This opportunity for public input is part of a major federal effort to re-examine vaccine policy caused in part by declining public confidence in vaccines,
increasing mistrust and skepticism of CDC, increased use of exemptions and “alternative” schedules,
concerns raised by pediatricians reflecting significantly increased parental uncertainty about both the safety and benefits of vaccines,
and recent public actions such as Jenny McCarthy's/Jim Carey's Green Our Vaccines rally at the Capitol last June,
calls by prominent scientists such as Bernadine Healy for improved safety science especially with respect to autism,
and the Government's concession in February, 2008, in the Poling case that vaccines can cause autism.

These comments should guide development and implementation of the Plan and make a record for Congressional and media oversight
of what the public wants and expects for future immunization activities.

The Plan sets forth five general goals and each goal has a series of objectives underpinning them:

Goal 1: Develop new and improved vaccines.

Goal 2: Enhance the safety of vaccines and vaccination practices.

Goal 3: Support informed vaccine decision-making by the public, providers, and policy-makers.

Goal 4: Ensure a stable supply of recommended vaccines, and achieve better use of existing vaccines to prevent disease, disability, and death in the United States.

Goal 5: Increase global prevention of death and disease through safe and effective vaccination.

Public input is specifically sought in response to the following questions, set forth in the introduction:
First, are the goals and indicators appropriate? Should the plan be fully achievable, aspirational, or a combination of the two?
In particular, we would appreciate some recommendations for the numeric targets for the indicators – in particular suggestions on how we ultimately set the targets.
We would also appreciate comments on the overall vaccine and immunization enterprise described in the draft strategic Plan, recognizing that the implementation plan will follow shortly.
Finally, we would appreciate guidance regarding how to think about the concept of ‘accountability' for non-federal stakeholders that are part of the plan, because their role is so critical.

However, I emphasize that public comments should go beyond these particular questions.
Safety must pervade all 5 goals.
Money should not be invested in vaccine development unless assurance is given that existing as well as new vaccines are truly safe,
individually and as part of the ever expanding vaccine regimen.
Honest communication requires a clear statement that the safety of the vaccine schedule has never been demonstrated;
therefore the schedule must be regarded as an unethical experiment and true informed decision-making weighing risks and benefits is not possible.
The world will increasingly reject vaccines not perceived as safe in developed countries.

In short, the Plan must propose and implement an aggressive “safety first” safety system that contains the following components:

1. Sound science.
2. Independence.
3. Meaningful oversight.
4. Transparency.
5. Accountability.
6. Honesty and integrity.
7. Adequate safety net.

A “safety first” agenda must be the cornerstone of this country's program of mass immunization.
Rapidly growing doubts undermine public confidence, threaten the benefits of vaccines, and risk return and spread of preventable infectious diseases.

1. Sound science.
The heart of an effective safety system is sound science.
The vaccine schedule has never been proven safe in animal or human trials that compare both the acute and chronic health status of vaccinated versus unvaccinated individuals.
The schedule must therefore be regarded as an unethical experiment.
Ethical codes from Hypocrites to Nuremberg and their modern embodiments in law emphasize the physician's duty to the individual patient, especially the mandate to avoid harm,
and must not be replaced or overwhelmed by one-size-fits-all industrialized medicine or a public health preference for herd immunity.
The NVP must include an extensive research program that entails both prospective [e.g., National Child Health Study] and retrospective studies in humans and animals.
It must be a comprehensive program, not just a single study, and must include research on mechanisms of immunity and adverse events and investigations on how to prevent and treat adverse effects.

Adequate safety science is decades late.
Gaps in our knowledge have and will continue to undermine public trust, as well as over-interpretation and “spin” put on the flawed and fraudulent studies conducted and funded by CDC.
The continued benefits of mass immunization can not be justified by “acceptable” levels of collateral damage.
The burden of both acute and chronic vaccine-caused injury must be determined and continuously monitored so that changes can be made in vaccines
(e.g., removal of heavy metals and viral interaction), the schedule (e.g. spreading out multiple vaccines), public health policy
(e.g. greater reliance on anti-virals and other prophylactic measures), administration, and screening of children with a genetic susceptibility to minimize adverse events.
This is not only an ethical obligation but a legal duty as set forth by Congress in Section 27 of VICA.

2. Independence.
As noted above, the ethically required studies on the safety of the vaccine schedule have never been done, primarily because those charged with safety research are also charged with vaccine development and promotion, a certain conflict of interest.
CDC has conducted and/or funded a series of studies purporting to disprove any connection between vaccines and autism.
These all suffer from serious design and methodological flaws including over-interpretation of results.
In one major study, Safety of Thimerosal-Containing Vaccines, Verstraeten et al (2003), protocols and inclusion/exclusion criteria were changed following initial results that showed an association between mercury in vaccines and neurodevelopmental delays including autism.
Documents revealed under FOIA show that this post hoc data manipulation was done after review of initial findings in a secret meeting with vaccine companies explicitly to conceal any “signal” of adverse events.
These revelations of scientific fraud have been detailed in Evidence of Harm by David Kirby and in articles by Robert F. Kennedy, Jr.
The lead author eventually published a retraction of any “no causation” interpretation in Pediatrics and called for additional research.

The safety system must be completely independent of CDC, the agency charged with promoting vaccines.
Structural separation of safety from promotion has been implemented long ago for agencies such as the National Transportation Safety Board, the Consumer Product Safety Commission, and the Nuclear Regulatory Commission (VSC) to avoid both the appearance and reality of conflicting interests.
Tom Insel, Chairman of the Interagency Autism Coordinating Committee and Director of NIMH, explained at an IACC meeting January 14 that HHS has a conflict of interest in conducting vaccine safety research because it is the “client” in Vaccine Court in order to help CDC delete a comprehensive program of vaccine safety research from the strategic plan for autism research.
Accordingly, a new Vaccine Safety Commission must be established which is independent of HHS.
It should have a separate budget from Congress of at least $100 million annually.

3. Meaningful oversight.
Vaccine policy is presently set by three committees composed almost exclusively of representatives from public health, academia, industry, and stakeholders with a financial interest in increased consumption of vaccines, with only token representation from parents and the vaccine safety advocacy community.
The new Vaccine Safety Commission must be overseen by parents, the only group with an unyielding commitment to the health of their children and by representatives from the vaccine safety community. \
Parents who favor full vaccination and parents who have concerns over vaccine safety share a common interest in the safest possible schedule.
Avoiding acute and chronic adverse events is absolutely crucial to maintain high coverage rates thereby reducing the risks from infectious disease.
The Commission should have available advice from industry, academia, doctors, and public health professionals, but the final decisions must be left with those most committed to healthy children and those free of both the appearance and reality of financial conflicts.

4. Transparency.
The present secrecy surrounding vaccine safety data is anathema to public confidence.
The taxpayers have paid for the FDA/CDC VAERS system and the CDC's Vaccine Safety Datalink (VSD) since 1991 and they are hailed as the premier databases for assessing vaccine safety. Yet these vital data are kept secret from the public and researchers independent of CDC and industry.
For example, critical VAERS data on vaccine distribution, necessary to calculate adverse event rates, is withheld by FDA, who claims it is an industry “trade secret”.
Indeed, in part to keep VSD away from FOIA and Congressional subpoenas, CDC moved the database to the “custody” of a trade association of HMO's.
Petitioners' counsel and their experts can't even gain access to VSD for purposes of effective case presentation in Vaccine Court.
In 2005, IOM recommended transparency of VSD but to date these data remain a closely guarded secret.
VSD and all industry data submitted pre- and post-licensure to FDA must be made public on an ongoing basis.
CDC, NIH, and Congress have noted serious flaws in VSD.
It should be upgraded from “administrative” (billing records) to a research quality database by, e.g., linking mothers and children, including maternal exposures,
long-term tracking of children and their health outcomes, standardized diagnostic criteria, and inclusion of unvaccinated children and their waiver status.
Appropriate debates over interpretation should occur in the open scientific literature and not behind closed doors.

5. Accountability.
The new Vaccine Safety Commission must have the authority to clear vaccines for inclusion on the schedule, remove them from the schedule, and approve the Vaccine Information Statements on risks and benefits and other information which by law must be given to parents and patients prior to vaccination.
Moreover, vaccination must remain voluntary, not only because this is a basic ethical requirement, but because the right of refusal is a powerful motive toward safer vaccines.
Religious, medical, and philosophical exemptions must be available in every state.

6. Honesty and integrity.
HHS has conceded (in secret settlements) and the Vaccine Court has held (in at least 12 published decisions) that vaccines can cause autism.
The question now shifts to how many children have been injured and what are the appropriate biomarkers to use in determining entitlement to compensation.
Yet, HHS dishonestly states as late as a February 20 statement: “ SEQ CHAPTER \h \r 1The government has never compensated, nor has it ever been ordered to compensate, any case based on a determination that autism was actually caused by vaccines.”
Such denial is unacceptable and is guaranteed to undermine public trust.
HHS must publicly admit, and include on VIS's and other materials that vaccines can cause autism.
Such admission will help stimulate necessary safety research and encourage parents to work with their pediatricians to take precautions where indicated.
VIS's must also clearly state that the safety of the schedule has not been proven by comparison to unvaccinated animals and humans, and that the schedule must be regarded as experimental. They should also describe the health status of children included in industry trials and state that safety has not been verified in less healthy children; and list the contraindications and adverse events as contained on the FDA-approved label. Communicating the benefits of vaccines with accurately disclosing their risks and gaps in safety knowledge is dishonest and further undermines public trust.

7. Adequate Safety net.
No vaccine or schedule can be made perfectly safe.
To preserve the benefits of full vaccination, society has a legal and ethical duty to generously compensate those injured by vaccines, in effect “collateral damage” in the war against infectious disease.
The tort law system under state law is the traditional means of motivating product safety and compensation of the injured. Congress replaced this with the Vaccine Court and VICP in 1986 in order to serve the twin goals of protecting industry from “excessive” litigation and protecting public confidence in vaccines by implementing a non-adversarial family-friendly no-fault compensation program.
The failure of VICP to largely achieve this second goal is and will continue to undermine public acceptance of full vaccination.
Necessary changes include: making the program optional; increasing the statute of limitations to at least the traditional state limits; preserving the right to “opt out” of the program before or after decision to pursue traditional tort remedies; faithfully implementing the Congressionally mandated lower burden of proof by resolving scientific doubt in favor of petitioners; providing for discovery and juries; providing timely compensation to lawyers and expert witnesses; no limits on compensation for pain and suffering or death; and providing that awards to children will be administered through trusts independent of Government.

An effective safety system, as outlined above, is an essential part of the National Vaccine Plan.

Are You Concerned About Vaccine Safety Research?

Your support is needed to insure that vaccines are as safe as possible.
Please see the following recommended talking points for submitting comments via email or telephone during the audio conference:

The CDC's vested interests in vaccine promotion precludes their ability to conduct unbiased vaccine safety research.
This research must be overseen by an independent agency and conducted by unbiased researchers.
Parent stakeholder involvement in all aspects of research is paramount in this process.

The CDC's ISO lacks the budget and infrastructure to conduct adequate safety research and relies on the flawed and deficient VAERS and VSD databases to detect adverse effects.
The funding of safety research must be increased and based on sound datasets capturing all potential adverse events.

In the interest of transparency, the unrestricted use of CDC's VAERS and VSD datasets must be made available to outside,
independent scientists immediately in a manner that preserves patient privacy.

The ISO studies vaccine safety only after a vaccine has been licensed, relegating safety as secondary to vaccine promotion. Vaccine safety policy should ensure that comprehensive research is transparent to the public and conducted to examine the effects of the total vaccination schedule, not just individual vaccines, before licensure.

NVPO must ensure that a comprehensive program of vaccine safety research is initiated through the establishment of the expert panel recommended by the Writing Group,
which shall be charged with recommending an array of research on health outcomes in vaccinated versus unvaccinated populations.

The treatment of our children as guinea pigs in the ever expanding and untested vaccine schedule is unethical.
Billions of dollars are spent to license, promote and pay for vaccinations, while the CDC shamefully spends only about $20 million annually for safety research.
At a minimum, vaccine safety should have the same priority as vaccine development and promotion.
The U.S. government needs a “Safety First” agenda for vaccines.

Scientists like Dr. Wakefield, have been persecuted for conducting safety research where findings are viewed as unfavorable by those with vested interests in vaccine uptake.
The U.S. government must support scientists currently engaged in much needed safety research;
they must not be persecuted for conducting research that closes acknowledged vaccine safety research gaps.