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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

Jul 10, 2021 - Health

Fauci says Pfizer CEO apologized for not giving warning on booster announcement

Anthony Fauci speaks during a Senate Appropriations Subcommittee hearing in Washington, D.C. on Wednesday, May 26, 2021. Photo: Sarah Silbiger/UPI/Bloomberg via Getty Images

Dr. Anthony Fauci told CNN's Wolf Blitzer that Pfizer CEO Albert Bourla apologized to him for not giving health officials advance notice that the company would seek an authorization for a third dose of its coronavirus vaccine.

The big picture: After Pfizer's announcement, the Centers for Disease Control and Prevention and the Food and Drug Administration published a joint statement saying Americans do not need boosters yet.

Jul 12, 2021 - Health

Most unvaccinated people have low incomes

Data: U.S. Census Household Pulse Survey; Note: Does not include respondents who didn't report income; Chart: Axios Visuals

More than half of unvaccinated Americans live in households that make less than $50,000 annually, according to the latest Census Bureau data.

Why it matters: Making it easier for the working poor to get the COVID-19 vaccine, without dinging their already-low incomes, could help boost the country's vaccination rates.

Updated Jul 12, 2021 - World

Israel offers COVID-19 vaccine booster shot as Delta variant spreads

A health care worker administering a coronavirus vaccine in Modi'in-Maccabim-Re'ut, Israel, on July 5. Photo: Gil Cohen Magen/Xinhua via Getty Images

Israel on Monday will begin offering a third dose of Pfizer and BioNTech's coronavirus vaccine as a booster shot for people with weakened immune systems, according to the Times of Israel.

Why it matters: It's one of the first countries to offer booster shots to bolster protection against the rapidly spreading Delta variant. The Israeli Health Ministry is still determining whether an extra shot should be offered to the general public.

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