FDA to warn J&J vaccine can lead to increased risk of rare syndrome

US regulators have found that the chances of developing neurological condition are low

The US Food and Drug Administration (FDA) is planning to warn that Johnson & Johnson's coronavirus vaccine can lead to an increased risk of a rare neurological condition known as Guillain-Barré syndrome, another setback for a vaccine that has largely been sidelined in the United States.

Although regulators have found that the chances of developing the condition are low, they appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the US, according to people familiar with the decision.

US federal officials have identified roughly 100 suspected cases of Guillain-Barré disease among recipients of the Johnson & Johnson shot through a federal monitoring system that relies on patients and health care providers to report adverse effects of vaccines. The reports are considered preliminary. Most people who develop the condition recover.

The FDA has concluded that the benefits of the vaccine in preventing severe disease or death from the coronavirus still very much outweigh any danger, but it plans to include the proviso in fact sheets about the drug for providers and patients.


‘Benefits outweigh risks’

"It's not surprising to find these types of adverse events associated with vaccination," said Dr Luciana Borio, a former acting chief scientist at the FDA under president Barack Obama. The data collected so far by the FDA, she added, suggested that the vaccine's benefits "continue to vastly outweigh the risks".

In a statement released on Monday, the US Centers for Disease Control and Prevention said the cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older.

The database reports indicate that symptoms of Guillain-Barré developed within about three weeks of vaccination. One recipient, a 57-year-old man from Delaware who had suffered both a heart attack and a stroke within the last four years, died in early April after he was vaccinated and developed Guillain-Barré syndrome, according to a report filed to the database.

The Biden administration is expected to announce the new warning as early as Tuesday. European regulators may soon follow suit. No link has been found between Guillain-Barré syndrome and the coronavirus vaccines developed by Pfizer-BioNTech or Moderna, the other two federally authorised manufacturers. Those rely on a different technology.

Nearly 13 million people in the US have received Johnson & Johnson’s shot, but 92 per cent of Americans who have been fully vaccinated received shots developed by Pfizer-BioNTech or Moderna. Even though it requires only one dose, Johnson & Johnson’s vaccine has been marginalised by manufacturing delays and a 10-day pause while investigators studied whether it was linked to a rare but serious blood clotting disorder in women. That investigation also resulted in a warning added to the fact sheet.

– New York Times