A safety watchdog has flagged that U.S. drugmaker Pfizer Inc PFE.N and the updated vaccine COVID-19 BNTX. of German partner BioNTech could be linked to a type of stroke in older adults, according to preliminary data analyzed by US health authorities.
What are the possible health consequences of vaccines?
According to Reuters (14/01/23), the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said last Friday that a CDC vaccine database revealed a potential safety issue in which people aged 65 and older were more likely to have an ischemic stroke 21 days after receiving the Pfizer/BioNTech bivalent shot, compared to days 22-44.
An ischemic stroke, also known as brain ischemia, is caused by blockages in the arteries that carry blood to the brain.
The FDA and CDC said other large studies, the CDC's Adverse Vaccine Event Reporting System, other countries' databases and Pfizer-BioNTech's databases had not highlighted this safety issue, adding that more research is needed.
"Although the body of data currently suggests that it is highly unlikely that the signal in the VSD (Vaccine Safety Datalink) represents a real clinical risk, we believe it is important to share this information with the public," the health authorities said.
Pfizer's response
Pfizer and BioNTech said in a statement that they have been made aware of limited reports of ischemic strokes in people 65 and older after vaccination with their updated vaccine.
"Neither Pfizer, the CDC, or the FDA have observed similar findings in other surveillance systems in the US and worldwide, and there is no evidence to suggest that ischemic stroke is related to the use of the vaccines COVID-19Pfizer said.
Source: protothema.gr