The Centers for Disease Control & Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) met today to discuss Janssen (Johnson & Johnson) COVID-19 Vaccine and the recommendations for use in the United States following a nationwide pause earlier this month. After discussing the benefits and risks associated with the vaccine, ACIP voted to recommend the Janssen COVID-19 vaccine for persons 18 years of age and older in the U.S. population under the U.S. Food & Drug Administration's (FDA) Emergency Use Authorization (EUA).
Initially the Committee discussed the following policy options and recommendations for the Janssen vaccine:
- Recommend against use for all persons.
- Reaffirm recommendations for all age and sex; FDA to include warning statement with EUA.
- Recommend vaccination only for adults 50 years of age and older.
-
Reaffirm recommendations for use; women younger than 50 years should be aware of the increased risk of thrombocytopenia syndrome (TTS) and may choose another COVID-19 vaccine (i.e., mRNA vaccines).
After discussion, the Committee vote narrowed the recommendation to the following two options:
- The Janssen COVID-19 vaccine is recommended for persons 18 years of age and older in the U.S. population under the FDA’s EUA.
-
The Janssen COVID-19 vaccine is recommended for persons 18 years of age and older in the U.S. population under the FDA’s EUA. Women younger than 50 years should be aware of the increased risk of thrombocytopenia syndrome (TTS) and may choose another COVID-19 vaccine authorized for use in the United States (i.e., mRNA vaccines).
A vote on the first option resulted in ten members voting in favor, four opposing and one abstaining. The language for option one was then passed.
Next steps:
The FDA will put out newly approved EUA language to include the new thrombosis and thrombocytopenia risk of the J&J COVID vaccines. A CDC Clinician Outreach and Communication Activity (COCA) call will take place early next week. In addition to the COCA call, the FDA and CDC will issue an update in a Morbidity and Mortality Weekly Report (MMWR), as well as communications and education materials as early as next week.
MPA will provide additional information when available.