Storage, Dosage and Administration

Storage, Dosage and Administration

The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older. The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the FD&C Act, unless the declaration is terminated or authorization revoked sooner.

How It's Supplied

The Janssen COVID-19 Vaccine is supplied in a carton of 10 multi-dose vials (NDC 59676-580-15). A maximum of 5 doses of 0.5 mL can be withdrawn from the multi-dose vial (NDC 59676-580-05). The vial stoppers are not made with natural rubber latex.


Storage and Handling*

Storage Prior to First Puncture of the Vaccine Vial

  • Store unpunctured multi-dose vials of the Janssen COVID-19 Vaccine at 36°F to 46°F (2°C to 8°C) and protect from light. Do not store frozen
  • Unpunctured vials of the vaccine may be stored between 47°F to 77°F (9°C to 25°C) for up to 12 hours

The Janssen COVID-19 Vaccine is initially stored frozen by the manufacturer, then shipped at 36°F to 46°F (2°C to 8°C). If vaccine is still frozen upon receipt, thaw at 36°F to 46°F (2°C to 8°C). If needed immediately, thaw at room temperature (maximally 77°F/25°C). Do not re-freeze once thawed.

  • At room temperature, a carton of 10 vials will take ~2 hours to thaw
  • At room temperature, an individual vial will take ~1 hour to thaw

Storage After First Puncture of the Vaccine Vial

  • After the first dose has been withdrawn, hold the vial between 36°F and 46°F (2°C to 8°C) for up to 6 hours or at room temperature (maximally 77°F/25°C) for up to 2 hours
  • Discard the vial if vaccine is not used within these times

Dose Preparation

  • The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent sterile suspension that does not contain a preservative
  • Visually inspect the Janssen COVID-19 Vaccine vials for particulate matter and discoloration prior to administration. If either of these conditions exist, do not administer the vaccine
  • Before withdrawing each dose of vaccine, carefully mix the contents of the multi-dose vial by swirling gently in an upright position for 10 seconds. Do not shake
  • Each dose is 0.5 mL. Each vial contains 5 doses. Do not pool excess vaccine from multiple vials
  • Record the date and time of first use on the Janssen COVID‑19 Vaccine vial label

As the vaccination provider, you must communicate to the recipient, or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website JanssenCOVID19Vaccine.com to obtain the Fact Sheet) prior to the individual receiving the Janssen COVID‑19 Vaccine.


Administration

  • Visually inspect each dose in the dosing syringe prior to administration
  • Verify the final dosing volume of 0.5 mL
  • Do not administer if vaccine is discolored or contains particulate matter
  • Administer the Janssen COVID-19 Vaccine intramuscularly
  • There is no information on the co-administration of the Janssen COVID-19 Vaccine with other vaccines

Provide a vaccination card to the recipient or their caregiver with the name of the vaccine (“Janssen COVID-19 Vaccine”) and date of administration to document vaccination.


Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. For more information, visit: www.cdc.gov/vsafe


Ensuring the Authenticity of the Janssen COVID-19 Vaccine

Johnson & Johnson and Janssen Pharmaceuticals are committed to identifying and mitigating the risks of counterfeit healthcare products. Information regarding how we address counterfeiting can be found at healthforhumanityreport.jnj.com

The Janssen COVID-19 Vaccine is to be administered intramuscularly by a healthcare professional.

An authentic Janssen COVID-19 Vaccine includes the Janssen name and logo on the carton. The Janssen COVID-19 Vaccine is supplied in multi-dose vials. The vial stoppers are not made with natural rubber latex.

The Janssen COVID-19 Vaccine is never sold online and is distributed only through government channels. Janssen cannot verify the authenticity of products acquired outside of the legitimate supply chain. If you suspect the Janssen COVID-19 Vaccine you have may be counterfeit, contact us at 1-800-565-40081-800-565-4008 (US Toll Free) or 1-908-455-99221-908-455-9922 (US Toll).

COVID-19=coronavirus disease 2019; EUA=Emergency Use Authorization; FD&C Act=Federal Food, Drug, and Cosmetic Act.

Current as of February 27, 2021.

Important safety information

CONTRAINDICATIONS

Do not administer the Janssen COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Janssen COVID-19 Vaccine.

WARNINGS AND PRECAUTIONS

Monitor Janssen COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

ADVERSE REACTIONS

Adverse reactions reported in a clinical trial following administration of the Janssen COVID-19 Vaccine include injection site pain, headache, fatigue, myalgia, nausea, fever, injection site erythema and injection site swelling. In clinical studies, severe allergic reactions, including anaphylaxis, have been reported following the administration of the Janssen COVID-19 Vaccine.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Janssen COVID-19 Vaccine.

Reporting Adverse Events and Vaccine Administration Error

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for mandatory reporting of the listed events following Janssen COVID-19 Vaccine administration to the Vaccine Adverse Event Reporting System (VAERS):

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods below. Reports should include the words “Janssen COVID-19 Vaccine EUA” in the description section of the report as the first line.

Report adverse events to Janssen Biotech, Inc. by calling 1-800-565-40081-800-565-4008 or provide a copy of the VAERS form by faxing 1-215-293-9955.

PREGNANCY AND LACTATION

DOSING AND SCHEDULE

The Janssen COVID-19 Vaccine is administered intramuscularly as a single dose (0.5 mL).

There are no data available on the use of the Janssen COVID-19 Vaccine to complete a vaccination series initiated with another COVID-19 vaccine.

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at www.JanssenCOVID19Vaccine.com/EUA-factsheet.

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Important safety information

CONTRAINDICATIONS

Do not administer the Janssen COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Janssen COVID-19 Vaccine.

WARNINGS AND PRECAUTIONS

Monitor Janssen COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

ADVERSE REACTIONS

Adverse reactions reported in a clinical trial following administration of the Janssen COVID-19 Vaccine include injection site pain, headache, fatigue, myalgia, nausea, fever, injection site erythema and injection site swelling. In clinical studies, severe allergic reactions, including anaphylaxis, have been reported following the administration of the Janssen COVID-19 Vaccine.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Janssen COVID-19 Vaccine.

Reporting Adverse Events and Vaccine Administration Error

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for mandatory reporting of the listed events following Janssen COVID-19 Vaccine administration to the Vaccine Adverse Event Reporting System (VAERS):

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods below. Reports should include the words “Janssen COVID-19 Vaccine EUA” in the description section of the report as the first line.

Report adverse events to Janssen Biotech, Inc. by calling 1-800-565-40081-800-565-4008 or provide a copy of the VAERS form by faxing 1-215-293-9955.

PREGNANCY AND LACTATION

DOSING AND SCHEDULE

The Janssen COVID-19 Vaccine is administered intramuscularly as a single dose (0.5 mL).

There are no data available on the use of the Janssen COVID-19 Vaccine to complete a vaccination series initiated with another COVID-19 vaccine.

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at www.JanssenCOVID19Vaccine.com/EUA-factsheet.

cp-213942v1