TY - JOUR T1 - Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021. AU - Oliver,Sara E, AU - Wallace,Megan, AU - See,Isaac, AU - Mbaeyi,Sarah, AU - Godfrey,Monica, AU - Hadler,Stephen C, AU - Jatlaoui,Tara C, AU - Twentyman,Evelyn, AU - Hughes,Michelle M, AU - Rao,Agam K, AU - Fiore,Anthony, AU - Su,John R, AU - Broder,Karen R, AU - Shimabukuro,Tom, AU - Lale,Allison, AU - Shay,David K, AU - Markowitz,Lauri E, AU - Wharton,Melinda, AU - Bell,Beth P, AU - Brooks,Oliver, AU - McNally,Veronica, AU - Lee,Grace M, AU - Talbot,H Keipp, AU - Daley,Matthew F, Y1 - 2022/01/21/ PY - 2022/1/20/entrez PY - 2022/1/21/pubmed PY - 2022/1/29/medline SP - 90 EP - 95 JF - MMWR. Morbidity and mortality weekly report JO - MMWR Morb Mortal Wkly Rep VL - 71 IS - 3 N2 - On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use as a single-dose primary vaccination in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS), a rare condition characterized by low platelets and thrombosis, including at unusual sites such as the cerebral venous sinus (cerebral venous sinus thrombosis [CVST]), after receipt of the vaccine.* ACIP rapidly convened two emergency meetings to review reported cases of TTS, and 10 days after the pause commenced, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in persons aged ≥18 years, but included a warning regarding rare clotting events after vaccination, primarily among women aged 18-49 years (3). In July, after review of an updated benefit-risk assessment accounting for risks of Guillain-Barré syndrome (GBS) and TTS, ACIP concluded that benefits of vaccination with Janssen COVID-19 vaccine outweighed risks. Through ongoing safety surveillance and review of reports from the Vaccine Adverse Event Reporting System (VAERS), additional cases of TTS after receipt of Janssen COVID-19 vaccine, including deaths, were identified. On December 16, 2021, ACIP held an emergency meeting to review updated data on TTS and an updated benefit-risk assessment. At that meeting, ACIP made a recommendation for preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine, including both primary and booster doses administered to prevent COVID-19, for all persons aged ≥18 years. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines. SN - 1545-861X UR - https://www.unboundmedicine.com/medline/citation/35051137/Use_of_the_Janssen__Johnson_&_Johnson__COVID_19_Vaccine:_Updated_Interim_Recommendations_from_the_Advisory_Committee_on_Immunization_Practices___United_States_December_2021_ DB - PRIME DP - Unbound Medicine ER -