Where did this concern come from if not from stats about people over 65 who suffered ischemic stroke 3 weeks after vaccination? If it is not an actual concern, why is it only pfizer?
The alert came from one of the safety databases that is used by the CDC. It was not noticed in any other safety database at this time. These are safety monitoring platforms. Below is a good interview that explains the situation, from a link that @anneg posted above, post #546. It was helpful, IMO, in the understanding of this alert from the CDC. So I am posting it again, in response to your question.
I had the Moderna bivalent, but my husband had the Pfizer bivalent vaccine. If we had known this at the time, I think he would have had the Moderna vaccine as well, even though all his previous vaccinations had been with Pfizer. Just in case.
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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.
Unger: So you said the possible stroke concern has been identified in one safety platform. Can you just for the perspective of folks out there, how many different safety platforms look at COVID vaccines?
Dr. Fryhofer: Well, there are several of them. And there's been no signal so far in the BA database. It has not been observed in the CMS database. It has not been observed in VAERS, which is CDC and FDA's Vaccine Adverse Event Reporting System. In addition, Pfizer's global safety database has not indicated the safety concern is real, which seems to be a step ahead of us.
And vaccination administration has also not reported this finding. There have been no red flags from any of the other vaccine safety platforms indicating an increased risk of ischemic stroke. This preliminary signal has only been seen in just this one platform, CDC's Vaccine Safety Datalink.
Unger: So at this point, has the CDC made any changes to its COVID vaccine recommendations?
Dr. Fryhofer: No. There is no change in current recommendations. CDC continues to recommend everyone six months and older stay up to date on COVID vaccinations. And that includes getting a dose of the updated bivalent vaccine when eligible.
Unger: So what's the current evidence supporting COVID vaccination with the updated bivalent booster doses?
Dr. Fryhofer: Well, here's what we do know. Getting a dose of the updated vaccine, which is the bivalent vaccine, cuts the risk of hospitalization by nearly three-fold as compared to those previously vaccinated but not bivalently boosted. The updated COVID vaccine also reduces risk of death by COVID by nearly 19-fold as compared to those who are unvaccinated. To repeat, at least for now, there is no change in CDC recommendations for COVID vaccination. But for transparency, CDC and FDA wanted the public to be aware.
FDA described this finding to the media as listening to the radio and hearing static in the background. Now, static doesn't mean someone is really talking. This issue will be addressed at the upcoming VRBPAC meeting on January 26. VRBPAC is FDA's independent Vaccine and Related Biologicals Product Advisory Committee. So more to come.
Unger: So you outlined a lot of benefits, obviously, of getting the bivalent booster. In this case, there isn't—this transparency does engender confidence in the system. But I think it probably could be a little confusing to folks out there. So could you help us put this in context for everyone?
Dr. Fryhofer: Well, Todd, you are so right. And I respect and appreciate the transparency. But the announcement comes at a time when daily COVID deaths are rising and vaccine uptake remains low. CDC says only 16% of those age five and older have received the updated bivalent booster. This signal involves those age 65 and older. And this is group is one of the most vulnerable to complications from COVID. And only 39% of them have been bivalently boosted.
So this message is very confusing and a little scary if you only read the headline and not the fine print. And that's why we're talking today. And it may make some people afraid to get the updated shot. FDA told media outlets that if they continue to dig deeper, they hope the signal will disappear.
And, of course, that's my hope too. And I think everyone hopes that. But understand this preliminary safety signal is only for Pfizer, not for Moderna. Those who need a dose of updated vaccine and feel nervous about this announcement could go ahead now and get a Moderna dose of updated COVID vaccine. So there is another option.
www.cdc.gov
www.ama-assn.org
www.cidrap.umn.edu
www.reuters.com
torontosun.com
