J&J’s Covid-19 Vaccine May Trigger Neurological Condition In
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Johnson & Johnson’s Covid-19 vaccine may trigger a rare neurological condition in a small number of people who receive the vaccine, the Food and Drug Administration said. Reports to a database operated jointly by the agency and the Centers for Disease Prevention and Control suggest there may be a link between the inoculations and Guillain-Barré syndrome, the FDA said in a statement.

The agency said there have been about 100 preliminary reports of GBS, as the condition is often called, in people who have received the J&J vaccine. To date, about 12.8 million doses of the J&J vaccine have been used in the United States, suggesting a rate of about one case of GBS per 128,000 people vaccinated. In most cases, the people reporting the condition developed it about two weeks after receiving the one-dose vaccine.

Most are older males, which fits with the known pattern of GBS, said John Moore, an immunologist at Weill Cornell Medicine. “A rare, but very probably real consequence of the vaccine,” said Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia. “Again, the benefits of the vaccine clearly and definitely outweigh its very rare risks.”

The FDA’s statement comes after a similar signal of GBS was identified with AstraZeneca’s Covid vaccine. Last week the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee recommended adding a warning to the label of the AstraZeneca vaccine, Vaxzevria, to inform health care providers. Its statement said it is not currently clear if the AstraZeneca vaccine triggers the condition. “At this stage the available data neither confirms nor rules out a possible association with the vaccine,” the EMA said.

The FDA said to date there has been no signal to suggest the messenger RNA vaccines — those made by Moderna or Pfizer and its partner BioNTech — trigger GBS. There are multiple known causes of Guillain-Barré syndrome. Some viral infections, including influenza, have been shown to increase one’s risk of developing GBS, as have some gastrointestinal infections. And several vaccines have been shown to, on rare occasions, induce the condition.