The US Food and Drug Administration (FDA) has warned that Johnson & Johnson’s (J&J) Coronavirus vaccine increases the risk of a rare neurological disorder known as Guillain-Barre syndrome.
Guillain-Barre syndrome is a rare disorder in which the body’s immune system attacks the nerves. Weakness and tingling in the extremities are usually the first symptoms that can quickly spread and paralyze the whole body.
In an official statement, FDA said that more than 100 cases and 1 death from Guillain-Barre syndrome have been reported in the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety monitoring system launched by the US government to collect reports of adverse events after vaccination.
People aged above 50, particularly men, with underlying health conditions are at the highest risk as they accounted for most of the cases that occurred about 2 weeks after receiving J&J’s COVID-19 vaccine.
While the benefits of J&J’s COVID-19 vaccine, including protection against the Delta variant and other serious outcomes, continue to outweigh the risks, the FDA has directed J&J to add the warning about Guillain-Barre syndrome to the label of the vaccine.
The FDA’s warning comes as yet another setback for the J&J’s COVID-19 vaccine, which has had its fair share of problems.
This year in April, the CDC and FDA briefly paused the use of the J&J vaccine because of cases of a rare type of blood clotting complication, Cerebral Venous Sinus Thrombosis (CVST), but resumed its use after categorizing the risk as low and the condition as treatable. However, J&J was directed to update the vaccine’s label and add a warning about the risk.
Following the reports of CVST cases in the US, the European Commission (EC) decided against renewing the contract of the J&J for the supply of its COVID-19 vaccine once it expires at the end of 2021.
The same month, J&J halted the manufacturing as 15 million doses of its COVID-19 vaccine went to waste after workers at a manufacturing plant in Baltimore, Maryland, which was simultaneously manufacturing two Coronavirus vaccines, accidentally conflated the ingredients of J&J’s vaccine with that of another vaccine, causing the company to delay the delivery of over 24 million doses due to quality control concerns.