Tainya C. Clarke

Safety monitoring of health outcomes following RSVPreF3 + AS01 and RSVPreF vaccination among Medicare beneficiaries aged 65 years and older in the United States, 2023–2024

Patricia C. Lloyd, Purva B. Shah, Henry T. Zhang, Nimesh Shah et autres

us (code pays fourni par la source)

Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States

Shelby S. Fisher, Arnstein Lindaas, Stella G. Muthuri, Patricia C. Lloyd et autres

INTRODUCTION: Neurologic or immune-mediated conditions have been evaluated as potential adverse events (AEs) in coronavirus disease 2019 (COVID-19) vaccine safety surveillance. To contextualize United States (US) surveillance findings, it is important to quantify the association of AEs with COVID-19 diagnoses among US …

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Safety monitoring of health outcomes following influenza vaccination during the 2023–2024 season among U.S. Commercially-insured individuals aged 6 months through 64 years: Self-controlled case series analyses

Patricia C. Lloyd, G. P. Acharya, Henu Zhao, Bowen Chen et autres

us, gb (code pays fourni par la source)

Effectiveness over time of a primary series of the original monovalent COVID-19 vaccines in adults in the United States

J. Bradley Layton, Patricia C. Lloyd, Lauren Saag Peetluk, Yixin Jiao et autres

With data from 2 US claims databases (Optum, CVS Health) supplemented with Immunization Information System COVID-19 vaccine records, we evaluated overall and time-specific vaccine effectiveness (VE) of an initial primary series for 3 monovalent COVID-19 vaccines-BNT162b2, mRNA-1273, and JNJ-7836735-in adults (18-64 years). …

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Safety Monitoring of Bivalent COVID ‐19 mRNA Vaccines Among Recipients 6 Months and Older in the United States

Patricia C. Lloyd, Elizabeth R. B. Smith, Joann F. Gruber, Michelle Ondari et autres

PURPOSE: Active monitoring of health outcomes after COVID-19 vaccination provides early detection of rare outcomes post-licensure. We evaluated health outcomes following bivalent COVID-19 Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273.222) vaccination in the United States. METHODS: Multiple health outcomes were monitored monthly from August …

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Safety monitoring of health outcomes following influenza vaccination during the 2023–2024 season among U.S. Medicare beneficiaries aged 65 years and older

Patricia C. Lloyd, G. P. Acharya, Henu Zhao, Nimesh Shah et autres

us (code pays fourni par la source)

Evaluation of Guillain-Barré syndrome following Respiratory Syncytial Virus Vaccination among Medicare Beneficiaries 65 Years and Older

Patricia C. Lloyd, Purva B. Shah, Henry T. Zhang, Nimesh Shah et autres

Abstract Importance The United States Food and Drug Administration conducts routine post-market surveillance of approved vaccines to identify and characterize health outcomes risk associated with vaccination. Pre-licensure clinical trials of RSVPreF3+AS01 and RSVPreF vaccines identified a small number of Guillain-Barré syndrome cases, …

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Safety Monitoring of Health Outcomes following Influenza Vaccination during the 2023-2024 Season among U.S. Medicare Beneficiaries Aged 65 Years and Older

Patricia C. Lloyd, G. P. Acharya, Henu Zhao, Nimesh Shah et autres

ABSTRACT Background Influenza vaccination is widely recommended for individuals aged 6 months and older in the United States (U.S.). While the safety of annual influenza vaccines is well established, FDA conducts routine monitoring and evaluation of safety. This study assessed the safety …

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Safety Monitoring of Mpox Vaccines in Adults Aged 18–64 Years during the 2022 Mpox Outbreak in the U.S.

Joann F. Gruber, Kathryn Matuska, Carla E Zelaya, Jing Wang et autres

Abstract Two vaccines (JYNNEOS; ACAM2000) were available in the United States to prevent mpox during the 2022 clade II mpox outbreak with the majority of people receiving JYNNEOS. As part of the Biologics Effectiveness and Safety (BEST) Initiative, FDA monitored the safety …

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Evaluating the Risk of Cardiovascular Adverse Events and Appendicitis After COVID-19 Diagnosis in Adults in the United States: Implications of the Start of Follow-Up

J. Bradley Layton, Arnstein Lindaas, Stella G. Muthuri, Patricia C. Lloyd et autres

Abstract Purpose This study evaluated the association between coronavirus disease 2019 (COVID-19) diagnosis and adverse events (AEs), including cardiovascular AEs and appendicitis, in US adults before the introduction of COVID-19 vaccines. Real-world studies of AEs after COVID-19 suggest that diagnoses of AEs …

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Effectiveness Over Time of a Primary Series of the Original Monovalent COVID-19 Vaccines in Adults in the United States

J. Bradley Layton, Patricia C. Lloyd, Lauren Saag Peetluk, Yixin Jiao et autres

With data from 2 US claims databases (Optum, CVS Health) supplemented with Immunization Information System COVID 19 vaccine records, we evaluated overall and time-specific vaccine effectiveness (VE) of an initial primary series for 3 monovalent COVID 19 vaccines—BNT162b2, mRNA-1273, and JNJ-7836735—in adults …

us (code pays fourni par la source)

Risk of Neurologic or Immune-Mediated Adverse Events After COVID-19 Diagnosis in the United States

Shelby S. Fisher, Arnstein Lindaas, Stella G. Muthuri, Patricia C. Lloyd et autres

us (code pays fourni par la source)