Safety Concerns about the of H1N1 Swine flu Vaccine & Public Policy

In the 1976 swine flu vaccine program, 40 million people were vaccinated with an inadequately tested vaccine.  The government gave the vaccine manufacturers immunity from liability, but created an alternative compensation program.  Five thousand people sought benefits for vaccine injuries.

Today, as in 1976, official concern has focused on flu vaccine availability without regard for the safety of an H1N1 vaccine. Many national regulatory agencies have set-up fast-track approval processes for the H1N1 vaccine, which means that a vaccine might be licensed without the usual safety and efficacy data requirements.

Vaccine safety will therefore have to be monitored through post-marketing surveillance.

But there is reason for concern that we will repeat the debacle of the 1976 H1N1 outbreak in the USA, where mass vaccination was associated with complications, which stopped the campaign and led to the withdrawal of the vaccine.

What’s more, today, the government has NOT established an ALTERNATIVE COMPENSATION PROGRAM–as it had in 1976. The existing vaccine compensation program covers only designated vaccines and does NOT cover most adult vaccines. 

The U.S. government has adopted (what critics regard) a reckless policy encouraging (if not mandating) the use of untested. controversial vaccines with novel adjuvants likely to be used to strengthen vaccines and stretch the supply–they are named MF59 (Novartis) and ASO3 (Glaxo Smith-Kline).  Only 3 vaccines using these adjuvants have been licensed in Europe, and none have been given a license in the US. 

It is likely that these adjuvants will cause far more damage and autoimmune illness than the swine vaccine used in 1976. 

Indeed, Manufacturers have been given immunity from liability, as have the government program planners.  But no compensation mechanism has been created for citizens who are likely to suffer harm. This is but a tacit acknowledgement that the vaccines are likely to produce harm.

Below, AHRP board member,  Dr. Meryl Nass summarizes the facts. She notes that countries need to assess carefully the risks and benefits of rapid approval of an H1N1 vaccine, especially since the disease has so far been mild with most patients making a full recovery. They must also ensure that they have strong post-marketing surveillance in place before rolling out a vaccine.

Additional information is posted on Dr. Nass’ blog

Posted by Vera Sharav

1.  The USG is using laws designed for dealing with a very deadly pandemic or bioterrorism to bring in a mass vaccination program for swine flu, specifically the Public Readiness and Emergency Preparedness Act 0f 2006 .

2.  This law removes liability from the manufacturer, medical practitioners who use the product, and "government program planners" who decided on using the law.  A suit can only be brought if the DHHS Secretary allows it, and if there is willful misconduct on the part of the manufacturer.

This law has been invoked for swine flu drugs (tamiflu and relenza) for swine flu vaccines, and for novel vaccine adjuvants (which may be used in vaccines to stretch the supply and possibly convey broader immunity)  http://edocket.access.gpo.gov/2009/pdf/E9-14948.pdf .

3.  If testing of these products is very limited, then the manufacturers are unlikely to become aware of their flaws, and specifically their adverse effects.  Then there can be no willful misconduct.

4.  Due to the fear that swine flu will cause a large outbreak once students return to schools, where the virus might rapidly spread, the US government has stated that vaccine is likely to be available, and used, before clinical trials are completed.
WHO says vaccine will be ready in September.  Novartis began testing in humans in late July, and Sanofi-Aventis and Glaxo-Smith Kline plan to start human testing soon.

The Europeans are also planning for use before testing is completed, despite warnsings by experts about the potential dangers of untested vaccines.

5.  The adjuvants likely to be used to strengthen vaccines and stretch the supply are name MF59 (Novartis) and ASO3 (Glaxo Smith-Kline).  Only 3 vaccines using these adjuvants have been licensed in Europe, and none have been given a license in the US.  Two vaccines using these adjuvants are only used in people above the age of 65 (Fluad-MF59), and those with serious kidney disease (Fendrix-ASO3).  Both advanced age and kidney failure weaken the immune system, so more powerful vaccines are needed, and autoimmunity is unlikely to result from a large immune stimulant.  Cervarix is the third European vaccine using ASO3, and its safety is controversial.

6.  The then-Acting DHHS Secretary issued an emergency declaration in response to the swine flu epidemic on April 26, 2009.  This allows use of unapproved (unlicensed) medical treatments and tests, or use of approved treatments for unapproved uses. 

According to the Congressional Research Service, on April 27, 2009, the Food and Drug Administration issued four Emergency Use Authorizations in response to requests from the CDC to make available certain drugs, diagnostic tests and respiratory protection devices.

7.  Vaccines containing MF59 and ASO3 have not had emergency use authorizations issued for them–yet.  However, the government has purchased $698 million dollars’ worth of these adjuvants in recent weeks. 
http://www.hhs.gov/news/press/2009pres/07/20090713b.html
https://www.medicalcountermeasures.gov/BARDA/MCM/panflu/factsheet.aspx

US and WHO officials have indicated the likelihood of their use, which is the only way to achieve adequate amounts of vaccine for the US and world population in the fall.

8.  These vaccines have never been demonstrated to be safe in children, pregnant women or young adults.  They have not undergone comprehensive testing; for example, MF59 has not and will not be tested for carcinogenicity by the manufacturer.  See page 391 re MF59 carcinogenicity testing.

9.  The result of the new bioterrorism laws (passed with the expectation of use for much more dangerous epidemics than the current swine flu), which allow use of untested products AND give manufacturers an incentive to avoid comprehensive testing (to avoid being found guilty of negligence and willful misconduct) have combined with the political imperative to provide citizens vaccines in a hurry, yielding a Perfect Storm.

In the 1976 swine flu vaccine program, 40 million people were vaccinated with an inadequately tested vaccine.  The government gave the vaccine manufacturers immunity from liability, but created an alternative compensation program.  Five thousand people sought benefits for vaccine injuries.

Today, untested vaccines with novel adjuvants that are likely to cause more autoimmune illness than occured in 1976 will almost certainly be used.  The manufacturers have been given immunity from liability, as have the government program planners.  But no compensation mechanism has been created.  And the public has not been informed.
  

Meryl Nass, MD
Mount Desert Island Hospital
Bar Harbor, Maine 04609
W  207 288-5081 ext. 1220
C   207 522-5229
H   207 244-9165
pager 207 818-0708
http://anthraxvaccine.blogspot.com
http://www.anthraxvaccine.org