2009. It’s never been done before — vaccinating Americans against two different flu threats in one season. But that’s what public health officials all over the country are beginning to plan. They need to deploy two different flu vaccines available on different schedules — and targeted at different people.
The new H1N1 swine flu virus, officially declared pandemic on June 13, may well come back to the Northern Hemisphere early this fall, before public health officials have a vaccine against it.
Health officials expect seasonal flu strains will circulate this fall and winter along with the new pandemic strain. “Doing these two things simultaneously is unprecedented,” says Dr. Bruce Gellin, director of the National Vaccine Program Office in the Department of Health and Human Services. “Trying to keep track of both and not be distracted by either is our challenge.”
The H1N1 swine flu virus being used to make the vaccine isn’t growing as fast as expected. To compensate for lower yields, officials hope they can add an immune-boosting ingredient called an adjuvant. This could reduce the amount of viral protein needed in each dose and stretch the 251 million doses the U.S. government has ordered.
The problem is that no U.S. flu vaccine has ever included an adjuvant
Reports suggest vaccine’s immune adjuvants can increase the risk for vaccine-induced chronic inflammation and cause rheumatoid arthritis, MS and lupus. The squalene adjuvant is a type of oil. The Chiron company (recently merged with Novartis Pharmaceutical Company), makes an adjuvant called MF-59 which contains two main ingredients of concern — squalene and gp120. A number of studies have shown that squalene can trigger all of the above-mentioned auto-immune diseases when injected.
Meanwhile, health officials should do what they can to see if the new vaccine is safe and effective. However, the National Vaccine Information Center (www.nvic.org) reports that U.S. health officials are expected to bypass normal FDA licensing procedures and include squalene adjuvants in some swine flu vaccines released for public use.
Preparing For Surprises
In 1976 a paralyzing disease called Guillain-Barre Syndrome struck more than 500 people who had been vaccinated against a different swine flu. The crash campaign halted after 40 million Americans had been immunized.
This time, a World Health Organization (WHO) official says, the chances of a Guillain-Barre repeat should be smaller because today’s vaccines are more purified. “But to be honest, it is only when you have large-scale use that you know the safety profile,” says Dr. Marie-Paule Kieny, director of the WHO Initiative for Vaccine Research.
“Particularly with influenza, we’ve learned to expect surprises,” Gellin says. “We’re ready for surprises, and have to be able to look for them, acknowledge them and figure out how best to deal with them. With rare events, you may not be able to see them until you’ve had a significant number of people who’ve received a vaccine,” he says.
Fear Versus Fact
The fear is widespread. Fear that this season will be like the 1918 flu when millions died. First of all, there is no comparison. In 1918, no techniques were available to determine if it was even a flu virus that struck. Most of the people who died actually died from pneumonia. At that time there were no hospitals as we know them today, no antibiotics and no intravenous fluids.
Let’s look at the facts:
Does the gravity of the illness justify mass immunizations?
Based on this and the number of documented deaths from H1N1 (522 of 43,771 actual cases as of August 21), the death rate is 0.011 or approximately 1 percent. So IF you did get the H1N1 virus, there is a 99 percent chance you would not die from it based on confirmed cases. The CDC estimates that one million people have been infected with the H1N1 virus between April and June 2009 in the U.S. which makes the risk of dying from the disease much less (0.05 percent).
Of this small fraction who do die, the distributions of death also vary considerably by age, according to data from the CDC:
- Ages 25-49 ———41%
- Ages 50 to 64 —–24%
- Ages 5 to 24 ——16%
- Over age 65 ——- 9%
- Ages 0 to 4 ——– 2%
Those least likely to die are babies up to age 4 years, yet they are being targeted for vaccination. Children below age 2 years get absolutely no protection from the flu vaccines.
Most people who die from the flu have either an immune-suppressing chronic illness, such as diabetes, direct immune dysfunction, and dietary deficiencies of critical immune-supporting nutrients, chronic pulmonary disease, heart disease or cancer.
A study by the CDC found that 32 percent of children dying from H1N1 flu had asthma. Two thirds of the children who died had neurological disorders, such as seizures and cerebral palsy. So the vast majority of children who have died from the flu have one of a number of chronic health conditions, yet the media gives the impression that perfectly healthy children are dying.
Are the vaccines in question safe?
Have they been adequately tested? Is their testing “honest?” ― i.e., are they testing the exact same vaccine they will have for the public? No.
Two kinds of injected influenza vaccines (both regular flu and swine flu) are available this year — one contains thimerosal (a mercury-based preservative) is added to the H1N1 swine flu vaccine. As a general rule, the vaccines that come in single dose packages do not contain mercury, while those in multi-dose vials do. Some clinics pre-fill their syringes from multi-dose vials containing mercury.
Thus, if you are offered a flu-shot dose in a syringe, you need to verify the syringe was filled by the vaccine’s manufacturer and not by anyone else.
The amount of mercury in the thimerosal-preserved vaccines is about 25 micrograms. The EPA safe dose for exposure to mercury (which should not be exceeded) is 0.1 micrograms per kilogram of body weight per day. So, if a child receives a shot with 25 micrograms of mercury, the child would have to weigh 550 pounds to remain within the recommended safe level of exposure.
The first trial testing a candidate 2009 H1N1 influenza vaccine in pregnant women was launched September 11, as announced by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Up to 120 women 18 to 39 years of age who are in their second or third trimester (14 to 34 weeks) of pregnancy were enrolled into this initial trial
However, the testing vaccine contains no thimerosal, a mercury preservative, or adjuvant! The actual H1N1 vaccine will contain thimerosal (mercury) and an adjuvant which can cause adverse risks. Why would the government test the safety of a vaccine that does not contain two of the parts of the vaccine which have been shown to be a risk for harm? FDA licensure is supposed to indicate that the government has certified the vaccine is made properly and meets specific manufacturing and quality standards.
With regard to injecting these vaccines into pregnant women, we know that some of the mercury will cross the placental barrier to the fetus. We tell pregnant women not to eat fish, and yet our government is not warning them about having mercury injected into their bodies while they are pregnant!
According to the FDA, candidate swine flu vaccines will be tested for one to three weeks on 850 children and adults before being released for public use. Those trials are testing the same vaccine in various groups of healthy individuals, including adults, the elderly and children (see www.clinicaltrials.gov).
In spite of the plan for very small short clinical trials, the government reportedly has contracted with vaccine manufacturers to produce a total of 251 million doses of swine flu vaccine (see www.nvic.org).
If you receive the swine flu vaccine this year, be sure to keep the card they give you, and make sure the card lists the manufacturer and lot number of the vaccine. However, if you are injured by the vaccine, you will have to apply to a special program for compensation. You will have no appeal and no right to pursue any kind of civil litigation.
It is interesting to note that the pharmaceutical companies have been granted immunity from all lawsuits such as those that resulted from the 1970s swine flu vaccine with its Guillain Barre paralyzing complications.
Do these vaccines work?
We don’t know. The H1N1 virus has mutated over many months as do all flu viruses. The flu vaccines are always made from last year’s viruses.
It’s important to ask yourself why medical professionals and virologists (those who study these viruses) are so adamant that they do not plan to immunize themselves or family members.
There’s no need to panic — despite the daily bad news barrage about swine flu. Remember, the best treatment for common influenza and the swine flu is prevention.
What can I do to protect myself?
- Wash your hands, wash your hands, wash your hands many times with soap
- Stay healthy
- Get plenty of sleep
- Eat a well-balanced diet
- Enhance your immune system with vitamins and IV nutrients
- Do plenty of exercise
- Manage your stress
- Drink plenty of liquids (½ your body weight in ounces)
- Refrain from touching surfaces which may have the virus
- Do not get close to people who are sick (a Harvard study found adults should be considered contagious until at least 7 days after the start of symptoms, while children could be contagious for 10 to 14 days)
- Stay away from crowded areas if there is a swine flu outbreak in your area
FDA Public Health Alert: Potential Medication Errors with TAMIFLU for Oral Suspension (September 25, 2009)
Prescribers and pharmacists should be alert for potential dosing errors with TAMIFLU (oseltamivir) for Oral Suspension. U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while TAMIFLU is dosed in milligrams (mg). The dosing dispenser packaged with TAMIFLU has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser.
Health care providers should write doses in mg if the dosing dispenser with the drug is in mg.
Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.
This article is not meant to be medical advice, it is for information only. Consult with your physician and make the best personal decision for yourself.