The US Food and Drug Safety Agency (FDA) plans to issue a warning about a possible link between the Johnson & Johnson vaccine and the development of Guillain-Barré syndrome. According to The New York Times, the regulator considers that this serious neurological condition is three to five times more likely to develop after this vaccine is given. However, he maintains that it is a rare situation.
The Food and Drug Administration (FDA) identified 100 potential cases of this syndrome after the vaccine was taken, through a surveillance system whose patient information is provided by health insurance companies, and confirmed to the North American Journal a source close to the process. Clearance of the condition is temporary and most people who report having the syndrome have recovered.
However, the US Food and Drug Administration still believes that the benefits of the vaccine, as a tool to prevent serious illness or death from COVID-19, still far outweigh the potential side effects. “It’s not surprising to find these kinds of adverse reactions associated with vaccination,” Luciana Borio, a physician and former researcher with the U.S. Food and Drug Administration during the Barack Obama administration, explains to The New York Times.
But according to a statement on Monday, the Centers for Disease Control and Prevention said most cases were reported two weeks after vaccination and that the syndrome manifested itself mainly in men over 50. One case in the database reports that a 57-year-old man from Delaware who had had a heart attack and stroke in the past four years died in April of this year, weeks after being vaccinated and developing Guillain-Barré.
Among other problems, Guillain-Barré causes muscle weakness and loss of sensation in the legs and arms.
The warning is expected to be issued by Tuesday and European authorities will follow suit and also include side effects associated with the Johnson & Johnson vaccine.
Because it was developed in a different way and using other technologies, there is no evidence linking Guillain-Barré to the Pfizer-BioNTech or Moderna vaccines. This isn’t the first time a Johnson & Johnson vaccine has been challenged in the United States, and its use was suspended for some time earlier this year for safety reasons.