Pfizer's bivalent COVID shot may be linked to stroke risk
CDC says it’s investigating possible link between Pfizer’s Covid booster and strokes among seniors over age of 65
- Officials say over-65s who receive the bivalent shot suffer increased stroke risk
- Leading regulators still recommend the Covid booster shot to Americans
- Ischemic strokes are caused when artery blockages deny blood to the brain
Health officials are investigating whether Pfizer’s updated Covid booster increases the risk of strokes in people over the age of 65.
The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) said their surveillance system flagged a link between the new shot and a higher risk of an ischemic stroke three to four weeks post-vaccination.
Officials said other systems put in place to track vaccine injuries have not found a similar link, which makes them believe it is a statistical anomaly rather than a true cause for alarm.
‘Although the totality of the data currently suggests that it is very unlikely that the signal … represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,’ a joint statement from the CDC and FDA said.
CDC officials report that people over 65 who receive the updated Covid booster shot could be at an increased risk of suffering a stroke (file photo)
An ischemic stroke, also known as brain ischemia, is caused by blockages in arteries that carry blood to the brain. According to CDC data, 39 percent of elderly Americans over 65 have received the bivalent booster.
The CDC’s Vaccine Safety Datalink (VSD) detected the possible link, with officials saying it met statistical criteria needed to spur further investigation.
They added ‘there also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation.’
Vaccine adverse effect trackers from the Centers for Medicare and Medicaid Services, Department of Veterans Affairs did not show an elevated risk.
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Pfizer and BioNTech said in a statement that they have been made aware of limited reports of ischemic strokes in people 65 and older following vaccination with their updated shot.
‘Neither Pfizer and BioNTech nor the CDC or the FDA have observed similar findings across numerous other monitoring systems in the US,’ Pfizer added.
‘Globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.’
This safety concern has not been identified with Moderna’s bivalent shot. Both vaccines were authorized in late-August by the FDA.
Pfizer/BioNtech and Moderna’s bivalent shots, which target both the original coronavirus and Omicron sub-variants, have been authorized for use in children six months and older.
The shots were brought into the fold because they directly target the Omicron variant.
Original Covid vaccines that rolled out in late 2020 were tailored towards the Wuhan strain of the virus, which emerged at the start of that year.
The Omicron variant, which took over the world at the end of 2021, mutated to bypass protection from those shots, though.
Dr Ashish Jha (pictured), who leads America’s Covid response has, pushed for more more of the population to receive the shots
These bivalent shots are meant to bolster protection against infection and slow the spread of the many emerging forms of Omicron.
Both the CDC and FDA continue to recommend that everyone aged six months and older stay up-to-date with their COVID-19 vaccination, despite this warning.
White House officials have pushed these vaccines in recent months, and expressed disappointment in the relatively low uptick of them in the population.
Last week, Dr Ashish Jha, the Biden Administration’s Covid response coordinator, even warned Americans who had not received the bivalent jab were vulnerable to the budding XBB.1.5 variant.
‘If you had an infection before July OR your last vaccine was before bivalent update in September… your protection against an XBB.1.5 infection is probably not that great,’ he wrote on Twitter.
According to most recent CDC data, 50million Americans have received the updated booster – around 15 percent of the US population.
But, the largest portion of people who have received the shot so far could be at an increased stroke risk.
Per CDC data, 21million Americans over 65 have received the bivalent booster. That accounts for nearly two-in-five senior citizens in America.
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