Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021.

Abstract

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.

• Authors: Sara E Oliver, Megan Wallace, Isaac See, Sarah Mbaeyi, Monica Godfrey, Stephen C Hadler, Tara C Jatlaoui, Evelyn Twentyman, Michelle M Hughes, Agam K Rao, Anthony Fiore, John R Su, Karen R Broder, Tom Shimabukuro, Allison Lale, David K Shay, Lauri E Markowitz, Melinda Wharton, Beth P Bell, Oliver Brooks, Veronica McNally, Grace M Lee, H Keipp Talbot, Matthew F Daley
• Journal: MMWR. Morbidity and mortality weekly report (MMWR Morb Mortal Wkly Rep) Vol. 71 Issue 3 Pg. 90-95 (Jan 21 2022) ISSN: 1545-861X [Electronic] United States
• PMID: 35051137 (Publication Type: Journal Article)

Chemical References

• Ad26COVS1
• COVID-19 Vaccines

Topics

• Ad26COVS1 (adverse effects)
• Adult
• Adverse Drug Reaction Reporting Systems
• Advisory Committees
• Aged
• COVID-19 (prevention & control)
• COVID-19 Vaccines (therapeutic use)
• Centers for Disease Control and Prevention, U.S.
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Female
• Humans
• Male
• Middle Aged
• Risk Assessment
• SARS-CoV-2 (immunology)
• Thrombocytopenia (chemically induced)
• United States (epidemiology)
• Vaccination (standards)