The FDA issued a warning about a rare paralyzing syndrome linked to Johnson & Johnson's coronavirus vaccine

johnson & johnson vaccine
A vial of Johnson & Johnson's (Janssen's) COVID-19 vaccine. Eduardo Sanz/Europa Press via Getty Images
  • Federal officials are warning of a rare, serious disorder linked to J&J coronavirus vaccine.

  • Authorities said 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 condition, called Guillain-Barré syndrome.

  • See more stories on Insider's business page.

Officials at the US Food and Drug Administration warned of a rare but serious neurological disorder linked to Johnson & Johnson's coronavirus vaccine on Monday.

100 cases of Guillain-Barré syndrome have been reported among people who received J&J's vaccine, the FDA said in a statement, and the FDA changed its fact sheets on the vaccine for providers and patients.

"Reports of GBS after receipt of the J&J/Janssen COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare, but do likely indicate a small possible risk of this side effect following this vaccine," the Centers for Disease Control and Prevention said in a separate statement. "These cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older."

The FDA said 95 of the 100 cases were hospitalized, and one person died. Supportive care is generally recommended for any case of GBS, as patients are at risk of developing neuromuscular respiratory failure, and requiring a ventilator.

Read more: We got an exclusive look inside Moderna's labs, where the biotech upstart is planning what comes after its blockbuster coronavirus vaccine

The Washington Post first reported that the FDA planned to issue a warning earlier on Monday.

Health officials say the vaccine's benefits still outweigh its risks

Health authorities continue to stress that J&J's vaccine is safe, and that its benefits outweigh the risks. Unvaccinated people are still at the greatest risk of hospitalization and death from the coronavirus.

Still, the warning is another black mark for J&J's shot. The vaccine has also been connected to cases of rare but serious blood clots.

J&J said it's been in discussions with the FDA and other regulators about the cases of Guillain-Barré. The company noted that while the syndrome is very rare, the rate of reported cases after vaccination exceeds what you'd expect "by a small degree."

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 across the US.

About 3,000 to 6,000 people develop Guillain-Barré each year, the CDC said. 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.

Some of the first symptoms of the syndrome can include a tingling in the feet or hands. Others include difficulty swallowing, speaking, chewing, seeing, or facial paralysis.

The muscle weakness prompted by GBS can often make it difficult to walk or climb stairs, a tell-tale sign many people use to know to seek care, according to the National Institutes of Health.

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

In April, US health officials halted use of the J&J vaccine 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, showed 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.

Read the original article on Business Insider