Johnson & Johnson’s Janssen COVID-19 Vaccine Overview and Safety

Johnson & Johnson’s Janssen COVID-19 Vaccine Overview and Safety

General Information

Johnson & Johnson’s Janssen COVID-19 Vaccine: CDC and FDA have recommended a pause in the use of Johnson & Johnson’s J&J/Janssen COVID-19 Vaccine in the United States out of an abundance of caution, effective Tuesday, April 13. The Advisory Committee on Immunization Practices (ACIP) will hold its second emergency meeting to discuss J&J/Janssen COVID-19 Vaccine on April 23, 2021. 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 seek medical care right away.

Name: JNJ-78436735

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

Who Should Get Vaccinated
Who Should NOT Get Vaccinated
  • 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:

  • Pain
  • Redness
  • Swelling

Throughout the rest of your body:

  • Tiredness
  • Headache
  • Muscle pain
  • Chills
  • Fever
  • Nausea

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.

Other Authorized and Recommended COVID-19 Vaccines in the U.S.

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

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