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
| Autor: | Jose R. Romero, Amy Blain, Grace M. Lee, Danielle Moulia, Heather M. Scobie, Julia W. Gargano, Megan J. Wallace, Alice Guh, Veronica V. McNally, Jessica R. MacNeil, Stephen C. Hadler, John R. Su, Beth P. Bell, Matthew F. Daley, Sara E. Oliver, H. Keipp Talbot, Karen R. Broder |
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| Rok vydání: | 2021 |
| Předmět: |
Emergency Use Authorization
medicine.medical_specialty Health (social science) Epidemiology business.industry Health Toxicology and Mutagenesis Viral Vaccine 010102 general mathematics General Medicine 01 natural sciences Vaccination 03 medical and health sciences Patient safety 0302 clinical medicine Health Information Management Immunization Interim Family medicine Johnson Johnson Medicine 030212 general & internal medicine 0101 mathematics Risk assessment business |
| Zdroj: | MMWR. Morbidity and Mortality Weekly Report. 70:651-656 |
| ISSN: | 1545-861X 0149-2195 |
| DOI: | 10.15585/mmwr.mm7017e4 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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