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FDA finds no stroke risk in older people who take Pfizer boosters

FDA finds no stroke risk in older people who take Pfizer boosters
FDA finds no stroke risk in older people who take Pfizer boosters


A nurse fills a syringe for a patient receiving a COVID-19 booster shot at the Pfizer-BioNTech vaccination clinic in Southfield, Michigan, on September 29, 2021.

Emily Erkonin | Reuters

The Food and Drug Administration has seen no indication that older people have an increased risk of stroke after receiving treatment. Pfizer’s Booster shots of Omicron, federal health officials said Thursday.

The FDA has begun a broad review of federal data after investigators at the U.S. Centers for Disease Control and Prevention (CDC) discovered a possible risk of stroke in older adults given Pfizer boosters. .

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

“So far, the data we have seen suggest that there are no safety risks to bivalent boosters at ages 65 and older.

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The FDA reviewed CMS data from 4.25 million older adults who received Pfizer’s omicron booster and found no increased risk of stroke. An agency review of VAERS data also found no increased risk.

The Department of Veterans Affairs also conducted a preliminary review of the database but did not identify an increased risk of stroke, Forsey said. I checked what was done.

“We have reached out to a number of international regulatory bodies, and various countries in Europe and Israel have shown no increased risk of stroke with surveillance systems,” Forshee said. told the commission.

“We also reached out to Pfizer, and they looked at their global safety database, and we didn’t see any increase or signal for ischemic stroke in their system,” Forsey added.

CDC investigators found that of nearly 550,000 recipients in the VSD database, 130 seniors had a stroke in the 21 days after receiving Pfizer boosters. A man in his 70s died a month after he suffered a stroke, according to data released Thursday.

Dr. Nicola Klein, principal investigator for the CDC’s Vaccine Safety Data Link, said statistical signals of potential stroke risk were first identified in late November and persisted through January, but the strength of the signals remained strong. He said the pressure had eased somewhat.

“With the data from just a few days ago, I’d say it’s significantly weakened and actually showed no signs for the first time in the past week,” Klein told the FDA’s Vaccine Advisors Panel.

However, although the data are preliminary, the researchers found that older people who received both Pfizer’s omicron booster and a high-dose or adjuvant flu vaccine on the same day may be at higher risk of stroke. We performed a small-scale analysis to show.

Although the FDA has not identified the risk of stroke, the FDA is investigating potential safety concerns that may arise from administering micron injections of Covid concurrently with high-dose or adjuvant flu vaccinations. Forshee said the study is starting. The study will help authorities prepare for a vaccine campaign for the 2023-2024 respiratory virus season, he said.




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