了关于确诊为COVID-19疫苗相关心肌炎的住院患者的心血管结局的随访信息。这些患者大多数在确诊前已接种两剂mRNA COVID-19疫苗基础免疫。在本研究中，在接种疫苗后约5个月的中位随访中，持续存在异常的心脏磁共振成像(CMR)结果（这是心肌损伤的标志）的情况很常见。这些CMR结果的临床和预后意义尚不清楚。
很遗憾，这个议题被政治化。使得很多人，尤其年轻人受到伤害。