The Food and Drug Administration (FDA) has revealed that Pfizer’s “booster” shots may be linked to an increased risk of strokes.
The FDA says it found a preliminary link among people who received a Covid bivalent booster and a flu shot on the same day.
The federal agency revealed that it uncovered the link while searching vaccine injury databases after a separate safety concern was raised about Pfizer’s jab.
Earlier this month, one of the country’s vaccine surveillance systems flagged a possible association between the Omicron-specific shot and an elevated risk of an ischemic stroke among seniors over 65. as Slay News reported.
After investigating the link, FDA officials said most of the stroke patients had also received their flu shot on the same day, which might be a factor.
Millions of Americans got both shots at the same time this winter following a major public health push by Democrat President Joe Biden’s White House.
As Slay News reported, Dr. Ashish Jha, White House Covid Response Coordinator, said in September: “I believe this is why God gave us two arms — one for the flu shot and the other for the Covid shot.”
The FDA is launching a bigger study to examine potential safety problems arising from vaccinating against Covid and flu simultaneously.
The findings will help the agency decide whether to continue with its recommendation to get both vaccines at the same time next winter.
For now, health officials are still recommending people get both shots at once because getting infected with the flu or Covid also raises the risk of strokes.
Dr. Walid Gellad, a professor of medicine at the University of Pittsburgh who was not involved in the analysis, said the issue required further investigation.
“Sometimes signals are not clear,” Gellad said.
“It makes sense to look into it more, and it doesn’t make sense to change practice given the known benefits (of getting the booster) in this age group.”
The possible link between the shots and strokes was found as part of an independent FDA review into Pfizer’s Covid vaccine.
The findings were presented today at a meeting of outside experts that advise the FDA on vaccine policy.
In November, a small real-time government surveillance system that monitors vaccine injuries known as the Vaccine Safety Datalink (VSD) detected a possible link between the Covid shot and strokes among over-65s.
Investigators found that 130 seniors suffered strokes in the 21 days after receiving Pfizer’s booster among about 550,000 recipients in the VSD database.
One man in his 70s died a month after the stroke, which was determined as his likely cause of death.
The FDA reviewers ran a small analysis that indicated seniors who received both the Pfizer omicron booster and a high-dose or adjuvanted flu vaccine on the same day may have a higher risk of stroke.
It comes as a key panel of advisors to the FDA recommended switching the entire vaccine series to bivalent booster doses.
Currently, a person receiving the original two-dose vaccine regimen will receive the original vaccine doses tailored to the Wuhan strain, but the bivalent shot as a booster.
The Vaccines and Related Biological Products Advisory Committee, which is made up of outside experts that advise regulators, voted 21-0 to make the original regimen the bivalent shots too.
The FDA will now need to approve this change, which it is likely to do in the coming days.
While it will only impact people who are still unvaccinated against the virus, the change could be a key step towards making the Covid vaccine an annual shot – like it is for the flu.
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