New safety concerns regarding Janssen COVID-19 vaccines and ITP

Jan. 12, 2022

The U.S. Food and Drug Administration (FDA) announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering and recipients. These revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia (ITP), a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 Vaccine.

Specifically, the updated fact sheet includes information about reports of adverse events following use of the vaccine which suggest an increased risk of ITP during the 42 days following vaccination, and that individuals with a history of ITP should discuss the risk and the potential need for platelet monitoring following vaccination with their healthcare provider.

The FDA and Centers for Disease Control and Prevention (CDC) continue to monitor the level of potential excess risk. Individuals should speak to their healthcare provider to determine which COVID-19 vaccine is most appropriate for their own situation.

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. The Janssen COVID-19 Vaccine is a suspension for intramuscular injection.

The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination. See this Fact Sheet for instructions for preparation and administration.

Visit the FDA for the updated Fact Sheet 

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