ZAP // Rawpixel
A safety monitoring system in the United States has identified a potential safety issue with the recent Pfizer/BioNTech vaccine update, according to which people aged 65 and over are more likely to have a stroke 21 days after taking it.
The safety monitoring system has identified that the recent update of the vaccine against covid-19 from the US pharmaceutical company Pfizer and its German partner BioNTech may be linked to a type of stroke in older adults.
According to preliminary data analyzed by US health authorities, cited by the agency Reuterspeople over the age of 65 may be more likely to experience an ischemic stroke 21 days after receiving the Pfizer / BioNTech bivalent injection compared to the probability over the 22-44 day period.
The potential security issue was discovered after analyzing data from the Vaccine Safety Datalink (VSD), US Centers for Disease Control and Prevention (CDC) safety monitoring system, and was released by the US health regulator, the Food and Drug Administration (FDA).
One ischemic strokealso known as cerebral ischemia, is caused by the obstruction or sudden reduction of blood flow in an artery in the brain, resulting in a lack of vascular circulation in the region, and is responsible for 85% of stroke cases.
According to the FDA and CDC, other large studies, notably from the CDC Vaccine Adverse Event Reporting System, databases from other countries, and Pfizer/BioNTech databases, did not flag this problem security, so the alert requires further investigation.
“While the totality of currently available data suggests that this VSD alert is very unlikely to represent a true clinical risk, we believe it is important to share this information with the public.”
Pfizer and BioNTech confirmed in a statement that they have been made aware of limited reports of ischemic strokes in people aged 65 years and older following vaccination with the updated vaccine.
“Neither Pfizer nor BioNTech, nor the CDC or the FDA have identified similar cases in several other monitoring systems in the US and worldwide, and there is no evidence to support the conclusion that ischemic stroke is associated with the use of Covid-19 vaccines” of the two companies”, says the communiqué.
The safety alert was not identified with Moderna’s bivalent vaccine.
ZAP // 
