FDA pulls emergency authorization of J&J’s Covid-19 shot after final batch expired last month

The Food and Drug Administration (FDA) has pulled its emergency authorization for the Johnson & Johnson Covid-19 vaccine after the pharmaceutical giant's Janssen unit made the request for removal. 

Bloomberg reported that Janssen Pharmaceuticals, a company owned by Johnson & Johnson, told the FDA that previously acquired jabs have reached their expiration date and that US demand for the product is no more. 



“FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization,” reads the statement, which notes the firm “does not intend to update the strain composition of this vaccine to address emerging variants.”

This news comes two years after the CDC and FDA released a joint statement in April 2021 indicating that administration of the Johnson & Johnson shot would be halted, as the organizations had observed numerous instances of "rare and severe type of blood clot in individuals after receiving the J&J vaccine."

Another complication that was linked with the shot is Guillain-Barré syndrome (GBS), which Yale Medicine noted is a condition severe enough to warrant the FDA placing a warning label on the jabs about the higher chances of being afflicted with GBS, particularly during the first 42 days following the inoculation. Symptoms stemming from the illness can include weakness, problems moving one's mouth, bowel and bladder control issues, inability to move eyes, paralysis, and even death, per Yale Medicine. 

The CDC confirmed the authorization removal on its website and recommends that adults who have received the now-discontinued jab do a mix-and-match of sorts by either receiving a bivalent mRNA dose from either Moderna or Pfizer-BioNTech.

Any and all remaining doses of J&J's Covid-19 shots expired on May 7, according to the CDC, suggesting that the authorization was not pulled until almost a month after the batch had gone bad.

Janssen reportedly did not ask for the withdrawal until May 22, two weeks after the CDC's claimed expiration date.