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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 20, 2021 - Health

In-N-Out refuses to follow San Francisco's vaccine mandate

Photo: James Leynse/Corbis via Getty Images

The California burger chain In-N-Out is refusing to follow San Francisco's vaccination mandate, which requires restaurants to check for customers' proof of vaccination to dine indoors, the Washington Post reports.

Driving the news: The San Francisco Public Health Department has had to remind employees multiple times to check for proof of vaccination since September, ultimately resulting in the city's only In-N-Out location getting shut down on Oct. 14. It is the only time the agency has ordered a restaurant's closure over a mandate violation, officials told the Post.

Hawaii invites fully vaccinated travelers to return from Nov. 1

Hawaii Gov. David Ige. Photo: Darryl Oumi/Getty Images

Hawaii Gov. David Ige (D) announced plans Wednesday to soon welcome back nonresidents to the island state who are fully vaccinated against COVID-19 for nonessential travel.

Why it matters: Hawaii's tourist-dependent labor market suffered one of the worst blows in the U.S. last year and the state's climb out of its pandemic-sized hole is moving slowly, Axios' Courtenay Brown notes.

Oct 20, 2021 - Health

New York City announces COVID vaccine mandate for all public workers

A health care worker administering a dose of the COVID-19 vaccine to a student in Staten Island in August. Photo: Jeenah Moon/Bloomberg via Getty Images

New York City Mayor Bill de Blasio on Wednesday announced an expanded COVID-19 vaccine mandate that covers all of the city's public employees, including police officers and firefighters.

Why it matters: Around 71% of city workers have already satisfied the mandate by receiving at least one dose. The remaining 46,000 unvaccinated employees will have to receive their first dose by Oct. 29 or will risk being placed on unpaid leave until they can show proof of a first dose, the Wall Street Journal reported.

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