Vaccine Safety and the CDC

[Pat Robinson]

I happened upon this old vaccine report from government archives - one that didn't receive public comments. It is a fascinating read. I thought this quote was pretty damning:

"National Institutes for Health (NIH) -

Following the disappointment of the HIV vaccine trial, which really called into question a lot of the scientific theories, NIH has established a new branch in the Division of HIV / AIDS on vaccine discovery. This is a clear indication that they are going back to square one to develop the science for a new generation." (Page 111.)

http://bepast.org/docs/focus%20on%20anthrax/anthrax_vaccine/ACIP_CD...

Interestingly, they eliminated Pregnancy Categories on drug labeling then also! (Page 110.) http://www.drugs.com/pregnancy-categories.html

There is a lot of cross-agency documentation and "collaboration" that hasn't been examined but shines a light on the lack of science and process safety. For instance this quote from the National Vaccine Program.

"NVP Responsibilities include vaccine research; vaccine development; safety and effcacy testing of vaccines; licensing of vaccine manufacturers and vaccines; production and procurement of vaccines; distribution and use of vaccines; evaluating the need for, the effectiveness, and adverse effects of vaccines and immunization activities; coordinating governmental and non-governmental activities; and funding of federal agencies. Dr. Birkhead assumed it was fair to say that the full panoply of these responsibilities had not totally been assumed at this level by the NVP, but it is a work in progress." (Page 111.)

In relation to escalating costs of mandating vaccines and mandating payment for covering vaccine mandates: "The Vaccine Finance Working Group convened a two-day stakeholder meeting in Rockville, Maryland in April 2008. The stakeholder meeting was very broad, including representatives from the pharmaceutical industry, insurance industry, large and small employers, state Medicaid directors, consumer and parent groups, and many other groups." (Page 112.)

"Dr. Sawyer emphasized that a very important group is the 24% under 12 months old who are unvaccinated and ineligible. In his state’s outbreak these statistics held true. He also stressed that there are some very strong feelings among those parents who were inadvertently subjected to the measles because of the decision of others to exert personal belief exemption. He asked that those in a position to emphasize that in their communities to do so because it resonates with a lot of people, and may help to decrease the rate of personal belief exemptions , at least among a subset of that group." (Page 126.)

"Dr. Schaffner, National Foundation for Infectious Diseases, assured everyone that his comments were not to divert attention from domestic responsibilities, or to incite an international incident. However, he expressed concern that their colleagues in Europe and in Israel tolerate on-going outbreaks of measles and other childhood communicable diseases." (Page 127.)

vs.

"With regard to the issue of economic cost, LCDR Parker responded that containing an outbreak is, indeed, very expensive. Public health officials in San Diego have estimated the cost for that outbreak as nearing $100,000. The public health containment costs alone among the vaccine refuser community in Indiana in the 2005 outbreak was estimated to be $167,000." (Page 127.)

Could we make the point that the disease is so benign that other countries are not spending hundreds of thousands of dollars when Europeans are unfearful of these childhood communicable diseases?

"There currently are a lot of measles in Europe. The issues of how to raise the perception of the seriousness of measles, as well as the need to maintain very high coverage, have been a challenge for many years within the European region, and it is a reality that a number of countries have either not taken measles as seriously as they should or have not been able to do as much as they would like." (Page 127.)

Measles is commonly benign is why!

Vaccine safety starts at page 129.

All in all, it is interesting to mine an old document which seems more forthcoming as the committee didn't have the defensiveness of being watched.

Karen R. Broder, MD Immunization Safety Office Office of the Chief Science Officer (OCSO), CDC:

7 Vaccine Safety Questions, per CDC:

"The seven vaccine safety questions, also not presented in any order of priority and available to the public through the website, are:

1.  Are vaccines (e.g., influenza vacci nes, meningococcal conjugate vaccine [MCV4]) associated with increased risk for Guillain-Barré Syndrome (GBS)?
   
   
2.  Is live, attenuated influenza vaccine (LAIV) associated with increased risk for asthma and/or wheezing, particularly in young children or persons with history of wheezing?
   
   
3.  Is exposure to thimerosal associated with increased risk for clinically important tics and / or Tourette syndrome?
   
   
4.  Are acellular pertussis vaccines associated with increased risk for acute neurological events, particularly hypotonic-hyporesponsive episodes (HHE)?
   
   
5.  Is immunization associated with increased risk for neurological deterioration in children with mitochondrial disorders?
   
   
6.  Is combination measles, mumps, rubella, and varicella (MMRV) vaccine associated with increased risk for febrile seizure and, if so, are there sequelae?
   
   
7.  Are varicella vaccines (varicellaa nd MMRV) associated with increased risk for clinically important events related to varicella vaccine virus reactivation? " (Page 132.)
   
   

Have these safety questions been resolved?

• Is it appropriate to vaccinate every child while the CDC is still researching safety in special populations?

"In the thematic area of special populations, the following populations were identified: premature and low birth weight infants; pregnant women; adults 65 years and older; persons with primary immunodeficiency; persons with secondary immunodeficiency; persons with autoimmune disorders; and children with inborn errors of metabolism.

In the area of clinical outcomes, the following were highlighted:

• autoimmune diseases;
• central nervous system demyelinating disorders;
• encephalitis / encephalopathy;
• neurodevelopmental disorders, including autism spectrum disorder (ASD);
• vasculitis syndromes; myopericarditis (not associated with smallpox va ccine);
• clinically important outcomes related to postimmunization fever; and
• postvaccination syncope and sequeale." (Page 133.)

"There has been much publicity and discussion related to mitochondrial disorders in general, as well as whether they have any associations with vaccines and/or autism. There are a few ongoing activities that will help us better understand the state of science and knowle dge, and identify potential research priorities."  (Page 136.)

All while we are still mandating mass vaccination:

"CISA’s mission includes studying pathophysiologic mechanisms and biologic bases of adverse events following immunization, as well as providing evidence-based immunization safety assessments. Aligned with that mission, CISA experts form ed a work group about a year ago to focus on metabolic disorders, and now have another one that is focusing on mitochondrial disorders in order to identify key research questions and study methods related to these conditions.

Specifically, they plan to develop clinical protocols t hat will help to assess how immunization may affect or trigger these conditions. They also will consider the feasibility of developing clinical guide lines for assessment of patients with these conditions.

Discussions are also underway at CDC regarding a feasibility and validation study to examine health and medical information in children who have died or who are suspected to have died of mitochondrial disease to determine whether information is available that could help assess how the health outcomes of these conditions were affected." (Page 137.)

"Dr. Iskander responded, however, with increasing numbers of vaccines, especially with increasing numbers of combination vaccines, preventable adverse events are also on the rise (e.g., vaccine administration errors, post-vaccination syncope)." (Page 138.)