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AUTHORIZATION OF USE

The 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.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME

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.

CONTRAINDICATIONS

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).

Cases of TTS following administration of the Janssen COVID-19 Vaccine have been reported in males and females, in a wide age range of individuals 18 years and older, with the highest reporting rate (approximately 8 cases per 1,000,000 doses administered) in females ages 30-49 years; overall, approximately 15% of TTS cases have been fatal.

The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia. Specific risk factors for TTS following administration of the Janssen COVID-19 Vaccine and the level of potential excess risk due to vaccination are under investigation. Currently available evidence supports a causal relationship between TTS and the Janssen COVID-19 Vaccine.

Healthcare professionals should be alert to the signs and symptoms of TTS in individuals who receive the Janssen COVID-19 Vaccine. In individuals with suspected TTS following administration of the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended.

The American Society of Hematology has published considerations relevant to the diagnosis and treatment of TTS following administration of the Janssen COVID-19 Vaccine (https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia).

Recipients of Janssen COVID-19 Vaccine should be instructed to seek immediate medical attention if they develop 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.

ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

In study COV3001, the most common local solicited adverse reaction (≥10%) reported was injection site pain (48.6%). The most common systemic adverse reactions (≥10%) were headache (38.9%), fatigue (38.2%), myalgia (33.2%), and nausea (14.2%).

Severe allergic reactions, including anaphylaxis, have been reported following administration of the Janssen COVID-19 Vaccine.

Adverse Reactions Identified during Post Authorization Use

Anaphylaxis and other severe allergic reactions, thrombosis with thrombocytopenia, Guillain-Barré syndrome, and capillary leak syndrome have been reported following administration of the Janssen COVID-19 Vaccine during mass vaccination outside of clinical trials.

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.

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS


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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