The CDC has observed a preliminary “safety signal” for the COVID-19 vaccine and is now looking into whether or not the bivalent Pfizer-BioNTech vaccine causes a high risk of ischemic stroke in adults aged 65 and above.
Preliminary evidence reviewed by US health regulators suggests that the upgraded COVID-19 injection developed by Pfizer Inc (PFE.N) and its German partner BioNTech may be linked to a type of cerebral stroke in the elderly.
On Friday, the CDC and FDA reported that a CDC vaccination database found that adults 65 and older were more likely to suffer an ischemic stroke 21 days after getting the Pfizer/BioNTech Bivalent injection than on days 22–44.
Ischemic strokes, also called brain ischemia, are brought on by clogging the arteries that provide blood to the brain. Ischemic strokes are responsible for 87% of all strokes and afflict around 800,000 individuals annually in the United States. Strokes caused by a lack of oxygen to the brain are more prevalent among the elderly, although they may happen to anybody.
According to the FDA and CDC, there is a need to conduct further investigation into this safety risk since there was no anticipation from extensive studies such as the Vaccine Adverse Event Reporting System at the CDC, databases owned by Pfizer-BioNTech, and databases in other countries.
Health officials stated that it was necessary to convey this information to the public, even though the totality of the data presently implies that it is highly improbable that the signal in the VSD (Vaccine Safety Datalink) reflects a significant clinical risk.
In a joint statement, Pfizer and BioNTech noted that they had received reports of ischemic strokes in patients aged 65 and older after receiving their improved vaccine.
Pfizer’s COVID bivalent booster dosage with the flu vaccination on the same day may significantly increase a person’s risk of stroke, according to experts. The FDA claimed this based on their investigation (FDA). After hearing of a different safety problem with Pfizer’s vaccine, the FDA investigated vaccine injury databases and discovered the connection.
In January, the country’s vaccination monitoring systems identified a possible link between the Omicron-specific dose and an increased risk of ischemic stroke, particularly among those over 65.
The inquiry into this is still ongoing. Most patients allegedly had the influenza shot and the Pfizer bivalent booster dosage on the same day, according to the FDA investigators studying the probable relationship between the vaccinations and stroke risk.
A severe pandemic flu epidemic has just hit the United States. To counter this, the government mandated that everyone get both immunizations. Since there has been an uptick in the number of reported cases of COVID-19, this action marks a preventative step.
The FDA is beginning a more comprehensive study to investigate concerns about COVID and flu vaccinations. Based on the results, the FDA may determine whether it will still suggest receiving both vaccinations at once next winter.
However, health experts insist that patients should receive both vaccines at once since contracting either COVID or the flu increases the risk of stroke. In addition, it is imperative to perform further study regarding this matter. However, they agree that there is the only reason to discontinue supplying the booster once a definitive study conclusion is given since the advantages of this dose much exceed the risks.