Pfizer bivalent vaccine linked to increased risk of stroke in older adults? U.S. Health Authorities: Investigation underway, no need to change vaccination guidelines at this time
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Jan. 13 (Bloomberg) — An analysis of preliminary data by U.S. health authorities shows that a real-time safety monitoring system has flagged a possible link between the Pfizer/BioNTech bivalent New Crown vaccine and a type of stroke in the elderly.
The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) said Friday that the CDC’s Vaccine Safety Datalink (VSD) identified a possible safety issue: Compared with 22 to 44 days after vaccination, older adults aged 65 and older were more likely to have a stroke 21 days after receiving the Pfizer/BioNTech bivalent vaccine. Ischemic stroke is more likely to occur 21 days after vaccination. Ischemic stroke, also known as cerebral ischemia, is caused by a blockage in an artery that supplies blood to the brain.
Other large studies, the health authority’s Vaccine Adverse Event Reporting System (VAERS), other country databases and the Pfizer/BioNTech database did not flag these safety concerns, “which require additional investigation,” the two agencies said. According to the U.S. health authorities, “Although the totality of the data known to date suggests that it is very unlikely that the signals in the VSD represent a true clinical risk, we believe it is important to share this information with the public.”
Pfizer and BioNTech issued a statement saying that the companies have been made aware of a small number of reports of ischemic stroke in people 65 years and older after receiving the Pfizer/BioNTech bivalent vaccine, and that “neither Pfizer, BioNTech, the CDC nor the FDA have observed similar conditions in a large number of surveillance systems in the U.S. and globally . There is no evidence to conclude that ischemic stroke is associated with the use of the Pfizer/BioNTech bivalent vaccine.”
The Modena bivalent vaccine has not been found to have the aforementioned safety issues. The CDC and FDA have indicated that there is no need to change vaccination guidelines at this time and continue to recommend timely vaccination of all persons aged 6 months and older with the New Crown vaccine.
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