The European Medicines Agency (EMA) reported on Wednesday (18/1) that it found no link between Pfizer’s updated vaccine against Covid-19 and the increased risk of stroke ( ischemic stroke) in older adults.
“The EMA can confirm that so far no such signal has been identified in the European Union. The agency will continue to evaluate all available data to determine whether emerging safety information could point to a similar signal in the EU.”
Last Friday (1/13), the Food and Drug Administration (FDA) – a health agency equivalent to Anvisa – and the Center for Disease Control and Prevention (CDC), both from the United States, reported that a security monitoring system signaled that the immunizer could be linked to a possible security issue. The suspicion arose after an analysis of preliminary data by US health authorities.
Persons aged 65 years and older would have been shown to be more likely to have an ischemic stroke 21 days after receiving the Pfizer/BioNTech bivalent injection compared to the prevalence observed in the following weeks.
“While the totality of data currently suggests that the signal in the VSD (vaccine safety datalink) is very unlikely to represent a true clinical risk, we believe it is important to share this information with the public,” US health officials explained.
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Pfizer and partner BioNTech said they were made aware of the limited reports of ischemic strokes in the elderly after immunization with the updated vaccine to combat infection with the Omicron variant of the coronavirus. But they also noted that there was no evidence to suggest an association between them.
“The EMA will continue to evaluate all available data to determine whether emerging safety information could point to a similar signal in the EU,” the EU medicines agency said.
(With information from Reuters agency)
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