학술논문
Evaluation of potential adverse events following COVID-19 mRNA vaccination among adults aged 65 years and older: Two self-controlled studies in the U.S.
Document Type
Academic Journal
Author
Shoaibi A; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U. S. Food & Drug Administration, 10903 New Hampshire Ave., Building 71, Silver Spring, MD 20993, United States. Electronic address: Azadeh.Shoaibi@fda.hhs.gov.; Lloyd PC; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U. S. Food & Drug Administration, 10903 New Hampshire Ave., Building 71, Silver Spring, MD 20993, United States. Electronic address: Patricia.Lloyd@fda.hhs.gov.; Wong HL; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U. S. Food & Drug Administration, 10903 New Hampshire Ave., Building 71, Silver Spring, MD 20993, United States. Electronic address: Huilee.Wong@fda.hhs.gov.; Clarke TC; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U. S. Food & Drug Administration, 10903 New Hampshire Ave., Building 71, Silver Spring, MD 20993, United States. Electronic address: Tainya.Clarke@fda.hhs.gov.; Chillarige Y; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: ychillarige@acumenllc.com.; Do R; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: rdo@acumenllc.com.; Hu M; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: mhu@acumenllc.com.; Jiao Y; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: yjiao@acumenllc.com.; Kwist A; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: akwist@acumenllc.com.; Lindaas A; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: alindaas@acumenllc.com.; Matuska K; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: kmatuska@acumenllc.com.; McEvoy R; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: rmcevoy@acumenllc.com.; Ondari M; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: mondari@acumenllc.com.; Parulekar S; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: sparulekar@acumenllc.com.; Shi X; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: xshi@acumenllc.com.; Wang J; Acumen, LLC, 500 Airport Blvd. Suite 100, Burlingame, CA 94010, United States. Electronic address: jwang@acumenllc.com.; Lu Y; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U. S. Food & Drug Administration, 10903 New Hampshire Ave., Building 71, Silver Spring, MD 20993, United States. Electronic address: Yun.Lu@fda.hhs.gov.; Obidi J; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U. S. Food & Drug Administration, 10903 New Hampshire Ave., Building 71, Silver Spring, MD 20993, United States. Electronic address: Joyce.Obidi@fda.hhs.gov.; Zhou CK; Formerly Affiliated with US Food and Drug Administration, Silver Spring, MD, United States.; Kelman JA; Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop B3-30-03, Baltimore, MD 21244-1850, United States.; Forshee RA; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U. S. Food & Drug Administration, 10903 New Hampshire Ave., Building 71, Silver Spring, MD 20993, United States. Electronic address: Richard.Forshee@fda.hhs.gov.; Anderson SA; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, U. S. Food & Drug Administration, 10903 New Hampshire Ave., Building 71, Silver Spring, MD 20993, United States. Electronic address: Steven.Anderson@fda.hhs.gov.
Source
Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Our near-real-time safety monitoring of 16 adverse events (AEs) following COVID-19 mRNA vaccination identified potential elevation in risk for six AEs following primary series and monovalent booster dose administration. The crude association with AEs does not imply causality. Accordingly, we conducted robust evaluation of potential associations.
Methods: We conducted two self-controlled case series studies of COVID-19 mRNA vaccines (BNT162b2 and mRNA-1273) in U.S. Medicare beneficiaries aged ≥ 65 years. Adjusted incidence rate ratio (IRRs) and 95 % confidence intervals (CIs) were estimated following primary series doses for acute myocardial infarction (AMI), pulmonary embolism (PE), immune thrombocytopenia (ITP), disseminated intravascular coagulation (DIC); and following monovalent booster doses for AMI, PE, ITP, Bell's Palsy (BP) and Myocarditis/Pericarditis (Myo/Peri).
Results: The primary series study included 3,360,981 individuals who received 6,388,542 primary series doses; the booster study included 6,156,100 individuals with one monovalent booster dose. The AMI IRR following BNT162b2 primary series and booster was 1.04 (95 % CI: 0.91 to 1.18) and 1.06 (95 % CI: 1.003 to 1.12), respectively; for mRNA-1273 primary series and booster, 1.01 (95 % CI: 0.82 to 1.26) and 1.05 (95 % CI: 0.998 to 1.11), respectively. The hospital inpatient PE IRR following BNT162b2 primary series and booster was 1.19 (95 % CI: 1.03 to 1.38) and 0.86 (95 % CI: 0.78 to 0.95), respectively; for mRNA-1273 primary series and booster, 1.15 (95 % CI: 0.94 to 1.41) and 0.87 (95 % CI: 0.79 to 0.96), respectively. The studies' results do not support that exposure to COVID-19 mRNA vaccines elevate the risk of ITP, DIC, Myo/Peri, and BP.
Conclusion: We did not find an increased risk for AMI, ITP, DIC, BP, and Myo/Peri and there was not consistent evidence for PE after exposure to COVID-19 mRNA primary series or monovalent booster vaccines. These results support the favorable safety profile of COVID-19 mRNA vaccines administered in the U.S. elderly population.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Published by Elsevier Ltd.)
Methods: We conducted two self-controlled case series studies of COVID-19 mRNA vaccines (BNT162b2 and mRNA-1273) in U.S. Medicare beneficiaries aged ≥ 65 years. Adjusted incidence rate ratio (IRRs) and 95 % confidence intervals (CIs) were estimated following primary series doses for acute myocardial infarction (AMI), pulmonary embolism (PE), immune thrombocytopenia (ITP), disseminated intravascular coagulation (DIC); and following monovalent booster doses for AMI, PE, ITP, Bell's Palsy (BP) and Myocarditis/Pericarditis (Myo/Peri).
Results: The primary series study included 3,360,981 individuals who received 6,388,542 primary series doses; the booster study included 6,156,100 individuals with one monovalent booster dose. The AMI IRR following BNT162b2 primary series and booster was 1.04 (95 % CI: 0.91 to 1.18) and 1.06 (95 % CI: 1.003 to 1.12), respectively; for mRNA-1273 primary series and booster, 1.01 (95 % CI: 0.82 to 1.26) and 1.05 (95 % CI: 0.998 to 1.11), respectively. The hospital inpatient PE IRR following BNT162b2 primary series and booster was 1.19 (95 % CI: 1.03 to 1.38) and 0.86 (95 % CI: 0.78 to 0.95), respectively; for mRNA-1273 primary series and booster, 1.15 (95 % CI: 0.94 to 1.41) and 0.87 (95 % CI: 0.79 to 0.96), respectively. The studies' results do not support that exposure to COVID-19 mRNA vaccines elevate the risk of ITP, DIC, Myo/Peri, and BP.
Conclusion: We did not find an increased risk for AMI, ITP, DIC, BP, and Myo/Peri and there was not consistent evidence for PE after exposure to COVID-19 mRNA primary series or monovalent booster vaccines. These results support the favorable safety profile of COVID-19 mRNA vaccines administered in the U.S. elderly population.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Published by Elsevier Ltd.)