There has been a lot of talk 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 vaccine. Pfizer-BioNTech Covid-19 bivalent booster. Unsurprisingly, the chatter was a lot like the 2020 movie I’m thinking of ending things-all over. This is not surprising because throughout the pandemic communications regarding the Pfizer-BioNTech Covid-19 vaccines have earned an F grade. This has been way too high, relied too heavily on Pfizer press releases and, in turn, generated far too much unnecessary fear.
So let’s put this latest announcement from the CDC and the FDA into proper perspective. This shouldn’t be the cause of any panic. A “safety signal” is when more people than expected have some type of undesirable outcome. In this case, the CDC found in its Vaccine Safety Datalink (VSD) surveillance system that in people age 65 and older, a higher than expected number of people had an ischemic stroke within 21 days (compared to 22 to 44 days) after receiving the Pfizer-Bivalent BioNTech Covid-19 vaccine. They did not find the same type of signal in other Covid-19 vaccines such as the Moderna bivalent booster.
Keep in mind that this bump seen in ischemic strokes doesn’t prove anything on its own. It is not enough to conclude in any way that the bivalent Pfizer-BioNTech Covid-19 vaccine somehow caused these 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 landslides that happened in California simply because the latter happened after the former . Just because things happened around the same time doesn’t mean they were related in any way. The ischemic stroke bump could have been purely coincidental.
At the same time, the CDC and FDA cannot simply ignore such a safety signal. They have to approach it like walking into your parents’ room in the middle of the night – extremely cautious. You never know what you may find.
So, the next step after detecting any safety signal is to look at more data and studies to see if such a finding can actually be confirmed. It’s like hearing a rumor that a friend of yours has had some kind of, uh, enhancement surgery. You don’t just assume it’s true and introduce your friend to others by saying, “This is Harry and he has great news for you all” or “This is Lori and she has something she wants out of Her chest. it is now on his chest. Instead, before doing so, you could make some additional observations, maybe even conduct studies. Some of them can be indirect requests such as asking your friend: “When you say you have to buy pants, should those pants be bigger” or “Is it an exaggeration to say that your sweaters have stretched? Other approaches may be more direct. Either way, the bottom line is that you wouldn’t jump to conclusions just by hearing one thing. Similarly, the CDC and FDA would need to perform a series of analyzes on different data sources to come to a more solid conclusion.
And that’s what they did. So far, the original security signal has not been supported by other data sources. For example, the CDC mentioned that it had previously reviewed the following data sources and found no increased risk of ischemic stroke:
- A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database
- A preliminary study using the veterans database
- The Vaccine Adverse Event Reporting System (VAERS) operated by the CDC and the FDA
- Pfizer-BioNTech Global Safety Database
Additionally, the CDC pointed out that “other countries have not observed an increased risk of ischemic stroke with updated (bivalent) vaccines.” This highlights the importance for countries around the world to work together and share data.
A single such safety signal in a database that has not been seen elsewhere or confirmed in any way should not be enough to change vaccination practices. This assumes that the adverse event is not more clearly related to the vaccine. It’s not as if people’s heads fell off as soon as they got the shots. As a result, the CDC is not changing any of its Covid-19 recommendations at this time. Until further notice, they will continue to recommend “that everyone 6 months and older stay up to date with the COVID-19 vaccination; this includes people who are currently eligible to receive an updated (bivalent) vaccine. This is a reasonable approach since the benefits of vaccines still far outweigh the risks. The Covid-19 pandemic is not over despite what some politicians and TV personalities are saying.
Does this close the chapter on this new safety signal? No, it shouldn’t yet. The rest of the scientific community should have time to review all the available data and the analyzes themselves. It will be important for the FDA, CDC and Pfizer to be as transparent as possible. The upcoming Jan. 26 meeting of the FDA’s Vaccines and Related Biologics Advisory Committee will provide an opportunity for further review and discussion. In the meantime, the FDA, CDC, public health experts and other scientists should continue to collect data and analyze the use and safety of Covid-19 vaccines. And the government should push Pfizer to release all of its data on its Covid-19 vaccines.
A big problem during much of the pandemic was that Pfizer and Moderna released press releases about the results of their Covid-19 vaccine clinical trials before they had properly shared all of their data with the community. science in the broad sense. The US government cannot allow these pharmaceutical companies to directly or indirectly influence health policy in this way or at least have the perception that they allow these companies to do so. Instead, it should be independent scientists reviewing the data and then providing their interpretations to government and the public.
This safety signal announcement only adds to the perception that bivalent boosters have been rushed to the public. As I covered for Forbes on September 12, 2022, people wondered why the bivalent vaccine received Emergency Use Authorization (EUA) from the FDA before undergoing comparable amounts of human testing that earlier versions of the vaccines underwent in 2020 and 2021. While that doesn’t necessarily mean bivalent boosters aren’t safe and effective, the resulting optics haven’t been so good. All of this has only added to the cloud of suspicion over Covid-19 vaccines that anti-vaxxers like septic tanks have tried to create. It also showed how cutting corners for short-term benefits is not beneficial in the long term, which the Trump and Biden administrations have been guilty of doing. All things considered, is it really surprising that only 15.9% of those five and older received the bivalent Covid-19 boosters?
At this point, this safety signal information should not be a reason not to get the bivalent Covid-19 booster. Ultimately, based on the information available so far, there is a good chance that this signal will turn out to be a chance find and a bit of a no-no. However, the same does not apply to the risks of contracting Covid-19 if you are not up to date with your vaccinations.