Johnson & Johnson has updated its Covid-19 vaccine factsheets to include information on the rare neurological case of Guillain-Barré syndrome.
“Updates with this new information will be implemented in other regions of the world according to local regulatory procedures,”J&J said, after the United States Food and Drug Administration red-flagged the condition seen in vaccine recipients. J&J’s vaccine is part of India’s vaccine basket as well, in a deal with local producer Biological E.
“Rare cases of the neurological disorder, Guillain-Barré syndrome have been reported following vaccination with the Janssen Covid-19 vaccine. Most occurred within 42 days after vaccination,” J&J said.
“While the chance of having this occur is very low, Johnson & Johnson has updated its Covid-19 Vaccine factsheet to include important information about these rare cases and on the signs and symptoms of Guillain-Barré syndrome,”it added.
Further, the American company said, “any adverse event report about individuals receiving Johnson & Johnson’s single-shot Covid-19 vaccine, as well as our own assessment of the report, is shared with the US Food and Drug Administration, the European Medicines Agency, the World Health Organization and other health authorities around the world where our vaccine is authorized.”
J&J reiterated that its single-shot Covid-19 vaccine offers protection against Covid-19 disease and prevents hospitalization and death, including in countries where viral variants are highly prevalent.