South San Francisco, CA April 13, 2021 from CDC
CDC and FDA have recommended a pause in the use of the Johnson & Johnson’s Janssen COVID-19 vaccine in the United States out of an abundance of caution, effective Tuesday, April 13. CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday, April 14, to address this issue.
People who have received the J&J/Janssen COVID-19 vaccine within the past three weeks who develop severe headache, abdominal pain, leg pain, or shortness of breath should contact their health care provider.
Manufacturer: Janssen Pharmaceuticals Companies of Johnson & Johnson
Type of Vaccine: Viral Vector
Number of Shots: 1 shot
How Given: Shot in the muscle of the upper arm
Does NOT Contain: Eggs, preservatives, latex
Full List of Ingredients [PDF – 6 pages]external icon
- The J&J/Janssen vaccine is recommended for people aged 18 years and older.
- Learn more about how CDC is making COVID-19 vaccine recommendations and CDC’s vaccine rollout recommendations
- If you have had a severe allergic reaction (anaphylaxis) or an immediate allergic reaction—even if it was not severe—to any ingredientexternal icon in the J&J/Janssen COVID-19 vaccine (such as polysorbate), you should not get the J&J/Janssen COVID-19 vaccine.
- An allergic reaction is considered severe when a person needs to be treated with epinephrine or EpiPen© or if they must go to the hospital. Experts refer to severe allergic reactions as anaphylaxis. Learn about common side effects of COVID-19 vaccines and when to call a doctor.
- An immediate allergic reaction means a reaction within 4 hours of getting vaccinated, including symptoms such as hives, swelling, or wheezing (respiratory distress).
If you aren’t able to get the J&J/Janssen COVID-19 vaccine, you may still be able to get a different type of COVID-19 vaccine. Learn more information for people with allergies.
Possible Side Effects
In the arm where you got the shot:
Throughout the rest of your body:
- Muscle pain
These side effects usually start within a day or two of getting the vaccine. Side effects might affect your ability to do daily activities, but they should go away in a few days.
You should get the first COVID-19 vaccine that is available to you. Do not wait for a specific brand. All currently authorized and recommended COVID-19 vaccines are safe and effective, and CDC does not recommend one vaccine over another.
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.
Learn more about vaccine safety monitoring after a vaccine is authorized or approved for use.
How Well the Vaccine Works
- The J&J/Janssen vaccine was 66.3% effective in clinical trials (efficacy) at preventing laboratory-confirmed COVID-19 illness in people who had no evidence of prior infection 2 weeks after receiving the vaccine. People had the most protection 2 weeks after getting vaccinated.
- The vaccine had high efficacy at preventing hospitalization and death in people who did get sick. No one who got COVID-19 at least 4 weeks after receiving the J&J/Janssen vaccine had to be hospitalized.
- Early evidence suggests that the J&J/Janssen vaccine might provide protection against asymptomatic infection, which is when a person is infected by the virus that causes COVID-19 but does not get sick.
- CDC will continue to provide updates as we learn more about how well the J&J/Janssen vaccine works in real-world conditions.
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
- 45.1% Hispanic or Latino
- 52.4% Not Hispanic or Latino
- 2.5% Unknown
- 55.5% Male
- 44.5% Female
- <0.1% Undifferentiated or unknown sex
- 66.5% 18–59 years
- 33.5% 60 years and older
- 19.6% 65 years and older
- 3.5% 75 years and older