Two friends independently emailed me a recent article from CNN’s website with the headline, “COVID shots may increase risk of stroke in older adults, particularly when paired with flu vaccines,” and asked whether they should forgo the new COVID vaccine.
Apparently, they, like whoever composed the headline, failed to read the entire article, which offered critical context.
The background is that in January, the CDC and FDA issued a public communication explaining that one of the CDC’s vaccine safety monitoring databases had detected a small risk of stroke for older adults who received a dose of Pfizer’s bivalent COVID-19 vaccine and a high-dose flu shot on the same day. The FDA then examined more closely the medical records of seniors on Medicare for the possibility of strokes after vaccination.
The CNN article went on to clarify, correctly, that “the risk identified in the FDA’s study appears to be very small — roughly 3 strokes or transient ischemic attacks for every 100,000 doses given — and the study found it may be primarily driven by the high-dose or adjuvanted flu vaccines, which are specially designed to rev up the immune system so it mounts a stronger response to the shot.” The high-dose vaccines have been shown to provide greater protection against flu for people 65 and over.
The article also quoted Dr. Steve Nissen, a cardiologist and researcher at the Cleveland Clinic, who added more perspective on the stroke risk: “The absolute risk is miniscule,” and is trivial compared to the risk of the elderly dying from COVID.
The article further clarified that at least five other recent studies, many intended specifically to evaluate whether there is a link between the vaccines and strokes— “have not found any additional risk of stroke after vaccination for COVID-19, influenza or both.” (Emphasis added.) It also included this quote from Dr. Tom Shimabukuro, director of the Immunization Safety Office at the CDC: “Available data do not provide clear and consistent evidence of a safety problem for ischemic stroke with bivalent mRNA COVID-19 vaccines when given alone or given simultaneously with influenza vaccines.”
Near the end, the article emphasized that researchers currently recommend that “everyone should still get vaccinated since an increase in risk of a stroke after vaccination is dwarfed by the increased risk of stroke or other serious outcomes following either a flu or COVID-19 infection.”
It concludes with a quote from Dr. William Schaffner, an eminent infectious disease expert at Vanderbilt University, making the same point: “The risk of serious disease associated with both influenza and COVID for the population at highest risk, which is of course, older persons, is so much greater than the potential increased risk associated with a vaccine.”
In order to accurately capture the nuance of an article, headline writers and editors should read it before finalizing the headline.
Henry I. Miller, MS, MD
Henry I. Miller, MS, MD, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. His research focuses on public policy toward science, technology, and medicine, encompassing a number of areas, including pharmaceutical development, genetic engineering, models for regulatory reform, precision medicine, and the emergence of new viral diseases. Dr. Miller served for fifteen years at the US Food and Drug Administration (FDA) in a number of posts, including as the founding director of the Office of Biotechnology.
