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| REUTERS |
The Centers for Disease Control and Prevention (CDC) says that a preliminary COVID-19 vaccine “safety signal” has been identified and is investigating whether the Bivalent Pfizer-BioNTech vaccine creates an increased risk of ischemic stroke in people 65 and older.
In the Friday statement, the CDC said that the preliminary signal hasn’t been identified with the Bivalent Moderna COVID-19 vaccine.
“Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” the CDC said.
“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination.”
According to the CDC, an ischemic stroke “occurs when blood clots or other particles block the blood vessels to the brain.” --->READ MORE HERE
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| Joseph Prezioso/AFP via Getty Images |
The deadline has passed for Pfizer to submit the results of a study exploring the frequency of heart inflammation following receipt of the company’s COVID-19 vaccine.
Pfizer was required by the U.S. and Food and Drug Administration (FDA) to conduct multiple studies on its vaccine after the FDA approved the shot in August 2021 because regulators determined that without the studies, there would not be sufficient data to assess the “known serious risks of myocarditis and pericarditis,” or heart inflammation and a related condition.
Regulators were also concerned about the potential risk of subclinical myocarditis, or heart inflammation without typical symptoms.
The FDA told Pfizer to carry out six studies, with various deadlines for completion and reporting final results to the agency. The first final deadline arrived on Dec. 31, 2022.
Pfizer was required to submit a report on the study, which was to assess the incidence of subclinical myocarditis following administration of a third dose of Pfizer’s vaccine, or a booster shot, in people aged 16 to 30.
It’s unclear whether Pfizer met the deadline. The company and the FDA did not respond to requests for comment, and neither have issued any information about the study or its results since the deadline passed. --->READ MORE HEREFollow links below to relevant/related stories and resources:
CDC and FDA investigating link between Pfizer's bivalent COVID-19 shot and strokes
CDC identifies possible safety issue with Pfizer’s updated Covid-19 vaccine but says people should still get boosted
USA TODAY: Coronavirus Updates
WSJ: Coronavirus Live Updates
YAHOO NEWS: Coronavirus Live Updates
NEW YORK POST: Coronavirus The Latest
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