The FDA adds new warning to Johnson & Johnson COVID-19 vaccine for rare side effect

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The US Food and Drug Administration will soon add a warning label to Johnson & Johnson COVID-19 vaccines after about 100 people out of 12.8 million vaccinated patients developed Guillain-Barré syndrome, a largely recoverable neurological condition, according to multiple reports.

The Biden administration is expected to announce the new warning as early as Tuesday, according to The New York Times. Officials are still encouraging people to seek vaccination, as the possible side effects of vaccines are much less deadly than the effects of COVID-19.

Guillain-Barré syndrome (GBS) is a neurological disorder that has been reported in about 100 out of 12.8 million Johnson & Johnson vaccine recipients, according to multiple reports. GBS is fully recoverable in most patients.

The FDA says according to its evaluation of the Johnson & Johnson vaccine, it “continues to find the known and potential benefits clearly outweigh the known and potential risks.”

In a statement released Monday, the Centers for Disease Control and Prevention said the cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older.

European regulators may soon follow suit. No link has been found between Guillain-Barré syndrome and the coronavirus vaccines developed by Pfizer-BioNTech or Moderna, the other two federally authorized manufacturers. Those rely on a different technology.

Guillain-Barré syndrome usually occurs at a rate of about 60 to 120 cases each week, according to CDC data. While the cause of the syndrome is not fully understood, it often follows infection with a virus, including influenza, or bacteria. Each year in the United States, an estimated 3,000 to 6,000 people develop the illness.

The FDA said it had evaluated the available information for the Johnson & Johnson vaccine “and continues to find the known and potential benefits clearly outweigh the known and potential risks,” the agency said.

Daily Planet

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