Posted: Saturday, January 14, 2023. 8:34 am CST.
By Zoila Palma Gonzalez: On Friday, the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said that they had flagged drugmaker Pfizer Inc and BioNTech’s updated COVID-19 shot, Reuters report.
Health officials say that the shot could be linked to a type of brain stroke in older adults.
The vaccine database reportedly revealed the possible safety issue in which people 65 and older were more likely to have an ischemic stroke 21 days after receiving the Pfizer/BioNTech bivalent shot, compared with days 22-44.
However, other large studies did not flag this safety issue, therefore the CDC noted that this required more investigation.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public,” U.S. health authorities said.
Pharmaceuticals, Pfizer, and BioNTech said that they are aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated shot.
“Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines,” the companies added.
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