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10.15585/mmwr.mm7017e4

http://scihub22266oqcxt.onion/10.15585/mmwr.mm7017e4
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33914723!8084127!33914723
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suck abstract from ncbi


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pmid33914723      MMWR+Morb+Mortal+Wkly+Rep 2021 ; 70 (17): 651-656
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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 #MMPMID33914723
  • MacNeil JR; Su JR; Broder KR; Guh AY; Gargano JW; Wallace M; Hadler SC; Scobie HM; Blain AE; Moulia D; Daley MF; McNally VV; Romero JR; Talbot HK; Lee GM; Bell BP; Oliver SE
  • MMWR Morb Mortal Wkly Rep 2021[Apr]; 70 (17): 651-656 PMID33914723show ga
  • On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Janssen COVID-19 (Ad.26.COV2.S) vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson; New Brunswick, New Jersey), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for its use in persons aged >/=18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of the Janssen COVID-19 vaccine after reports of six U.S. cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, a rare thromboembolic syndrome, among Janssen COVID-19 vaccine recipients (3). Two emergency ACIP meetings were rapidly convened to review reported cases of thrombosis with thrombocytopenia syndrome (TTS) and to consider updated recommendations for use of the Janssen COVID-19 vaccine in the United States. On April 23, 2021, after a discussion of the benefits and risks of resuming vaccination, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in all persons aged >/=18 years under the FDA's EUA, which now includes a warning that rare clotting events might occur after vaccination, primarily among women aged 18-49 years. 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 COVID-19 vaccines, is required to guide vaccine decision-making and ensure early recognition and clinical management of TTS.
  • |*Drug Approval[MESH]
  • |*Practice Guidelines as Topic[MESH]
  • |Adolescent[MESH]
  • |Adult[MESH]
  • |Adverse Drug Reaction Reporting Systems[MESH]
  • |Advisory Committees[MESH]
  • |COVID-19 Vaccines/*administration & dosage/*adverse effects[MESH]
  • |COVID-19/epidemiology/prevention & control[MESH]
  • |Centers for Disease Control and Prevention, U.S.[MESH]
  • |Drug Labeling[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Risk Assessment[MESH]
  • |Safety-Based Drug Withdrawals[MESH]
  • |Thrombocytopenia/*epidemiology[MESH]
  • |Thrombosis/*epidemiology[MESH]
  • |United States Food and Drug Administration[MESH]
  • |United States/epidemiology[MESH]


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