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The vast majority of the over one billion doses of vaccines manufactured worldwide each year are given to healthy babies, children and adults.  Thus, it is critical that vaccines be demonstrated to be safe and effective.  FDA demands that vaccines undergo a rigorous and extensive development program in the laboratory, as well as in animal studies and human clinical trials, to determine their safety and effectiveness.  Highly trained FDA scientists and clinicians carefully review all the information in a marketing application before approval and use by the public. Prior to licensure, as part of FDA’s review, FDA takes all the ingredients into account, including the active ingredients as well as other substances.  After FDA approves a vaccine, FDA and CDC continuously monitor its safety.

Why is aluminum in some vaccines?
vaccineAluminum salts are incorporated into some vaccine formulations as an adjuvant to enhance the immune response in the vaccinated individual.  The aluminum salts in some U.S. licensed vaccines  are aluminum hydroxide, aluminum phosphate, alum (potassium aluminum sulfate), or  mixed aluminum salts.  For example: aluminum salts are used in DTaP vaccines, the pneumococcal conjugate vaccine, and  hepatitis B vaccines.

Aluminum adjuvant containing vaccines have a demonstrated safety profile of over six decades of use and have only uncommonly been associated with severe local reactions. Of note, the most common source of exposure to aluminum is from eating food or drinking water. 

Are other adjuvants used in US vaccines?

Yes, there is one other adjuvant used in one U.S. licensed vaccine.  Cervarix, a vaccine licensed by FDA on October 16, 2009, to prevent cervical cancer caused by human papillomavirus types 16 and 18, includes AS04 in its formulation.  AS04 is a combination of aluminum hydroxide and monophosphoryl lipid A (MPL).  MPL is a purified fat-like substance.

How does FDA evaluate adjuvants for safety and efficacy?
When evaluating a vaccine for safety and efficacy, FDA considers adjuvants as a component of the vaccine; they are not licensed separately.

Why are antibiotics in some vaccines?
Certain antibiotics may be used in some vaccine production to help prevent bacterial contamination during manufacturing.  As a result, small amounts of antibiotics may be present in some vaccines.  Because some antibiotics can cause severe allergic reactions in those children allergic to them (like hives, swelling at the back of the throat, and low blood pressure), some parents are concerned that antibiotics contained in vaccines might be harmful.  However, antibiotics most likely to cause severe allergic reactions (e.g., penicillins, cephalosporins and sulfa drugs) are not used in vaccine production, and therefore are not contained in vaccines.

Examples of antibiotics used during vaccine manufacture include neomycin, polymyxin B, streptomycin and gentamicin.  Some antibiotics used in vaccine production are present in the vaccine, either in very small amounts or they are undetectable.  For example, antibiotics are used in some production methods for making inactivated influenza virus vaccines.  They are used to reduce bacterial growth in eggs during processing steps, because eggs are not sterile products.  The antibiotics that are used are reduced to very small or undetectable amounts during subsequent purification steps.  The very small amounts of antibiotics contained in vaccines have not been clearly associated with severe allergic reactions.

Why is formaldehyde in some vaccines?
Formaldehyde has a long history of use in the manufacture of certain viral and bacterial vaccines.  It is used to inactivate viruses (e.g., influenza, polio) and to detoxify bacterial toxins, such as the toxin used to make diphtheria vaccine.  Formaldehyde is diluted during the manufacturing process, but residual quantities of formaldehyde may be found in some current vaccines.  The average quantity of formaldehyde to which a young infant could be exposed to at one time through vaccines is very small and is considered to be safe.  Although high concentrations of formaldehyde can damage DNA (the building block of genes) and cause cancerous changes in cells in the laboratory, formaldehyde is an essential component in human metabolism and is required for the synthesis of DNA and amino acids (the building blocks of protein).  Therefore, all humans have detectable quantities of natural formaldehyde in their circulation. In addition, quantities of formaldehyde at least 600-fold greater than that contained in vaccines have been found to be safe in animals.

Why are sugars, amino acids, and proteins added to some vaccines?
These materials may be added as stabilizers.  They help protect the vaccine from adverse conditions such as the freeze-drying process, for those vaccines that are freeze dried.  Stabilizers added to vaccines include: sugars such as sucrose and lactose, amino acids such as glycine or the monosodium salt of glutamic acid and proteins such as human serum albumin or gelatin.  Sugars, amino acids and proteins are not unique to vaccines and are encountered in everyday life in the diet and are components that are in the body naturally.

Why are there preservatives in some vaccines?
Preservatives are added to vaccine formulations filled into multi-dose vials to prevent the growth of bacteria or fungi that may be introduced into the vaccine during its use, e.g., repeated puncture of the vaccine vial. 

Why is fetal calf/bovine serum in some vaccines?

In the manufacture of viral vaccines, the virus may be grown in cells.  These cells need a source of nutrition, which in some instances may be provided by fetal bovine serum.

Source Courtesy: FDA


Cancer fraud: Among the many long-running cancer scams is the Hoxsey Cancer Treatment, an herbal regimen that has no proven benefit. Another scam involves products called black salves. These are offered with the false promise of drawing cancer out from the skin, but they are potentially corrosive to tissues.

Cancer requires individualized treatment by a specialized physician. No single device, remedy, or treatment can treat all types of cancer.

Patients looking to try an experimental cancer treatment should enroll in a legitimate clinical study. For more information, visit the National Cancer Institute Clinical Trials Web site.

HIV/AIDS fraud: There are legitimate treatments that can help people with the human immunodeficiency virus (HIV). While early treatment of HIV can delay progression to AIDS, there is currently no cure for the disease.

Relying on unproven products and treatments can be dangerous and cause delays in seeking legitimate medical treatments that have been proven in clinical trials to improve quality of life.

Safe, reliable testing to determine whether you have HIV can be done by a medical professional.

To date, there is one FDA-approved testing system that allows individuals to test themselves at home. It is an HIV collection system that tests only for HIV-1, which is the cause of the majority of the world's HIV infections.

The test, sold either as The Home Access HIV-1 Test System or The Home Access Express HIV-1 Test System, allows blood samples to be sent to a laboratory for testing with an FDA approved HIV-1 test.

Arthritis fraud: The U.S. Federal Trade Commission says consumers spend about $2 billion annually on unproven arthritis remedies that are not backed by adequate science.

For current, accurate information on arthritis treatments and alternative therapies, visit theArthritis Foundation Web site.

Fraudulent "diagnostic" tests: Doctors often use in vitro diagnostic (IVD) tests—in tandem with a physical examination and a medical history—to get a picture of a patient's overall health.

These tests involve blood, urine, or other specimen samples taken from the body. They help diagnose or measure many conditions, including pregnancy, hepatitis, fertility, HIV, cholesterol, and blood sugar.

It's rare that the use of only one of these tests can provide a meaningful diagnosis. You can buy IVD tests in stores, through the mail, or online. Many of these tests are regulated by FDA and sold legally. However, many others are marketed illegally and do not meet FDA's regulatory requirements. These tests may not work or may be harmful.

To find out whether FDA has cleared or approved an IVD test for a particular purpose, call FDA at (888) 463-6332, or your local FDA district office.

Bogus dietary supplements: The array of dietary supplements—including vitamins and minerals, amino acids, enzymes, herbs, animal extracts and others—has grown tremendously.

Although the benefits of some of these have been documented, the advantages of others are unproven. For example, claims that a supplement allows you to eat all you want and lose weight effortlessly are false.

Claims to treat diseases cause products to be considered drugs. Firms wanting to make such claims legally must follow FDA's premarket New Drug Approval process to show that the products are safe and effective.

Weight loss fraud: Since 2003, FDA has worked with national and international partners to take hundreds of compliance actions against companies pushing bogus and misleading weight loss schemes.

FDA has recently enhanced efforts to stop sales and importation of—and to warn consumers about—weight loss products that contain dangerous prescription drug ingredients that are not listed on the label.

Sexual enhancement product fraud: FDA has warned consumers about numerous illegal drugs promoted and sold online for treating erectile dysfunction and for enhancing sexual performance.

Although they are marketed as "dietary supplements," these products are really illegal drugs that contain potentially harmful ingredients that are not listed on the label.

Diabetes fraud: FDA has taken numerous compliance actions against sales of fraudulent diabetes "treatments" promoted with bogus claims such as

  • "drop your blood sugar 50 points in 30 days"
  • "eliminate insulin resistance"
  • "prevent the development of type 2 diabetes"
  • "reduce or eliminate the need for diabetes drugs or insulin"

Influenza (flu) scams: Federal agencies have come across contaminated, counterfeit, and subpotent influenza products.

FDA, with U.S. Customs and Border Protection, has intercepted products claimed to be generic versions of the influenza drug Tamiflu, but which actually contained vitamin C and other substances not shown to be effective in treating or preventing influenza.

Courtesy Source: FDA


Drug companies seeking approval to sell a drug in the United States must test it. First, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in humans is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit. The company then sends FDA's Center for Drug Evaluation and Research (CDER) the data from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.

Over-the-counter (OTC) drugs are regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System."

How can I find out if my medicine is approved by FDA?

To find out if your drug has been approved by FDA, use Drugs@FDA, a catalog of FDA-approved drug products, as well as drug labeling. Drugs@FDA contains most of the drug products approved since 1939.



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Deadline on 4th Sep 2009

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Location: Ministry of Health, Sultanate of Oman
Desired Qualifications: Diploma In Pharmacy+3 years experience
Apply with 2 pp + Biodata with 3 referee names +copies of certificates
Deadline: Not known, please confirm the vacancy with authorities.

Useful Links for a Pharmacist/ Assistant Pharmacist

Regulation Exam Material
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