A nurse fills syringes for patients who are receiving a coronavirus (COVID-19) booster on the Pfizer-BioNTech vaccination clinic in Southfield, Michigan, September 29, 2021.
Emily Elconin | Reuters
The Food and Drug Administration found no increased risk of stroke in seniors who received it by Pfizer an omicron-like injection, a federal health official said Thursday.
The FDA launched an in depth review of federal data after investigators from the Centers for Disease Control and Prevention found a possible risk of stroke in seniors who received a Pfizer booster.
The CDC 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 their vaccine hostile event reporting system.
“To date, the info we have seen suggests no safety risk for bivalent boosters aged 65 and older,” Richard Forshee, deputy director of the FDA’s office of biostatistics, told the vaccine agency’s independent committee.
The FDA reviewed CMS data from 4.25 million seniors who received Pfizer’s omicron booster and didn’t discover any increased risk of stroke. The agency’s review of VAERS data also found no increased risk.
The Department of Veterans Affairs also conducted an initial review of its database and didn’t discover an increased risk of stroke, Forshee said. The FDA also contacted international partners and Pfizer to seek out out what they observed in their data.
“We’ve got contacted many of our international regulatory agencies, and various countries in Europe, in addition to Israel, haven’t shown an increased risk of stroke in their surveillance systems,” Forshee told the FDA committee.
“We also contacted Pfizer, and so they consulted their global safety database and saw no increase or ischemic stroke signal in their systems,” Forshee added.
CDC investigators found that 130 seniors suffered a stroke inside 21 days of receiving a Pfizer booster amongst roughly 550,000 recipients in the VSD database. One man in his 70s died a month after suffering a stroke, which was his probable cause of death, based on figures released on Thursday.
Dr. Nicola Klein, principal investigator on the CDC Vaccine Safety Datalink, said the statistical signal indicating a potential stroke risk was first identified in late November and persevered into January, although the strength of the signal weakened somewhat.
“I’ll say that in the info just a few days ago, it weakened significantly and really didn’t signal that last week for the primary time,” Klein told the FDA’s panel of vaccine advisers.
Nevertheless, researchers did a small study that showed that seniors who received each the Pfizer omicron booster and the high-dose or adjuvanted flu vaccine on the identical day could also be at higher risk of having a stroke, although the info is preliminary.
While the FDA has not identified a risk of stroke, the agency is launching a study to analyze potential safety concerns which will arise from administering Covid omicron injections similtaneously high-dose or adjuvant flu shots, Forshee said. He said the study will help the agency prepare for the 2023-2024 respiratory virus season vaccine campaign.