Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine - United States, March-April 2021.

@article{Shay2021SafetyMO,
  title={Safety Monitoring of the Janssen (Johnson \& Johnson) COVID-19 Vaccine - United States, March-April 2021.},
  author={David K. Shay and Julianne M Gee and John R Su and Tanya R. Myers and Paige L. Marquez and Ruiling Liu and Bicheng Zhang and Charles Licata and Thomas A. Clark and Tom T. Shimabukuro},
  journal={MMWR. Morbidity and mortality weekly report},
  year={2021},
  volume={70 18},
  pages={
          680-684
        }
}
On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Janssen (Ad.26.COV2.S) COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson) (1). The Janssen COVID-19 vaccine, the third COVID-19 vaccine authorized for use in the United States, uses a replication-incompetent human adenoviral type 26 vector platform* (2) and is administered as a single intramuscular dose, whereas the first two authorized vaccines… Expand
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Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients — United States, April 2021
TLDR
Patient and provider education about the risk for TTS with the Janssen COVID-19 vaccine, especially among women aged <50 years, as well as the availability of alternative CO VID-19 vaccines, is required to guide vaccine decision-making and ensure early recognition and clinical management of TTS. Expand
US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021.
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A case series of 12 US patients with CVST and thrombocytopenia following use of the Ad26.COV2.S vaccine is described to inform clinical guidance as Ad 26.COv2.C.S vaccination resumes in the US as well as investigations into the potential relationship between Ad26,COV1.S and heparin exposure. Expand
Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
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A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe–critical disease, including hospitalization and death, in an international, randomized, double-blind, placebo-controlled, phase 3 trial. Expand
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Fundamental vaccine safety concepts are described, an overview of VAERS is provided for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and how CDC and FDA analyze VAERS data are explained. Expand
Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination
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It is recommended that treatment with platelet transfusions be avoided because of the risk of progression in thrombotic symptoms and that the administration of a nonheparin anticoagulant agent and intravenous immune globulin be considered for the first occurrence of these symptoms. Expand
Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination
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Vaccination with Ch adenoviral vector encoding the spike protein antigen of severe acute respiratory syndrome coronavirus 2 can result in the rare development of immuneThrombotic thrombocytopenia mediated by platelet-activating antibodies against PF4, which clinically mimics autoimmune heparin-induced thromBocy topenia. Expand
Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination
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Findings in five patients who presented with venous thrombosis andThrombocytopenia 7 to 10 days after receiving the first dose of the ChAdOx1 nCoV-19 adenoviral vector vaccine against coronavirus disease 2019 (Covid-19) suggest that they represent a rare vaccine-related variant of spontaneous heparin-induced thromBocytopensia. Expand