The Centers for Disease Control and Prevention (CDC) has launched an investigation into a preliminary safety concern detected by one of its monitoring systems. The Vaccine Safety Datalink (VSD) detected a possible risk for stroke in people ages 65 and older who received the Pfizer booster shot targeting the omicron Covid variant.
New CDC Report: The new Pfizer bivalent vaccine "met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65"
— Marty Makary MD, MPH (@MartyMakary) January 13, 2023
CDC should make public the raw dataset.https://t.co/G347r2grXe
The concern relates to the Pfizer omicron booster shot and the possibility of a risk of stroke for seniors. However, after reviewing data from various sources, investigators have not found an increased risk of stroke following the Pfizer booster.
Both Pfizer and the CDC have not observed an association between the booster shot and ischemic stroke. The CDC has not changed its recommendation for the Pfizer omicron shot, and people can still receive the booster shot with confidence.
In order to further investigate the preliminary safety concern, an upcoming meeting of the FDA’s panel of independent vaccine experts on Jan. 26 will discuss the investigation. The FDA will analyze the data and offer advice on changes to the safety profile of the Pfizer omicron booster shot if necessary.
Through its Vaccine Adverse Event Reporting System and other surveillance systems, the CDC will keep an eye on how safe and effective the vaccine is. The CDC is committed to ensuring the safety of those who receive the Pfizer omicron booster shot, and the investigation is a reflection of that commitment.
Given this, the CDC recommends that anyone who has gotten the Pfizer omicron booster shot and is having any strange symptoms go to the doctor and tell them what’s going on. The CDC will continue to provide updates on the investigation and its findings.