The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration’s (FDA) surveillance system flagged a possible link between the new Pfizer-BioNTech bivalent Covid-19 vaccine and strokes in people aged 65 and over, but both agencies announced on Friday that they’ll continue to recommend the shots.
According to a statement on the CDC website, the surveillance raised a question of whether the risk of stroke – which occurs when arteries pumping blood to the brain are blocked by a blood clot – was elevated in the 21-day period post-vaccination versus 22 to 44 days post-vaccination.
The release says that CDC’s Vaccine Safety Datalink – the real-time surveillance system – met criteria warranting further investigation into the possible higher risk of ischemic stroke caused by the bivalent Pfizer vaccine in people 65 and older
The CDC and FDA, however, said that they’ve found no evidence of increased risk of ischemic stroke among people 65 and older jabbed with Pfizer’s bivalent booster, noting that neither the data from the Centers for Medicare and Medicaid Services, Department of Veterans Affairs and other sources have shown an elevated risk of stroke.
Both agencies underscored in their statement that, be that as it may, they felt it is important to share the information with the public when one of their safety monitoring systems detects a signal, as it was in this case despite the fact that the signal doesn’t represent true clinical risk.
It’s also worth noting that no similar safety signal was identified for Moderna’s bivalent booster dose.
Both Pfizer and BioNTech stressed in their statements that no evidence exists to conclude that the use of the companies’ COVID-19 vaccines is associated with ischemic stroke.
The CDC’s conclusion says that no change was needed for its recommendation regarding the bivalent boosters, which advises that everyone stays up to date on their COVID-19 vaccinations.
Despite the Biden administration’s six-week push to increase vaccination of people over 65 ahead of the holidays, according to the CDC, less than 40% percent of people in that age group got the booster shot since it was made available compared to 94% who have gotten the two primary series messenger-RNA shots.
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