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  • Better vaccines for the next pandemic

    Posted on December 5th, 2009 editor No comments

    New technologies promise an end to shortages

    By Henry I. Miller – washingtontimes.com 12/7/09

    The H1N1 swine flu has sickened at least 22 million and killed almost 4,000 in the United States since April, according to the Centers for Disease Control and Prevention.

    The shortage of the promised supplies of H1N1 flu vaccine has led to long waits in clinic lines for many Americans, frantic calls to doctors’ offices, and growing concern that immunization will arrive too late to prevent illness. In high-risk populations such as asthmatics, young children and expectant mothers, that anxiety is fueled by the possibility of life-threatening consequences should they become infected.

    Overall, though, we were lucky this time around. Vaccine manufacturers have been able to produce substantial amounts of vaccine in record time and, as flu viruses go, the current H1N1 is tame. But the H1N1 immunization effort should be a wake-up call to health officials: We are woefully unprepared to deal with a true pandemic of a highly lethal virus. We need to modernize the technology used to make vaccines, so that they can be developed and manufactured more quickly. If large numbers of people were being killed by H1N1, shortages of vaccine would cause riots.

    The trouble with our current vaccine production system is that it is not rapidly scalable to demand. It is an 80-year-old system that depends on harvesting the vaccine from fertilized chicken eggs. Manufacturers grow the virus in the eggs until there is a sufficiently high titer, and then the virus is harvested, killed and purified.

    The entire process takes months. To harvest a suitable amount of vaccine for flu season requires millions of eggs. In 21st century America, we are waging war on a lethal infectious disease with World War I-era technology.

    Fortunately, there are two newer, far superior ways to create vaccines.

    The first is a process using recombinant DNA, or “gene-splicing,” technology to create a vaccine that induces the body to make its own antigen, and then to produce antibodies to that antigen. Researchers produce DNA of the target virus gene in a laboratory and introduce it into a circle of DNA called a plasmid, which acts as a carrier.

    The plasmids containing the viral gene can easily and quickly be grown in large amounts. When the plasmids are injected into the muscle of a subject, they are taken up by cells that use the viral gene to make a viral protein, usually a protein that appears on the surface of the virus. (Sometimes, a second gene is present that directs the synthesis of an internal protein of the flu virus.) The viral protein – which is noninfectious and harmless – enters the bloodstream, where the immune system recognizes it as foreign and starts to make antibodies against it.

    If the subject is later exposed to the flu virus, more antibodies are produced and bind to and neutralize the virus. Thus, the plasmid DNA that contains the viral gene is the vaccine.

    The entire process, once the viral DNA is isolated, takes only a few days. This process is cost-effective and produces a vaccine with numerous advantages over the traditional versions.

    DNA vaccines have a high heat tolerance, which means they can be transported over long distances without becoming inactivated, and can be stored in locations (such as developing countries) that lack refrigeration.

    The vaccines are also easily altered in the lab, so that if the virus were to mutate, the genetic code could be changed accordingly and production could resume quickly. Another advantage is that because DNA vaccines do not contain whole viruses, there is no threat of viral infection from an immunization.

    Another promising new vaccine process uses cell cultures of various kinds as a stand-in for the eggs in the traditional model. Manufacturers expose animal or insect cells grown in tissue culture to live virus, allow it to multiply and then harvest, inactivate and purify the virus particles.

    This method saves time in scaling up to meet vaccine needs and avoids relying on eggs, which is cumbersome and could be vulnerable to infection if there were an outbreak of avian flu – thereby creating unacceptable and possibly lethal delays for the production process.

    Federal health officials have already recognized the importance of these two cutting-edge approaches. A recent example is a contract from the U.S. Department of Health and Human Services (HHS) to the drug company Novartis, to support a new vaccine manufacturing facility that utilizes cell-based technology and other new processes to produce vaccine. And in June, HHS awarded a $35 million contract to Protein Sciences to develop and test a vaccine produced from gene-based technology.

    These investments – and others like them – are good first steps, but we need to go further. Research and testing of DNA vaccines in particular must be expanded. Other vaccine manufacturers should be encouraged to branch into new technologies. The government should provide support for basic and proof-of-principle research. Even in the short term, expanding the use of gene and cell-based vaccine technologies could lead to a flu season without the threat of vaccine shortages.

    Eventually, it might even yield the holy grail of flu vaccines – a “universal” vaccine based on the virus’ internal proteins, so that it is active on many different strains, year after year. Developing these new technologies for mass production is essential if we want to be prepared for the next pandemic.

    Dr. Henry I. Miller, a physician and fellow at Stanford University’s Hoover Institution, was an official at the Food and Drug Administration from 1979 to 1994. He is the author of “To America’s Health: A Proposal to Reform the FDA” (Hoover Institution Press, 2000).

    DNAWellnessinfo.com Resource: http://www.washingtontimes.com/news/2009/dec/07/better-vaccines-for-the-next-pandemic/

  • Scientists looking for new ways to produce flu vaccine

    Posted on November 24th, 2009 editor No comments
    November 24, 10:06 AM Madison Science News Examiner Laine Stewart

    With the widespread shortage of the H1N1 vaccine, scientists are seeking faster and better ways to produce flu vaccine.

    The traditional method, used for more than 50 years, involves growing a modified version of the current season’s flu virus in chicken eggs. The virus replicates inside the chicken egg and is harvested. The whole process, from vaccine development to harvestation, takes around five months.

    Photo credit: AP Photo/Bela Szandelszky

    Photo credit: AP Photo/Bela Szandelszky

    Viruses are essentially DNA surrounded by a protein coat. Researchers are seeking a protein in the virus coat that the immune system will notice and treat as foreign. The next time someone around you sneezes and you inhale the flu virus, the immune system will recognize the coat protein and attack the virus. Although this sounds simple, coming up with the appropriate protein is extremely difficult.

    One possible way of introducing this protein is to take the gene that builds the protein coat on the flu virus and incorporate it into a harmless virus, which is then introduced into the body. The immune system becomes acquainted with protein coat of the flu virus, but you don’t become ill. The immune system will now recognize and attack the harmful flu virus the next time you come into contact with it.

    Another possibility is injected the “naked DNA” of the flu virus into the body. The body’s own cells will take up the DNA and produce the coat protein, essentially doing the job of the chicken eggs that are currently used. It greatly accelerates the process and eliminates the worry for those with egg allergies.

    The ultimate goal is to develop a universal flu vaccine from a protein that is contained within all flu viruses. Viruses mutate and change slightly each year, which is why yearly flu vaccines are necessary. “We’re not anywhere near close to that, but the concepts are starting to fall into place,” says Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases. [NPR]

    DNAWellnessinfo.com Resource: http://bit.ly/5PNPSC

  • Vical’s DNA Vaccine Technology Addresses Challenges of Emerging Diseases

    Posted on November 10th, 2009 editor No comments

    November 10, 2009: 06:30 AM ET – money.cnn.com

    GALVESTON, Texas, Nov. 10, 2009 (GLOBE NEWSWIRE) — Vical Incorporated (Nasdaq:VICL) today is presenting a strong rationale advocating the use of DNA vaccine technology for emerging and/or pandemic infectious diseases. At the University of Texas Medical Branch Symposium, “The Changing Landscape of Vaccine Development,” Larry R. Smith, Ph.D., the company’s Vice President of Vaccine Research, systematically outlined the advantages of DNA vaccine technology over conventional vaccine technology in dealing with serious emerging threats.

    Dr. Smith’s presentation, “DNA Vaccines: Rapid Response to Pandemic Outbreaks,” highlights historical data from multiple human clinical trials of DNA vaccines demonstrating safety, broad immunogenicity, and initial indications of efficacy. A favorable safety profile has been established through testing of various DNA vaccines in human subjects now totaling in the thousands. Recent studies of DNA vaccines formulated with Vical’s Vaxfectin(R) adjuvant or polaxamers have shown clear ability to elicit both antibody and T-cell immune response. These advantages, coupled with rapid development speed, excellent flexibility, and manufacturing which is not dependent upon cell culture or chicken eggs, encourage the use of DNA vaccine technology for emerging threats such as the recent H1N1 swine flu and other emerging diseases.

    As previously announced, Vical was the first company to produce a vaccine candidate against A/H1N1 pandemic influenza (swine flu) after the initial reports of widespread outbreaks in Mexico, and the first to announce robust immunogenicity results from animal testing in two species. The U.S. Navy has awarded a contract for $1.25 million to support preparations for a Phase 1 clinical trial of the company’s H1 vaccine to be conducted in collaboration with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the Navy.

    About Vical

    Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company’s DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

    The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

    This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Vical’s DNA vaccine technology and its vaccine against H1N1 pandemic influenza, potential human clinical testing of such a vaccine, potential development of other DNA vaccines, as well as the company’s focus, collaborative partners, and product candidates. Risks and uncertainties include whether Vical or others will develop vaccines for future pandemics or emerging diseases; whether Vical will receive all, if any, of the committed Navy funding; whether Vical will conduct a human clinical trial of the H1 vaccine; whether Vical, NMRC or others will continue development of the pandemic influenza DNA vaccine candidate; whether the company’s DNA vaccine candidate will be effective in protecting humans against H1N1 strains of influenza; whether the influenza vaccine or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

    CONTACT: Vical Incorporated
             Alan R. Engbring
             (858) 646-1127
             Website:  www.vical.com
    
    DNAWellnessinfo.com Resource:  http://money.cnn.com/news/newsfeeds/articles/globenewswire/178011.htm

  • Boost Your Immune System to Fight The Flu

    Posted on October 12th, 2009 editor No comments
    Below is an interesting article on how to protect yourself from the flu and boosting your immune system.  The information presented is sound and for many health conscious individuals, already known.  What you may not know is there are genetically guided nutritional products that allow you to achieve the desired results, without guessing what specific products you personally may need.  If you are interested in learning more about DNA guided nutrition, please click here.

    Written by Kristi Runyon

    Monday, 12 October 2009 17:33
    altUntil H1N1 vaccines are available the general public has little or no protection against swine flu.   So what can you do to arm yourself against the flu?  You can start by taking steps to strengthen your immune system.

    Several factors can contribute to a healthy immune system.  Your body’s ability to fight off illness can be affected by diet, exercise, sleep, and stress.
    The Cleveland Clinic offers some good advice on how your daily habits can either strengthen or weaken your immune system:

    Source: my.clevelandclinic.org/

    How can I strengthen my immune system?
    While it is difficult to enhance a normal functioning immune system, there are things that you can do to protect and strengthen your immune system during periods of illness or in the face of chronic disease. The three areas that are most important in protecting and bolstering the immune system are diet and nutrition, exercise, and stress reduction.

    Diet, nutrition, and immunity
    There have been many excellent books written about the relationship between diet, nutrition, and immunity. (Please refer to the reading list below.) There are two major changes you can make in your diet to help your immune system. First, you can enrich your diet with antioxidants and, second, you can make sure you are getting enough nutrients and micronutrients.

    Antioxidants
    Antioxidants are vitamins and minerals, found in foods and available as supplements, that remove harmful oxidants from the bloodstream. Oxidants, also known as free radicals, are the toxic byproducts our bodies make when we turn food into energy. They are also byproducts of cigarette smoke, pollution, sunlight exposure, and other environmental factors. Free radicals are capable of damaging DNA and suppressing the body’s immune system.

    Free radicals also play an important role in the development of many human diseases. In fact, there are several journals now dedicated to their study and investigation. Nearly all types of cancers have been related to diets that are poor in antioxidants. Data from some research also suggest that a diet high in antioxidants might also protect against cancer.

    Heart disease and atherosclerosis (hardening of the arteries) are also brought about, in part, by free radicals. Certain diseases of the central nervous system — such as dementia and some forms of kidney, gastrointestinal, and skin disease — also involve free radicals. You cannot prevent these diseases simply by taking antioxidants. You can, however, ensure that you are doing everything possible to lessen their effects. Most importantly, you should eliminate environmental factors that promote the production of free radicals.

    Nutrients and micronutrients
    Marginal nutrient deficiencies in the diet can also weaken the immune system. Marginal deficiency is a state of gradual vitamin loss that can lead to a general lack of well being and impairment of certain biochemical reactions. Marginal deficiencies of micronutrients (nutrients required only in a small amount) do not cause obvious symptoms of disease, but they can affect your mental abilities, your coping abilities, and your body’s ability to resist disease and infection. They might also slow your recovery from surgery.

    Marginal nutrient deficiencies are very common in both younger and older individuals. The typical American diet is often deficient in a variety of nutrients including calcium, iron, vitamin A, and vitamin C. Furthermore, the recommended daily allowance (RDA) for many nutrients might be well below what is needed to optimally protect the immune system. For this reason, vitamin and mineral supplements are used to protect us against micronutrient deficiencies.

    Foods
    You can further modify your diet by eating less saturated fat and animal protein (particularly red meat), by limiting dairy products (particularly those with fat), by modifying your use of oils and fats, and by eating more fresh fruits, vegetables, and whole grains.

    Take a minute to examine your diet. How many times a week do you eat fried foods or red meat? What types of oils do you use in your cooking? Do these oils include cooking oil as well as butter and margarine? What types of garnishes and sauces do you use? Do they contain egg yokes or oils? What types of dairy are you consuming? If you drink milk, which is good for you, is it anything less than skim or 1%? Do the yogurts and cheeses you eat contain a lot of fat?

    Recommendations
    Try eliminating red meat from your diet or, if necessary, eat it no more than once every 10 days. Also eliminate or reduce your intake of fried meats. Try to replace the meats in your diet with servings of fish, particularly oily fish such as salmon. Salmon contains a rich form of an oil known as omega-3 fatty acids, which has natural anti-inflammatory properties.
    Use only olive oil in your cooking. Olive oil is rich in mono-saturated fats. All other oils, with the possible exception of canola oil, have unfavorable types of fats for the immune system. Avoid excessive use of margarine. Though most margarines are unsaturated in their fat content they are artificially prepared and the long-term effects of their use are not known. Try to minimize the use of all fats, but wherever possible use olive oil in cooking and for dressing salads.
    Eat more fruits and vegetables. Green leafy vegetables such as broccoli are very rich in antioxidants. Add several servings a week to your diet. Do not overcook them and think of creative ways to prepare them. Add more servings of other fruits and vegetables to your diet, as they are rich sources of antioxidants as well.
    Add fiber to your diet. Fiber can be found in many types of whole grains. If you are going to add rice, which is healthy, try to add brown rice. Brans and cereals are also helpful, but avoid those with any form of artificial sugar.
    Drink plenty of water.
    If you follow these guidelines, you will move your diet in the proper direction toward protecting your immune system. As an added benefit, you will be following a diet that is also good for your cardiovascular system. (These recommendations are similar those of the STEP II diet promoted by the American Heart Association.)

    Ideally, fat should account for less than 30 percent of your total calories. Less than 7 percent of your total calories should come from saturated fats. In addition, you should try to eat less than 200 milligrams (mg) of cholesterol per day.

    Nutritional supplements
    Much has been said about nutritional supplements and their ability to enhance or protect health. While there is a lot of debate in the medical literature, and many doctors do not discuss their use with their patients, some CFS specialists believe that nutrients can provide a measure of protection for the immune system. No matter how well you design your diet for nutrition, you can still augment it with supplemental antioxidants. Some of the best studied and most readily available as supplements are beta carotene, selenium, vitamin C, vitamin E, and vitamin A.

    Supplementing your diet with a balanced multivitamin is essential. To do this, you should add beta carotene in a dose of 25,000 international units (IU) twice per day. In addition, vitamin C in doses of at least 500 to 1000 mg a day is recommended. Why these vitamins? Beta carotene is one of the most potent nutrients and can protect the body from oxidative stress. Populations that have diets high in beta carotene have a lower incidence of certain forms of cancer.

    Several studies have shown that beta carotene supplements can do little to reduce cancers in people who smoke cigarettes. This fact should not be surprising. Dietary modifications are made to bring back a failing immune system or to protect a healthy immune system, not to overcome overwhelming toxic effects of activities such as smoking.

    Vitamin C is also an extraordinarily important antioxidant. While many studies have shown that daily ingestion of vitamin C does little to protect you from the common cold, it can reduce the severity of colds. Furthermore, there are several controlled studies performed in populations of people working under heavy stress that have shown a profound protective effect of vitamin C in terms of common colds and pneumonia.

    Other nutrients that might be helpful include selenium in doses of 200 micrograms (mcg) per day and vitamin E in doses of 400 IU per day. Many over-the-counter vitamins with similar doses are available. There is no difference between natural vitamins and synthetic vitamins.

    Exercise and immunity
    Even more so than nutrition, exercise has the capacity to protect and even enhance the immune response. Experimental studies have shown that a regular exercise program of brisk walking can bolster many defenses of the immune system, including the antibody response and the natural killer (T cell) response.

    Fortunately, the intensity and duration of exercise needed to support the immune system is less than that needed to provide the best cardiovascular training. Thus, even relatively low levels of aerobic exercise can protect your immune system. Twenty to 30 minutes of brisk walking five days per week is an ideal training program for maintaining a healthy immune response.

    Exercise can also improve your mental wellness. Regular aerobic exercise can help relieve mild to moderate degrees of depression and anxiety. People who exercise also have less loneliness and anger, and are better able to control their own destiny. It is not clear whether exercise boosts the immune system directly or works through a link with the brain and nervous system.

    Stress and immunity
    The final component for fine-tuning your immune system is reducing the stress in your life by achieving a higher level of spiritual harmony. Altered mood states such as depression, anxiety, and panic are harmful to the body in many ways. Secondary symptoms such as fatigue, difficulties with memory and concentration, aches and pains, and problems with sleep are common in people with mood disorders. Mood disorders also harm the immune system.

    There are many techniques you can use to reduce stress and anxiety in your life. Guided imagery involves focusing on mental images, such as a serene setting. You can also try yoga or tai chi, which combine both mental and physical exercise, and can help heal the mind and the body. You might consider using biofeedback, a process in which you monitor certain functions of the body, such as blood pressure, and learn to alter these functions through relaxation. Other simple techniques include breathing exercises or taking a walk and appreciating the beauty in the world around you.

    For people who have severe mood disorders, antidepressants and other psychotropic medicines, as well as counseling, are essential.

    Putting it all together
    Diseases such as chronic fatigue syndrome, fibromyalgia, and many other poorly understood illnesses should no longer be viewed as disorders of either the mind or the body. The mind and body act as one unit and thus we must approach them together.

    To maintain the strongest immune system possible, you must have a nutritious diet, get regular exercise, and reduce stress in your life. You must attend to all three of these areas to achieve your optimum health.

    Some people eat a nutritious diet and exercise regularly, but are so keyed up in their lives that their stress levels overcome all of the success they achieve in the first two areas. Other people might have successfully modified their mental and spiritual state but are eating unhealthy diets or are sedentary. Others might make significant advances in all three areas, but are doing foolish and harmful things to their bodies, such as smoking or using excessive alcohol, which take away from their achievements.

    Dr. Andrew Weil, noted author and director of the program in integrative medicine at the University of Arizona, has written extensively about the body’s ability to heal itself. Many health care providers have witnessed people overcome complex medical illnesses without the assistance of medicine. Though medicines are vital for overcoming many acute illnesses, they might be less important in overcoming chronic diseases.

    You can take advantage of the body’s inner ability to heal by eating well, exercising regularly, and striving for spiritual well-being. Eliminate other negative factors such as drugs, alcohol, tobacco, and other insults to the your body. Only you can put it all together and it cannot be achieved overnight. There is no better time to start than now.

    DNAWellnessinfo.com Resource:  http://www.wtvq.com/health/537-boost-your-immune-system-to-fight-the-flu

    DNA Guided Nutrition:  To learn more click here.

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