A health official in the United States (US) with the Food and Drug Administration, has disclosed that Pfizer Inc.’s bivalent vaccine for Covid-19 has high probability of causing stroke in people 65 and older. The official said that the discovery was found in preliminary data from one of several vaccine safety databases.
The health official, in a statement on the Food and Drug Administration’s website, noted that the potential risk with Pfizer’s vaccine was not found in other safety databases, nor was it seen with Moderna Inc.s Covid vaccine.
The statement, however, indicated that early finding still needs more investigation and recommendations, adding that the vaccines have not been changed.
A spokesperson for the Centers for Disease Control and Prevention, Kristen Nordlund, was cited to have stated in an email: “when we find a signal, we look for it in other parts of the system, which is what we’ve done (and will continue to do).”
The agencies in the statement maintained that the possible link to stroke was seen in the CDC’s Vaccine Safety Datalink. Investigation of the signal raised a question of whether people 65 and older who received the Pfizer-BioNTech bivalent shot were more likely to have an ischemic stroke, a loss of blood flow in the brain, in the 21 days following vaccination compared with days 22-44 following vaccination.
They declared: “the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk.”
Pfizer’s bivalent booster was administered to protect two omicron variants, called BA4 and BA5. It was noted that messenger RNA Covid shots have been linked to pericarditis and myocarditis, inflammation of the heart and its surrounding tissue that’s usually mild.
The CDC revealed that of the 550,000 people – 65 and older – who were vaccinated and received the Pfizer bivalent booster, 130 suffered strokes in the first three weeks after receiving the shot, according, noting that no deaths have been reported.