NEW YORK, Oct 26, (Agencies): A new study suggests that seniors, particularly those aged 85 and older, face a slightly elevated risk of stroke from blood clots in the brain when they receive both COVID and flu vaccines simultaneously. This safety concern was raised by experts from the US Food and Drug Administration (FDA) who analyzed Medicare claims data.

The FDA's findings indicate that the risk is minimal, with approximately 3 strokes per 100,000 doses given. The risk seems to be associated with high-dose or adjuvanted flu vaccines, which are designed to boost the immune system's response.

Additional analysis of Medicare claims data showed a slight increase in stroke risk for adults aged 65 and older who received only high-dose flu shots, accounting for 1-2 strokes per 100,000 doses. However, experts emphasize that this risk is significantly smaller than the risks associated with COVID-19 itself.

Despite this finding, numerous other studies have not identified any increased stroke risk following COVID-19 or flu vaccinations, whether given alone or together. Health officials continue to recommend vaccination, as the benefits far outweigh the minimal potential risk.

Dr. William Schaffner, an infectious disease expert at Vanderbilt University, highlights that the risks of severe illness from influenza and COVID-19 in older populations significantly outweigh any potential vaccine-related risks.

Individuals who are concerned about potential interactions between vaccines could consider scheduling them at different times, although health experts maintain that the benefits of vaccination remain crucial and outweigh the slight risks reported.

In an observational study, FDA investigators examined the medical claims of over 5.3 million adults aged 65 and older who received bivalent COVID-19 vaccines. The study found no increased stroke risk in the general population following COVID-19 vaccination.

While an elevated risk of stroke due to blood clots was observed in adults aged 85 and older who received Pfizer vaccines, those who received Moderna shots did not show the same risk. Seniors aged 65 and older who received a bivalent vaccine and a high-dose or adjuvanted flu shot simultaneously also faced an increased risk of brain blood clots.

The study's findings suggest an association but cannot establish causation. It is important to note that the study is pending peer review.

Furthermore, a separate FDA investigation of over 4 million records found a minor and tenuous link between seizures in children aged 2 to 5 and COVID-19 vaccination. The study showed that these children were slightly more likely to experience seizures after COVID-19 vaccination, particularly when compared to 2020 seizure rates during a year with lower infectious disease transmission in kids. However, this link disappeared when compared to 2022 seizure rates, which reflected a return to higher infection rates among children.

The authors of this study have urged further investigation to better understand this connection, particularly in a more comprehensive epidemiological study.

It's essential to interpret these findings with caution, as most reported cases of seizures were associated with fever, a common occurrence in children, and can be triggered by vaccination.

Approximately 4% of children experience febrile seizures, according to the National Institute of Neurological Disorders and Stroke. Experts find these findings generally not concerning and emphasize the importance of childhood vaccination to protect against COVID-19 and its potential complications.