MMWR Released for Updated Recommendations for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome

Hello Immunization Partners,

On April 23, 2021, the Advisory Committee on Immunization Practices (ACIP) met to review information on the safety of Janssen (Johnson & Johnson) COVID-19 vaccine. After a discussion of the benefits and risks of resuming vaccination, the ACIP voted to reaffirm its original recommendation for use of the Janssen COVID-19 vaccine in all persons aged ≥ 18 years under the Food and Drug Administration’s (FDA) emergency use authorization (EUA), which now includes a warning that rare clotting events might occur after vaccination, primarily among women ages 18–49 years.

During the April 23 review, CDC reported on a total of 15 confirmed cases (including the previously reported 6 cases) of thrombosis with thrombocytopenia syndrome (TTS). On average, these cases were diagnosed 1–2 weeks after vaccination and occurred among the 7 million individuals vaccinated with the Janssen vaccine in the U.S before the pause. All 15 patients were women: thirteen were age 18–49 years and 2 were age 50–64 years. The incidence of TTS among women 18-49 years who received Janssen vaccine was 7 cases per million. For women aged 50 years and older the incidence was less than 1 per million.  No apparent links with typical risk factors for thrombosis (e.g., obesity, oral contraceptive use) were observed. Also, ACIP evaluated the benefits of the Janssen vaccine, including its high level of protection against circulating COVID-19 variants and the advantages of a single-dose vaccine.

On April 27^th the MMWR, 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 was released and recaps the ACIP meeting and vote.

Additional resources:  

• ACIP Presentation Slides: April 23, 2021 meeting gateway page

• CDC COCA Update for Clinicians: Johnson & Johnson/Janssen COVID-19 Vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS) 
• American Society of Hematology: Vaccine-Induced Immune Thrombotic Thrombocytopenia: Key Takeaways and FAQs
• American Society of Hematology and CDC Joint Webinar – Diagnosis and Management of Suspected Vaccine-Induced Immune Thrombotic Cytopenia (VITT) following Johnson & Johnson (Janssen) COVID-19 Vaccination (4/20/21)

Thank you for all your hard work to protect Michiganders from vaccine-preventable diseases!

-The Immunization Nurse Education Team, Andrea, Heidi, Maria, and Terri