Getting the Pfizer Covid bivalent booster and flu shot on the same day increases the risk of a stroke, analysts at the Food and Drug Administration (FDA) have claimed. FDA scoured through vaccine injury databases and found the preliminary link after a separate safety issue about Pfizer's vaccine was raised, which has now raised concerns.
Earlier this month, one of the nation's vaccine surveillance systems raised concerns over a suspected link between the Omicron-specific vaccination and the risk of an ischemic stroke among seniors above the age of 65. According to FDA authorities who have been looking into the link said that majority of the patients had also received their flu vaccination on the same day, which may be a factor.
Millions of Americans received both the Pfizer booster and flu vaccine at the same time this winter following a major White House public health initiative. White House Covid Response Coordinator Dr. Ashish Jha stated in September: "I believe this is why God gave us two arms â one for the flu vaccination and the other for the Covid shot."
However, the initiative might backfire now as the new study reveals scary new details.
According to a DailyMail.com report, The FDA will now start a bigger study to investigate any potential safety issues associated with receiving both the flu and the Covid vaccines at the same time, following the initial findings. The agency's decision over whether to stick with its advice to receive both vaccines at the same time next winter will be influenced by the findings.
Health officials nevertheless advise having both vaccinations at once for the time being because acquiring the flu or Covid increases the risk of strokes.
According to Dr. Walid Gellad, a professor of medicine at the University of Pittsburgh who was not involved in the analysis, the subject requires more research.
"Sometimes signals are not clear. 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," he told the outlet.
A New Concern
The potential link between Pfizer and flu vaccines and strokes was found in the course of an independent FDA investigation into Pfizer's Covid vaccination The findings was shared on Thursday at a gathering of external specialists who counsel the FDA on vaccine regulations.
A potential connection between the Covid shot and strokes among people over 65 was first detected in November by the Vaccine Safety Datalink (VSD), a modest real-time government surveillance system that tracks vaccine injuries.
Among the approximately 550,000 recipients of Pfizer's booster in the VSD database, investigators found that 130 seniors experienced strokes in the 21 days after taking it.
A stroke was revealed to be one 70-year-old man's likely cause of death after he died a month later. Officials claim that the correlation between the Covid jab and the overall rise in strokes is decreasing over time.
Richard Forshee, deputy director of the FDA's biostatistics office, told the agency's independent vaccine committee: "So far the data that we have seen suggests the absence of a safety risk for the bivalent boosters in age 65 years and older."
The FDA examined data from 4.25 million seniors who got Pfizer's omicron booster, but no increased stroke risk was found. The agency's analysis of the VAERS database likewise failed to uncover an elevated risk.
Also, the stroke link was not confirmed when the FDA contacted Pfizer and international health agencies to inquire about what they had seen in their data.
However, a limited analysis conducted by the FDA reviewers revealed a possible increased risk of stroke in seniors who had the Pfizer omicron booster and a high-dose or adjuvanted flu vaccine on the same day.
It comes after a significant group of FDA consultants suggested changing the entire vaccine series to bivalent booster doses.
Currently, someone getting the original two-dose vaccination schedule will receive the original two doses of the Wuhan strain-specific vaccine but the bivalent injection as a booster.
The original schedule would also include the bivalent shots, according to a 21-0 vote of the advisory committee for vaccines and related biological products, which is made up of external specialists who provide guidance to authorities.
This modification must now be approved by the FDA, which it will probably do in the next few days.