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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.
MMWR Morb Mortal Wkly Rep. 2021 Apr 30; 70(17):651-656.MM

Abstract

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.

Authors

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Pub Type(s)

Journal Article

Language

eng

PubMed ID

33914723

Citation

MacNeil, Jessica R., et al. "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." MMWR. Morbidity and Mortality Weekly Report, vol. 70, no. 17, 2021, pp. 651-656.
MacNeil JR, Su JR, Broder KR, et al. 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. MMWR Morb Mortal Wkly Rep. 2021;70(17):651-656.
MacNeil, J. R., Su, J. R., Broder, K. R., Guh, A. Y., Gargano, J. W., Wallace, M., Hadler, S. C., Scobie, H. M., Blain, A. E., Moulia, D., Daley, M. F., McNally, V. V., Romero, J. R., Talbot, H. K., Lee, G. M., Bell, B. P., & Oliver, S. E. (2021). 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. MMWR. Morbidity and Mortality Weekly Report, 70(17), 651-656. https://doi.org/10.15585/mmwr.mm7017e4
MacNeil JR, et al. 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. MMWR Morb Mortal Wkly Rep. 2021 Apr 30;70(17):651-656. PubMed PMID: 33914723.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - MacNeil,Jessica R, AU - Su,John R, AU - Broder,Karen R, AU - Guh,Alice Y, AU - Gargano,Julia W, AU - Wallace,Megan, AU - Hadler,Stephen C, AU - Scobie,Heather M, AU - Blain,Amy E, AU - Moulia,Danielle, AU - Daley,Matthew F, AU - McNally,Veronica V, AU - Romero,José R, AU - Talbot,H Keipp, AU - Lee,Grace M, AU - Bell,Beth P, AU - Oliver,Sara E, Y1 - 2021/04/30/ PY - 2021/4/29/entrez PY - 2021/4/30/pubmed PY - 2021/5/4/medline SP - 651 EP - 656 JF - MMWR. Morbidity and mortality weekly report JO - MMWR Morb Mortal Wkly Rep VL - 70 IS - 17 N2 - 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. SN - 1545-861X UR - https://www.unboundmedicine.com/medline/citation/33914723/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_ L2 - https://doi.org/10.15585/mmwr.mm7017e4 DB - PRIME DP - Unbound Medicine ER -