Here we go again, messing with people’s immune systems and acting like we know what we are doing. The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.

So if you are a US citizen aged 18 to 49 who is granted access via your doctor to this novel vaccine you can become a guinea pig, lab rat, mouse or the equivalent as a human experimental subject. Make no mistake, you will be a test subject, that’s how the FDA’s “Approved Status” system is designed. You think it means approved as safe, but it only means approved to use so we can see what happens.

Unlike current flu vaccines, Flublok does not use the influenza virus or eggs in its production. Flublok’s novel manufacturing technology allows for production of large quantities of the influenza virus protein, hemagglutinin (HA) – the active ingredient in all inactivated influenza vaccines that is essential for entry of the virus into cells in the body. The majority of antibodies that prevent influenza virus infection are directed against HA.

Does the paragraph above from the FDA’s press release make sense to you? If so, you must work for the FDA. Really, it is a collection of words that does not really make sense but helps to create an impression that the agency knows what it’s doing and is completely science based. Only an ignorant person or a fool believes that.

While the technology is new to flu vaccine production, it is used to make vaccines that have been approved by the FDA to prevent other infectious diseases. Do you find this particularly reassuring?

“This approval represents a technological advance in the manufacturing of an influenza vaccine,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus.”

Each year, the FDA, World Health Organization, the Centers for Disease Control and Prevention and other public health experts collaborate on the review of influenza disease surveillance and laboratory data collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season. Based on that information and on the recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee, the FDA selects the different influenza strains each year that manufacturers should include in their vaccines for the U.S. population for the upcoming influenza season. The closer the match between the circulating strains causing disease and the strains in the vaccine, the better the protection against influenza.

Of course the match is never perfect and always a bit too late. The time pressure can easily result in shortcuts and errors in quality control, if nothing else. Every vaccine exposes recipients to risk of harm and in many more cases than the FDA would care to admit, to actual harm. The unknown harms and longer term risks are simply ignored. The people at the FDA who highly recommend these vaccines are the same idiots who supported the massive Tamiflu push. This made a lot of money for some people but the vaccine is worthless.

Flublok contains three, full-length, recombinant HA proteins to help protect against two influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain.

As it does with all influenza vaccines, the FDA will evaluate Flublok annually prior to use by the public each flu season. The recombinant HA proteins produced in the baculovirus expression system and included in Flublok will be assessed by the FDA.

The effectiveness of Flublok was evaluated in a study conducted at various sites in the United States that compared the use of Flublok in about 2,300 people to a placebo that was given to a control group of similar size. Flublok was about 44.6 percent effective against all circulating influenza strains, not just the strains that matched the strains included in the vaccine.

Really, this is nonsense. The FDA press release reads more like an advertisement. They are trying to sell something here and if you’re smart you aren’t buying. That is a pathetically inadequate evaluation study. What does “44.6 percent effective against all circulating influenza strains” actually mean?

Flublok’s safety evaluation was conducted in a study of about 2,500 people who were vaccinated with Flublok. The most commonly reported adverse events included pain at the site of injection, headache, fatigue and muscle aches, events also typical for conventional egg-based, inactivated influenza vaccines.

So what this means is explained above. They FDA wants more people to try this novel vaccine. Remember: caveat emptor.

Flublok has a shelf life of 16 weeks from the date of manufacture. Health care providers should check the expiration date before administering Flublok.

Flublok is manufactured by Protein Sciences Corp, of Meriden, Conn.

For more propaganda:

The FDA, an agency within the U.S. Department of Health and Human Services, claims that it protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also supposedly responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. The FDA does employ many well-meaning and dedicated people and it is not their fault that the agency is ultimately a serious danger to the well being of the nation it serves and a threat to the rest of the world.

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