Had you not been paying attention to the real news and events occurring around the world prior to last week and awoke from that slumber you’d be left to believe that all was well in the world since all the media outlets were transfixed by a non-news story, news story. The balloon boy was everywhere…

What was not everywhere was any in-depth reporting of swine flu vaccine side effects, the stripping of our rights as free citizens when it comes to what goes into our bodies or the desperately needed “other side of the story” to counter Rear Admiral Anne Schuchat MD.

I cringed during her interview on 60 minutes as she sat deadpanned, staring straight into the camera and without hesitation told an anxious nation that the Swine flu vaccine has been tested, is safe and children and pregnant women should get it immediately. Her recommendations followed heart wrenching images of a high school teenage football player who had succumbed to H1N1 and was battling for his life in the hospital as distraught parents held on to hope.

As I watched I thought to myself that the strongest parent with the deepest conviction and ability to think critically could not shield themselves from the doubt that was being instilled by our nation’s undisputed expert on infectious disease with a young boy clinging to life in the background.

Shame on 60 minutes, shame on Anderson Cooper, Sanjay Gupta, Larry King and every other media outlet that refuses to tell the other side of the Swine flu story. Shame on them for not interviewing those with a different analysis of the data. Shame on them for blindly accepting everything we are being told by the government and its experts. What happened to their responsibility to find the truth?           

This week the CDC reported another 10 deaths in children from H1N1 adding to the previous report from August of 36 deaths. The following is from the CDC website: 

Eleven influenza-associated pediatric deaths were reported to CDC during week 40 (Arizona, Colorado, Idaho, Kentucky, Louisiana [2], North Carolina, Ohio, South Carolina, and Tennessee [2]). Ten of these deaths were associated with 2009 influenza A (H1N1) virus infection and one was associated with an influenza A virus for which the subtype is undetermined. These deaths occurred between August 30 and October 10, 2009. Since August 30, 2009, CDC has received 43 reports of influenza-associated pediatric deaths that occurred during the current influenza season (three deaths in children less than 2 years, five deaths in children 2-4 years, 16 deaths in children 5-11 years, and 19 deaths in individuals 12-17 years). Thirty-nine of the 43 deaths were due to 2009 influenza A (H1N1) virus infections. A total of 86 deaths in children associated with 2009 H1N1 virus have been reported to CDC. Among the 43 deaths in children, 28 children had specimens collected for bacterial culture from normally sterile sites and seven (25.0%) of the 28 were positive; Staphylococcus aureus was identified in five (71.4%) of the seven children. One S. aureus isolate was sensitive to methicillin, three were methicillin resistant, and one did not have sensitivity testing performed. All seven children with bacterial coinfections were five years of age or older and four (57.1%) of the seven children were 12 years of age or older.

In the report issued on the deaths of 36 children form H1N1 we learn that the majority of those deaths occurred in children with very significant neurodevelopmental disorders. According to the data some of these children also had chronic pulmonary disorders and some were obese. In fact, most who died had multiple, severe, chronic health conditions.  Interestingly, the CDC found that 13 (52%) of the children who died had received at least 1 dose of the 2008--09 seasonal flu vaccine including 11 children who had these high-risk medical conditions. Of further interest is that 15 of those who died and who had chronic medical conditions had also received antiviral treatment. What role, if any, these two factors had in the deaths was not discussed in the CDC report.

The most recent reports from the CDC on children’s deaths associated with H1N1 fails to provide the in-depth characteristics previously provided in their August report. If we are to assume all things are equal then the more recent deaths would display similar characteristics. Yet Schuchat looks into that camera and tells parents that all children are at risk and that the vaccine has been tested and is safe for them.

How could that be when the package insert dated September 2009 for Novartis Vaccines and Diagnostics Limited Influenza A (H1N1) 2009 Monovalent Vaccine states: 

Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

Under the adverse reactions section Novartis notes they base this off the seasonal flu vaccine: 

Adverse Reaction information is based on studies conducted with seasonal trivalent Influenza Virus Vaccine manufactured by Novartis (FLUVIRIN). 

Obviously they don’t have enough information on the H1N1 trials to even discuss adverse reactions for that specific vaccine.

In discussing its use in specific populations Novartis states it has not been tested in pregnant or nursing women: 

Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine have not been established in pregnant women, nursing mothers or children less than 4 years of age.

The Novartis package insert states that three clinical studies were carried out on a total of 520 pediatric subjects (age range 6-48 months) but they do not report on any data from those studies – that seems strange doesn’t it?

Even better (or worse) is Sanofi Pastuer’s package insert for their H1N1 vaccine relying on data for its seasonal flu vaccine which states its only been tested on 31 children! 

According to the package insert for Australia's CSL, which is distributing 21 million doses of their H1N1 vaccine, it has also not been tested in these populations and in fact, unlike their competitors, their seasonal flu vaccine has also not been tested on children: 

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in children. Safety and effectiveness in the pediatric population have not been established.

Here’s what the CDC has to say about its use in pregnant women and children: 

What studies have been done on the 2009 H1N1 flu shots and have any been done in pregnant women?

 

Studies to test the 2009 H1N1 flu shots in healthy children and adults and pregnant women are being done now. These studies are being conducted by the National Institute of Allergy and Infectious Diseases (NIAID). More information can be found at http://www3.niaid.nih.gov/news/QA/vteuH1N1qa.htm.

So after review of initial safety data from just 500 adults in three trials of H1N1 vaccine, additional trials of similar design began in children in mid-August of 2009 and won’t be completed until May 2010. You can see for yourself what they are doing in these studies of children (take a close look at the exclusion criteria):

Under the heading Preventing and Managing Allergic Reactions in the package insert, Novartis stresses the importance of reviewing the patient’s history and to assess benefits and risks prior to giving the vaccine. It also states that treatment and supervision for possible anaphylactic reactions MUST be available: 

Prior to administration of any dose of Influenza A (H1N1) 2009 Monovalent Vaccine, the healthcare provider should review the patient’s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with Influenza A (H1N1) 2009 Monovalent Vaccine and to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Funny, I didn’t see any of that going on in those videos of the drive through flu shots.

Keeping in mind that they are using data from the regular seasonal flu vaccine its interesting to note the following for the Novartis vaccine:

• Safety data have only been collected on a total of 2768 adult and geriatric subjects since 1982.
• Nine clinical studies have been conducted since 1997 with only 1261 subjects
• 96% of those subjects were white
• All studies were conducted in the UK

After they were injected with the vaccine the subjects were followed for 3 days (yes - just 3 days) to see if they had any reaction.

So let’s get this straight - about 3000-4000 adult white people in the United Kingdom were followed for three days after getting a seasonal flu vaccine and we are supposed to feel safe now that its being used on hundreds of millions of people just because the vaccine for H1N1 is being manufactured in a similar fashion? This is for a virus whose antigenic characteristics indicate that it is only distantly related antigenically and genetically to seasonal influenza.

It’s as if everyone woke up and decided to suspend all manner of critical thinking.

According to Novartis the following adverse reactions were uncovered during post marketing surveillance of the regular seasonal flu vaccine: 

Body as a whole: Local injection site reactions (including pain, pain limiting limb movement, redness, swelling, warmth, ecchymosis, induration), hot flashes/flushes; chills; fever; malaise; shivering; fatigue; asthenia; facial edema.

• Immune system disorders: Hypersensitivity reactions (including throat and/or mouth edema). In rare cases, hypersensitivity reactions have lead to anaphylactic shock and death.

• Cardiovascular disorders: Vasculitis (in rare cases with transient renal involvement), syncope shortly after vaccination.

• Digestive disorders: Diarrhea; nausea; vomiting; abdominal pain.

• Blood and lymphatic disorders: Local lymphadenopathy; transient thrombocytopenia.

• Metabolic and nutritional disorders: Loss of appetite.

• Musculoskeletal: Arthralgia; myalgia; myasthenia.

• Nervous system disorders: Headache; dizziness; neuralgia; paraesthesia; confusion; febrile convulsions; Guillain-Barré Syndrome; myelitis (including encephalomyelitis and transverse myelitis); neuropathy (including neuritis); paralysis (including Bell’s Palsy).

• Respiratory disorders: Dyspnea; chest pain; cough; pharyngitis; rhinitis.

• Skin and appendages: Stevens-Johnson syndrome; sweating; pruritus; urticaria; rash (including non-specific, maculopapular, and vesiculobulbous).

Note to Anderson Cooper and every other supposed “investigative reporter” – next time you have the Admiral on why not ask her about these data and how she can look at anyone with a straight face and say its been tested and found to be safe.

If you want more information check out our Swine Flu website set up to try and keep track of the constant changes in this very serious issue.

As always I look forward to your feedback comments and questions.

Regards,
Matthew McCoy DC, MPH
matthewmccoy@comcast.net
Editor - Journal of Pediatric, Maternal & Family Health - Chiropractic
http://www.chiropracticpediatricresearch.net