Janssen COVID-19 Vaccine (Johnson & Johnson) Questions

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CDC and FDA have recommended a pause in the use of the Janssen (Johnson & Johnson) COVID-19 vaccine in the United States out of an abundance of caution, effective Tuesday, April 13. Of the 6.8 million Janssen COVID-19 vaccine doses administered in the United States to date, six cases of a type of blood clot called “cerebral venous sinus thrombosis” (CVST) were seen in combination with low levels of blood platelets (thrombocytopenia). CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday, April 14, to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.

If you are a COVID-19 Vaccination Provider with Janssen (Johnson & Johnson) vaccine:

  1. Mark any Janssen/J&J vaccine in your inventory “Do not use. Awaiting guidance.”
  2. Continue to store the vaccine in the refrigerator between 2°C and 8°C (36°F and 46°F).
  3. Follow vaccine storage practices and continue to monitor and document storage unit temperatures.

Vaccine Supply and Distribution

The minimum order size and increment for Janssen COVID-19 Vaccine is 100 doses (2 cartons of 10 multidose vials, 5 doses per vial) per order.

Vaccination Schedule and Use

Janssen COVID-19 Vaccine is authorized and recommended for persons 18 years of age and older.

The recommendation for Janssen COVID-19 Vaccine should be implemented in conjunction with the Advisory Committee on Immunization Practices’ (ACIP) interim recommendations for allocation of COVID-19 vaccine. You may also consider sub-prioritization among recommended populations.

All people for whom vaccination is indicated should receive 1 dose of Janssen COVID-19 Vaccine.

COVID-19 vaccines are not interchangeable. The safety and efficacy of a mixed-product series have not been evaluated. In most cases, if patients begin a series with an mRNA COVID-19 vaccine, they should complete the series with the same product. In limited, exceptional situations where a patient received the first dose of an mRNA COVID-19 vaccine but is unable to complete the series with either the same or different mRNA COVID-19 vaccine (e.g., due to contraindication), you may consider a single dose of Janssen COVID-19 Vaccine, with a minimum interval of 28 days between doses. See the Contraindications and Precautions section of CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines for additional information on use of Janssen COVID-19 Vaccine and additional precautions for people with a contraindication to mRNA COVID-19 vaccines.

Yes. You should routinely administer Janssen COVID-19 Vaccine alone, with a minimum interval of 14 days before or after administration of any other vaccine.

However, you may administer Janssen COVID-19 Vaccine and other vaccines within a shorter period in situations where the benefits of vaccination are deemed to outweigh the potential unknown risks of vaccine coadministration (such as tetanus-toxoid-containing vaccination as part of wound management, measles or hepatitis A vaccination during an outbreak) or to avoid barriers to or delays in COVID-19 vaccination (for example, in long-term care facility residents or healthcare personnel who received influenza or other vaccinations prior to or upon admission or onboarding). If Janssen COVID-19 Vaccine is administered within 14 days of another vaccine, do not repeat doses of either vaccine. This deviation from CDC guidance does not require reporting to the Vaccine Adverse Event Reporting System (VAERS).

Learn more about coadministration with other vaccines.

Vaccine Indications

Yes, you may administer any currently authorized COVID-19 vaccine to people with underlying medical conditions; the Advisory Committee on Immunization Practices (ACIP) does not state a product preference. This includes people with:

  • Immunocompromising conditions or people who take immunosuppressive medication or therapies
  • Autoimmune conditions
  • A history of Guillain-Barré syndrome
  • A history of Bell’s palsy
  • A history of dermal filler use

Learn more about vaccinating patients with underlying medical conditions.

Immunocompromised patients can receive any currently authorized COVID-19 vaccine; however, you should consider counseling them and timing immunosuppressive therapies.

Counsel immunocompromised patients about the:

  • Unknown vaccine safety profile and effectiveness in immunocompromised populations
  • Potential for reduced immune responses
  • Need to continue to follow current guidance to protect themselves against COVID-19

Data are currently insufficient to inform optimal timing of COVID-19 vaccination and receipt of immunosuppressive therapies. However, based on general best practices for vaccination of immunocompromised people, ideally COVID-19 vaccination should be completed at least two weeks before initiation of immunosuppressive therapies. When it is not possible to administer a complete COVID-19 vaccine series (i.e., 2 doses of an mRNA vaccine or a single dose of Janssen COVID-19 Vaccine) in advance, you may still vaccinate patients on immunosuppressive therapy. Decisions to delay immunosuppressive therapy to complete COVID-19 vaccination should consider the patient’s risks related to their underlying condition.

At this time, revaccination is not recommended after patients regain immune competence. Recommendations on revaccination or additional doses of COVID-19 vaccines may be updated when more information is available.

Learn more about vaccinating patients with underlying medical conditions.

Yes. Pregnant or lactating people can receive any of the currently authorized COVID-19 vaccines; the Advisory Committee on Immunization Practices (ACIP) does not state a product preference.

When making a decision about vaccination, you and your pregnant patient should consider the:

  • Level of COVID-19 community transmission
  • Patient’s personal risk of contracting COVID-19
  • Risks of COVID-19 to the patient and potential risks to the fetus
  • Efficacy of the vaccine
  • Side effects of the vaccine
  • Limited data about the vaccine during pregnancy

Encourage pregnant people who choose to be vaccinated to enroll in v-safe, a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after COVID-19 vaccination. A v-safe pregnancy registry has been established to follow outcomes among pregnant people who are vaccinated.

Learn more about vaccination of pregnant or lactating people.

Recommendations for vaccination depend on when a person has or had SARS-CoV-2 infection and when they received treatment.

People with a history of infection: Offer vaccination regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection.

While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. While vaccine supply remains limited, people with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination, if desired. However, they should recognize that the risk of reinfection and, therefore, the need for vaccination, can increase with time following initial infection.

People with a current infection: Defer vaccination of people with known current SARS-CoV-2 infection until the person has recovered from acute illness (if the person has symptoms) and until criteria have been met for them to discontinue isolation. This recommendation applies to any vaccine, including the first and second doses of COVID-19 vaccine.

People who previously received passive antibody therapy as part of COVID-19 treatment: Defer vaccination for at least 90 days after receipt of passive antibody therapy (monoclonal antibodies or convalescent plasma). This recommendation applies to people who receive passive antibody therapy before receiving any COVID-19 vaccine dose and to those who receive passive antibody therapy after the first dose of an mRNA COVID-19 vaccine but before the second dose, in which case the second dose should be deferred for at least 90 days following receipt of the antibody therapy.

Learn more about COVID-19 vaccination and SARS-CoV-2 infection.

No, your patient may be vaccinated. Although people who have received passive antibody therapy as treatment for COVID-19 should wait 90 days before vaccination, there is no minimum interval between antibody therapies not specific to COVID-19 treatment and COVID-19 vaccination.

As with other vaccines, a moderate or severe illness is a precaution to receiving any currently authorized COVID-19 vaccine. It is not considered a contraindication. Generally, vaccination should be delayed until the acute illness has improved. However, if you and your patient feel the potential benefits of vaccination outweigh the potential risks, they may receive COVID-19 vaccine.

The following considerations can be used to help the provider conduct a risk assessment for COVID-19 vaccination:

  • Risk of exposure to SARS-CoV-2 (e.g., living in a congregate setting, such as a long-term care facility; or occupation)
  • Risk of severe disease or death due to COVID-19 (e.g., because of age or underlying medical conditions)
  • Whether the patient has previously been infected with SARS-CoV-2 and, if so, how long ago
    • Note: Vaccination is recommended for people with a history of COVID-19. However, because the risk of reinfection is low in the months after initial infection, people with a precaution to vaccination and recent COVID-19 may choose to delay vaccination.

Contraindications and Precautions

Contraindications to vaccination with Janssen COVID-19 Vaccine include:

  • Severe allergic reaction (e.g., anaphylaxis) to a component of Janssen COVID-19 Vaccine
  • Immediate allergic reaction of any severity or known (diagnosed) allergy to a component of the vaccine (see Appendix C for a list of vaccine components)

Do not vaccinate people with a contraindication. Consider referral to an allergist-immunologist or other vaccine alternative. You may consider mRNA COVID-19 vaccination for people with a contraindication to Janssen COVID-19 Vaccine (including a contraindication due to a known polysorbate allergy). People with a contraindication to Janssen COVID-19 Vaccine have a precaution to mRNA vaccines. In these cases, consider consultation with an allergist-immunologist to help determine if the patient can safely receive vaccination. Healthcare providers and health departments may also request a consultation from the Clinical Immunization Safety Assessment COVIDvax Project. Vaccination of these people should only be done in an appropriate setting under the supervision of a healthcare provider experienced in the management of severe allergic reactions.

Learn more about COVID-19 vaccine contraindications and precautions.

Precautions for Janssen COVID-19 Vaccine include:

  • History of an immediate allergic reaction to any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies)
  • Contraindication to an mRNA COVID-19 vaccine
  • Moderate or severe acute illness

The following considerations can be used to help the provider conduct a risk assessment for vaccination of patients with a precaution to vaccination:

  • Risk of exposure to SARS-CoV-2
  • Risk of severe disease or death due to COVID-19
  • Unknown risk of anaphylaxis (including fatal anaphylaxis) following COVID-19 vaccination in a person with a history of an immediate allergic reaction to other vaccines or injectable therapies
  • Ability of the patient to be vaccinated in a setting where appropriate medical care is immediately available for anaphylaxis. For people with a contraindication to another type of COVID-19 vaccine (e.g., mRNA vaccines), vaccination with another type (e.g., Janssen viral vector vaccine) should only be done in an appropriate setting under the supervision of a healthcare provider experienced in the management of severe allergic reactions.

Learn more about COVID-19 vaccine contraindications and precautions.

People with a contraindication to mRNA COVID-19 vaccines may be able to receive Janssen COVID-19 Vaccine at least 28 days after the mRNA vaccine, but it is considered a precaution. In these cases, consider consulting with an allergist-immunologist to help determine if the patient can safely receive vaccination. Healthcare providers and health departments may also request a consultation from the Clinical Immunization Safety Assessment COVIDvax Project. Vaccination of these people should only be done in an appropriate setting under the supervision of a healthcare provider experienced in the management of severe allergic reactions.

See more information on:

Vaccine Storage and Handling

Store Janssen COVID-19 Vaccine in the refrigerator between 2°C and 8°C (36°F and 46°F) until the expiration or beyond-use date (BUD). Refer to the Janssen COVID-19 Vaccine product information or Janssen COVID-19 Vaccine Storage and Handling Summarypdf icon for more information.

After first puncturing the vial, the vial should be held between 2°C and 8°C (36°F and 46°F) for up to 6 hours OR at room temperature (up to 25°C [77°F]) for up to 2 hours.

See Janssen COVID-19 Vaccine Storage and Handling Summarypdf icon for more storage and handling information.

CDC requires vaccination providers participating in the COVID-19 Vaccination Program to use a specific type of TMD called a “digital data logger” (DDL) to monitor vaccine temperatures. A DDL provides the most accurate storage unit temperature information, including details on how long a unit has been operating outside the recommended temperature range (referred to as a “temperature excursion”). DDLs using a buffered temperature probe provide the most accurate way to measure actual vaccine temperatures. Always use DDLs with a current and valid Certificate of Calibration Testing.

For more storage and handling information, see:

No. After the vial is first punctured, the vaccine vial may be held:

  • For up to 2 hours at room temperature; discard any vaccine not used within 2 hours
    —–OR—-
  • For up to 6 hours refrigerated between 2°C and 8°C; discard any vaccine not used within 6 hours

You should not add these time limits together (i.e., you may not hold the vaccine at room temperature for 2 hours and then hold it refrigerated for another 6 hours).

If you do not reach the 2-hour time limit at room temperature, you may transfer the punctured vial to a refrigerated storage unit between 2°C and 8°C for the remaining time, up to 2 hours. For example, a vial held at room temperature for 1 hour after first puncture can be stored in the refrigerator (between 2°C and 8°C) for no more than 1 hour before using or discarding. If the 2-hour time limit at room temperature has been reached, the vaccine must be discarded and cannot be transferred to the refrigerator.

See Janssen COVID-19 Vaccine Storage and Handling Summarypdf icon for more storage and handling information.

The allowed storage time after first vial puncture or dose withdrawal is either a maximum of 6 hours refrigerated or 2 hours at room temperature. These maximum hold times and temperatures are not cumulative. You should discard the punctured vial once it exceeds either of these conditions, even if there are doses remaining. If stored in the refrigerator after the first puncture, the vaccine can be moved to room temperature for brief periods of time for administration. This does not affect the maximum 6-hour hold period for vaccine stored in the refrigerator.

See Janssen COVID-19 Vaccine Storage and Handling Summarypdf icon for more storage and handling information.

If the vaccine experienced problems during shipment (for example, damage or temperature excursion), contact:

  • Directly distributed vaccine (Pfizer): Contact Pfizer at 800-666-7248 (option 8) or CVGovernment@Pfizer.com.
  • Centrally distributed vaccine (for example, Moderna): Contact McKesson Specialty Customer Service at (833) 343-2703, Monday–Friday, 8 AM–8 PM Eastern Time.

If the vaccine experienced problems after it was received and placed into storage, contact the vaccine manufacturer for guidance on improper storage and handling.

For temperature excursions (out-of-range temperatures), take immediate action:

  • Label the vaccine “Do Not Use” and store at the recommended temperature range until you receive manufacturer guidance.
  • Document the date and length of time of the excursion, storage unit temperature, room temperature, and inventory affected.
  • Record any other relevant information.
  • Contact the manufacturer for guidance on whether to use affected vaccines and whether patients need to be recalled for revaccination.
  • Document the event and action taken for record-keeping requirements.

Vaccine Administration

No. Janssen COVID-19 Vaccine comes in a multidose vial and does not require reconstitution.

See Janssen COVID-19 Vaccine Preparation and Administration Summarypdf icon for more information.

Each multidose vial of Janssen COVID-19 Vaccine contains five 0.5 mL doses.

CDC recommends healthcare providers follow the dosing guidance from the manufacturer as outlined in the Emergency Use Authorization (EUA)external icon. CDC will update its guidance if the EUA and ancillary supply kits support obtaining additional doses per vial in the future.

No. CDC recommends following these practices:

  • Never combine or “pool” partial doses from two or more vials to obtain a full dose of vaccine.
  • Withdraw only the number of doses authorizedexternal icon for the specific vaccine.
  • Discard vaccine vial and remaining vaccine if the amount of vaccine left in the vial is not a full dose.

Although no one wants to waste vaccine, it is crucial for infection control and patient safety to administer vaccine properly. Combining vaccine doses from multiple vials can result in cross-contamination, potentially causing bacterial infection in patients.

If Janssen COVID-19 Vaccine is inadvertently administered to a patient age 16 through 17 years, do not repeat the dose with Pfizer-BioNTech COVID-19 Vaccine.

This is considered a vaccine administration error. Determine how the error occurred and implement strategiespdf icon to prevent it from happening again. Report this error to VAERSexternal icon.

If any of the currently authorized COVID-19 vaccines are administered subcutaneously, do not repeat the dose. The series is complete, and no additional doses are needed.

Inform the recipient of the potential for local and systemic adverse events.

This is considered a vaccine administration error. Determine how the error occurred and implement strategiespdf icon to prevent it from happening again. Report this error to VAERSexternal icon.

Review resources on vaccine administration:

If a lower-than-authorized dose volume is administered for any of the currently authorized vaccines, adhere to the following interim recommendation:

  • If more than half of the dose was administered, do not repeat the dose. The series is complete, and no additional doses are needed.
  • If less than half of the dose was administered or the proportion of the dose cannot be estimated, administer the authorized dose immediately in the opposite arm.

This is considered a vaccine administration error. Determine how the error occurred and implement strategiespdf icon to prevent it from happening again. Report this error to VAERSexternal icon.

Interim recommendations for COVID-19 vaccine administration errors differ from ACIP’s general best practice guidelines. Review vaccine administration errors and deviations for COVID-19 vaccines to learn about the interim recommendation for each type of error.

For all vaccine administration errors:

Vaccination providers should not waste any viable vaccine doses. Vaccination providers are required to administer vaccine to prioritized groups based on the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, state, territory, or tribal guidance. However, we recognize that, on occasion, this may not be possible. If members of prioritized populations are not available, efforts should be made to administer vaccine to qualified individuals rather than wasting doses.

Facilities must continue to prepare only enough doses to accommodate scheduled demand for each clinic day. If, despite such efforts, the facility has vaccine doses that are expiring near the end of the clinic day, these vaccine doses may be administered to available qualified individuals, regardless of prioritization status. The provider must not receive any direct or indirect incentive for vaccinating these individuals. Note that planning for excess doses at the end of the vaccination clinic violates the terms of the CDC COVID-19 Provider Agreement.

Yes. CDC recommends the following observation periods after COVID-19 vaccination:

  • 30 minutes for people with:
    • A history of an immediate allergic reaction of any severity to another vaccine or injectable therapy
    • A contraindication to an mRNA COVID-19 vaccine who receive Janssen COVID-19 Vaccine
    • History of anaphylaxis due to any cause
  • 15 minutes for all other people

Vaccine Safety and Efficacy

Common side effects include:

Local reactions:

  • Pain
  • Redness
  • Swelling

Systemic reactions:

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

Clinical trial data demonstrated vaccine efficacy was 66.3% at least 14 days after vaccination against symptomatic, laboratory-confirmed COVID-19 in persons without evidence of previous SARS-CoV-2 infection; 93.1% for the prevention of COVID-19-associated hospitalization; and 75% against all-cause death.

Learn more about Janssen COVID-19 Vaccine’s efficacy.

Off-Site Clinics

CDC does not recommend predrawing vaccine. If vaccine must be predrawn:

  • Set up a separate administration station for each vaccine type to prevent medication errors.
  • Draw up vaccines only after arriving at the clinic site or mass vaccination event.
  • Each person administering vaccines should draw up no more than one multidose vial or 10 doses* at one time.
  • Monitor patient flow to avoid drawing up unnecessary doses.
  • Predraw reconstituted vaccine into a syringe only when ready for administration.
  • If predrawn vaccine is not used within 30 minutes of being reconstituted, follow manufacturer guidance for storage conditions and time limits.

*You may withdraw a total of 12 doses (2 multidose vials) of Pfizer-BioNTech COVID-19 Vaccine. This applies only to Pfizer-BioNTech COVID-19 Vaccine.

See CDC’s Vaccine Storage and Handling Toolkitpdf icon for more information.

CDC recommends transporting vaccine in vials. However, there may be instances when the only option is to transport predrawn vaccine in a syringe. U.S. Pharmacopeia includes guidance for transporting predrawn vaccine in syringes in the USP COVID-19 Vaccine Toolkit: Operational Considerations for Healthcare Practitionersexternal icon.

Need more Information?

Get your Questions answered about other specific COVID-19 vaccines, including:

Page last reviewed: April 6, 2021