A small official analysis suggests that there may be an increased risk of stroke if an individual receives both the Pfizer Covid booster and a flu shot on the same day.
The FDA discovered a potential connection by searching vaccine injury records after concerns were raised about the safety of Pfizer's vaccine.
In the beginning of this month, a vaccine monitoring system in the country noted a potential link between the Omicron vaccine and an increased possibility of an ischemic stroke in individuals aged 65 and above.
According to the FDA officials investigating the link, it has been observed that most patients had received their flu shot on the same day, which could be a contributing factor.
During winter, following a public health campaign by the White House, millions of Americans received both flu and Covid shots simultaneously. In September, Dr. Ashish Jha, White House Covid Response Coordinator, stated that getting both shots at the same time is possible because humans have two arms.
The FDA is conducting a larger study to investigate possible safety issues that may arise from administering Covid and flu vaccines together.
The agency will base their decision on whether to continue recommending getting both vaccines at the same time next winter on the findings.
Currently, health officials continue to advise individuals to receive both doses of the vaccine at the same time as being infected with either flu or Covid can increase the likelihood of experiencing a stroke.
According to Dr. Walid Gellad, a medicine professor at the University of Pittsburgh who was not part of the study, there is a need for further investigation on the matter.
Following a federal audit that discovered the NIH's inadequate oversight of the use of millions of dollars in federal funds for research at the Wuhan Institute of Virology, which is the focus of concerns regarding a possible Covid lab leak, this announcement has been made.
It is understandable that signals can be ambiguous. However, it is advisable to further investigate the situation before considering any changes. It is not advisable to alter the current practice, considering the confirmed advantages of receiving the booster in this age category.
During an independent FDA review of Pfizer's Covid vaccine, a potential connection between the vaccine and strokes was discovered. This information was presented today at a meeting of external experts who provide advice to the FDA on vaccine policy.
In November, the Vaccine Safety Datalink (VSD), which monitors vaccine injuries in real-time for the government, identified a potential connection between the Covid vaccine and strokes in individuals over the age of 65.
According to investigations, among around 550,000 recipients in the VSD database, 130 seniors experienced strokes within 21 days of receiving Pfizer's booster. One man in his 70s died a month after experiencing a stroke, which was likely the cause of his death. However, officials noted that the overall incidence of strokes appears to decrease over time, suggesting a weaker connection to the Covid vaccine.
During a meeting with the FDA's independent vaccine committee, Richard Forshee, who is the deputy director of the agency's biostatistics office, stated that the data seen thus far indicates no safety risk for the bivalent booster shots in individuals who are aged 65 years and older.
According to the FDA's review, there were no reports of increased stroke risk among the 4.25 million seniors who received the Pfizer's omicron booster. Additionally, the VAERS database was also reviewed and showed no increased risk.
Although the FDA contacted Pfizer and international health agencies to inquire about their findings, they did not confirm a connection between the blot clots and Pfizer Omicron booster. However, through a limited analysis, the FDA reviewers found that seniors who received both the Pfizer Omicron booster and a high-dose or adjuvanted flu vaccine on the same day might face a higher risk of stroke.
It comes as a key panel of advisors to the FDA has recommended switching the entire vaccine series to bivalent booster doses.
Currently, someone who has received the original two-dose vaccine will receive the original vaccine doses specifically designed for the Wuhan strain, but will receive a bivalent shot as a booster.
A group of outside experts called the Vaccines and Related Biological Products Advisory Committee voted 21-0 to recommend keeping the original vaccine regimen, which includes the bivalent shots. The FDA is expected to approve this change soon. This change will only affect those who haven't received the vaccine yet and could be an important step toward making the Covid vaccine an annual shot, similar to the flu shot.