The European Union’s drug regulator has not identified any safety signals in the region related to U.S. drugmaker Pfizer Inc and German partner BioNTech’s updated COVID-19 shot, the agency said on Wednesday.
On Friday, the U.S. Food and Drug Administration and the Centres for Disease Control and Prevention said that a safety monitoring system had flagged that the shot could possibly be linked to a type of brain stroke in older adults, according to preliminary data. “EMA can confirm that to date no such signal has been identified in the EU. EMA will continue to evaluate all available data to determine whether emerging safety information could point to a similar signal in the EU,” the agency told Reuters in response to a question.
Pfizer and BioNTech said in a statement on Friday that they were aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated shot.
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Pfizer further noted that neither the companies nor the CDC and FDA had observed similar findings across other monitoring systems and said there was no evidence to suggest an association with the use of the companies’ COVID-19 vaccines.
The EMA said it was aware of the U.S. announcement, in which the FDA and CDC also said they had not found signs of a link to stroke in other monitoring databases.
“EMA will continue to evaluate all available data to determine whether emerging safety information could point to a similar signal in the EU,” its statement read.
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