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US FDA, CDC see early signs of Pfizer bivalent COVID shot relation to stroke

Early data analyzed by US health regulators, a safety monitoring system, warned that the revised COVID-19 shot from US pharmaceutical company Pfizer and German partner BioNTech might be connected to a specific type of cerebral stroke in older persons.

The Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC) announced on Friday that a CDC vaccine database had found a potential safety issue in which people 65 and older were more likely to suffer an ischemic stroke 21 days after receiving the Pfizer/BioNTech bivalent shot than they were to do so between days 22 and 44.

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Blockages in the arteries that provide blood to the brain are what cause an ischemic stroke, sometimes referred to as brain ischemia.

The CDC’s Vaccine Adverse Event Reporting System, other countries’ databases, and Pfizer databases, BioNTech according to the FDA and CDC, did not identify this safety problem, and further research is needed.

Although the sum of the data currently indicates that it is highly improbable that the signal in VSD (Vaccine Safety Datalink) represents a real clinical danger, the health authorities stated that they felt it was vital to share this information with the public.

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In a statement, Pfizer and BioNTech stated that they were made aware of a small number of cases of ischemic strokes in adults 65 and older after receiving their revised dose.

The companies further stated that there is no evidence to support a link between the use of the COVID-19 vaccines produced by the companies and ischemic stroke. “Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the US and globally,” they added.

The CDC and FDA continue to advise that everyone aged six months and older maintain current COVID-19 vaccination records. Moderna’s bivalent vaccine has not been linked to this safety issue.



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