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FDA adds warning on J&J COVID-19 vaccine for rare neurological disorder

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eMediNexus    13 July 2021

The U.S. Food and Drug Administration has added a warning to the fact sheet for Johnson & Johnson COVID-19 vaccine stating that according to available data, there is an increased risk of a rare neurological disorder during the six weeks after vaccination.

In a letter to J&J, the FDA mentioned the likelihood of developing Guillain-Barré syndrome (GBS) after inoculation as being very low. However, the agency emphasized that recipients of the J&J vaccine should seek medical attention if they experience symptoms such as weakness or tingling sensation, difficulty in walking or difficulty with facial movements. Nearly 12.8 million individuals have been administered J&J’s vaccine in the United States, and among 100 preliminary reports of GBS in those who have received the vaccine, 95 are serious cases that needed hospitalization and there has been one death… (Reuters, July 12, 2021)

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