The Centers for Disease Control and Prevention on Friday said it was “highly unlikely” that the Pfizer omicron booster carries a risk of stroke in seniors after it launched an investigation right into a preliminary safety hazard detected by one in every of its monitoring systems.
CDC, in a press release posted Friday on its website, said a surveillance system called Vaccine Safety Datalink detected a possible risk of stroke in people aged 65 and older who received a Pfizer booster vaccine targeting the omicron Covid variant. A CDC spokesperson said this issue was first discovered in late November.
A spokesman said in mid-December the CDC said concerns persist and launched an investigation to determine whether seniors are at higher risk of stroke in the primary 21 days after receiving a Pfizer booster. An identical initial signal was not detected for the Moderna amplifier.
The VSD monitoring system showed that 130 people aged 65 and older had a stroke inside 21 days of receiving the Pfizer omicron booster among the many roughly 550,000 seniors who received the injection, a CDC spokesperson said. No deaths have been reported. The Washington Post previously reported on the case.
According to the CDC, no other surveillance system has thus far detected similar concerns concerning the safety of the Pfizer amplifier. Researchers found no increased risk of stroke with the Pfizer booster after reviewing data from the Center for Medicare and Medicaid Services, the Department of Veterans Affairs, the Vaccine Antagonistic Response Reporting System and Pfizer’s global database.
“While the totality of the information now suggests that the signal in the VSD is impossible to represent an actual clinical risk, we consider it is crucial to share this information with the general public as we now have done in the past when one in every of our monitoring systems detected a signal,” the CDC said in a post on its website.
Monitoring systems often detect safety signals that result from aspects aside from the vaccine, according to a press release from the CDC on Friday. An agency spokesman said investigators hoped to get a clearer picture and more data in the approaching weeks.
The investigation will likely be discussed at an upcoming meeting of the Food and Drug Administration’s Panel of Independent Vaccine Experts on January 26.
In a Friday statement, Pfizer said there isn’t any evidence that ischemic stroke is linked to the corporate’s Covid vaccine. Neither Pfizer and its German partner BioNTech nor the CDC nor the FDA have observed such an association in many other US and international monitoring systems, company spokesman Kit Longley said.
“Compared to published rates of ischemic stroke in this older population, corporations have thus far seen a lower variety of reported ischemic strokes after vaccination with the BA.4/BA.5 omicron adapted bivalent vaccine,” said Longley.
The CDC did not change its suggestion for the Pfizer omicron injection. Anyone 5 years of age and older is eligible for a booster after completing the first series of vaccinations. The youngest children aged 6 months to 4 years receive an injection of omicron because the third dose of the essential series.