A nurses fills up syringes for patients as they receive their coronavirus disease (COVID-19) booster vaccination during a Pfizer-BioNTech vaccination clinic in Southfield, Michigan, September 29, 2021.
Emily Elconin | Reuters
The Food and Drug Administration hasn’t found an increased risk of stroke for seniors who’ve received Pfizer’s omicron booster shot, a federal health official said Thursday.
The FDA launched an intensive review of federal data after investigators on the Centers for Disease Control and Prevention detected a possible risk of stroke for seniors who received Pfizer’s booster.
The CDC’s Vaccine Safety Datalink, which monitors serious reactions to vaccines, showed a possible risk of stroke in late November. The FDA independently checked out data from the Centers for Medicare and Medicaid Services and its Vaccine Hostile Event Reporting System.
“To this point the information that we’ve seen suggests the absence of a security risk for the bivalent boosters in age 65 years and older,” Richard Forshee, deputy director of the FDA’s biostatistics office, told the agency’s independent vaccine committee.
The FDA reviewed CMS data from 4.25 million seniors who received Pfizer’s omicron booster and didn’t discover any increased stroke risk. The agency’s review of VAERS data also didn’t find an increased risk.
The Department of Veterans Affairs has also conducted preliminary review of its database and didn’t discover an increased stroke risk, Forshee said. The FDA also reached out to international partners and Pfizer to seek out out what they observed of their data.
“We contacted quite a few our international regulatory agencies, and various countries in Europe in addition to Israel have indicated no increased risk of stroke on their surveillance systems,” Forshee told the FDA committee.
“We also contacted Pfizer they usually consulted their global safety database they usually didn’t see any increase or a signal for ischemic stroke of their systems,” Forshee added.
CDC investigators found that 130 seniors suffered strokes within the 21 days after receiving Pfizer’s booster amongst about 550,000 recipients within the VSD database. One man in his 70s died a month after the stroke which was his likely explanation for death, in response to data presented Thursday.
Dr. Nicola Klein, the principal investigator of the CDC’s Vaccine Safety Datalink, said a statistical signal indicating a possible stroke risk was first identified in late November and has endured through January, though the signal’s strength has eased somewhat.
“I’ll say that in the information from just a pair days ago it has attenuated substantially and truly has not signaled this past week for the primary time,” Klein told the FDA panel of vaccine advisors.
Nevertheless, the investigators ran small evaluation that indicated seniors who received each the Pfizer omicron booster and a high-dose or adjuvanted flu vaccine on the identical day can have the next risk of stroke, though the information is preliminary.
Although the FDA has not identified a stroke risk, the agency is launching a study to look at potential safety concerns which will arise from administering the Covid omicron shots concurrently the high-dose or adjuvant flu shots, Forshee said. The study will help the agency prepare for the vaccine campaign within the 2023-2024 respiratory virus season, he said.
