• The EU says the new Covid-19 injection has not been associated with any safety alerts in the region.
• Pfizer and BioNTech say they are aware of a small number of cases of ischemic strokes.
• The FDA and CDC have found no such indications of relation to stroke in other databases.

The new Covid-19 injection from American pharmaceutical company Pfizer Inc. (PFE.N) and German partner BioNTech has not been associated with any safety alerts in the region, the European Union’s medicines authority reported on Wednesday.

The US Food and Drug Administration and the Centers for Disease Control and Prevention announced on Friday that preliminary data from a safety monitoring system suggested that the injection may be related to a specific form of brain stroke in older persons.

“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 the media in response to a question.

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In a statement released on Friday, Pfizer and BioNTech stated that they were aware of a small number of cases of ischemic strokes in adults 65 and older following vaccination with their revised injection.

Pfizer said that there was no evidence to support a relationship between the use of the firms’ Covid-19 vaccinations and the findings across other monitoring systems and that neither the companies nor the CDC or FDA had noticed similar findings.

The FDA and CDC also stated they had not discovered any indications of relation to stroke in other monitoring databases, and the EMA stated it was aware of the US announcement.

“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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