In a statement to Reuters on Tuesday, the European Medicines Agency (EMA) said it was looking at data concerning the safety of the J&J Covid-19 vaccine. The “EMA’s safety committee (PRAC) is analyzing data provided by [J&J]… on cases of Guillain-Barre syndrome (GBS) reported following vaccination,” it stated.
The medicines agency did not provide any details as to whether it had observed potential cases of GBS, but added that its review was part of regular summary safety reports.
On Monday, the US Food and Drug Administration (FDA) added a GBS warning to the fact sheet for the J&J vaccine, which has already been investigated for links to potentially fatal blood clotting.
The FDA said that there were 100 preliminary reports of GBS which were being investigated, including 95 serious cases that required hospitalization and one reported death.
The single-shot vaccine has been administered to 12.6 million people in the US and 18.6 million doses have been distributed around the EU for administration, according to the European Center for Disease Prevention and Control.
A number of experts have suggested that people who received a single shot of the J&J vaccine may need booster shots in the coming months, as new variants impact the jab’s efficacy.