For Worse or For Better
Clearing up confusion caused by a preprint research paper on a POTENTIAL association between long-COVID-like symptoms and COVID vaccines
Last week a SMALL, PRELIMINARY, NOT PEER-REVIEWED paper titled, Immunological and Antigenic Signatures Associated with Chronic Illnesses after COVID-19 Vaccination, was published on medRxiv. The authors theorize that COVID vaccines may be associated with a group of symptoms, such as fatigue, brain fog, and tinnitus, similar to long COVID.
The authors published the paper on medRxiv intending to increase academic discussion and further research. The medRxiv website specifically states —
But we all have heard — "the road to hell is paved with good intentions.”
Soon after publication, the article went viral and the anti-vaccination community is using it as evidence that the COVID vaccines are unsafe.
I’m speaking up and writing because the paper that was shared on
medRxiv is NOT an indictment against the COVID vaccines.
It is a part of the scientific process; the authors saw a group of patients with similar symptoms, which developed after receiving a COVID vaccine. This warranted further investigation.
The paper shared on medRxiv is a report of that preliminary investigation. It is the beginning of a scientific conversation. More research is needed. A bigger sample size is needed.
And key limitations of the research need to be addressed before we can make any conclusions about any safety concerns associated with the COVID vaccine.
Here are three important things to know about this study —
The authors begin and end the paper acknowledging that the COVID vaccine has saved lives and should continue to be administered. Specifically, they state in the Introduction of their work, “The rapid development and deployment of COVID-19 vaccines have been pivotal in mitigating the impact of the pandemic. These vaccines have significantly reduced severe illness and mortality associated with SARS-CoV-2 infection. Additionally, vaccinated individuals experience a lower incidence of post-acute sequelae of COVID-19 (PASC) or long COVID, thus highlighting an additional potential benefit of receiving the COVID-19 vaccines.”
One of the authors told STATNews, “I don’t think it’s [the results of the study] ready to be used in clinical decision-making. So, if anything, I’m just trying to tell people: This shouldn’t be factoring into your decision right now.”
The authors did NOT prove that the vaccine is unsafe.There are (at least) two major limitations of this research.
First, is the small sample size. With only 42 cases (individuals with long COVID-like symptoms), this study is NOT generalizable to the public. We cannot make conclusions about causation, policy decisions, or clinical decisions based on the findings of 42 cases compared to 22 controls. This is a small (often called a pilot) study that cataloged preliminary data about the differences between the cases and controls. In statistics, we say this study has NO statistical power. When a study lacks power, it is possible that what was seen in the results of the study could have happened by chance alone — or a genetic predisposition, unhealthy behaviors not associated with the vaccine, environmental exposure, or a combination of all of these that was NOT measured or accounted for in the study.
We canNOT make conclusions about cause and effect based on a small sample.
The second limitation is methodological. The researchers did NOT test for an active (asymptomatic) COVID infection among the participants. Therefore, we do NOT know if any of the cases or controls was actually sick with COVID during the study period (which was during the winter surge of 2022-23). These long COVID-like symptoms could actually be long COVID. We do NOT who (if anyone) had an asymptomatic case of COVID during the study period, as the researchers only tested for COVID antibodies (which measure previous exposure to the virus, vaccine, or both). The possibility that the SARS-CoV-2 virus is to blame for the symptoms experienced by these 42 cases canNOT be ruled out.
Therefore, we canNOT conclude that the vaccine is to blame when the research did not measure or control for the virus itself.
More research is needed.Research about vaccine safety is tricky — the scientific community wants to follow the science AND knows that it will likely take years and multiple studies to determine if there is a true risk associated with a vaccine. Any potential risk that is studied can be weaponized by the anti-vaccination community as truth or evidence.
Misinformation, disinformation, and a lack of scientific literacy are literally killing Americans (the first measles death in Texas was just reported; a child is dead because of misinformation surrounding vaccine safety).
That said, the authors of this study made a tragic and egregious error in naming the set of symptoms that are similar to long COVID — calling it post-vaccination syndrome (or PVS). Given that their study did NOT find an association between the COVID vaccine and this set of symptoms, naming the set of symptoms post-vaccination syndrome connects the dots between vaccine and illness (even if no connection exists). The authors are saying, “This is a small pilot study and no conclusions can be drawn from our work” out of one side of their mouths. And then out of the other side, they are naming the syndrome post-vaccination syndrome. This is a source of misinformation (created by the scientific community that is not paying attention to its words and the impact and power that they have).
Naming this syndrome in such a way is handing those who distrust science, research, and vaccines license to not get vaccinated; and to believe that vaccines are not safe. Naming the syndrome and associating it with vaccinations is problematic. You will notice that I have NOT used the syndrome name (aside from calling out how problematic the name is) throughout this post. I am hopeful that as/if this paper goes through the peer-review process the syndrome name will be removed, as it is not reflective of the research, findings, or key messages the authors communicate through the rest of their work.
Thankfully, I am not alone in thinking the name of the syndrome in the paper is a mistake. Adam Gaffney, an assistant professor at Harvard Medical School, also noted, “The term is a problem, it’s a real problem, especially at this political moment. We’re at a moment right now where the U.S. government is undercutting people’s trust in science and vaccinations probably like never before in history. And to coin this novel syndrome without even proving that it’s caused by the vaccine is very worrisome to me.”
I would encourage you NOT to use the syndrome name coined in this preliminary research.
What we know today is that the COVID vaccines — along with the MMR, pertussis, hepatitis, influenza, polio, HPV, and meningococcal vaccines, among others — are SAFE and EFFECTIVE. Vaccines prevent disease, severe symptoms, hospitalizations, and death. As Dr. Bill Foege says —
“Vaccines are the tugboats of preventive health.”
For worse or for better — this paper is out there.
But just because it is out there — it should NOT cause you to change your behaviors or break your trust in the safety and effectiveness of vaccines.
Please remember… We ALL need to be vaccinated to create healthy communities for all. Vaccines really do save lives.
This pre-print, preliminary study changes NOTHING.
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Epi(demiology) Matters is written by Dr. Becky Dawson, PhD MPH — an epidemiologist, teacher, mom, wife, and dedicated yogi. She is a tenured professor at Allegheny College, Research Director at a community hospital, and an exclusive contributor (all things health & medicine) at Erie News Now (NBC/CBS). Her goal is to create healthy communities for all. She writes Epi Matters — first & foremost because epidemiology does matter (to all of us) and she hopes that each post will help to educate and empower readers to be healthy and create healthy communities.
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