U.S. FDA, CDC see early signal of Pfizer bivalent COVID shot's link to
stroke
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[January 14, 2023]
(Reuters) -A safety monitoring system flagged that U.S. drugmaker
Pfizer Inc and German partner BioNTech's updated COVID-19 shot could be
linked to a type of brain stroke in older adults, according to
preliminary data analyzed by U.S. health authorities.
The U.S. 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 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.
An ischemic stroke, also known as brain ischemia, is caused by blockages
in arteries that carry blood to the brain.
The FDA and CDC said that other large studies, the CDC's Vaccine Adverse
Event Reporting System, other countries' databases and Pfizer-BioNTech's
databases had not flagged this safety issue, adding that it requires
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," the health authorities said.
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Vials with a sticker reading,
"COVID-19 / Coronavirus vaccine / Injection only" and a medical
syringe are seen in front of a displayed Pfizer logo in this
illustration taken October 31, 2020. REUTERS/Dado Ruvic/File Photo
Pfizer and BioNTech said in a
statement that they have been made 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.
This safety concern has not been identified with Moderna's bivalent
shot and both the CDC and FDA continue to recommend that everyone
aged 6 months and older stay up-to-date with their COVID-19
vaccination.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Devika
Syamnath)
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