Important update: Healthcare facilities
CDC has updated select ways to operate healthcare systems effectively in response to COVID-19 vaccination. Learn more
UPDATE
Given new evidence on the B.1.617.2 (Delta) variant, CDC has updated the guidance for fully vaccinated people. CDC recommends universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Children should return to full-time in-person learning in the fall with layered prevention strategies in place.
UPDATE
The White House announced that vaccines will be required for international travelers coming into the United States, with an effective date of November 8, 2021. For purposes of entry into the United States, vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. More information is available here.
UPDATE
Travel requirements to enter the United States are changing, starting November 8, 2021. More information is available here.

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

Johnson & Johnson’s Janssen COVID-19 Vaccine: Overview and Safety
Recommended for People 18 Years and Older

Stay up to date
Guidance for people who are immunocompromised

General Information

Manufacturer: Janssen Pharmaceuticals Companies of Johnson & Johnson

Number of Shots: 1 shot may be given in some situations.

People ages 18 years and older who are moderately or severely immunocompromised and who received Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 vaccine should get a second dose of an mRNA COVID-19 vaccine (Pfizer-BioNTech or Moderna).

Booster Shot: Everyone ages 18 years and older should get a booster. Some people can also choose to receive a second booster.

Type of Vaccine: Viral Vector

How Given: Shot in the muscle of the upper arm

Does NOT Contain: Eggs, preservatives, latex, or metals
See full list of ingredients

Name: JNJ-78436735

When to Consider J&J/Janssen COVID-19 Vaccine

In most situations, Pfizer-BioNTech or Moderna COVID-19 vaccines are preferred over the J&J/Janssen COVID-19 vaccine for primary and booster vaccination due to the risk of serious adverse events. Vaccine recipients must be informed of the risks and benefits of J&J/Janssen COVID-19 vaccination. The J&J/Janssen COVID-19 vaccine may be considered in some situations, including for persons who:

  • Had a severe reaction after an mRNA vaccine dose or who have a severe allergy to an ingredient of Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines).
  • Would otherwise remain unvaccinated for COVID-19 due to limited access to Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines).
  • Wants to get the J&J/Janssen COVID-19 vaccine despite the safety concerns.

Learn more about the considerations for J&J/Janssen COVID-19 vaccine.

Safety Data Summary

In most situations, Pfizer-BioNTech or Moderna COVID-19 vaccines are preferred over the J&J/Janssen COVID-19 vaccine for primary and booster vaccination due to the risk of serious adverse events.

  • There is a plausible causal relationship between J&J/Janssen COVID-19 vaccine and a rare and serious adverse event—blood clots with low platelets (thrombosis with thrombocytopenia syndrome, or TTS).

Learn more about vaccine safety monitoring after a vaccine is authorized or approved for use.

How Well the Vaccine Works

  • The J&J/Janssen COVID-19 vaccine was 66.3% effective in clinical trials at preventing laboratory-confirmed COVID-19 infection in people who received the vaccine and had no evidence of being previously infected. People had the most protection 2 weeks after getting vaccinated.
  • In the clinical trials, the vaccine had high efficacy at preventing hospitalization and death in people who did get sick.

Johnson & Johnson (J&J)/Janssen COVID-19 Vaccine Ingredients

The J&J/Janssen COVID-19 vaccine contains a piece of a modified virus that is not the virus that causes COVID-19. This modified virus is called the vector virus. The vector virus cannot reproduce itself, so it cannot cause COVID-19. This vector virus gives instructions to cells in the body to create an immune response. This response helps protect you from getting sick with COVID-19 in the future. After the body produces an immune response, it gets rid of all of the vaccine ingredients just as it would discard any information that cells no longer need. This process is a part of normal body functioning.

All COVID-19 vaccines are manufactured with as few ingredients as possible and with only the necessary amounts of each ingredient. Nearly all of the ingredients in COVID-19 vaccines are also the ingredients in many foods – fats, sugars, and salts. Each ingredient in the vaccine serves a specific purpose as seen in the table below.

Full list of ingredients

The J&J/Janssen COVID-19 vaccine contains the following ingredients:

Type of Ingredient

Type of Ingredient

Type of Ingredient

Ingredient

Ingredient

Ingredient

Purpose

Purpose

Purpose

A harmless version of a virus unrelated to the COVID-19 virus

Type of Ingredient

A harmless version of a virus unrelated to the COVID-19 virus

  • Recombinant, replication-incompetent Ad26 vector, encoding a stabilized variant of the SARS-CoV-2 Spike (S) protein
Ingredient
  • Recombinant, replication-incompetent Ad26 vector, encoding a stabilized variant of the SARS-CoV-2 Spike (S) protein

Provides instructions the body uses to build a harmless piece of a protein from the virus that causes COVID-19. This protein causes an immune response that helps protect the body from getting sick with COVID-19 in the future.

Purpose

Provides instructions the body uses to build a harmless piece of a protein from the virus that causes COVID-19. This protein causes an immune response that helps protect the body from getting sick with COVID-19 in the future.

Sugars, salts, acid, and acid stabilizer

Type of Ingredient

Sugars, salts, acid, and acid stabilizer

  • Polysorbate-80
  • 2-hydroxypropyl-β-cyclodextrin
  • Trisodium citrate dihydrate
  • Sodium chloride (basic table salt)
  • Citric acid monohydrate (closely related to lemon juice)
  • Ethanol (a type of alcohol)
Ingredient
  • Polysorbate-80
  • 2-hydroxypropyl-β-cyclodextrin
  • Trisodium citrate dihydrate
  • Sodium chloride (basic table salt)
  • Citric acid monohydrate (closely related to lemon juice)
  • Ethanol (a type of alcohol)

Work together to help keep the vaccine molecules stable while the vaccine is manufactured, shipped, and stored until it is ready to be given to a vaccine recipient.

Purpose

Work together to help keep the vaccine molecules stable while the vaccine is manufactured, shipped, and stored until it is ready to be given to a vaccine recipient.

A harmless version of a virus unrelated to the COVID-19 virus:
Recombinant, replication-incompetent Ad26 vector, encoding a stabilized variant of the SARS-CoV-2 Spike (S) protein

Purpose
Provides instructions the body uses to build a harmless piece of a protein from the virus that causes COVID-19. This protein causes an immune response that helps to protect the body from getting sick with COVID-19 in the future.

Sugars, salts, acid, and acid stabilizer:

  • Polysorbate-80
  • 2-hydroxypropyl-β-cyclodextrin
  • Trisodium citrate dihydrate
  • Sodium chloride (basic table salt)
  • Citric acid monohydrate (closely related to lemon juice)
  • Ethanol (a type of alcohol)

Purpose
Work together to help keep the vaccine molecules stable while the vaccine is manufactured, shipped, and stored until it is ready to be given to a vaccine recipient.

Ingredients that are NOT used in COVID-19 vaccines

The above table lists ALL ingredients in the J&J/Janssen COVID-19 vaccine. There are NO ingredients in this vaccine beyond what is listed in that table. The J&J/Janssen COVID-19 vaccine has:

  • No preservatives like thimerosal or mercury or any other preservatives.
  • No antibiotics like sulfonamide or any other antibiotics.
  • No medicines or therapeutics like ivermectin or any other medications.
  • No tissues like aborted fetal cells, gelatin, or any materials from any animal.
  • No food proteins like eggs or egg products, gluten, peanuts, tree nuts, nut products, or any nut byproducts (COVID-19 vaccines are not manufactured in facilities that produce food products).
  • No metals like iron, nickel, cobalt, titanium, rare earth alloys, or any manufactured products like microelectronics, electrodes, carbon nanotubes or other nanostructures, or nanowire semiconductors.
  • No latex. The vial stoppers used to hold the vaccine also do not contain latex.