The NIH Papers
MAY 2021
In May 2021 Dr Nath jumps on a paper with colleagues to discuss the importance of being cognizant of vaccinating in the environment of neurological complications.
“Concern about neurological complications from COVID‐19 vaccines escalated in the fall of 2020, when 2 patients developed transverse myelitis after receiving the Oxford/AstraZeneca vaccine. 1 One case was ultimately deemed unlikely to be related to the vaccination (the patient had pre‐existing multiple sclerosis), whereas the other was determined to be possibly related. 2 Data from the mRNA vaccine clinical trials showed that 7 cases out of 37,000 vaccine recipients developed Bell’s palsy and none developed Guillain‐Barré syndrome (GBS). “
“As of March 2, 2021, 51,755,447 dosages of the vaccines have been administered in the United States and 9,442 reports of adverse reactions to the vaccines have been submitted to VAERS. The most common neurological symptoms included dizziness, headache, pain, muscle spasms, myalgia, and paresthesias, which are expected to occur as acute, transient effects of the vaccination. Rare cases of tremor, diplopia, tinnitus, dysphonia, seizures, and reactivation of herpes zoster have been reported. There are also cases of stroke (17 cases), GBS (32 cases), facial palsy (190 cases), transverse myelitis (9 cases), and acute disseminated encephalomyelitis (6 cases) in the VAERS database. However, this does not suggest a causal link with the vaccination.”
“The GBS/Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Foundation provides the following guideline: for the rare person who develops GBS within 4 to 6 weeks of receiving an immunization, it seems prudent to avoid that vaccination in the future.“
Read the study HERE.
JULY 2021
In July 2021 Dr Nath detailed vaccines in general and the neurological complications identified with previous vaccines of the past, Guillain Barre, ADEM, Transverse myelitis, encephalitis, autonomic dysfunction. He points to VAERS already identifying multiple neurological complications to covid vaccines.
“…However, the rapidity of approval, and history of prior vaccination regimens resulting in neurological and other complications, creates concern surrounding widespread vaccination…
“A number of neurological complications of these vaccines are now being reported in the most comprehensive registry, the Vaccine Adverse Events Reporting System (VAERS) database. These include strokes, cranial neuropathies including Bell’s palsy, tinnitus and trigeminal neuralgia, peripheral neuropathies, dysautonomia, acute disseminated encephalomyelitis, transverse myelitis and AIDP .. however, it is too early to know the true incidence and risk factors for these complications. They are thought to be immune-mediated and early recognition and treatment with immunomodulatory therapies might be warranted…”
“Recently, blood clots occurring 7–14 days after administration have been reported, primarily in young women on oral contraceptive medications… Following review, the recommendation and emergency use authorization for this vaccine were reaffirmed for individuals aged 18 years and older, with a warning regarding rare clotting events primarily among women aged 18–49 years.”
“Prior studies have shed light on the likelihood of neurological complications following vaccination. These data can be difficult to interpret and are often seen as controversial, suffering from potential reporting bias and lack of clear causality, but illustrate theoretical concerns for both patients and physicians and must be acknowledged.”
Read the study HERE.
MAY 2022
NIH Study on Neurological complications after Covid vaccination. Dr Danice Hertz and Brianne Dressen were participants.
This observational study suggests that a variety of neuropathic symptoms may manifest after SARS-CoV-2 vaccinations and in some patients might be an immune-mediated process.
Immunotherapy and early intervention with the same appears to be key in treating this syndrome.
They studied 23 patients (92% female; median age 40years) reporting new neuropathic symptoms beginning within 1 month after SARS-CoV-2 vaccination. 100% reported sensory symptoms comprising severe face and/or limb paresthesias, and 61% had orthostasis, heat intolerance and palpitations. Autonomic testing in 12 identified seven with reduced distal sweat production and six with positional orthostatic tachycardia syndrome. Among 16 with lower-leg skin biopsies, 31% had diagnostic/subthreshold epidermal neurite densities ( 5%), 13% were borderline (5.01-10%) and 19% showed abnormal axonal swelling. Biopsies from randomly selected five patients that were evaluated for immune complexes showed deposition of complement C4d in endothelial cells. Electrodiagnostic test results were normal in 94% (16/17). Together, 52% (12/23) of patients had objective evidence of small-fiber peripheral neuropathy.
Complement system issues, involving the endothelial cells, the enothelium, blood vessel material.
Small fiber neuropathy in young healthy women. The typical onset is from diabetes, or in males aged 59.
“All our patients had neuropathic symptoms but objective findings of SFN were present in a few patients only.”
“Anti-spike protein immune responses may link post-Covid and post-vaccine syndromes.”
“In studies of mouse sensory ganglia, small-fiber neurons preferentially display the ACE-2 docking protein for SARS-COV- consistent with a potential predominance of SFN.” Once again, the neurotoxic spike protein comes into play. An auto-immunity as a secondary response then causing SFN?
100% of MRIs were normal. The ONE test that everyone is getting, isn’t showing anything for anyone. Yet that’s where the testing stops, and anxiety diagnosis is given. What would happen if doctors knew this information? That these MRIS were useless? What if they took the time to dig a little deeper? To look into the German paper that shows inflammatory markers? What about small fiber neuropathy testing and autonomic testing like the NIH has done? What about complement system function?
Read the study HERE.
OCTOBER 2023
in October 2023 Nath wrote an editorial in the prestigious journal Neurology. “Neurologic Complications With Vaccines: What We Know, What We Don’t, and What We Should Do”
A Short Summary:
“Despite such measures, vaccines are not without side effects including those that impact the nervous system. Numerous case reports and case series point to these possibilities… Action is needed to bring together manufacturers, health care agencies, clinical and bench scientists, and legislatures on a global platform to investigate vaccine-related neurological adverse events and develop ways to prevent and treat them.”
Potential neurological complications to watch for:
“The published literature has a large list of case reports and case series with a wide variety of neurological manifestations attributed to vaccines. While most side effects of vaccines are benign and transient, such as headache or fatigue, more serious side effects, including devastating neurological complications may occur.” “The same data set reveals that serious neurologic complications after vaccine administration across all vaccine types are extremely rare. Nonetheless, neurological manifestations that are potentially attributed to vaccines include immune-mediated syndromes; major categories of which include Guillain Barre Syndrome, small fiber neuropathies, transverse myelitis, and acute disseminated encephalomyelitis.“
Spectrum of neurological complications following COVID-19 vaccination, Neurol Sci 2022; 43(1):3-40.
Challenges to documenting complications
“Milder complications may have predominantly subjective symptoms which can be challenging to document. For example, our group reported cases of peripheral neuropathies temporally associated with the SARS-CoV-2 vaccines.12 Many patients had subjective symptoms that were dismissed. Diagnosis required skin biopsies and/or autonomic testing, procedures that are only available in specialized centers. This poses challenges in diagnosing these conditions at a global level.”
Neuropathic symptoms with SARS-CoV-2 vaccination
There is a great need to conduct research for identifying the underlying factors and subcellular mechanisms that result in the neurological manifestations from vaccines. Research may also guide the development of safer vaccines.
Etiology and Therapy
“Most likely mechanisms causing vaccine-mediated neurological manifestations are related to aberrant immune responses. Hence, one would reason that immunotherapies would be a reasonable treatment option. In fact, several case reports and case series seem to support this approach.”
Then Nath points out the important barriers restricting the scientists from doing what they want to do.
Responsibility of Monitoring Safety
“Role of various organizations and possible solutions Vaccine adverse event monitoring is not the portfolio of the National Institutes of Health (NIH) which is focused on disease-oriented and fundamental research. The United States Food and Drug Administration (FDA) evaluates the risks of the vaccines prior to approval. This is a rigorous process and picks up the common side effects. For example, the phase III randomized clinical trials of the mRNA vaccines show 12.5 additional serious adverse events per 10,000 vaccinated compared to placebo.” (paper)
No one has primary responsibility for investigating the mechanisms and treatments for side effects of vaccines.
PREP ACT and Manufacturer Immunity
“Thus, the bill provides immunity to drug companies from being sued for any unforeseeable side effect of vaccines. The PREP Act created a fund called the Countermeasures Injury Compensation Program (CICP). This provides compensation to the people who may have been injured from the vaccine. This was done to incentivize the companies to take on the risk for the development of the vaccines. However, no funds were obligated to provide any provisions for studying the underlying mechanisms of these side effects, for developing ways to prevent them or for treating them…
As a result, there is a gap in knowledge about the post-marketing neurological side effects of the vaccines, and lack of an organized effort to provide a definitive diagnosis or develop treatments for these patients”
“A simple solution might be to convene all stakeholders preferably at a global level to investigate the side effects and provide funding to conduct research to study and treat them (Table 2). Cooperation of the vaccine manufacturers would be critical since only they have access to proprietary information about the vaccines. This will help develop a better understanding of the spectrum of post-marketing side effects, identify those that are causally related and help develop ways of mitigating them. Above all it will build public trust and will go a long way towards reassuring them about the safety of vaccines.”
Future research needed to study neurological complications of vaccines
- Expansion of active surveillance programs
- Develop tools for gathering precise information on neurological complications
- Genetic susceptibility studies
- Immune profiling of individuals with neurological manifestations
- Determine association with comorbidities
- Develop animal models
- Conduct clinical trials for prevention and treatment of adverse events
Read the study HERE.