US FDA Revokes Emergency Use Authorization of J&J COVID-19 Vaccine

In 2022, the U.S. Food and Drug Administration announced that it would limit who can receive the Johnson & Johnson/Janssen Covid-19 shot due to the serious risk of blood clots, as reported by The Gateway Pundit.

The FDA announced that it would limit the authorized use of J&J Covid-19 shot to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to 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.

The change is being made after the investigation revealed that there is a risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets following administration of the Janssen Covid-19 shot.

The FDA also confirmed that individuals experienced an anaphylactic reaction after taking an mRNA Covid-19 shot.

On May 18, the Centers for Disease Control and Prevention (CDC) announced that Johnson & Johnson/Janssen COVID-19 shot are no longer available in the US, and all remaining doses will be disposed of in accordance with the law.

“Janssen COVID-19 Vaccine is no longer available in the U.S. All remaining U.S. government stock of Janssen COVID-19 Vaccine expired May 7, 2023. Dispose of any remaining Janssen COVID-19 Vaccine in accordance with local, state, and federal regulations,” CDC said.

On May 22, 2023, Janssen Biotech, Inc., a pharmaceutical subsidiary of Johnson & Johnson, made a surprising request for the voluntary withdrawal of the Emergency Use Authorization (EUA) for the Janssen COVID-19 Vaccine.

This decision came as a result of various factors, including the expiration of the last lots of the vaccine purchased by the U.S. Government, a lack of demand for new vaccine lots within the United States, and no intention to update the strain composition of the vaccine to address emerging variants.

Responding to this request, the U.S. Food and Drug Administration (FDA) revoked the EUA for the Janssen COVID-19 Vaccine on June 1, 2023.

The revocation of the EUA for Janssen appeared to be unlikely until Johnson & Johnson itself approached the FDA with the request to do so.