The FDA has now officially approved the first flu vaccine created with genetically modified materials, and more are on the way.
The new vaccine, Flublok, is the first flu vaccine to contain genetically modified (GM) proteins derived from insect cells. Developers say the vaccine contains recombinant DNA technology and an insect virus known as baculovirus that is purported to help facilitate the more rapid production of vaccines.
Flublok is produced by extracting cells from the fall armyworm, a type of caterpillar, and genetically altering them to produce large amounts of hemagglutinin, a flu virus protein that enables the flu virus itself to enter the body quickly.
The experimental vaccine was tested through two studies that tracked 2,497 over a six month period and previous studies were performed on rats to see if the vaccine impaired female fertility.
No studies have been done to look for long-term effects, carcinogenic or mutagenic potential, or for impairment of male fertility.
Two participants died during the study, one in the placebo group and one in the Flublok group. Researchers claim that the Flublok death was unrelated. The cause of that death is unknown.
In addition to reports of side effects such as injection-site pain, headache, nasopharyngitis, upper respiratory infection, cough, nasal congestion, pharyngolaryngeal pain and rhinorrhea, one study participant developed a more severe reaction. Protein Sciences reports in the vaccine insert:
One SAE in a Flublok recipient was assessed as possibly related to the vaccine: pleuropericarditis with effusions requiring hospitalization and drainage. No specific cause was identified. The patient recovered.
The vaccine was apparently tested on young children, as well, with unfortunate effects. The vaccine insert further says:
Data from a randomized, controlled study demonstrated that children 6 months to less than 3 years of age had diminished hemagglutinin inhibition (HAI) responses to Flublok as compared to a U.S.-licensed influenza vaccine approved for use in this population, strongly suggesting that Flublok would not be effective in children younger than 3 years of age. Safety and effectiveness of Flublok in children 3 years to less than 18 years of age have not been established.
Protein Sciences advises that Flublok is not recommended for elderly patients, pregnant women, children or nursing mothers.
The vaccine was found to be less than 45% effective at preventing the flu (44.6% efficacy rate in one trial and 44.8% in another).
Current flu vaccines are created using hundreds of millions of chicken eggs in a process that takes up to six months and is often unsuccessful. The new GM flu vaccines hope to speed up this process -- and make it much cheaper for vaccine manufacturers.
Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in announcing the vaccine approval:
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.
This new GM vaccine technology is largely thanks to U.S. taxpayers. The U.S. Department of Health and Human Services provided more than $1 billion in contracts to six vaccine corporations to develop cell-based flu vaccine technology in 2006, including Protein Sciences.
Health Impact News notes:
The HHS bailed out the small manufacturer, Protein Sciences, with a $147 million investment, allowing it to create the first gene-based flu vaccine to win FDA approval. It certainly won’t be the last however. Two other genetically engineered flu vaccines are under development. According to Reuters, one of them, created by Novavax, will use “bits of genetic material grown in caterpillar cells called “virus-like particles” that mimic a flu virus.”
The long-term effects of GM vaccines are still unknown. In 2006, researchers wrote in the Journal of Toxicology and Environmental Health:
Genetically modified (GM) viruses and genetically engineered virus-vector vaccines possess significant unpredictability and a number of inherent harmful potential hazards... Horizontal transfer of genes... is well established. New hybrid virus progenies resulting from genetic recombination between genetically engineered vaccine viruses and their naturally occurring relatives may possess totally unpredictable characteristics with regard to host preferences and disease-causing potentials.
...There is inadequate knowledge to define either the probability of unintended events or the consequences of genetic modifications.
It should be noted that many current vaccines and medicines already contain genetically modified ingredients. Gardisil, Cervarix, the Rotavirus vaccine and the Hepatitis B vaccine all contain GMOs. For instance, the National Vaccine Information Center says of the Rotavirus vaccines available:
Both are given orally and contain genetically engineered live attenuated human rotavirus strains or hybrid human-bovine reassortment rotavirus strains.
In addition, the vast majority of insulin used in the US is manufactured using genetically engineered bacteria.
Do you need a flu vaccine? That's your call. While the Center for Disease control claims that the flu is responsible for 36,000 deaths in the United States each year, the Huffington Post points out:
According to the National Vital Statistics System in the U.S., for example, annual flu deaths in 2010 amounted to just 500 per year -- fewer than deaths from ulcers (2,977), hernias (1,832) and pregnancy and childbirth (825), and a far cry from the big killers such as heart disease (597,689) and cancers (574,743).
...Even that 500 figure for the U.S. could be too high, according to analyses in authoritative journals such as the American Journal of Public Health and the British Medical Journal. Only about 15-20 per cent of people who come down with flu-like symptoms have the influenza virus -- the other 80-85 per cent actually caught rhinovirus or other germs that are indistinguishable from the true flu without laboratory tests, which are rarely done. In 2001, a year in which death certificates listed 257 Americans as having died of flu, only 18 were positively identified as true flus.
There is a vast difference between 36,000 deaths and 18.
Seniors 65 and older and children under 5 years of age are most susceptible to catching the flu and having adverse reactions to it, along with those with compromised immune systems.
If you decide to take a more natural route, keep in mind that elderberry syrup has been found to be effective at preventing the flu and far more effective at treating the flu than Tamiflu. One study found that 90% of flu victims who took elderberry extract had complete cure by day two, whereas placebo group symptoms lasted six days. Elderberries have been shown to be effective against ten known strains of influenza, including the type that includes H1N1.
Here is a simple recipe to make your own elderberry honey syrup for the flu season. Taking one tablespoon per day will help prevent contracting the flu, while you can treat the flu with two to three tablespoons per day.
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