April 23, 2021
FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review
Agencies Underscore Confidence in Vaccine’s Safety and Effectiveness Following Data Assessment; Available Data Suggest Potential Blood Clots Are Very Rare Events
Safety Data Summary
- In clinical trials, side effects were common within 7 days of getting vaccinated but were mostly mild to moderate.
- Side effects were more common in people 18–59 years old compared to people 60 years and older.
- CDC will continue to provide updates as we learn more about the safety of the J&J/Janssen vaccine in real-world conditions.
SOURCE: CDC - https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html (April 15, 2021)
Clinical Trial Demographic Information
Clinical trials for the J&J/Janssen vaccine included people from the following racial and ethnic categories:
- 62.1% White
- 17.2% Black or African American
- 8.3% American Indian or Alaska Native
- 5.4% Multiple races
- 3.5% Asian
- 0.3% Native Hawaiian or other Pacific Islander
Ethnicity:
- 45.1% Hispanic or Latino
- 52.4% Not Hispanic or Latino
- 2.5% Unknown
Sex breakdown:
- 55.5% Male
- 44.5% Female
- <0.1% Undifferentiated or unknown sex
Age breakdown:
- 66.5% 18–59 years
- 33.5% 60 years and older
- 19.6% 65 years and older
- 3.5% 75 years and older
SOURCE: CDC - https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html (April 15, 2021)