FDA Warns Of Possible Neurological Side Effects Of Johnson & Johnson's COVID-19 Vaccine

JAKARTA - The United States Food and Drug Administration (FDA) on Monday added a warning to its factsheet for Johnson & Johnson's COVID-19 vaccine, regarding data on an increased risk of a rare neurological disorder within six weeks of vaccination.

In a letter to the company, the FDA classified the chances of getting Guillain-Barré syndrome (GBS) after vaccination as 'very low'.

However, it said recipients of the Johnson & Johnson (J&J) vaccine should seek medical attention if they have symptoms including weakness or tingling sensations, difficulty walking or difficulty with facial movements.

About 12.8 million people have received the single-dose J&J vaccine in the United States. The FDA said the initial 100 reports of GBS in vaccine recipients included 95 serious cases requiring hospitalization and one reported death.

J&J said in a statement that they were discussing with regulators about the GBS case. It said the reported GBS case rate in J&J's COVID-19 vaccine recipients only slightly exceeded the background rate.

To note, this warning was first reported by the Washington Post on Monday.

GBS is a rare neurological condition, in which the body's immune system attacks the protective coating on nerve fibers. Most cases follow a bacterial or viral infection. however, most people recover completely from GBS.

This condition has been associated in the past with vaccination, most notably with vaccination campaigns during the swine flu outbreak in the United States in 1976, and decades later with vaccines used during the 2009 H1N1 flu pandemic.

Meanwhile, the US Centers for Disease Control and Prevention (CDC) said in a statement that the vast majority of cases were in men, many of whom were 50 years or older. No higher-than-expected cases of GBS were found in recipients of the mRNA-based vaccines from Pfizer and Moderna.

Last week, regulator European Medicines Agency (EMA) recommended a similar warning for AstraZeneca's COVID-19 injection, which is based on technology similar to Johnson & Johnson's vaccine.

The warning is another setback for the J&J injection, which should become an important tool for vaccinating in hard-to-reach areas and among those who hesitate to get vaccinated.

This is because this vaccine only requires one injection and has looser storage requirements than Pfizer or Moderna. Prior to this, however, the J&J vaccine was associated with rare, life-threatening blood clots, as well as production problems at the main plant.

However, US regulators decided in April that the benefits of the vaccine outweighed the risks of blood clotting problems.