On Jan. 13 2023, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for U.S. Disease Control and Prevention (CDC)) issued a public statement regarding the identification of a preliminary safety signal for ischemic stroke among adults over the age of 65 that occurs between one to 21 days after receiving Pfizer/BioNTech’s monovalent Comirnaty messenger RNA (mRNA) Covid-19 shot and the WT/OMI BA.4/BA.5 bivalent version of it.
The safety signal was detected in the CDC’s Vaccine Safety Datalink (VSD), however, a primary analysis conducted by federal public health officials did not find elevated stroke risk following Covid bivalent shots.
The first CDC analysis evaluated the risk of the stroke following a Covid bivalent shot. The study’s sample population included 5,397,278 adults over 65 years old, who were given either the monovalent Comirnaty bivalent WT/OMI BA.4/BA.5 shot or Moderna/NIAID’s bivalent Spikevax shot.
There were 2,886 cases of NHS; 2,641 cases of transient ischemic attack (TIA); 4,788 cases of NHS/TIA, and 808 cases of hemorrhagic stroke (HS) across both manufacturers of the Covid shots.
Approximately 10-15 percent of the sample cases claimed they had Covid disease between 31 to 365 days prior to suffering a stroke, and 34-45 percent had been given a high-dose or adjuvanted influenza vaccination at the same time.
The findings from the primary analysis showed that there were no statistically significant associations of an increased risk of stroke following administration of the Covid bivalent shots.
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