Pharmaceutical Johnson Johnson confirmed Monday that it is working with the U.S. Food and Drug Administration (FDA) on a possible relationship between its single-dose coronavirus vaccine and Guillain-Barré syndrome, a rare neurological disorder.
“We are in contact with the FDA and other regulatory agencies for the exceptional case of neurological disease, Guillain-Barré syndrome, that were found after vaccination with the COVID-19 Janssen vaccine,” said the company in a brief statement chain CNN.
“The likelihood of it happening is very low and the case rate slightly exceeds the background rate,” adds the multinational pharmaceutical company.
“All adverse events in people who received the Johnson Johnson single-dose vaccine and our own assessment of this information will be forwarded to the FDA, the European Medicines Agency and other relevant health authorities,” it said.
The company has advocated “awareness” of the symptoms of rare diseases such as Guillain-Barré Syndrome “to ensure that they can be identified quickly and treated effectively”.
The Centers for Disease Control and Prevention (CDC) reported this Monday that the FDA is investigating information about cases of Guillain-Barré syndrome in people vaccinated with the drug.