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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

Oct 16, 2021 - Health

Pope Francis calls on companies to release COVID vaccine patents

Pope Francis. Photo: Massimo Valicchia/NurPhoto via Getty Images

Pope Francis called on pharmaceutical companies on Saturday to release patents to make COVID-19 vaccines more accessible to the poor, Reuters reports.

Why it matters: There is a stark divide between countries that have access to COVID-19 shots and those that don't, and the gap has widened as some wealthier countries have begun distributing third doses.

Updated 2 hours ago - World

17 U.S. and Canadian missionaries kidnapped in Haiti

Haitian soldiers guard the public prosecutor's office in Port-au-Prince this month. Photo: Richard Pierrin/AFP via Getty Images

American officials and authorities in Haiti are working to try and free 17 hostages from a U.S.-based missionary group who were kidnapped in Port-au-Prince over the weekend, AP reported Monday.

The latest: Christian Aid Ministries said in a statement Sunday, "The group of 16 U.S citizens and one Canadian citizen includes five men, seven women, and five children." The Ohio-based organization said they were on a trip to visit an orphanage when they were kidnapped Saturday.

China's economic growth slows

A worker assembles heavy truck engines in Hangzhou in eastern China's Zhejiang Province, on Monday. Photo: Long We/Costfoto/Barcroft Media via Getty Images

China's economy grew 4.9% in the third quarter of 2021 compared with a year earlier, the country's National Bureau of Statistics announced Monday.

Why it matters: The gross domestic product growth in the July-September period in the world’s second-largest economy marked the "weakest pace since the third quarter of 2020 and slowing from 7.9% in the second quarter," Reuters notes.

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