I had a 65 yr old white male have a stroke shortly after getting vaccinated so I did a quick Google search and found this.
I'm joined today by AMA Board Chair Dr. Sandra Fryhofer who's also the AMA's liaison to ACIP, the CDC's Advisory Committee on Immunization Practices and a member of ACIP's COVID-19 vaccine workgroup. I'm Todd Unger, AMA's chief experience officer in Chicago. Dr. Fryhofer, thanks for joining us today.
Dr. Fryhofer: Todd, thanks for having me.
Unger: Well, let's get right into it. What do we know about this possible link between the updated Pfizer booster and increased risk of stroke?
Dr. Fryhofer: A new preliminary safety concern and increase in stroke risk has been identified for those 65 and older after receiving a dose of Pfizer's bivalent booster. Now, I want to be clear. There is no established link. This is just an early safety signal and one of many vaccine safety monitoring platforms. And on Friday the 13th of January, CDC and FDA made this joint announcement that an increased risk of stroke had been identified for those 65 and older who had received Pfizer's Omicron bivalent booster.
The preliminary signal found an increased risk of ischemic stroke and the 21 days following the Pfizer bivalent vaccine dose as compared with days 22 to 42 following vaccination. As I said, this is just a signal. The signal has only been seen for Pfizer's bivalent vaccine, not for Moderna's bivalent version. And the signal is only from one vaccine safety platform, VSD. That CDC's vaccine safety data link. And there are multiple different platforms which look at vaccine safety in different ways.
This signal has not been seen in the other vaccine safety platforms. Again, no other safety systems have shown this signal. So this may be a false alarm, or it could turn out to be real. Only time and further study and more data will tell.
Unger: Dr. Fryhofer, this announcement demonstrates a lot of transparency on behalf of the CDC and FDA. And it's especially important since the mRNA vaccine platform is somewhat new. And safety is being closely monitored and scrutinized. Tell us more about that.
Dr. Fryhofer: Well, I agree. Transparency is so important to encourage trust in the system and trust in vaccines. And that's why CDC and FDA made the joint decision to alert the public so early about this preliminary safety concern. But again, it's still unclear if this is a real signal or just an aberration.
We need more data. This preliminary signal has only been seen in just that one platform, VSD, CDC's Vaccine Safety Datalink. And the signal only applies to Pfizer bivalent updated vaccine. This signal has not been observed for Moderna.
Transcript
Unger: Hello and welcome to the AMA Update video and podcast. Today, we're discussing new announcements from the FDA and CDC about a possible increased risk of stroke following the Pfizer bivalent COVID booster and what we know about the new XBB Omicron variant.I'm joined today by AMA Board Chair Dr. Sandra Fryhofer who's also the AMA's liaison to ACIP, the CDC's Advisory Committee on Immunization Practices and a member of ACIP's COVID-19 vaccine workgroup. I'm Todd Unger, AMA's chief experience officer in Chicago. Dr. Fryhofer, thanks for joining us today.
Dr. Fryhofer: Todd, thanks for having me.
Unger: Well, let's get right into it. What do we know about this possible link between the updated Pfizer booster and increased risk of stroke?
Dr. Fryhofer: A new preliminary safety concern and increase in stroke risk has been identified for those 65 and older after receiving a dose of Pfizer's bivalent booster. Now, I want to be clear. There is no established link. This is just an early safety signal and one of many vaccine safety monitoring platforms. And on Friday the 13th of January, CDC and FDA made this joint announcement that an increased risk of stroke had been identified for those 65 and older who had received Pfizer's Omicron bivalent booster.
The preliminary signal found an increased risk of ischemic stroke and the 21 days following the Pfizer bivalent vaccine dose as compared with days 22 to 42 following vaccination. As I said, this is just a signal. The signal has only been seen for Pfizer's bivalent vaccine, not for Moderna's bivalent version. And the signal is only from one vaccine safety platform, VSD. That CDC's vaccine safety data link. And there are multiple different platforms which look at vaccine safety in different ways.
This signal has not been seen in the other vaccine safety platforms. Again, no other safety systems have shown this signal. So this may be a false alarm, or it could turn out to be real. Only time and further study and more data will tell.
Unger: Dr. Fryhofer, this announcement demonstrates a lot of transparency on behalf of the CDC and FDA. And it's especially important since the mRNA vaccine platform is somewhat new. And safety is being closely monitored and scrutinized. Tell us more about that.
Dr. Fryhofer: Well, I agree. Transparency is so important to encourage trust in the system and trust in vaccines. And that's why CDC and FDA made the joint decision to alert the public so early about this preliminary safety concern. But again, it's still unclear if this is a real signal or just an aberration.
We need more data. This preliminary signal has only been seen in just that one platform, VSD, CDC's Vaccine Safety Datalink. And the signal only applies to Pfizer bivalent updated vaccine. This signal has not been observed for Moderna.
