CNN
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The US Centers for Disease Control and Prevention said Friday that a Potential security issues But with the bivalent Covid-19 vaccine developed by Pfizer and BioNTech it is unlikely to represent a real risk. The agency said it continues to recommend people stay up to date with Covid-19 vaccines.
The CDC said one of its vaccine safety monitoring systems — a “near real-time surveillance system” called Vaccine Safety DataLink — detected a possible increase in a certain type of stroke among people age 65 and older who recently received one of Pfizer’s updated booster shots. . .
A rapid response analysis of that signal showed that older people who received bivalent boosters were more likely to have an ischemic stroke in the first three weeks after getting the shot, compared with four to six weeks.
Ischemic stroke, the most common form, is a blockage of blood in the brain. These are usually caused by clots.
The Vaccine Safety Datalink or VSD is one A network of large health systems across the country that provides data on vaccine safety and efficacy through patients’ electronic health records. The CDC said it has identified potential confounding factors in the data from VSDs that may have biased the data and require further investigation.
Of about 550,000 seniors who received the Pfizer bivalent booster and were tracked by VSD, 130 had a stroke within three weeks of the shot, according to a CDC official who spoke to CNN on condition of anonymity because they were not authorized to share the data. . . None of the 130 died.
The number of strokes detected is relatively low, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University and a member of the CDC Advisory Committee on Immunization Practices’ Covid-19 Vaccine Work Group.
“These strokes are not a definite adverse event at this point,” he said. “It’s like a radar system. You get a blip on the radar, and you have to investigate further to discover if that aircraft is friend or foe.”
The same safety signal was not identified with bivalent Moderna Booster, the CDC said in its notice.
The agency noted that it has failed to find similar increases in strokes in other large collections of medical records, including those maintained by Medicare, the US Department of Veterans Affairs, as well as its Vaccine Adverse Event Reporting System. VAERS
Neither Pfizer nor other countries using the vaccine have seen any increase in such strokes, the agency said, and no other database has detected the signal.
The CDC says it recommends no changes in vaccination practices at this time and that the risk of Covid-19 for older adults outweighs any potential safety issues with the vaccine.
“While the totality of the data currently suggests that it is highly unlikely that signaling in VSD represents a true clinical risk, we believe it is important to share this information with the public, As we have done in the pastWhen one of our security monitoring systems detects a signal,” the notice said
“CDC and FDA will continue to evaluate additional data from this and other vaccine safety measures. These data and additional analyzes will be discussed forthcoming January 26 meeting FDA’s Advisory Committee on Vaccines and Related Biological Products.
“Neither Pfizer nor BioEntech or the CDC or the US Food and Drug Administration (FDA) have observed similar results across numerous other monitoring systems in the US and worldwide and there is no evidence to conclude that ischemic stroke has occurred,” Pfizer said in a statement Friday. Associated with the use of the company’s COVID-19 vaccine.
“Compared to published incidence rates of ischemic stroke in this elderly population, companies to date have observed fewer ischemic strokes after vaccination with the Omicron BA.4/BA.5-adapted bivalent vaccine.”
Pfizer/BioNTech and Moderna’s bivalent boosters protect against the original strain of the coronavirus as well as the Omicron BA.4 and BA.5 subvariants. According to the CDC, just under 50 million Americans ages 5 and older have gotten them since it was approved last fall Information.
Schaffner said he was part of a briefing Thursday with members of the Covid-19 vaccine work group. He could not share specifics about the briefing but said security signals were discussed.
His biggest move was that the security surveillance system was working.
It’s very likely a false alarm, he said, but it’s being investigated, which is important.
“You want a surveillance system that occasionally sends false signals. If you don’t get a signal, you worry that you’re missing things.”
Schaffner said she urges people to get their Covid-19 boosters if they haven’t already — even those 65 and older.
“Undoubtedly, the risk of the whole series of adverse events, including hospitalization, is much higher with Covid-19 than with the vaccine,” he said.
He also said the signal — if real — may be more a factor in numbers than an indication that one manufacturer’s vaccine is riskier than another.
About two-thirds of people in the U.S. who got the updated booster — 32 million — got Pfizer, compared to about 18 million Moderna Shots.
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