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Photo: Patrick van Katwijk/BSR Agency via Getty Images

The Food and Drug Administration on Monday added a warning to the Johnson & Johnson coronavirus vaccine, saying the shot can lead to an increased risk of a rare neurological condition.

Driving the news: Although the chance of developing Guillain–Barré syndrome is "very low," the neurological disorder has occurred in some people who have received the J&J vaccine, the FDA said in its updated fact sheet for recipients of the shot.

  • Federal officials have identified around 100 suspected cases of the disease among J&J vaccine recipients based on preliminary reports provided by patients and health care workers.
  • Over 12.8 million people have received the J&J COVID vaccine, according to the CDC.
  • The reports show that symptoms developed within roughly 42 days of vaccination.

Yes, but: "Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship," an FDA official told Axios.

  • "Importantly, the FDA has evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks."
  • There is no link between the disease and the vaccines developed by Pfizer or Moderna.
  • "In the United States, nearly all COVID-19 hospitalizations and deaths are now occurring in unvaccinated people," the Centers for Disease Control and Prevention (CDC) said in a statement on Monday. "The risk of severe adverse events after COVID-19 vaccination remains rare."

The big picture: Johnson & Johnson has faced numerous setbacks in its vaccine deployment, including production delays, ruined doses and a safety pause after blood clots emerged as a side effect.

Worth noting: Around 3,000 to 6,000 people develop Guillain–Barré syndrome every year in the U.S. It's usually triggered by a respiratory or gastrointestinal infection, per the CDC. Most people fully recover.

Go deeper

Updated Oct 19, 2021 - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Vaccines: Mix-and-matching gains momentum — Boosters overtake first doses in U.S. — Pfizer to vaccinate Brazilian cityPanel endorses J&J booster.
  2. Health: Age is still a huge coronavirus risk factor — Unvaccinated 11x more likely to die from COVID — 5x more police officers died from COVID than guns.
  3. Politics: Over 30 states limited public health powers — Pope Francis calls on companies to release vaccine patents — Melbourne, "world's most locked-down city," to lift stay-at-home orders.
  4. Education: Education secretary reveals limits to Biden’s mask push on states — LA extends deadline for school employee vaccinations — Parent sues Wisconsin school district after child tests positive.
  5. Variant tracker: Where different strains are spreading.
Oct 19, 2021 - Health

Puerto Rico leads U.S. COVID vaccination rates

A mass vaccination event at the Puerto Rico Convention Center in San Juan, Puerto Rico, on March 31. Photo: Ricardo Arduengo/AFP via Getty Images

Puerto Rico has the highest percentage of people fully vaccinated against the coronavirus in the United States as of Oct. 19, according to data from the Centers for Disease Control and Prevention.

Why it matters: The island has managed to accomplish such feats amid frequent power outages, earthquakes and high dependence on imports of health technologies from outside the region.

Oct 19, 2021 - Health

Virginia governor has had long COVID for more than a year

Gov. Ralph Northam. Photo by Zach Gibson/Getty Images

Virginia Gov. Ralph Northam still has long COVID-19 symptoms more than a year after his initial infection, he said in an interview with the Virginian-Pilot.

Why it matters: The Democratic governor is one of millions of Americans suffering from symptoms of long COVID, which could have serious implications for employers and social programs if enough people can no longer work because of it, per Axios' Caitlin Owens.

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