Federal regulators have closely monitored reports of unfavourable incidents during the flurry of COVID-19 vaccine rollouts in the United States. The government is now disclosing its findings after monitoring the potential stroke risk associated with Pfizer’s new shot, as reported by Fierce Pharma.
Risk of ischemic strokes
After data from its Vaccine Safety Datalink indicated a potential risk of ischemic strokes in people 65 and older who received Pfizer and BioNTech’s updated COVID-19 vaccine booster, the Centers for Disease Control and Prevention (CDC) advises against making any changes to vaccination practices for the COVID-19 virus. The government stated in a statement released on Friday that the weight of the information points to an “extremely unlikely” clinical risk.
An ischemic stroke happens when the brain’s blood flow is interrupted, leaving the brain’s tissues without oxygen or nourishment.
Statistical criteria
The CDC identified “statistical criteria” to support further research into the stroke risk in some vaccine recipients, the CDC said in a statement on Friday. The Vaccine Safety Datalink is a “near real-time” surveillance system for the CDC. Officials specifically looked into whether those 65 and older had an increased risk of stroke in the first 21 days following vaccination compared to the next 21 days.
The CDC stated that “many subsequent investigations have not validated this signal,” and government organisations use numerous databases and technologies to support their safety evaluations. Overall, the CDC does not advise making any changes to immunisation practices.
The data and analyses will be covered at the forthcoming meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee. The CDC and the FDA “continue to analyse more data from these and other vaccine safety systems.”
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Source: Fierce Pharma
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