Getting The Flu Vaccine This Year Is Risky Business

Unapproved Flu Vaccines
Just recently, the FDA has agreed to distribute 61 million flu vaccines, manufactured by GlaxoSmithKline, under an Investigational New Drug (IND) application. Why is this potentially a problem? A drug released under an IND has undergone safety and efficacy testing in animals only. The drug has not been tested in humans.

Typically, a new drug must be tested in animals first to establish it is safe and effective for its intended use. The drug company then submits an IND to the FDA which includes all of the data supporting the safety and effectiveness. The IND is a request to "break the laws" set forth in the Food, Drug and Cosmetic Act (FDCA), which state that no unlicensed, unapproved, investigational drug product may be shipped across state lines or be administered to humans.

If the FDA does not respond "unfavorably" to the IND within 30 days, the drug company begins clinical research (testing in humans). If the drug proves to be safe and effective in humans, a drug company files a New Drug Application (NDA) for approval to market the drug in the United States. With this being said, the potential problem with GSK’s flu vaccine, Fluarix, is that it has not been proven to be safe and effective in humans. Nor, has it undergone the scrutiny of U.S. regulations.

In addition, Fluarix was manufactured in Germany under European regulations. Why is this potentially a problem? European (EU) regulations differ from U.S. regulations. EU tends to approve "systems" rather than individual products, as in the U.S. This is not to say that EU regulations are less stringent than those of the U.S., but the differences must be considered.

Illegally Imported Flu Vaccines
Recent reports of illegally imported flu vaccines have put the U.S. Immigration and Customs Enforcement on red alert. Mahmoud Abuarquob, of Somers Point, NJ, was arrested at the Philadelphia International Airport for illegally importing 810 doses of unapproved flu vaccine into the U.S. Abuarquob offered to sell the unapproved drug to Somers Point Memorial Hospital. The hospital immediately contacted law enforcement.

Distribution of Flu Vaccines Under Fraudulent Pretences
A woman claiming to be a "temporary nurse" for the American Heart Association, injected an unknown number of people at a Minneapolis college in an effort to help her daughter raise money for a school charity. A family member claimed she obtained the drug from her employer.

Another woman, from British Columbia, injected about 130 shoppers at three grocery stores. When recipients of the vaccines reported that they did not experience the usual stiffness and soreness associated with flu shots, police tracked down the nurse. She told police that she purchased the Aventis Fluzone vaccine from a distributor over the Internet.

What’s the message here? Buyer (or patient) beware. Go to your health organization for any medical treatment, including vaccinations. Never assume something is safe just because it "appears" to be safe. And, if your only flu vaccine option is Fluarix, read the "Informed Consent" information that health authorities are requiring the public to sign prior to inoculation. Ask questions about the drug and the information in the Consent form so that you can make an informed decision.

FDA Flu Information
General flu information, prevention and treatment, drugs, and information regarding flu shortage.