Vaccines Have Serious Side Effects

The Revised Authoritative Guide To Vaccine Legal Exemptions

Comprehensive, authoritative information about vaccine exemptions you can trust, from Alan Phillips, J.D., a leading vaccine rights attorney with years of experience helping clients throughout the U.S. legally avoid vaccines in a wide variety of vaccine-refusal settings. Critical details for parents, students, immigrants, healthcare employees, military personnel and contractors, agencies, attorneys and clientsvirtually anyone concerned with legally avoiding vaccines in the United States. This Guide provides and explains: Important background information about the legal system; How state and federal statutes, regulations, constitutions and legal precedent interact to define the boundaries of your legal exemption rights; How to deal with local authorities and to avoid mistakes that cost others their exemption; Where legal technicalities and practical reality differand what to do about it; Read more here...

The Revised Authoritative Guide To Vaccine Legal Exemptions Overview

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Vaccination Is Not Immunization Vaccine Risks Exposed

Doctor's New E-book Informs Parents About Vaccine Side Effects, The Link To Autism, Swine Flu Scam & More. Ends The Confusion On Whether Or Not To Vaccinate. Many Doctor Testimonials. Here's a look at some of what's covered. . . The disturbing truth: why children are growing sicker, fatter and dumber year after year. The shocking composition of what's really being injected into your child. Think only your children are at risk? Think again. As of 2008, adults are Medicine's newest target, with the Cdc's new Adult Immunization Schedule of 74 vaccines! What is the Germ Theory and why does the medical establishment ignore the errors inherent in it? The implications for your child's health are staggering! Do you know the difference between natural immunity and artificial immunity? 12 deadly reactions to the Dpt vaccine Did you know that the three vaccines contained in this three-in-one injection were never tested together before it was brought to market? In the 1940s. There's more: The truth about autism The evidence is piling up regarding the accine autoimmune brain programming connection and you must not wait another day to get the complete story. The false advertising behind the Mmr (measles-mumps-rubella) vaccine If so many doctors are refusing to give it to their children, what is that telling you? The most amazing statistic put forth from a source with no medical axe to grind Metropolitan Life Insurance. According to the ex-commissioner of the Fda, the number of adverse reactions to vaccines are being woefully underreported. If flu shots worked, why do you and your child get them year after year and why do you and your child keep getting the flu? It's all here. . .plus, the worrisome correlation between flu shots, mercury and Alzheimer's disease. What are toxics in vaccines and why are they being used on your child? And are you sure you want these poisonous substances injected into your child? What mandated vaccination really means and how your child can be made exempt if you choose Read more here...

Vaccination Is Not Immunization Vaccine Risks Exposed Overview

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Author: Tim O Shea
Official Website: www.immunitionltd.com
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Of Nanotherapeutic Vaccines

Effectors are produced in the subsequent response. The process, while tightly regulated, is amenable to intervention using nanotherapeutic vaccines. Nanobiological design strategies (discussed above) can take advantage of the numerous proteins and peptides now known to mediate the trafficking of carried materials to specific sites. In the device context, these trafficking moieties might assure delivery of antigens to the appropriate cellular compartments to trigger desired class I- or class II-mediated responses. Vaccine polypeptides, for instance, might be fused or formulated with pathogen polypeptides that will deliver them across epithelium from outside the host for use in mucosal vaccination 10.130 . Still other peptides are known to carry injected materials across the cell envelope into the cytosol 10.131 . Alternatively, vaccine entities taken up by receptor-mediated endo-cytosis (into endosomal vesicles, the traditional site of uptake for antigens destined for MHC class II...

DNA Nanovaccines Using Nanocapsules and Ultrasound Methods

The USDA is completing trials on a system for mass vaccination offish in fishponds using ultrasound. Nanocapsules containing short strands of DNA are added to a fishpond where they are absorbed into the cells of the fish. Ultrasound is then used to rupture the capsules, releasing the DNA and eliciting an immune response from the fish. This technology has so far been tested on rainbow trout by Clear Springs Foods (Idaho, US) a major aquaculture company that produces about one-third of all U.S. farmed trout.

Delivery of Drugs and Vaccines Gene Therapy

Well-established coupling strategies can now be applied to covalently link the functional groups of the nanotubes with peptides, maleimide linkers (for subsequent attachment of proteins via cysteine units), or the like. It is possible, for instance, to immobilize viral proteins (e.g., of the virus causing foot-and -mouth desease) while conserving their immunological properties (Figure 3.111). Thus the nanotube acts as a carrier for antigenes and might also be employed as a vehicle for vaccines. Nanotubes possess an important advantage over the carrier proteins commonly used for this purpose It is true that the correct immune response to the antigene is evoked in both cases, and also that in a mouse model an immunity against the actual virus is generated, but to the nanotubes themselves, there is no immune response at all. Carrier proteins, on the other hand, give rise to such a reaction by inducing the formation of unspecific antibodies.

Vaccines

A large number of reviews have appeared on the subject of using nanoparticles as delivery systems and adjuvants for vaccines 393-397 . Poly(methyl methacrylate) nanoparticles were shown to be very good adjuvants for a number of antigens 40, 43, 275, 276, 398-402 . Antigens may be incorporated into these nanoparticles by polymerization in the presence of the antigen by gamma irradiation at low temperatures, or they may be adsorbed to previously polymerized particles 30, 35, 403 . Adsorption to previously polymerized particles also allows the employment of heat polymerization since most antigens are heat sensitive. The adjuvant effect depended on the particle size as well as on the hydropho-bicity. The adjuvant effect increased with decreasing particle size 40, 398 and with increasing hydrophobicity 276, 400, 402 . Poly(methyl methacrylate) nanoparticles were superior to the conventional aluminum adjuvants which are the most frequently used adjuvants for human vaccination. The...

Gene Delivery Systems

For more than two decades, researchers have been working to alleviate disease through gene therapy. In this type of treatment a gene is delivered to cells, allowing them to produce their own therapeutic proteins. Traditionally, DNA delivery systems have been classified as viral vector mediated systems and nonviral vector mediated systems 125 . Currently, because of their highly evolved and specialized components, viral systems are by far the most effective means of DNA delivery, achieving high efficiencies (> 90 ) for both delivery and expression 126 . The most promising nonviral gene delivery system thus far, other than the gene gun, is DNA vaccine applications, comprised of ionic complexes formed between DNA and polycationic liposomes 127, 128 . A major problem in the practical application of gene transfer for therapeutic purposes (gene therapy) is the efficient delivery of the genetic material to the desired place of action, the target tissue. Nanotechnology appears to be one of...

Composition and Biocompatibility

A variety of inorganic materials can be used to generate nanoparticles for drug delivery that might be applied to cancer and tumor targeting. For example, iron oxide (Fe2O3) nanoparticles can be used to deliver anti-cancer agents.19 Fe2O3 nanoparticles targeted to a cancer can become hot enough in an applied oscillating magnetic field to kill cells. Calcium phosphate precipitates can also be also made into nanoparticles. Although calcium phosphate precipitates can be metabolized over time and would be considered biocompatible, these materials can act as a potent adjuvant, potentially enhancing their application to target the delivery of cancer antigens. In this way, calcium phosphate nanoparticles are similar to another inorganic salt precipitate, aluminum hydroxide (alum), that is currently approved as an adjuvant for human vaccines.21 Semiconductor nanocrys-tals (quantum dots) are another example of inorganic nanoparticles. Quantum dots have exceptional characteristics for in vivo...

The Precautionary Principle Should Not Be Used as a Basis for Aggressive Environmental Regulation

Nology start-up companies in the United States, which are currently struggling to obtain financing, would have little chance of weathering through such a regulatory storm. Further, established companies would be likely to reduce the resources devoted to developing products based on nanomaterials they might shift their research and development and manufacturing facilities overseas. Thus, for example, Nanomed Pharmaceuticals would be unable to obtain financing for further development of drugs and vaccines to treat cancer and neurodegenerative diseases, and IBM could reduce the resources devoted to developing nanoelectronic devices. By drowning part of an industry with significant economic potential, stringent regulation of nanomateri-als could indirectly condemn a large number of people to premature deaths.

Establishing Target Cell Contact

The options for drug administration in vivo are oral and parenteral. For obvious reasons, gravitation and centrifugation are not suitable for targeting in this case. Oral administration of gene vectors localizes delivery to the gastrointestinal tract and promises great potential for genetic vaccination. Bacterial vectors 151-155 , viral vectors 156, 157 , chitosan-DNA complexes 158-160 , and microencapsulated nucleic acids or viruses 161-167 are used for this purpose. For details, the reader is referred to the cited literature. A complete review volume has been dedicated recently to microencapsulated DNA formulations for vaccination purposes 168 .

Nanocarriers For Gene Delivery

In addition to traditional drugs, pDNA has recently also been used as a drug for cancer therapy for example, antigen-encoding pDNA has a potential application in DNA vaccine therapy for cancer. Moreover, new techniques to inhibit target gene expression through transcriptional regulation

Mannose Liposomes for Liver NPC Targeting

Because Man-C4-Chol has a cationic charge, a cationic charge could also be induced on the surface of a Man-liposome. Therefore, Man-liposomes are also an attractive potential gene carrier because of this cationic charge that would allow electrical interaction with the gene. As far as in vivo gene transfection is concerned, the highest gene expression was observed in the liver after intravenous injection of pDNA Man-liposome complexes (Man-lipoplex) in mice.66-68 In addition, gene transfer by a Man-liposome was mannose receptor-mediated because the gene expression with Man-lipoplex in the liver was significantly reduced by pre-dosing with manno-sylated bovine serum albumin. Because macrophages in the liver and spleen exist at the endothelial cells intervals and could make contact with the complex without passing through the sinusoid (100-200 nm), cell-selective gene transfection could be achieved by intravenous administration of Man-lipoplex. Therefore, a mannosylated gene carrier...

The Classification System Drug Device Biologic or Combination Product

A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound) applicable to the prevention, treatment, or cure of a disease or condition of human beings.29 CBER is responsible for regulating a wide variety of biologics blood and blood components, devices, allergenic extracts, vaccines, tissues, somatic cell and gene therapies, biotech derived therapeutics, and xenotransplanta-tion.30 CBER's responsibilities in regulating biologics are similar to CDER's responsibilities in regulating drugs. Approval must be granted for clinical testing of new biological products. In order to obtain a license to market, the agency must determine that a biological product is safe, pure, potent, and manufactured accordingly.31

Of Therapeutic Nanodevices

Therapeutic nanotechnology will be useful, of course, when the underlying biology of the disease states involved is amenable to intervention at the nanoscale. As we will discuss, while several disease states and physiological conditions (cancer, vaccination, cardiovascular disease, etc.) are particularly accessible to nanoscale interventions, some nanotechnological approaches may be applicable more broadly. Much as was the case with the introduction of recombinant protein therapeutics over the last 20 years, nanotherapeutics may present regulatory and pharmacoeconomic challenges related to their novelty and their cost of goods (COGs).

Delimiting Nanotherapeutic Action in Three Dimensional Space

Delivery of therapeutics to sites of action is a key strategy to enhance clinical benefit, particularly for drugs useful within only narrow windows of concentration because of their toxicity (i. e., drugs with narrow therapeutic windows). Diverse targeting approaches are available, ranging from methods exploiting differential extravasation limits of vasculature of different tissues (see the discussion of oncology below), sizes, and surface chemistry preferences for cellular uptake (see discussion of vaccines below) preferential partition of molecules and particles into specific tissues by virtue of their charges, sizes, surface chemistry, or extent of opsonization (see below) or the affinity of biological molecules decorating the nanodevice for counter-receptors on the cells or tissues of interest.

Applications for Nanotherapeutic Devices

As discussed above, nanotherapeutic devices are novel, emerging therapeutics with properties not fully understood or predictable. Nanotherapeutics, therefore, must be justifiable on at least two levels. As we have seen, the nature of the therapeutic task and the state of current nanoscale-materials technology make the incorporation of biological macromolecules unavoidable for many nanotherapeutics. Proteins, for example, typically are substantially more expensive than small molecule therapeutics, and precise nanostructures containing proteins will be more costly still. Nanotherapeutics must justify their high COGs. Secondly, as new therapeutic modalities, nanotherapeutics may carry significantly larger risks than those associated with more conventional therapies. Expensive, novel moieties, such as nanobiotechnological therapeutic devices, are therefore most likely to be accepted for treatment of conditions that not only are accessible to intervention at the nanoscale but also for...

And Specific Host Immune Responses

Immune responses directed to immunogens (molecules or structures capable of eliciting specific immune responses, also called antigens) are a pervasive aspect of the responses of vertebrates to exposure to foreign macromolecules, proteins, particles, and organisms (for overviews, see 10.1,123,124 ). Undesired antibody responses, in particular, are the single most important hurdle for clinical use of recombinant proteins. On the other hand, undesired cellular immune responses are key mediators of frequently devastating disorders for patients, whether the responses are directed to self (as in autoimmune disease) or to foreign antigens (as in transplant rejection). As we shall see, host immune responses to nanotherapeutic devices are a critical determinant of their efficacy. Any strategy (including the biotechnological strategies) that allows controlled manipulation of immune responses either to augment desirable responses, as in vaccines, or to mitigate deleterious responses holds...

The Potential for Gene Therapy as a Validation Delivery Platform

On the other hand, the gain in gene-transfer efficiency associated with synthetic complexes must be balanced against the general lack of stability of polyplex and lipoplex vectors in vivo and the tendency of locally delivered cationic agents to cause tissue necrosis, which can be dramatic. Nonviral vectors are inefficient, and high doses may be required to achieve therapeutic effects. High-dose administration may be limited, however, by motifs in the vector backbone that stimulate the immune system (MacColl et al. 2001). While CpG-dependent immune stimulation is Thl-biased, SCID mice (Ballas, Rasmussen, and Krieg 1996) have shown increased levels of IFN- and IL-12 following plasmid-vector delivery (Klinman et al. 1996). Significantly, nonviral vector administration to animals has generated anti-DNA antibodies, leading to renal disease and premature death (Deng 1999). Relevant to the present application, Payette and colleagues (2001) recently showed that intramuscular delivery of a...

Definition Of Nanoparticles For Pharmaceutical And Medical Purposes

Nanoparticles for pharmaceutical purposes are defined by the Encyclopedia of Pharmaceutical Technology 7 as solid colloidal particles ranging in size from 1 to 1000 nm (1 m). They consist of macromolecular materials and can be used therapeutically as drug carriers, in which the active principle (drug or biologically active material) is dissolved, entrapped, or encapsulated, or to which the active principle is adsorbed or attached. This definition was already formulated earlier in a number of reviews 1, 3, 6, 8 and includes monolithic nanoparticles with drug dispersed in the polymer network or dissolved in the polymer in form of an amorphous solid solution (Fig. 1a) as well as capsules with a shell-like wall (Fig. 1b). It also includes for instance nanoparticulate adjuvants in vaccines. This definition does not include solid lipid nanoparticles which are produced from lipids 9-11 . Nevertheless, solid lipid nanoparticles are described in Section 4.9.

Oligonucleotides and DNA

The entrapment of oligonucleotides and DNA in PEG-coated drug carriers is a main challenge. In particular, plas-mid DNA has potential as a therapeutic agent, as well as a new vaccination approach. A 13-mer oligonucleotide was entrapped in PEG-PLA nanospheres following the nano-precipitation method, with encapsulation yields as high as 33 . 76 . To achieve this, an insoluble complex between

Microbotics Nanoparticles Hitching a Ride on Bacteria

Vaccination has resulted in the eradication of smallpox and the control of measles, rubella, tetanus, diphtheria, and other infectious diseases in many areas of the world (at least where vaccines are available and affordable providing vaccines to many parts of the developing world still is one of the basic medical needs that is far from being met). The basic idea of vaccination is to inject weakened or killed forms of pathogens such as bacteria or viruses into the body in order for the immune system to develop antibodies against them. If the same types of microorganisms enter the body again, they will be recognized and destroyed by the antibodies. About 25 years ago, the basic idea of vaccination gave rise to bactofection the technique of using bacteria as nonviral gene carriers into target cells. The DNA cargo is transported inside the bacteria and, once it arrives at the target location, the bacteria are broken up in order to release the therapeutic gene or protein. A novel...

Truth claims and communicating science

If Bruner is right this presents a dilemma for science communication. For communication within the scientific community the paradigmatic mode is appropriate, but for communication with other audiences it may not be persuasive, particularly when it is challenged by a narrative account. In the UK this has been seen in a long running dispute over the MMR (measles, mumps, and rubella) vaccination for children. The epidemiological evidence (paradigmatic) is overwhelmingly in support of the efficacy of the triple vaccine. Yet a single paper in a medical journal, the Lancet, based on a handful of cases, purported to show a link between the triple vaccine and childhood autism. The paper attracted considerable media attention, including interviews with distressed parents of autistic children claiming that the disease was due to the triple vaccination. This led to a significant fall-off in the rates of vaccination and opened up the possibility of epidemics of dangerous childhood disease.

Global injustice or justice

Times the rate of the middle third, while the bottom third showed no increase (Scott, 2001). Despite global economic growth, poverty persists, with two fifths of humanity living on less than US 2 per day, the minimum for meeting basic needs. Healthy life expectancy (not just 'life expectancy') in Zimbabwe is 33.6 years, in Zambia 34.9 years and Afghanistan 35.5 years, whereas it is 75 years in Japan, 73.3 in Sweden and 72 years in Canada and in France. About 2.3 million people, mostly in the developing countries, die from eight diseases that could be prevented by vaccination (Pirages, 2005, pp46, 50).

Are there any institutions that are currently using nanotechnology in a similar way that you propose to use it in NAI

Sarah NAI is a completely theoretical project, but modern science is well on its way to making it a reality. A needle-free, nanotechnology-based vaccine has been developed for anthrax. In addition, similar nanotechnology-based vaccines have been developed for bubonic plague, staph, and ricin for the U.S. Army, as well as one for malaria for the U.S. Navy.

IiThe Center for Biologics Evaluation and Research

The CBER is responsible for the regulation of biological products, which is an umbrella term that includes many forms of products used in the treatment of human beings. The term is not without some ambiguity, but it is frequently used to distinguish from chemical drugs that are synthesized chemically. Examples of such products include allergenics used by physicians to identify allergies in humans blood and blood components used in transfusions gene-therapy products used to replace genetic material in human beings human tissues used in transplants, such as skin, ligaments, and cartilage xenotrans-plantation products in which animal tissue or organs are transplanted into human beings and vaccines. In addition to the regulation of such biologics, the CBER is responsible for the regulation of certain related medical devices that are used to safeguard biologics.

Drug Delivery Using Nanoparticles

The drug delivery systems will minimize drug degradation and loss and prevent harmful side effects by delivering therapeutic drugs to the desired site of the body. Drug delivery systems will have potential for many applications, including antitumor therapy, gene therapy, AIDS therapy, and the delivery of antibiotics and vaccines.

Biological Applications

Due to its low toxicity and large chemical inertness, nanodiamond is an attractive material for biological applications. Biological moieties may be attached by either covalent or noncovalent bonding. Most publications available to date describe the noncovalent adsorption of proteins, antibodies, enzymes, viruses, etc. In some cases, the surface of the diamond particles is pretreated, for instance, by coating it with L - polylysine or cellobiose, before the adsorption of the biologically active unit itself is effected. The diamond hybrid particles thus obtained suit to the preparation of transporting vehicles for vaccines or pharmaceutical actives or to the controlled release of genes, etc., inside living cells. In this regard then, the small particle size is rather beneficial.

The US Food and Drug Administration

And ultimately ingested by human beings. For instance, nanoscale detectors may be used to monitor enzyme interactions in farmland, nanoscale capsules may be used in the delivery of pesticides or for delivering growth hormones and vaccines, nanosensors may be used for monitoring soil conditions or for detecting pathogens, and other nanoscale devices may be used in other agricultural applications. As part of widescale food processing, nanoscale devices may find application in the form of nanocapsules to improve the availability of certain neutraceuticals in food products or may encapsulate flavor enhancers, nanotubes may be incorporated into food as gelation agents, and nanoemulsions may be used to improve the dispersion of nutrients. The packaging of food may benefit from the use of biodegradable nano-sensors that test for temperature and moisture content, from antimicrobial coatings formed from nanoparticles, and from films that incorporate nano-structures to render them lighter,...

Attachment Of Biomolecules

NTs are considered to be biocompatible572-576 and attract great interest as a material for biological applications. The main fields of such applications include (1) fabrication of bioprobes and biosensors, (2) synthesis of molecular structures for the transport of vaccines and drugs, especially water-insoluble substances into the body or to a certain body organ, (3) formation of anti-fouling surfaces (enzyme-containing composites), (4) use of NTs as a template to grow cells, and (5) creation of implantable bioelectronic devices.

Ligand Receptor Interactions

We have anchored ZZ-T onto live cells and studied the binding of IgG (immunoglobulin G) with the ZZ-T (fusion protein) on live cells 22 . The SEGNPs were prepared and labeled with the IgG. The binding of IgG-SEGNPs with ZZ-T anchored onto live cells has been directly measured in real time as shown in Figure 5 22 . The bound and unbound IgG-SEGNPs were distinguished using the diffusion distances of SEGNPs. The unbound probe created a large diffusion image and appeared dim because the intensity of the nanoparticles within the exposure time is distributed over each pixel of the entire diffusion area. The bound probe shrank to a single pixel of CCD resolution and appeared as a single bright spot because the bound probe on live cells would not move around and hence a single pixel collected all scattering intensity during the entire exposure time. The blank control experiments of ZZ-T-anchored cells incubated with nanoparticles or cells in the absence of ZZ-T incubated with IgG-SEGNPs...

What about Genetic Engineering and Robotics

Research workers at State University of New York at Stony Brook 11 reported synthesis of the polio virus from starting chemicals available in the modern biological laboratory. The only starting information used was knowledge of the DNA sequences in the polio virus. The implication is that this virus could be built to altered specifications, perhaps including those for which the Salk vaccine would be useless.

Committee Biographies

Mowery is the William A. and Betty H. Hasler Professor of New Enterprise Development at the Walter A. Haas School of Business at the University of California, Berkeley, a research associate of the National Bureau of Economic Research, and during the 2003-2004 academic year was the Bower Fellow at the Harvard Business School. He received his undergraduate and Ph.D. degrees in economics from Stanford University and was a postdoctoral fellow at the Harvard Business School. Dr. Mowery taught at Carnegie Mellon University, worked as a staff officer for the National Academies, and served in the Office of the United States Trade Representative as a Council on Foreign Relations' International Affairs Fellow. He has been a member of a number of NRC committees, including those on the Competitive Status of the U.S. Civil Aviation Industry, on the Causes and Consequences of the Internationalization of U.S. Manufacturing, on the Federal Role in Civilian Technology Development, on U.S....

In VitroIn Vivo Studies

Microparticulate delivery systems, potential drug vaccine carriers for poorly bioavailable drugs and vaccines via mucosal (particularly oral) routes, were reviewed 947 . A variety of therapeutic moieties, including peptides and proteins, show enhanced oral uptake when entrapped within various types of microparticulate system constructs, and this approach was used successfully for the oral, nasal, and rectal delivery of a variety of vaccines. As drug-delivery technology becomes more sophisticated and our understanding of the uptake and immunological mechanisms of mucosal sites becomes more defined, many further microparticulate constructs would emerge and demonstrate their potential.

Biomaterials Approach To Gene Delivery

Polymers can also play the role of a gene carrier by serving as a matrix for sustained release instead of a DNA-condensing polycation, or as an excipient in the naked DNA or polyplex formulation. Collagen gel represents the early example of a depot delivering naked DNA 104 . Polymers without charge can encapsulate instead of condense the DNA in nano- and microparticles. Examples are DNA-containing poly(lactide-co-glycolide) (PLGA) nanoparticles fabricated by double-emulsion and solvent evaporation techniques 9 . The DNA loading level is typically low and the transfection efficiency poor. Promising results have nevertheless been obtained by judicious application of this type of nanoparti-cles, for example, in DNA vaccination where transgene expression may not need to be high. Poly(ortho esters) (POE), synthesized by condensation copolymerization of a diketene ac-etal and diols, undergo hydrolysis to eventually generate monomeric diols and a small amount of acid. The hydrolysis of this...

Drug Delivery and Controlled Release

Some important practices for which nanocapsules are used include the adsorbing and coating of organs and tissues, peroral administration of drugs, vaccinations, the delivery of anti-inflammatory drugs, and the delivery of drugs for diseases and tumors. Nanocapsules can be targeted to specific organs or tissues by coating their surface with different materials. Nanocapsules are useful in this application due to their stability. Liposomes, on the other hand, often disintegrate due to the surfactants that are present in this method. Nanocapsules are also often used for peroral administration. An example of this can be applied to the digestive system. In order to influence the mode of interaction of the intestinal fluids with the intestine, the properties of these fluids are monitored in different tissues in the gut. Liposomes are often depleted by the salts present in these intestinal fluids, whereas nanoparticles are stable in the presence of these substances. In vaccination methods,...

Drug Delivery Applications Of Nanogels

Recently, there has been significant interest in developing nonviral vectors for synthetic vaccines designed to prime the adaptive immune system that are sought for a broad range of infectious diseases and for the treatment of cancer in both prophylactic and therapeutic settings 250-252 . However, many obstacles associated with the successful delivery of synthetic vaccines remain such as antigen loading capacity, maintaining the integrity of encapsulated proteins, and minimizing the nonspecific antigen-antibody reaction. Therefore, the delivery system that can effectively carry the protein antigens to antigen-presenting cells is most desirable. The feasibility of achieving these goals has been demonstrated using submicron-sized hydrophilic particles, which were loaded with high doses of protein 253 .

Potential Uses Of Nanotechnology In Pulmonary Diseases

Therapeutic Agent Delivery Nanotechnology will offer significant and increasing advantages in the administration of therapeutic agents. Materials that now require injection could potentially be inhaled or swallowed through the use of nano-engineered delivery devices, thus improving patient comfort and compliance 31, 85 . Even through-the-skin administration of some agents such as vaccines can be made more comfortable by employing multitudes of micro- or nanometer-scale needles, to which human nerves are insensitive, rather than a single painful injection 57 (Figure 11.3). Compliance may be improved with longer dosing intervals 61 , which is possible with the use of nanoparticulate delivery systems. Nanoparticulates may permit both the improvement in targeting of drugs to diseased tissue as well as an increase in the amount of drug that reaches sites of activity within abnormal cells. This site-specific (and also potentially metabolism-specific) targeting,...

Red and green biotechnology

Betaseron, etc., whereas green biotechnology is applied to agricultural processes, producing herbicide-tolerant soybeans, Bt corn, and disease-resistant papaya, etc. But what about vitamin C, beta-carotene-enhanced rice, India's Protato, hepatitus B vaccine in banana, or reduced mycotoxin in Bt corn In the past, distinguishing agricultural applications from medical applications of rDNA technologies has been relatively easy, as it is a simple matter to draw a line between, for example, herbicide-tolerant soybeans and insulin. But recent innovations have blurred this simple dichotomy. Most vitamin C tablets are now synthesized from corn, and over half the US corn crop is of genetically engineered varieties. The fact that the chemical composition of the vitamin C is identical, whether coming from genetically engineered corn or traditional corn, is irrelevant, because we are dealing with ethical issues of the use of rDNA. The point here is that vitamin C cannot be readily assigned to the...

Hypothesis 8 lack of confidence in the regulatory system

Yet it may be worth injecting a note of skepticism about the regulatory confidence assumption. On one hand, it has never been especially clear to me that the alleged American confidence in regulatory agencies is very robust. The way that hypothesis 8 is generally understood in the US context is that the good science used by US regulatory agencies is what leads to higher levels of public confidence in the regulatory process, but I demur. Here, an anecdote must suffice. I spent a long day at a conference in about 1999 listening to people touting Americans' confidence in the regulation of food and environmental biotechnology as a type of vaccination against the reactions then rampant in Europe, only to go back to my hotel room and hear US Senator Trent Lott (R Mississippi), then Majority Leader, on national television saying Well, of course, nobody believes the FDA. Lott was talking about drug approval rather than GMOs, but the point is that fissures and seams abound in every political...

Editor

Amiji's research interests include the synthesis of novel polymeric materials for medical and pharmaceutical applications surface modification of cationic polymers by the complexation-interpenetration method to develop biocompatible materials the preparation and characterization of polymeric membranes and microcapsules with controlled permeability properties for medical and pharmaceutical applications target-specific drug and vaccine delivery systems for gastrointestinal tract infections localized delivery of cytotoxic and anti-angiogenic drugs for solid tumors in novel biodegradable polymeric nanoparticles intracellular delivery systems for drugs and genes using target-specific, long-circulating, biodegradable polymeric nanoparticles and gold and iron-gold core-shell nanoparticles for biosensing, imaging, and delivery applications. His research has received sustained funding from the National Institutes of Health (NIH), the National Science Foundation (NSF), foundations, and...

Complicating Aspects

Oppositely, one could envisage how potential recognition by TLR proteins might be beneficial in certain applications. In particular, cancer cells or tumors sites that express a particular TLR might actually provide a unique targeting aspect for nanoparticles prepared from the right material. In fact, some studies have been described using empty RNA virus capsules from cowpea mosaic virus as biological nanoparticles for delivery.50 Because tumors can also contain a number of immune cells with some that might express TLR, the potential exists to have inherent targeting of nano-particles to cancers through these tumor-associated cells. Such a circumstance could reduce the complexity of construction for a targeted nanoparticle complex. Such a suggestion has solid grounding in the extensive use of nanoparticles as adjuvants used for vaccination.51 Additionally, nanoparticles such as liposomes can be selectively directed specifically to Langerhans cells in the skin as a means of enhancing...

Basic Immunology

In the case of both class I and class II, the antigen presenting complexes are moved to the cell surface after charging. The moving of molecules between different cellular locations (called trafficking) is tightly regulated by and driven by specific cellular proteins, systems, and structures. Proper trafficking is essential to assure that all cellular components assume their correct position in the cellular organization, which in this case, is to assure antigens are directed to the compartments that will (most often) produce most protective immune responses. These complex antigen processing and presentation systems can be perturbed and exploited to offer novel opportunities in vaccine design.

Increasing trust

This apparent 'crisis of confidence' was thoroughly explored by the House of Lords (2000) and at least two key reasons for it were suggested. First, that public confidence in scientific advice to government had been undermined by a series of events, most notably the way in which BSE ('mad cow disease') had been managed. This is a clear theme in the trust literature and a range of highly visible controversies such as Brent Spar (Lofstedt and Renn, 1997) and the MMR vaccination (Hobson-West, 2003) are seen as having been instrumental in eroding trust. Undoubtedly though, the BSE 'fiasco', as the House of Lords report terms it, is generally considered to be a watershed,7 heralding a marked diminution in public trust. Second, the House of Lords (2000) report claimed that there was unease about scientific advances running ahead of both public awareness and assent. The developments of modern genetic technologies, particular around GM foods, are arguably a case in point here. Publics felt...

Domesticated Viruses

The capabilities of viruses may be harnessed (Scott, 1985). Two hundred years ago Edward Jenner began to develop safe and effective anti-viral vaccines, a technique which amplifies the body's immune system. Slopek and co-workers (1983) have treated patients afflicted with drug resistant bacterial infection by using viral bacteriophages selected for their effectiveness against the resistant organism. British scientists (Williams, Smith and Huggins, 1983) have used bacteriophages to treat intestinal infections in animals and direct use of viruses to combat bacterial infections in humans have also been attempted. Bacteriophages have potential advantages over modern drugs they are highly specific, can leave the host cells unharmed with minimal side effects, and could be produced inexpensively. However, bacteria could develop resistances to bacteriophages as they do to some drugs. Other researchers have used exploited viruses to mass produce natural proteins in genetic engineering. For...

Biodefenses

Vaccines and Therapeutics Vaccines and therapeutics are areas that have, of course, been pursued for a long time centuries, in fact. Nowadays, the terrorist threat gives new impetus to these pursuits. Especially regarding vaccines, the lack of a strong market has made the large drug companies uninterested in working very hard in this area, and I assert that there is therefore a major role for the government. A totally different field that has received some attention lately, but probably not enough, is the area of edible vaccines.4 Synthetically coding for receptor sites on the protein coats of pathogens, and then inserting these DNA strings into a plant genome has produced interesting early results. Workers at the Boyce-Thompson Plant Research Institute at Cornell, in collaboration with researchers at Baylor University, have found immune response in human subjects generated by eating the potatoes that result from such genetic manipulation. Since we have experienced such difficulties...

Biological Sensing

To detect the mass of individual virus particles, Gupta et al. present the microfabrication and application of arrays of silicon cantilever beams with a nanoscale thickness. The dimensions of the fabricated cantilever beams were in the range of 4pm to 5pm in length, 1pm to 2pm in width and 20 nm to 30 nm in thickness. They demonstrated the detection of a single vaccinia virus particle with an average mass of 9.5 fg. This particle is a member of the Poxviridae family and forms the basis of the smallpox vaccine. Using the frequency spectra of the cantilever beams, they were able to detect the airborne virus particles because of the thermal and ambient noise and the optical detection method.

Virosomes

A key issue in the development of second-generation vaccines involves targeting and delivery of antigens to antigen-presenting cells (APCs). Remarkable advances have been achieved in vaccine preparation techniques and among them, virus-mimicking nanoparticles (virosomes) have demonstrated potency in eliciting immune responses while minimizing side effects. reconstituted viral envelopes mimic the outer surface of a virus, virosomes can be used for mild induction of antibody responses against a native virus (for example, influenza virosomes can be used as a flu vaccine). Antigen delivery using virosomes is efficient enough to elicit a measurable immune response, and this approach has been developed into two commercially available vaccines Epaxal for hepatitis A and Inflexal V for influenza from Berna Biotech in 1994 and 1999, respectively.

Peptide Delivery

Much of the research has focused on the absorption enhancement of peptide and protein drugs and vaccine antigens. Couvreur and co-workers have been studying whether nanoparticles composed of polyalkylcyanoacrylate derivatives enhance the absorption of orally administered insulin, using animal models 158-161 . They found that insulin encapsulated in polyisobutylcyanoacrylate nanocap-sules reduced glycemia by 50-60 , although free insulin did not affect glycemia when administered orally to diabetic rats. Kawashima et al. 162 reported that the absorption of elca-tonin, which is a calcitonin of eel, via the GI tract of rats was enhanced by poly(-lactide-glycolide) nanoparticles coated with chitosan, which is a mucoadhesive cationic polymer. They also studied the effect of chitosan-coated liposomes on the intestinal absorption of insulin in rats and reported that the blood glucose concentration decreased significantly after oral administration of insulin-loaded liposomes 163 . Sakuma et...

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