Covid-19 Vaccine Janssen

Dosage form: injection, suspension
Drug class:Viral vaccines

Medically reviewed by Drugs.com. Last updated on May 1, 2022.

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 receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

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