December 20, 2014
Many of the projected 135-139 million doses of influenza vaccines being produced for this flu season for use in the U.S. are now available to consumers from six manufacturers licensed by the Food and Drug Administration (FDA).
A variety of flu vaccines, including some that were not available during past influenza seasons, are available this year. In addition to the availability of vaccines that protect against three strains of influenza virus (trivalent), vaccines that protect against four strains of the virus (quadrivalent) will also be available this year.
In addition, a vaccine that is produced by growing the virus in cells rather than in eggs will be available for use in people 18 years of age and older.
Unlike eggs, cells can be frozen for later use to grow large volumes of cells for the production of vaccine. This could provide a faster start-up time of the manufacturing process for any unexpected need.
“New technologies are providing additional and diverse influenza vaccines, which helps to ensure an adequate supply in the Unites States,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research.
“Influenza seasons are unpredictable and can be severe, even deadly,” she added. “Last year’s influenza season brought an increase in reported hospitalizations and deaths compared to recent years, and vaccination is the best defense to prevent influenza.”
All of the vaccines have been determined by FDA to be safe and effective. Getting vaccinated early, before flu season is in full swing, is key to prevention.
Manufacturing flu vaccines is an exacting and complex process. New vaccines must be produced each year because the viruses change from year to year and because the protection received the previous year diminishes over time.
Each February, before one flu season ends, the FDA, World Health Organization, the Centers for Disease Control and Prevention (CDC) and other public health experts collaborate on collecting and reviewing data to identify the virus strains likely to cause the most illnesses in the next flu season. Based on that information and the recommendations of an FDA advisory committee, FDA selects the strains for manufacturers to include in their vaccines for use in the United States.
Both egg-based flu vaccines and vaccines made with newer technologies work the same way; they trigger the immune system of the person receiving the vaccine to produce antibodies capable of attacking the virus.
Vaccines are available in a variety of delivery methods, as a needle into muscle, as a needle injected into skin (approved for ages 18 through 64), and as a nasal spray (approved for people ages 2 through 49). In addition, one vaccine made in a high dose formulation is approved for people 65 years of age and older.
Under traditional egg-based production methods, once the influenza viruses have been selected, they are adapted for use in manufacturing and provided to companies licensed by FDA. The manufacturers inject each virus strain into eggs, which are incubated for several days to allow the virus to multiply.
The virus-loaded fluid from the eggs is then harvested and purified.
Manufacturers grow each strain separately then test it, including for potency. Then the strains are mixed and tested again. Once divided into standard dosages, the vaccines are put into containers such as vials, syringes or sprayers.
Test results are submitted to FDA, along with samples from each batch, or lot. FDA reviews the test results and the samples before releasing the vaccine for distribution in the United States. Each lot, or batch, undergoes testing before release by FDA.
FDA also inspects the manufacturing facilities on a regular basis and continues to monitor the safety of the vaccines once they are in use by the public.
The level of effectiveness can depend on the health and immune system of individuals and how well a particular season’s vaccine strains match circulating flu strains.
There is a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness and help prevent influenza-related complications.
CDC recommends that everyone six months of age and older get vaccinated soon after vaccine becomes available. Those people for whom vaccination is particularly important include young children, the elderly, pregnant women, and those who suffer from a variety of chronic illnesses, including asthma, diabetes and heart disease.
Although the winter months are usually the peak month for flu activity, influenza disease in people typically begins appearing in October.
FDA’s website has specific information about each flu vaccine, including the FDA-approved age range of use. The website also provides the names of the influenza viruses included in this season’s vaccines and an up-to-date list of the number of vaccine lots that have been released for each manufacturer.
December 10, 2014
OCD will not go away by itself, so it is important to seek treatment. The most effective approach to treating Obsessive-Compulsive Disorder combines medications with cognitive behavioral therapy.
A type of therapy called exposure and response prevention (ERP) is the most effective treatment. This therapy involves gradually exposing you to a feared object or obsession, such as dirt, and having you learn healthy ways to cope with your anxiety. Exposure therapy takes effort and practice, but you may enjoy a better quality of life once you learn to manage your obsessions and compulsions.
Doctors recommend a combination of natural Obsessive-Compulsive Disorder treatment products and a diet rich in herbs for effective and holistic obsessive compulsive disorder treatment. While treating obsessive compulsive disorder, behavioral therapists and psychologists advise people to interact with their families and friends on a regular basis.
December 2, 2014
The abuse of anabolic steroids can cause both temporary and permanent injury to anyone using them. Teenagers, whose bodies are still developing, are at heightened risk. An alarming number of them are trying steroids in hopes of improving their athletic prowess or their appearance. Ali Mohamadi, M.D., a medical officer in the Food and Drug Administration’s Division of Metabolism and Endocrinology Products, warns teens and parents about the dangers of steroid use.
Q: What are anabolic steroids and how many teens use them?
A: They are drugs that mimic the actions of the male sex hormone testosterone. This includes promoting the growth of cells, especially in muscle, and maintaining or increasing male physical characteristics. Various studies have been conducted and generally reflect the findings of a Youth Risk and Behavior Surveillance System study, which estimated that among U.S. high school students, 4.9% of males and 2.4% of females have used anabolic steroids at least once in their lives. That’s 375,000 young men and 175,000 young women.
Q. What are the side effects of taking anabolic steroids?
A: They are known to have a range of serious adverse effects on many organ systems, and in many cases the damage is not reversible. They include fertility problems, impotence, high blood pressure and cholesterol, and heart and liver abnormalities. Boys may experience shrinkage of the testes or the development of breast tissue; girls may experience menstrual irregularities and development of masculine qualities such as facial and body hair. Both may experience acne. Both boys and girls may also experience mood swings and aggressive behavior, which can impact the lives not only of those taking steroids, but of everyone around them.
Q: Are prescriptions needed to get steroids?
A: Yes, in fact anabolic steroids are classified as Schedule III Controlled Substances by the U.S. Drug Enforcement Administration with strict regulations, meaning that not only is a prescription required, but there are extra controls. For example, it is illegal to possess them without a prescription in the United States, and in most circumstances the prescription must be in written form and cannot be called in to a pharmacist. Labels on some steroids recommend testing of hormone levels during use.
The number of FDA-approved uses is limited. Most are prescribed as a replacement for sub-normal levels of steroids. They are also prescribed for conditions such as muscle wasting, poor wound healing, and very specific pulmonary or bone marrow disorders.
A health care professional can prescribe steroids off-label, meaning for conditions other than those that are FDA-approved. But children, particularly teens, are getting access to steroids and taking them for reasons far outside of their intended use.
Q: So how are teens getting access?
A: Some get prescriptions from a licensed practitioner for such purposes as introducing puberty to boys who are “late bloomers” or to stimulate growth among teens who are failing to grow. Some may be dealing with unscrupulous clinics or street dealers on the black market. Unfortunately, a number of vendors sell anabolic steroids online without a prescription. Individuals should also be aware that some dietary supplements advertised for body building may unlawfully include steroids or steroid-like substances, and the ingredient statement on the label may not include that information.
Q: What is the FDA doing to prevent those illegal sales?
A: FDA is taking a number of steps to discourage these practices. Action has been taken against illegal online distributors who sell steroids without valid prescriptions, but an ongoing problem is that you can take one site down and another pops up.
The challenge is intensified by the fact that many online providers don’t accurately advertise the contents of the products they sell, they may be operating outside the U.S., and the drugs aren’t prescribed by a licensed practitioner who can help individuals weigh the risks and benefits. In such cases, individuals may have no idea what they are taking, what the appropriate dose should be, or what levels of control and safety went into the manufacturing process. These facts make the risks of taking anabolic steroids bought without a prescription even greater than they otherwise would be.
Q: What would you say to a teen you knew was tempted by steroids?
A: I would emphasize both the short and long-term potential for serious harm to their health. Rather than making you look or perform better, steroids will more likely cause unfavorable results that could affect you for life. I would also remind them that there are a number of ways to increase muscle mass and athletic performance, including a sensible regimen of exercise and diet, without resorting to extreme and dangerous therapies.
Q: What would you like to say to parents?
A: Parents tend not to believe their teens would consider taking anabolic steroids, but the truth is that the frequency of steroid use in this age group is far greater than many would guess.
During this time of year, when children are in school and getting back into their athletic routines, parents should watch for potential signs of abuse. Mood swings are among the first side effects to show up, and steroid use may lead to mania or depression. Acne is also an early side effect and can be followed by breast development in boys or increased body hair in girls. A surprising gain of muscle mass should also raise questions. It’s a problem that is as real as it is surprising.