Janssen COVID-19 Vaccine (Johnson & Johnson)

On April 13, 2021, CDC and FDA recommended a pauseexternal icon in the use of Janssen COVID-19 Vaccine (Johnson & Johnson) out of an abundance of caution while they review data involving a small number of U.S. reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia in individuals after receiving Janssen COVID-19 Vaccine. The Advisory Committee on Immunization Practices (ACIP) met on April 14. After hearing additional data on these reports, ACIP agreed that more information is needed before policy recommendations can be made regarding the continued use of the Janssen COVID-19 vaccine. CDC will collect more information and convene another ACIP meeting on April 23 to review any additional scientific evidence.

At this time, the recommended pause supersedes any other recommendations for use of Janssen COVID-19 Vaccine.

Recommendations for clinicians related to the detection, evaluation, proper management, and reporting of cases of CVST with thrombocytopenia after receipt of Janssen COVID-19 Vaccine are outlined in Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. These can also be found in CDC’s Health Alert, issued April 13.

If you are a COVID-19 vaccination provider with Janssen COVID-19 Vaccine:

  1. Mark any Janssen COVID-19 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. Continue to monitor and document storage unit temperatures and follow recommended vaccine storage practices.
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Dosing information:
Multidose vial: 5 doses per vial
Dosage: 0.5mL
Do NOT mix with a diluent.
Discard vial when there is not enough vaccine to obtain a complete dose. Do NOT combine residual vaccine from multiple vials to obtain a dose.

Age Indications:
18 years of age and older

Schedule:
Single dose

Administration:
Intramuscular (IM) injection in the deltoid muscle

Administration Overview

Before administering vaccine, screen recipients for contraindications and precautions.

To assess patients correctly and consistently, vaccination providers should use a standardized, comprehensive screening tool.

Contraindications and Precautions
How to Prepare and Administer the Janssen Vaccine
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Document the Vaccination

COVID-19 vaccination providers must document vaccine administration in their medical record systems within 24 hours of administration and use their best efforts to report administration data to the relevant system for the jurisdiction (i.e., immunization information system) as soon as practicable and no later than 72 hours after administration.

Storage and Handling Overview
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Store vaccine in a refrigerator. Do not freeze.

The vaccine will arrive at a refrigerated temperature of 2°C to 8°C (36°F and 46°F).

  • Unpack the vaccine shipment following the manufacturer’s directions.
    • Check both temperature monitoring devices in the box (3M MonitorMark and FreezeMark).
  • An ancillary supply kit will arrive separately from the vaccine.
How to Store the Janssen COVID-19 Vaccine
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Report Adverse Events

Adverse events that occur in a recipient after COVID-19 vaccination are required to be reported to the Vaccine Adverse Event Reporting System (VAERS). FDA requires vaccination providers to report vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under an EUA. Reporting is encouraged for other clinically significant adverse events, even if it is not clear that a vaccine caused the adverse event. Complete and submit reports to VAERS onlineexternal icon.

For further assistance with reporting to VAERS, call 1-800-822-7967.

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What to Expect after a COVID-19 Vaccination

Print informationpdf icon for your patients on common side effects, helpful tips, and when to call a doctor after a COVID-19 vaccination.

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Page last reviewed: March 11, 2021