JANSSEN COVID-19 VACCINE- ad26.cov2.s injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AD26.COV2.S (UNII: JT2NS6183B) (AD26.COV2.S - UNII:JT2NS6183B)

Available from:

Janssen Products, LP

Administration route:

INTRAMUSCULAR

Therapeutic indications:

Janssen COVID-19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. Do not administer the Janssen COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Janssen COVID-19 Vaccine [see Description (13)] . Do not administer the Janssen COVID-19 Vaccine to individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine (e.g., AstraZeneca's COVID-19 vac

Product summary:

Janssen COVID-19 Vaccine is supplied in a carton of 10 multi-dose vials (NDC 59676-580-15). A maximum of 5 doses can be withdrawn from the multi-dose vial. The storage and handling information in this Fact Sheet supersedes the storage and handling information on the carton and vial labels. Storage Prior to First Puncture of the Vaccine Vial Store unpunctured multi-dose vials of the Janssen COVID-19 Vaccine at 2°C to 8°C (36°F to 46°F) and protect from light. Do not store frozen. Unpunctured vials of Janssen COVID-19 Vaccine may be stored between 9°C to 25°C (47°F to 77°F) for up to 12 hours. The Janssen COVID-19 Vaccine is initially stored frozen by the manufacturer, then shipped at 2°C to 8°C (36°F to 46°F). If vaccine is still frozen upon receipt, thaw at 2°C to 8°C (36°F to 46°F). If needed immediately, thaw at room temperature (maximally 25°C/77°F). At room temperature (maximally 25°C/77°F), a carton of 10 vials will take approximately 4 hours to thaw, and an individual vial will take approximately 1 hour to thaw. Do not refreeze once thawed. Storage After First Puncture of the Vaccine Vial After the first dose has been withdrawn, hold the vial between 2° to 8°C (36° to 46°F) for up to 6 hours or at room temperature (maximally 25°C/77°F) for up to 2 hours. Discard the vial if vaccine is not used within these times.

Authorization status:

unapproved drug other

Summary of Product characteristics

JANSSEN COVID-19 VACCINE- AD26.COV2.S INJECTION, SUSPENSION
JANSSEN PRODUCTS, LP
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FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE
(VACCINATION PROVIDERS)
EMERGENCY USE AUTHORIZATION (EUA) OF THE JANSSEN COVID-19 VACCINE
TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)
WARNING: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME
SEE _FULL EUA PRESCRIBING INFORMATION_ FOR COMPLETE WARNING.
THE JANSSEN COVID-19 VACCINE CAN CAUSE THROMBOSIS WITH
THROMBOCYTOPENIA
SYNDROME (TTS) WHICH MAY BE LIFE-THREATENING.
TTS MAY INVOLVE THROMBOSIS AT UNUSUAL LOCATIONS FOR A THROMBUS (I.E.,
CEREBRAL VEIN, VISCERAL ARTERY OR VEIN, EXTREMITY ARTERY, CENTRAL
ARTERY OR VEIN)
OR IN AN EXTREMITY VEIN OR PULMONARY ARTERY.
AMONG REPORTED CASES OF TTS FOLLOWING ADMINISTRATION OF THE JANSSEN
COVID-
19 VACCINE, SYMPTOMS BEGAN APPROXIMATELY ONE TO TWO WEEKS AFTER
VACCINATION.
INSTRUCT JANSSEN COVID-19 VACCINE RECIPIENTS TO SEEK IMMEDIATE MEDICAL
ATTENTION FOR SHORTNESS OF BREATH, CHEST PAIN, LEG SWELLING,
PERSISTENT
ABDOMINAL PAIN, NEUROLOGICAL SYMPTOMS (INCLUDING SEVERE OR PERSISTENT
HEADACHES OR BLURRED VISION), OR PETECHIAE BEYOND THE SITE OF
VACCINATION.
THE CLINICAL COURSE OF TTS FOLLOWING ADMINISTRATION OF THE JANSSEN
COVID-19
VACCINE SHARES FEATURES WITH AUTOIMMUNE HEPARIN-INDUCED
THROMBOCYTOPENIA. IN INDIVIDUALS WITH SUSPECTED TTS, THE USE OF
HEPARIN MAY
BE HARMFUL AND ALTERNATIVE TREATMENTS MAY BE NEEDED.
DO NOT ADMINISTER THE JANSSEN COVID-19 VACCINE TO INDIVIDUALS WITH A
HISTORY
OF THROMBOSIS WITH THROMBOCYTOPENIA FOLLOWING THE JANSSEN COVID-19
VACCINE OR ANY OTHER ADENOVIRUS-VECTORED COVID-19 VACCINE.
The U.S. Food and Drug Administration (FDA) has issued an Emergency
Use
Authorization (EUA) to permit the emergency use of the unapproved
product, the
Janssen COVID-19 Vaccine, for active immunization to prevent COVID-19
in individuals
18 years of age and older for whom other FDA-authorized or approved
COVID-19
vaccines are not accessible or clinically appropriate, and in
individuals 18 years of age
and older who elect to rece