FDA reissues EUA for Janssen COVID-19 vaccine, includes warning about risks of myocarditis, pericarditis

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The U.S. Food and Drug Administration (FDA) said on Tuesday it has revised a fact sheet and reissued an emergency use authorization (EUA) for the Janssen COVID-19 vaccine to include a warning about risks related to myocarditis and pericarditis.

Specifically, the warning states that reports of adverse events after use of the vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly from 0 through 7 days following vaccination.

The FDA also included in its fact sheet information about myocarditis and pericarditis after administration of the Janssen COVID-19 vaccine.

An additional revision states that facial paralysis, including Bell’s palsy, has been reported after administration of the vaccine.

The agency revised the scope of its authorization for a booster dose of the vaccine to reflect that it may be administered as a first booster dose at least two months after completion of primary vaccination with an authorized or approved COVID-19 vaccine.

On February 27, 2021, the agency issued an EUA for the Janssen COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older. Last May, it limited the authorized use of the Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate. The FDA also authorized its use by 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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