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The FDA is reportedly planning to warn about a second rare side effect linked to Johnson & Johnson’s coronavirus vaccine

  • US officials reportedly plan to warn of a rare but serious disorder linked to J&J’s coronavirus vaccine.
  • Authorities plan to say that the vaccine is still safe, and that its benefits outweigh the risks.
  • Vaccines from Pfizer-BioNTech and Moderna haven’t been linked to the rare side effect, which can cause temporary paralysis.

US health officials plan to warn of a rare but serious neurological disorder linked to Johnson & Johnson’s coronavirus vaccine, The Washington Post reported on Monday, citing four people it didn’t identify.

About 100 cases of Guillain-Barré syndrome have been reported among people who received J&J’s vaccine, the newspaper said, citing the US Centers for Disease Control and Prevention. Still, health authorities plan to say that the vaccine is safe, and that its benefits outweigh the risks, the Post reported.

The CDC and Food and Drug Administration did not immediately respond to requests for comment. J&J did not immediately respond to Insider’s inquiry.

Vaccines from Moderna and from Pfizer-BioNTech are being used much more frequently in the US, and those shots haven’t been linked to the condition. About 12.8 million doses of J&J’s shot have been administered.

About 3,000 to 6,000 people develop Guillain-Barré each year, according to the CDC. The disorder often follows infections with a virus or bacteria. The syndrome causes muscle weakness and sometimes paralysis, which is usually temporary, and it is more common among older men.

The warning would be a second black mark for J&J’s shot. The vaccine has also been connected to cases of rare but serious blood clots.

This is the second time that J&J’s shot has been linked to side effects 

US health officials halted use of J&J vaccine on April 13 after more than a dozen people — mostly women under the age of 50 — developed a rare type of blood clot after getting the shot. 

Three of the cases were fatal, according to data shared by the CDC at the time.

Regulators allowed vaccine distribution to resume on April 23, with a new warning attached.

The cause of Guillain-Barré isn’t fully understood. A 1976 version of the flu vaccine, developed to fight a potential pandemic strain of influenza, was linked to a slightly higher risk of developing GBS.

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