Health
FDA reports first ‘no signal’ of stroke risk with Pfizer booster, launches study of concomitant flu vaccination – Endpoint News
The FDA has detected no potential safety signs, including stroke, in people over the age of 65 who have received Pfizer’s bivalent Covid booster, a senior official said on Thursday. I told the members of the association (VRBPAC)…
Updates come as FDA and CDC Research A ‘preliminary signal’ that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s latest injections.
As of Jan. 11, 21.3 million bivalent boosters have been administered to people over the age of 65, said Tom Shimabukuro, director of the CDC’s Immunization Safety Office. According to a joint statement from the FDA and CDC, he found a potential problem with only one of the CDC’s multiple safety systems, his Vaccine Safety Datalink.
VSD Signal Rapid Response Study Shows People Aged 65 and Older Vaccinated with Pfizer-Biontech COVID-19 Vaccine, Bivalent, May Develop Ischemic Stroke 21 and 22 Days After Vaccination The question arose as to whether it was high. -44 after vaccination.
Nicola Klein, director of the Kaiser Permanente Vaccine Study Center, said the monitoring system “has been signaling for weeks”, but “results are subject to confounding factors that change over time.” It is possible,” he also said.
Researchers identified a “sparse but present” cluster of patients aged 65 and older who experienced ischemic stroke 11 to 22 days after receiving boosters, although the number of incidents decreased over time. She added that the incidence in the control group may have been lower than expected.
Last week, Israeli and EU drug regulators announced that they found no link between booster shots and ischemic stroke.
“There is no over-reporting of stroke by VAERS. We didn’t see an increase,” said Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Drug Safety.
He said Thursday that the only safety signals observed in the adult population after the Pfizer booster were myocarditis and pericarditis in individuals aged 18 to 35, also observed after the monovalent primary vaccine series. And while a CDC analysis suggests that people who received flu vaccines concurrently may be at increased risk, Forshee said the FDA analysis included a 65-year-old More than 4.25 million doses of Pfizer’s vaccine were included in these people, 38% of whom had concurrent influenza vaccinations. We have detected such a risk.
“We continue to do more work to classify the different flu vaccines that are administered. I don’t see any signs of it,” Forshee said.
Forsey said authorities have initiated a formal epidemiological study that will specifically focus on high doses or co-administration of flu vaccines.
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