The Centers for Disease Control and Prevention on Friday said it is “very unlikely” that Pfizer’s omicron-enhancing drug poses a stroke risk to seniors after it launched an investigation into concerns. Preliminary safety information detected by one of their monitoring systems.
CDC, in a statement posted to its website on Friday, says a monitoring system called Vaccine Safety Data Link has detected a possible risk of stroke in people 65 years of age and older who received Pfizer’s booster shot targeting the variable. omicron Covid. A CDC spokesperson said the issue was first detected in late November.
In mid-December, the CDC concluded the concern persisted and opened an investigation into whether older adults were more likely to have a stroke during the first 21 days after receiving the Pfizer booster, the spokesperson said. . The same preliminary signal was not detected for the Moderna turbocharger.
A CDC spokesperson said VSD’s surveillance system found that 130 people aged 65 and older had a stroke within 21 days of Pfizer’s omicron-enhanced injection of the approximately 550,000 elderly people who received the shot. . No deaths have been reported. The Washington Post previously reported.
According to the CDC, to date, no other surveillance system has detected a similar safety concern for the booster drug Pfizer. After reviewing data from the Centers for Medicare and Medicaid Services, the Department of Veterans Affairs, the Vaccine Adverse Event Reporting System, and Pfizer’s global safety database, investigators found no findings. increased risk of stroke after booster injection of Pfizer.
“Although the full range of data currently suggests that it is highly unlikely that signals in VSD represent a real clinical risk, we believe it is important to share this information with the public, as we I have done in the past, when one of our safety surveillance systems detected a signal,” the CDC said in a post on its website.
Surveillance systems often detect safety signals due to factors other than vaccines, according to the CDC’s Friday statement. An agency spokesperson said investigators expect a clearer picture and more data in the coming weeks.
The investigation will be discussed at an upcoming meeting of the Food and Drug Administration’s independent panel of vaccine experts on January 26.
In a statement Friday, Pfizer said there is no conclusive evidence that ischemic strokes are linked to the company’s Covid vaccine. Company spokesman Kit Longley said neither Pfizer nor its German partner BioNTech, CDC or FDA have observed such an association in many other surveillance systems in the US and globally.
“Compared to published rates of ischemic stroke in this older population, companies have so far observed a low number of reported ischemic strokes,” said Longley. than after vaccination with two values of omicron BA.4/BA.5”.
The CDC has not changed its recommendation for Pfizer’s omicron injection. Everyone 5 years of age and older is eligible for a booster shot after completing their primary series of vaccines. The youngest children aged 6 months to 4 years were given omicron as the third dose in their main series of injections.
