Johnson & Johnson (Janssen) COVID-19 Vaccine

Johnson & Johnson's (J&J) 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 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.

• FDA Emergency Use Authorization Letter 
• EUA Fact Sheet and Full EUA Prescribing Information for Vaccination Providers 
• EUA Fact Sheet for Vaccine Recipients & Caregivers 

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. Information to be communicated includes:

• FDA has authorized the emergency use of the Janssen COVID-19 Vaccine, which is not an FDA approved vaccine.
• The recipient or their caregiver has the option to accept or refuse the Janssen COVID-19
  Vaccine.
• The significant known and potential risks and benefits of the Janssen COVID-19 Vaccine, and the extent to which such risks and benefits are unknown.
• Information about available alternative vaccines and the risks and benefits of those alternatives.

For more information on the Johnson & Johnson COVID-19 Vaccine, visit janssencovid19vaccine.com.Storage, Handling, & Administration for Johnson & Johnson (Janssen) COVID-19 Vaccine

Age Indication: 18 year or older

Dose: 0.5 mL

Route: Intramuscular

Dose preparation: Single-dose; 5 doses per vial 

Johnson & Johnson COVID-19 Storage and Handling

Storing Johnson & Johnson's Janssen COVID-19 Vaccines

Refrigerator

2°C to 8°C | 36°F to 46°F

• Unopened vial: Up to 6 months in the refrigerator at this temperature 
• Punctured vial: Up to 6 hours 
• Do not store frozen.

Room Temperature

9° to 25°C | 47° to 77°F

• Unopened vial: Up to 12 hours 
• Punctured vial: Up to 2 hours | Maximum 25°C/77°F

Thawing Johnson & Johnson's Janssen COVID-19 Vaccine Vials

Refrigerator

2°C to 8°C | 36°F to 46°F

• Keep in refrigerator until thawed (slower process).

Room Temperature

9° to 25°C | 47° to 77°F

• For immediate use,
  • A carton of 10 vials will take approximately 2 hours to thaw
  • An individual vial will take approximately 1 hour to thaw.

Vial Expiration Date Look Up

You must look up the expiration date for the Moderna COVID-19 vaccine through their Look Up Vial Expiration Date tool. 

• Go to vaxcheck.jnj. The expiration date tool will display. 
• Enter your lot number, printed on the carton and vial of the vaccine, in the Enter Lot # field.

         

• Click Check Lot. The expiration date will display stating if the vaccine is ready to use or not. 

           

• Key in the expiration date in LINKS.

For more information or to view LINKS training videos, visit lalink.org.

Temperature Excursions for Johnson & JohnsonIn the event of a temperature excursion, contact Johnson & Johnson: 

Online Temperature Excursion Tool	janssenmd.com/janssen-covid19-vaccine/interactive-content/stability-information
Email:	jsccovidtempexcursion@its.jnj.com
Phone Number:	1-800-565-4008
	1-908-455-9922