FDA Finds Unexpected Problems with Flu Vaccine: Study

This article originally appeared in The Epoch Times and was republished with permission.

Guest post by Zachary Stieber

Some people who received a COVID-19 vaccine were at higher risk of stroke but an analysis found that the risk was connected to influenza vaccination, U.S. Food and Drug Administration (FDA) researchers said in a new study.

The researchers, analyzing data from Medicare, detected an elevated stroke risk among the elderly following receipt of a bivalent COVID-19 vaccine made by Pfizer and Moderna and available from the fall of 2022 to the fall of 2023. There was an elevated risk of nonhemorrhagic stroke or transient ischemic attack in people 85 or older following Pfizer vaccination and people aged 65 to 74 following Moderna vaccination, the researchers found.

But the researchers then looked at which people received an influenza shot at the same time as a COVID-19 shot and saw that the elevated risk only persisted among people who received the vaccines concomitantly.

“This finding suggests that the observed association between vaccination and stroke in the concomitant subgroup was likely driven by a high-dose or adjuvanted influenza vaccination,” Steven Anderson, director of the Office of Biostatistics and Epidemiology at the FDA, and the other researchers wrote.

High-dose influenza vaccines are primarily for the elderly, while adjuvanted influenza vaccines are another type of flu shot.

The researchers also found an elevated risk of nonhemorrhagic stroke among people who received an influenza vaccine and did not get a COVID-19 vaccine, supporting the finding.

“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the researchers said, adding later that “more studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”

The study was published by the Journal of the American Medical Association. It was previously filed as a preprint.

Previous Findings

The possible stroke risk for Pfizer’s bivalent vaccine and the elderly was first reported in early 2023. The FDA and U.S. Centers for Disease Control and Prevention (CDC) said at the time a safety signal appeared in a government monitoring system.

The CDC later said data from the system suggested the elevated risk stemmed from receiving an influenza vaccine with a COVID-19 shot.

Read the full story in The Epoch Times.