Monday, December 3, 2012

Musing on issues of mandatory flu vaccinations

Many healthcare institutions are imposing mandates on staff for flu vaccinations, with penalties ranging from wearing masks throughout the workday (even for those with no cough or sneeze--which demonstrates the lack of scientific basis for this measure, since merely breathing on someone has never been demonstrated to transmit influenza) to blanket firings of employees who refuse to comply.

This week yet another paper came out showing a bump in paralytic Guillain Barre syndrome (GBS) cases two weeks following flu vaccinations, putative evidence for disease causality.  Several papers (and CDC) have revealed an increase in GBS cases after receiving 2009 swine flu vaccinations, and after several other flu vaccines.

Interestingly, a new Novartis flu vaccine (Flucelvax) is available in the US this year, manufactured in a canine kidney cell line.  This method of flu vaccine production was not approved in the US until 2 weeks ago. Why might this be a problem?  

Those of us old enough to remember lining up at school for polio vaccine (produced in monkey kidney cells) got a dose that included the extraneous monkey virus SV40.  Ten to thirty million of us (per NIH) or perhaps 100 million Americans got this virus from polio vaccines, which subsequently has appeared in a variety of tumors, especially mesothelioma. 

Has this newly-approved vaccine, Flucelvax, also made in a mammalian kidney cell culture, been proven to be free of extraneous mammalian viruses?

Four weeks before the new vaccine was approved, two Novartis flu vaccines were banned in ItalySwitzerland, Germany, France, Austria, and Spain due to particulates in the vaccine vials.  

Novartis supplies the US with 30 million flu vaccine doses.  Five other companies also supply flu vaccine to the US market.  Worryingly, the package insert for Flucelvax says, 
"FLUCELVAX should be inspected visually for particulate matter and discoloration prior to administration. If either condition exists, do not administer the vaccine."
Did FDA approve vaccine that was banned in Europe?  Maybe.  Is Flucelvax one of the vaccines that health care workers are being forced to receive?  It certainly looks like it.

Patients sometimes report that flu vaccine "gave them the flu." Doctors pooh-pooh this notion.  Yet look at the Flucelvax package insert.  The most commonly reported unsolicited adverse events after receiving Flucelvax were runny nose, headache, and oral pain (might that be sore throat?).  Cough was reported in 2% of elderly recipients after vaccination.  No wonder they think the vaccine gave them the flu:  they developed identical symptoms.  And the vaccine is associated with myalgia, fatigue and malaise in about 10% of recipients, but Novartis says the control group had about the same symptom frequency.

Like pregnant women, US healthcare workers are being herded into a great experiment (mass vaccination for flu) using new vaccines whose safety and efficacy are unknown.  (The flu strains are changed each year and there is virtually no testing of the newly crafted vaccines before use, as they are grandfathered in by FDA, based on data from vaccines used in previous years.)  

Whether this decreases flu cases or increases clinical flu infections (as appears to have been the case for the 2008 flu vaccine, according to studies in several Canadian provinces) is unknown, and what the side effect profile of this year's flu vaccine is remains unknown.  

Former FDA Commissioner Jane Henney, M.D. once said she never uses a drug until it has been on the market at least a year, since the side effects are not truly known until there has been mass use of the product, and some time has passed in which to experience the adverse effect.

Were Henney to follow her own admonition today, she could be out of a job.  She is a professor of medicine and Provost at the University of Cincinnati, where flu shots are required this year.

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