Persistent levels of spike protein from COVID-19 vaccines could be associated with a range of chronic symptoms like excessive fatigue, brain fog and muscle aches, according to a Yale University study published Wednesday.
The study describes these symptoms and others — including tingling and numbness, exercise intolerance and difficulty concentrating — as post-vaccine syndrome or PVS. Other symptoms included trouble falling or staying asleep, nerve damage, muscle aches, anxiety, tinnitus and burning sensations. The study was published as a preprint, meaning it has not yet found a home in a scientific journal and has yet to be vetted by outside scientists via peer review.
The researchers studied 42 individuals they diagnosed with PVS. The researchers tested for dozens of potential biological signatures of the syndrome using serology, or blood tests, uncovering a range of hypotheses about the underlying causes.
The researchers hesitated to pinpoint any one single cause, emphasizing that further studies are needed.
But perhaps the most striking clue the researchers picked up was significantly higher circulating levels of spike protein as compared to the control group. Individuals vaccinated 600 to 700 days prior had more elevated levels of spike protein than other participants who had been vaccinated more recently.
However the study only measured each individual’s spike protein levels once, thus could not determine whether the spike protein was increasing over time.
“This suggested that prolonged antigen persistence might be associated with PVS in a subgroup of patients,” the study reads.
The study included participants who had received the Pfizer, Moderna and Johnson & Johnson shots.
Another potential signal of the syndrome explored in the paper is T cell exhaustion — when white blood cells progressively lose the ability to fight off infections. People with PVS also had fewer antibodies against the spike protein as compared to the control group. It’s also possible that the syndrome is associated with a reactivation of dormant Epstein-Barr virus (EBV), a common and usually latent virus.
The researchers acknowledged that PVS has been neglected by health authorities, as many consider the topic “radioactive.”
“This is a hard topic to study. People don’t want to fund it and journals don’t want to publish it because it is viewed as radioactive and I’m so grateful to my co-authors for staying the course,” said David Putrino, director of Rehabilitation Innovation for the Mount Sinai Health System and a coauthor of the paper, in an X thread. “To anyone saying that this paper will embolden antivax movements, please take a moment to consider an alternate take: failing to be transparent in the moment, denying the lived experience of many and hiding the truth is what emboldens anti-science movements. In the history of drug discovery, there has never been a drug that didn’t produce side effects in a percentage of users. Pretending this fact isn’t real is dishonest.”
Yet some in the scientific community criticized the scientists for publishing the preprint at all.
The study drew data from the Yale School of Medicine’s Listen to Immune, Symptom and Treatment Experiences Now (LISTEN) study, as well as the Centre for Post COVID Care at Mount Sinai Hospital.
The PVS group had poorer health and a poorer quality of life than average, despite the cohort having no preexisting comorbidities and being relatively young (median age 43).
Long COVID shares many of the same symptoms of PVS, the researchers wrote, though there are some differences. While long COVID can be associated with elevated SARS-CoV-2 antibodies, the individuals with PVS in the new study had lower antibodies than the control group.
The preprint states that the condition afflicts a small fraction of people receiving COVID-19 vaccines. The researchers were quick to emphasize that the COVID-19 vaccines saved lives.
“By revealing distinct immunological features of PVS, this study helped generate hypotheses regarding the underlying pathobiology of this condition,” the study reads. “Understanding such mechanisms will help improve the overall safety profile of COVID-19 vaccines and support public health strategies that maximize vaccine efficacy while minimizing adverse effects.”
The study arrives amid Robert F. Kennedy Jr.’s first days at the helm of the Department of Health and Human Services.
His ascension to the role of HHS secretary could prompt a second look at policies promulgated by the Biden administration around the COVID-19 vaccine, including the decision to mandate vaccination of some individuals with a previous COVID-19 infection as a precondition for employment.
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