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A San Diego based 501(c)(3) organization dedicated to developing curative therapies through a pre-emptive and personalized approach based on a) early diagnosis; b) immunology; and c) regenerative medicine. CureScienceTM is focused on accelerating the translation through in-house research, establishing ThinkTanks and a patient-centric ecosystem. The goal is to implement paradigm-shifting ways of “fast-forwarding” c...

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Janara Bino
Executive Assistant
Mathew Loren
Bioengineer
Lawrence D. Jones, Ph.D.
Writer, Science & Technology
Misa Anekoji
Postdoctoral Scientist
Amanda Wilburn
Clinical Research Coordinator
Igor Tsigelny
Scientist, Computational Biology
Valentina Kouznetsova
Scientist, Bioinformatics

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COVID-19 Vaccine Surveillance- November update

COVID-19 Vaccine Surveillance- November update

Adverse effects of COVID-19 vaccines – what are they? Mass vaccinations against COVID-19 are being done around the globe. As of 3rd November 2021, over 7.1 billion doses of the COVID-19 vaccine have been administered throughout the world. Before their approval, these vaccines went through rigorous clinical trials and were found to be safe. Their administration to the general population on such a large scale has uncovered some adverse effects. However, most of the adverse effects are minor such as pain at the site of injection, headache, fatigue, and muscle pain. The major adverse effects are extremely rare which include anaphylaxis, vaccine‑induced immune thrombotic thrombocytopenia (VITT), myocarditis, and pericarditis. These latter disorders are by far the most important adverse effects caused by COVID-19 vaccines. Some other adverse effects include skin reactions, Bell’s palsy, rhabdomyolysis, vasculitis, pityriasis-rosea, reactivation of herpes simplex, varicella-zoster, reactivation of hepatitis C, ocular adverse effects, stroke, myelitis, and more. People with a history of chronic diseases and those who have previously been exposed to SARS-COV 2 are at greater risk to these reactions. Studies have also found that these adverse effects are slightly more prevalent in women. The exact type of adverse effect depends upon the medical history, age, and gender of the individual as well as the type and dose of the vaccine administered. The following are the developments in the understanding of some of the previously known adverse effects: Anaphylaxis Anaphylaxis is a potentially life-threatening allergic reaction that occurs minutes after receiving the COVID-19 vaccine. Anaphylaxis is one of the earliest reported adverse effects due to the COVID-19 vaccination. It is being hypothesized that anaphylaxis can occur due to the formation of a polyethylene glycol (PEG)-conjugated lipid derivative triggered by mRNA vaccines. This explains an observed trend that females are more susceptible to this allergic reaction. Hormonal differences can also be one of the contributing factors for the adverse reaction of anaphylaxis. Myocarditis Myocarditis is the inflammation of the walls of the heart. It is also one of the earliest reported adverse effects of COVID-19 vaccines. Myocarditis is more prevalent in males of younger age who received Pfizer/BioNTech, Moderna, or Janssen vaccine. According to a hypothesis, myocarditis is somehow associated with IFN-gamma and TNF-alpha. This hypothesis also explains the observed trend in terms of the age and gender of the affected individuals. Neurological Adverse Effects There are a variety of neurological adverse effects which occur following COVID-19 immunization. These include Guillain-Barre syndrome, Bell’s palsy, venous sinus thrombosis, and acute transverse myelitis. It is difficult to draw a causal association between such a wide spectrum of neurological adverse effects and COVID-19 vaccines, but identification of risk factors can reduce the incidence of these unwanted events. Patone et al. compared the risk of neurological disorders caused by the COVID-19 virus to the neurological adverse effects caused by the vaccines in an important review. The article reported that neurological complications of COVID-19 infection are much more prevalent than the adverse effects of the vaccines. This is an encouraging finding for the general population concerned about the devastating neurological adverse effects caused by COVID-19 vaccination. Recommendations regarding Vaccination Although the exact mechanisms of many of the adverse effects are still unknown, the epidemiological data can be used to understand certain patterns about these adverse effects which can help us prevent these events. Some recommendations are given below: People suffering from metabolic, musculoskeletal, immune system, and renal disorders should avoid inactivated virus-based COVID-19 vaccines. People suffering from diseases related to the vascular system should avoid mRNA-based vaccines. Studies have found that antibodies produced in response to the vaccination do cross the placental barrier and are also secreted in breast milk. Despite this, there were no significant adverse effects on the health of newborns. Therefore, it is safe for pregnant women to get the vaccination. CDC advises women younger than 50 years of age to be aware of the risk of TTS associated with Johnson & Johnson’s Janssen vaccine. Deaths after COVID-19 vaccine About 9,367 deaths following COVID-19 vaccination have been reported to the Vaccine Adverse Event Reporting System (VAERS). It is important to note that these deaths do not necessarily have a causal relationship with COVID-19 vaccination. They only have a temporal association with the administration of either the first or second dose of the vaccine. Schneider et al. performed an autopsy investigation on 18 individuals who died after receiving a shot of the COVID-19 vaccine. The authors reported that 13 of these 18 individuals died due to pre-existing diseases which were not related to the COVID-19 vaccine. CONCLUSION The benefits of COVID-19 vaccines clearly outweigh their potential risks. Mass vaccination is still the best way out of this pandemic. The transparency regarding the reporting of adverse effects of COVID-19 vaccines is essential to this mass vaccination strategy. It also allows to point out some general patterns so that at-risk individuals can take proper preventive measures. Written by: Numair Arshad

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COVID-19 Vaccines

COVID-19 Vaccines

Types of vaccines Vaccines can stimulate the body to produce a protective immune response. The vaccine itself can mimic natural infection, but it does not actually cause illness. If a pathogen infected the body after vaccination, the immune system would quickly prevent the pathogen from spreading in the body and causing disease. Vaccines can be divided into the 3 types: inactivated pathogen, recombinant protein-based, and genetic vaccine. In general, inactivated pathogen and recombinant protein-based vaccines induce humoral immunity (Th2-biased) via MHC II pathway. Genetic vaccine such as mRNA and DNA vaccine can induce both cellular and humoral immunity via MHC I and MHC II pathways. The emergence and rapid spread of a novel severe acute respiratory syndrome (SARS) like coronavirus SARS-CoV-2 is causing the global coronavirus disease 2019 (COVID-19) pandemic and destroying global health and economy. To date, SARS-CoV-2 has infected over 264 million people and caused more than 5.22 million deaths. Understanding how SARS-CoV-2 enters human cells is a high priority for deciphering its mystery and curbing its spread. Studies revealed that a virus surface spike protein mediates SARS-CoV-2 entry into cells by binding to its receptor human ACE2 (hACE2) through its receptor-binding domain (RBD). Therefore the spike protein is an excellent target for developing successful vaccine to protect from infection and curb the pandemic. To date, there are two mRNA vaccines (Pfizer-BioNTech and Moderna) and two virus vector-based vaccines (JNJ and AstraZeneca) have been approved in USA and Europe, two or three inactivated vaccines has also been approved in China and India. There are a few other vaccines still in clinical trial stages. We briefly discuss as follows: Genetic vaccines Vaccines from Pfizer-BioNTech, Moderna, and Johnson & Johnson are being administered in the U.S. The FDA has authorized—and the CDC has approved—booster shots for all three vaccines, along with a “mix-and-match” approach that would allow people to choose a different vaccine for their booster than the one they started with. They are all genetic vaccines. 1. mRNA vaccines Both Pfizer-BioNTech and Moderna vaccines are mRNA. Unlike vaccines that put a weakened or inactivated disease germ into the body, the mRNA vaccine delivers a tiny piece of genetic code from the SARS CoV-2 virus to host cells in the body, essentially giving those cells instructions, or blueprints, for making copies of spike proteins (the spikes you see sticking out of the coronavirus in pictures online and on TV). The spikes do the work of penetrating and infecting host cells. These proteins stimulate an immune response, producing antibodies (humoral immune response) and developing T cell and memory cell immune response that will recognize and respond if the body is infected with the actual virus. Both vaccines showed about 95% efficacy in Phase 3 clinical trials with two shots (21-28 days interval). This figure has changed over time. At six months after vaccination both Pfizer and Moderna still are considered highly effective, several recent studies showed Moderna to be more protective. One study published in The New England Journal of Medicine found Moderna vaccine to be 96.3% effective in preventing symptomatic illness in health care workers compared to 88.8% for Pfizer. Another, from the CDC, found Moderna’s effectiveness against hospitalization held steady over a four-month period, while Pfizer’s fell from 91% to 77%. This research is still limited and more data is needed to fully understand the differences between the two vaccines. Moderna reported that studies showed its vaccine is effective against the Beta, Delta, Eta, and Kappa variants, although it did show it to be about two times weaker against Delta than against the original virus. The Pfizer vaccine was found to be more than 95% effective against severe disease or death from the Alpha variant (first detected in the United Kingdom) and the Beta variant (first identified in South Africa) in two studies based on real-world vaccinations. 2. DNA vaccine INOVIO's DNA vaccine candidate (INO-4800) against SARS-CoV-2, is composed of a precisely designed DNA plasmid that is injected intradermally followed by electroporation using a proprietary smart device, which delivers the DNA plasmid directly into cells in the body and is intended to produce a well-tolerated immune response. As one of the only nucleic-acid based vaccines that is stable at room temperature for more than a year, at 37°C for more than a month, has a five-year projected shelf life at normal refrigeration temperature and does not need to be frozen during transport or storage, INO-4800 is anticipated to be well-positioned for a primary series immunization as well as a booster. Currently this DNA vaccine is under Phase 3 clinical trials in multiple countries in Latin America, Asia, and Africa. Regulatory authorization in India follows authorizations from health authorities in Brazil, Philippines, Mexico and Colombia. 3. Virus vector-based vaccine Johnson & Johnson and Oxford-AstraZeneca have developed similar virus vector-based COVID-19 vaccines. Unlike the mRNA vaccines, virus vector-based vaccines can be stored in normal refrigerator temperatures, and because it requires only a single shot, it is easier to distribute and administer. The virus vector-based vaccines use a different approach than the mRNA vaccines to instruct human cells to make the SARS CoV-2 spike protein. Scientists engineer a harmless adenovirus as a shell to carry genetic code on the spike proteins to the cells. The shell and the code cannot make you sick, but once the code is inside the cells, the cells produce a spike protein to train the body’s immune system, which creates antibodies and memory cells to protect against an actual SARS-CoV-2 infection. Both vaccines obtained similar overall efficacy (75%) and over 85% efficacy against moderate and severe disease. Johnson & Johnson reported in July 2021 that its vaccine is also effective against the Delta variant, showing only a small drop in potency compared with its efficacy against the original strain of the virus, although one recent study suggested that the J&J vaccine is less effective against Delta. Recombinant S protein-based or peptide vaccine 1. NovaVax NovaVax has developed a recombinant Spike protein vaccine which is highly effective in clinical trials. It is simpler to make than some of the other vaccines and can be stored in a refrigerator, making it easier to distribute. Unlike the mRNA and vector vaccines, the Novavax vaccine takes a different approach. It contains the spike protein of the coronavirus itself, but formulated as a nanoparticle, which cannot cause disease. When the vaccine is injected, this stimulates the immune system to produce antibodies and T-cell immune responses. Studies have shown 90% effectiveness against lab-confirmed, symptomatic infection and 100% against moderate and severe disease in Phase 3 trial results released in a company statement in June. The company says the vaccine was 91% protective of people in high-risk populations such as people older than 65, those with health conditions that increase risk of complication, and those in situations where they are frequently exposed to the virus. 2. Virus-like particles The company VBI has developed virus-like particle vaccine ( VBI-2900) that consists of three enveloped virus-like particle (eVLP) vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, (2) VBI-2902, a monovalent COVID-19-specific vaccine expressing the native SARS-CoV-2 spike protein, and (3) VBI-2905, a monovalent COVID-19-specific vaccine expressing the spike protein from the Beta variant (also known as B.1.351). The vaccine program has been developed through collaborations with the National Research Council of Canada (NRC), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Government of Canada, through their Strategic Innovation Fund. In Phase 1 study, VBI-2902a induced neutralization titers in 100% of participants, with a GMT of 329, 4.3x the GMT of the convalescent serum panel, after two doses. After two doses, VBI-2902a also induced antibody binding titers in 100% of participants, with a GMT of 4,047 units/mL, 5.0x the GMT of the convalescent serum panel 3. Peptide vaccine Emergex announced approval to initiate Phase I clinical trial of its next generation COVID-19 vaccine candidate in November. This is a synthetic peptide vaccine designed to prime T-Cells to rapidly remove viral-infected cells from the body after infection. This vaccine may offer broad immunity against SARS-CoV-1 and all SARS-CoV-2 variants and provide long-lasting immunity that does not require seasonal booster vaccines. Emergex vaccines have been designed to be administered via the skin using micro needles and to be stable at ambient room temperature for more than three months, facilitating rapid and efficient distribution across the world and making administration of the vaccine more patient friendly. Inactivated virus vaccine Inactivated COVID-19 vaccines have also been approved in China (developed by Sino Biologics and Beijing Kexing) and in India (developed by Bharat Biotech). Written by: Feng Lin, M.D., Ph.D. References: Scudellari M. Nature, 2021, 595-640-644 Shang J, Wan Y, Luo C, et al. PNAS, 2020, 117:112-11734

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Immune Maps in the Brain Create Memory of Past Infections

Immune Maps in the Brain Create Memory of Past Infections

Implications for Psychosomatic Disorders Introduction Jack was severely allergic to pollen from flowers. His friends wanted to play a prank on him and decided to scare him by placing an artificial flower with no pollen in his backpack. As soon as Jack opened his backpack and saw this flower, he started showing symptoms similar to an actual allergic response, and soon developed a full-blown allergic response. Though this story is a figment of the writer’s imagination, this is what happened almost 150 years ago when Mackeszie and researchers studied the effects of an artificial flower on subjects allergic to pollen. This phenomenon is termed as a psychosomatic disorder. Cleveland Clinic defines psychosomatic disorder as “a psychological condition involving the occurrence of physical symptoms, usually lacking a medical explanation.” This suggests that a disorder may manifest without any apparent physical cause, solely due to “some unknown” effect of the nervous system. While there is no consensus about psychosomatic disorders and its underlying causes, a recently published study by researchers at Technion hints at a possible role of the brain in producing certain immune-related diseases. The Brain and The Immune System It has long been recognized that the immune system can affect the functioning of the brain, indirectly through immune mediators, and directly through the actions of immune cells on the nervous system. What this recent study shows is that the converse is true as well. The immune system is directly represented in certain areas of the brain and through these areas, the brain can regulate the immune system. The Study In the study that was published in a recent issue of Cell, Asya Rolls and her team of researchers from Technion – Israel Institute of Technology used a mouse model to induce inflammation in a part of the gut called the colon. In these mice, inflammation of the colon (colitis) was associated with an increase in the activity of neuronal cells. Specifically, an area of the brain called the insular cortex showed neuronal activation following colitis. This suggested that there was some correlation between colitis and brain activation. However, the key question was whether the reverse was true? To examine this, researchers artificially activated these same brain neurons in healthy mice. Surprisingly, they found that this led to inflammation that was restricted to the same region of the intestine but not to other areas of the body. This meant that the insular cortex region of the brain had formed a memory of the earlier inflammation and could stimulate the same response in the absence of any pathology in the intestine. Additionally, when these neurons were suppressed, it reduced the inflammation in the colon. So, the key takeaway from this study is that the insular cortex region of the brain can retain information related to immune signaling, similar to the way the brain retains memory. Further studies are essential to elucidate the mechanism involved in this communication between the nervous system and the immune system. Role of Insular Cortex The insular cortex region of the brain is also responsible for perception of sensations from inside the body, a process known as interoception. These are largely unconscious perceptions, and include perception of physical sensations in relation to organs such as heart beat, respiration, satiety, etc. It is interesting that the same brain area that is responsible for interoception is also involved in “remembering” the immune response. Conclusion This is a very important study which suggests that the brain may be programmed to store information about the immune system, similar to that of the sensory and motor systems. This may have implications for many immune-related disorders such as allergies, ulcerative colitis, Crohn’s disease, autoimmune disease, etc. Better understanding the mechanisms and pathways of neuroimmune signaling may help us manipulate it to manage related disorders. Written by: Sandeep Pingle, MD PhD

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PICK’S DISEASE

PICK’S DISEASE

Pick’s disease (PiD) was discovered by Arnold Pick in 1892. The meaning of the term “pick’s disease” has changed dramatically over the years. In the past, it was used to describe Frontotemporal dementia (FTD) but now it represents a histopathological (the study of tissues and cells under a microscope) subtype of FTD. FTD belongs to an even broader pathology called frontotemporal lobe degeneration (FTLD). FTD is any form of dementia in which frontal and temporal lobes of the brain degenerate. It is characterized by the presence of intraneuronal inclusions in the form of pick bodies and ballooned cells in the brain called pick cells. These inclusions contain aggregates of abnormal tau protein. Tau protein in PiD is 3-repeat, meaning the Tau protein exists in various isoforms and large amounts of 3-repeat have profound axonal transport defects and locomotor impairments. PiD is a primary tauopathy (deposition of abnormal levels of Tau protein). Healthy tau protein helps in the assembly of microtubules in the neurons. It is coded by the MAPT gene. Like all other types of dementia, it is a neurodegenerative disease. Atrophy in the PiD brain is limited to frontal and temporal lobes. This atrophy results in the formation of a characteristic knife-edge-like shape of the brain. Damage to the frontal lobe results in behavioral decline while damage to the temporal lobes results in language decline. The age of onset of PiD ranges from 40 to 75 years. PiD is more prevalent in men than in women. FTD is divided into clinical subtypes such as behavior called behavioral variant of Frontotemporal dementia (bvFTD) and diminished language skills called primary progressive aphasia (PPA). bvFTD presents the most common set of symptoms in PiD. Most cases of PiD have a sporadic origin. Characteristic symptoms of PiD include abrupt mood change, compulsive behavior, stereotypic and immoral behaviors, difficulty in speech, disinhibition, and apathy. Caregiving in PiD is particularly difficult due to the inappropriate behavior of patients towards caregivers. PiD patients show stereotypic, sexually inappropriate, and impulsive behavior. PiD patients also suffer from anomia; a condition in which a person has difficulty remembering the names of objects and places. Akinesia and rigidity may occur in the later stages of the disease. Diagnosis of living PiD patients is difficult because of the lack of specific biomarkers for pick bodies. Antibodies can be used in the diagnosis of PiD. Cognitive and behavioral tests are currently the best option for diagnosing PiD. Despite all these options, many PiD patients are misdiagnosed. Brain imaging can be used to visualize atrophy. Most patients suffering from PiD have mixed pathology in which other neurodegenerative diseases are also involved. Frontotemporal lobar atrophy is a prominent sign of PiD. Knife-edge-like cortical atrophy can be observed upon gross examination. The risk of PiD increases with age. High education, regular physical exercise, and a healthy diet can be effective in the prevention of all types of dementia including PiD. There are three stages of PiD. These are called initial, steady and terminal stages. Symptoms get worse with advancing stages. Males suffering from PiD show aggressive behavior. No treatment can slow down or reverse the progression of PiD. Different drugs can be used to manage the symptoms and the treatment is highly individualized. Cholinesterase inhibitors are used for the behavioral management of PiD. The drugs being used to manage symptoms of PiD are intended for symptomatic treatment of other disorders such as AD. Much work needs to be done to understand the pathophysiology of PiD in order to develop disease-modifying treatments. Written by: Numair Arshad & Lawrence D. Jones, Ph.D.

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