FDA revokes emergency approval for Johnson & Johnson COVID vaccine

The revocation happened officially due to the manufacturer’s own request, according to the FDA.

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(LifeSiteNews) — The U.S. Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) of the Johnson & Johnson COVID vaccine. 

The revocation happened officially due to the manufacturer’s own request, according to the FDA. The Johnson & Johnson (J&J) COVID inoculation is produced by its subsidiary Janssen Biotech and was authorized for emergency use on February 27, 2021.

“On May 22, 2023, Janssen Biotech, Inc. requested the voluntary withdrawal of the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine,” the FDA website states. “Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and they do not intend to update the strain composition of this vaccine to address emerging variants. On June 1, 2023, FDA revoked the EUA for this vaccine.”

While J&J’s EUA was officially withdrawn because all the available doses in the U.S. have expired and the pharma giant decided to discontinue the product, the FDA and others have raised concerns about the safety of the J&J injection in the past.

In May 2022, the FDA limited the use of the J&J COVID vaccine for some adults due to increased risk of blood clots. A year earlier, in April 2021, the FDA and CDC had temporarily put a “pause” on the J&J shot after cases of thrombosis with thrombocytopenia syndrome (TTS) occurred within a week or two after receiving the inoculation. 

Moreover, in July 2021, the FDA added the risk of Guillain-Barré syndrome (GBS), a rare neurological disorder that can cause paralysis, as a potential side effect of the J&J COVID shot after preliminary reports of GBS following vaccination had been recorded.

 

Andreas Wailzer