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