Pfizer Covid-19 Bivalent Vaccine And Stroke Risk: What You Need To Know – Forbes

There’s been a lot of chatter about the January 13 announcement from the Centers for Disease Control … [+] and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) about a possible “safety signal” for the Pfizer-BioNTech Covid-19 bivalent booster vaccine. (Photo by Michael Matthey/picture alliance via Getty Images)
There’s been a lot of chatter about the January 13 announcement from the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) about a possible “safety signal” for the Pfizer-BioNTech Covid-19 bivalent booster vaccine. Not surprisingly the chatter has been a bit like the 2020 movie I’m Thinking of Ending Things—all over the place. That’s not surprising because throughout the pandemic, communications regarding the Pfizer-BioNTech Covid-19 vaccines have deserved an F grade. It’s been far too F-word upped, relied far too much on Pfizer press releases, and, in turn, generated far too much unnecessary fear.
So let’s put this latest CDC and FDA announcement into proper perspective. It shouldn’t be the cause of any panic. A “safety signal” is when a greater than expected number of people have some type of adverse outcome. In this case the CDC found in their Vaccine Safety Datalink (VSD) surveillance system that among those 65 years and older, a higher than expected number of people had suffered ischemic strokes within 21 days (compared to 22 to 44 days) after getting the Pfizer-BioNTech Covid-19 bivalent vaccine. They didn’t find the same kind of signal in other Covid-19 vaccines such as the Moderna bivalent booster.
Keep in mind this observed bump in ischemic strokes alone does not prove anything. It’s not enough to conclude in any way that the Pfizer-BioNTech Covid-19 bivalent vaccine somehow caused those additional strokes. That would be like saying that Donald Trump’s release of his digital trading card non-fungible tokens (NFTs) somehow led to the mudslides that have been occurring in California simply because the latter occurred after the former. Just because things have happened around the same time doesn’t mean that they were linked in any way. The bump in ischemic strokes could have been purely coincidental.
At the same time, the CDC and FDA can’t simply ignore such a safety signal. They’ve got to approach it like walking into your parents’ bedroom in the middle of night—extra cautious. You never know what you may find. And an ischemic stroke is not something just to pass off lightly. You don’t typically say, “I’m running late to our date because of this ischemic stroke that I’m having. Go ahead and order the appetizers as I’ll be there soon.” An ischemic stroke is a medical emergency because a clot in an artery in your head has blocked blood flow to parts of your brain. It’s called ischemic because it is starving your brain tissue of oxygen. Without oxygen, your brain tissue will quickly die. And your brain tissue ain’t like breadsticks at the Olive Garden. You can’t simply ask for more. Once it’s gone, it’s gone forever.
Here are the warning signs of a stroke. (Image: Getty)
So the next step after any safety signal is detected is to look at more data and studies to see whether such a finding can actually be confirmed. It’s similar to hearing a rumor that one of your friends has gotten some type of, ahem, enhancement surgery. You don’t simply assume that it’s true and introduce your friend to others by saying, “This is Harry and he has some big news for all of you” or “This is Lori and she has something that she wants to get off her chest that’s now on her chest.” Instead, before doing so, you might conduct some more observations, perhaps even run some studies. Some of this may be indirect inquiries such as asking your friend, “When you say you need to buy some pants, would these pants need to be larger?” Or “Is it a stretch to say your sweaters have stretched?” Other approaches may be more direct. Regardless, the bottom line is that you wouldn’t jump to conclusions simply based on hearing one thing. Similarly, the CDC and FDA would have to conduct an array of analyses on different data sources to come to a stronger conclusion.
And that’s what they’ve been doing. So far, the original safety signal has not been supported by other data sources. For example, the CDC did mention that they have already looked at the following data sources and have not found any increased risk of ischemic stroke:

Moreover, the CDC emphasized that “other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines.” That highlights the importance of countries around the world working together and sharing data.
Pfizer’s bivalent booster vaccine has already been administered in t a number of different … [+] countries, including Italy, as pictured here. (Photo by Riccardo Fabi/NurPhoto via Getty Images)
A single such safety signal in one database that hasn’t been seen elsewhere or confirmed in any way should not be enough to change vaccination practices. That’s assuming that the adverse event is not more clearly linked to the vaccine. It’s not as if people’s heads fell off as soon as they got the vaccines. As a result, the CDC is not altering any of their Covid-19 recommendations right now. Until further notice, they will continue to recommend “that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine.” This is a reasonable approach since the benefits of the vaccines still far, far outweigh the risks. The Covid-19 pandemic is not over regardless of what some politicians and TV personalities may say.
So does this close the chapter on this newest safety signal? No, it shouldn’t yet. The rest of the scientific community should have time to review all of the available data and the analyses themselves. It will be important for the FDA, CDC, and Pfizer to be as transparent as possible. The upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee will offer an opportunity for further review and discussion. In the meantime, the FDA, CDC, and public health experts and other scientists should continue to collect data on and analyze the use and safety of the Covid-19 vaccines. And the government should push Pfizer to release all of its data on its Covid-19 vaccines.
One big issue throughout much of the pandemic has been Pfizer and Moderna issuing press releases about their Covid-19 vaccine clinical trial results before they’ve properly shared all of their data with the broader scientific community. The U.S. government can’t have such pharmaceutical companies directly or indirectly influencing health policies in such a manner or at least the perception that they are allowing such companies to do so. Instead, it should be independent scientists reviewing the data and then providing their interpretations to the government and the public.
This safety signal announcement only adds to the perception that the bivalent boosters were rushed on to the public. As I covered for Forbes on September 12, 2022, people have wondered why the bivalent vaccine received emergency use authorization (EUA) from the FDA prior to going through comparable amounts of human testing that earlier versions of the vaccines went through in 2020 and 2021. While this doesn’t necessarily mean that the bivalent boosters aren’t safe and effective, the resulting optics haven’t been that great. All of this has only added to the cloud of suspicion over Covid-19 vaccines that anti-vaxxers like septic tanks have been trying to create. It also has shown how taking short-cuts for short-term benefits ain’t beneficial in the longer run, something both the Trump and Biden Administrations have been guilty of doing. All things considered, has it been really surprising that only 15.9% of those five years and older have gotten the Covid-19 bivalent boosters?
At this point, this safety signal news shouldn’t be a reason not to get the Covid-19 bivalent booster. Ultimately, based on the available information to date, there’s a decent chance that this signal will turn out to be a coincidental finding and somewhat of a nothingburger. However, the same does not apply to the risks of getting Covid-19 if you are not up-to-date on your vaccination.
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