The FDA has decided no danger of stroke for seniors who obtained Pfizer’s Omicron boosters

A nurse refills syringes for patients as they receive their booster shots against coronavirus disease (COVID-19) during a Pfizer-BioNTech immunization clinic in Southfield, Michigan September 29, 2021.

Emily Elconin | Reuters

The Food and Drug Administration has not found an increased risk of stroke for seniors who have received it Pfizers Omicron booster shot, a federal health official said Thursday.

The FDA launched a comprehensive review of federal data after investigators from the Centers for Disease Control and Prevention identified a possible risk of stroke for seniors who received Pfizer’s booster shot.

The CDC’s Vaccine Safety Datalink, which monitors severe reactions to vaccines, showed a possible risk of stroke in late November. The FDA independently reviewed data from the Centers for Medicare and Medicaid Services and their Vaccine Adverse Event Reporting System.

“So far, the data we’ve seen indicate that there is no safety risk for the bivalent boosters at ages 65 and older,” Richard Forshee, deputy director of the FDA’s Office of Biostatistics, told the agency’s independent vaccines committee .

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The FDA reviewed CMS data from 4.25 million seniors who received Pfizer’s Omicron booster and found no increased risk of stroke. The Agency’s review of the VAERS data also revealed no increased risk.

The Department of Veterans Affairs also conducted a preliminary review of its database and found no increased risk of stroke, Forshee said. The FDA also reached out to international partners and Pfizer to find out what they observed in their data.

“We have contacted a number of our international regulatory agencies and various countries in Europe as well as Israel have reported no increased risk of stroke in their surveillance systems,” Forshee told the FDA committee.

“We also contacted Pfizer and they consulted their global safety database and they saw no increase or signal of ischemic stroke in their systems,” Forshee added.

CDC investigators found that among approximately 550,000 recipients in the VSD database, 130 seniors suffered a stroke in the 21 days after receiving Pfizer’s booster shot. A man in his 70s died a month after the stroke that was his probable cause of death, according to data presented Thursday.

dr Nicola Klein, the principal investigator for the CDC’s Vaccine Safety Datalink, said a statistical signal indicating a potential risk of stroke was first identified in late November and persisted through January, although the signal’s strength has waned somewhat.

“I will say that it has moderated significantly in the data from a few days ago and has not signaled for the first time in the past week,” Klein told the FDA’s panel of vaccine advisors.

However, investigators performed small analyzes that suggested seniors who received both Pfizer’s Omicron booster shot and a high-dose or adjuvanted flu vaccine on the same day may have a higher risk of stroke, although the data are preliminary.

Although the FDA has not identified a risk of stroke, the agency is starting a study to examine potential safety concerns that could arise from co-administration of the Covid-Omicron vaccines with the high-dose or adjuvant flu vaccines, Forshee said. The study will help the agency prepare for the vaccination campaign in the 2023-2024 respiratory virus season, he said.

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