US FDA and CDC see early signal of link between Pfizer’s bivalent COVID vaccine and stroke

Jan 13 (Reuters) – A safety watchdog has reported that U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech’s updated COVID-19 vaccine may be linked to some type of accident stroke in the elderly, according to preliminary data analyzed by the United States. health authorities.

The US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said on Friday that a CDC vaccine database had uncovered a possible safety issue in which people over 65 and more were more likely to have an ischemic stroke 21 days after receiving the bivalent Pfizer/BioNTech vaccine, compared to days 22-44.

An ischemic stroke, also known as cerebral 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 Vaccine Adverse Event Reporting System, other countries’ databases, and Pfizer-BioNTech’s databases did not report this issue. security, adding that it requires further investigation.

“Although the totality of the data currently suggests that the signal in 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,” said health authorities.

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 and BioNTech, nor the CDC or FDA have observed similar results in many other surveillance systems in the United States and around the world and there is no evidence to conclude that ischemic stroke is associated with the use of companies’ COVID-19 vaccines,” the companies added.

This safety issue has not been identified with Moderna’s bivalent vaccine (MRNA.O) and the CDC and FDA continue to recommend that anyone 6 months and older stay current with their COVID-19 vaccination .

Reporting by Bhanvi Satija in Bengaluru; Editing by Devika Syamnath

Our standards: The Thomson Reuters Trust Principles.

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