Johnson & Johnson is in talks with the FDA over the COVID-19 vaccine's adverse effects.
Johnson & Johnson (JNJ.N) said on monday that it was in talks with the US Food and Drug Administration regarding rare occurrences of Guillain-Barré syndrome, a neurological condition that has been linked to immunization with the Janssen COVID-19 vaccine.
Guillain-Barré syndrome is extremely rare, and the incidence of reported cases outnumbers the background rate by a fair margin, as per J&J. The argument comes after a claim in the Washington Post on monday that the FDA was about to issue a new warning on J&J's coronavirus vaccine because of a rare autoimmune disease.
The argument follows a report in Monday's Washington Post that the FDA was poised to put a new warning on J&J's coronavirus vaccination due to a rare autoimmune illness. According to a companion statement from the Centers for Disease Control and Prevention, which monitors vaccine safety systems with the FDA, about 100 preliminary reports of Guillain-Barre syndrome have been detected in vaccine recipients after the administration of 12.8 million doses of the Johnson & Johnson vaccine in the United States. According to the FDA statement, 95 of these complaints were significant enough to require hospitalization. Only one person died. Neither agency provided any details concerning the deceased.
Guillain-Barré syndrome is extremely rare, and the incidence of reported cases outnumbers the background rate by a fair margin, as per J&J. The argument comes after a claim in the Washington Post on monday that the FDA was about to issue a new warning on J&J's coronavirus vaccine because of a rare autoimmune disease.
The argument follows a report in Monday's Washington Post that the FDA was poised to put a new warning on J&J's coronavirus vaccination due to a rare autoimmune illness. According to a companion statement from the Centers for Disease Control and Prevention, which monitors vaccine safety systems with the FDA, about 100 preliminary reports of Guillain-Barre syndrome have been detected in vaccine recipients after the administration of 12.8 million doses of the Johnson & Johnson vaccine in the United States. According to the FDA statement, 95 of these complaints were significant enough to require hospitalization. Only one person died. Neither agency provided any details concerning the deceased.