Safer Childhood Vaccines Task Force?

What happened?

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Disclaimer: I am not an attorney; this is my opinion and interpretation.

Why haven’t we heard of the “Safer Childhood Vaccines Task Force”, or SCVTF?

Why isn’t the SCVTF operating alongside the Vaccine Adverse Event Reporting System, VAERS, and the National Vaccine Injury Compensation Program, NVICP?

The same legislation that established VAERS and the NVICP also called for the creation of a Safer Childhood Vaccine Task Force, SCVTF.

National Childhood Vaccine Injury Act

When I am discussing the vaccine safety issue, I often point out that the fact that some children are harmed or killed by routine childhood vaccinations is memorialized in the title of the act.

The formal legislative title is the “National Childhood Vaccine Injury Act”, or NCVIA.

It was not named the “National Parents Imagining, Hallucinating, or Faking Childhood Vaccine Injuries Act”. https://www.congress.gov/bill/99th-congress/house-bill/5546

I highly recommend that everyone at least skim the legislation to understand what happened versus what was supposed to happen. https://www.hrsa.gov/sites/default/files/hrsa/vicp/title-xxi-phs-vaccines-1517.pdf .

On Thursday, January 4^th, The Highwire with Del Bigtree featured a historical retrospective about the lead up and subsequent passage of the NCVIA in the 1980’s. https://thehighwire.com/ark-videos/1986-the-untold-story/ .

The episode centered on an interview with Barbara Lo Fisher, a key figure in the development of the legislation, and one of the founders of the National Vaccine Information Center, https://www.nvic.org/newsletter/jan-2024/1986-myths-vs-facts .

I don’t have any specific knowledge regarding the origin of the legislation, and if there was any way that it could have been prevented. I know from my personal experience that when Public Health Pharma desires legislation to be passed, they will do and say anything, true or false, to achieve that objective.  

This program reminded me of research I did in 2018 about the NCVIA, when the Informed Consent Action Network, ICAN, obtained a legal stipulation from Health and Human Services and the National Institute of Health that neither agency could provide documents responsive to the agencies’ compliance to the requirement to establish a Task Force and submit progress reports biannually to the Congress, as directed by the section, shown below. https://icandecide.org/article/stipulated-order-showing-that-nih-and-hrsa-have-not-acted-in-their-duties-regarding-vaccine-safety/  

(Bold type added).

MANDATE FOR SAFER CHILDHOOD VACCINES

SEC. 2127. ø300aa–27 (a) GENERAL RULE. — In the administration of this subtitle and other pertinent laws under the jurisdiction of the Secretary, the Secretary shall—

(1) promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on the effective date of this part, December 22, 1987, and promote the refinement of such vaccines, and

(2) make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines

(b) TASK FORCE. —

(1) The Secretary shall establish a task force on safer childhood vaccines which shall consist of the Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, and the Director of the Centers for Disease Control.

(2) The Director of the National Institutes of Health shall serve as chairman of the task force.

(3) In consultation with the Advisory Commission on Childhood Vaccines, the task force shall prepare recommendations to the Secretary concerning implementation of the requirements of subsection (a).

(c) REPORT. — Within 2 years after the effective date of this part December 22, 1987, and periodically thereafter, the Secretary shall prepare and transmit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursuant to subsection (a) during the preceding 2-year period.”

The 2018 ICAN stipulation documented that the task force had never been convened, therefore none of the work product that was supposed to improve vaccine safety could have been accomplished.

Shortly after, in early 2019, there were several congressional hearings held with the premise to address growing “vaccine hesitancy”, and misinformation. You may recall one hearing featuring an 18-year-old boy from Ohio named Ethan Lindenberger, who had been raised without vaccines. Lindenberger’s claim to fame was a desire to assert his adulthood by getting vaccinated, a decision celebrated by the legislators and media. https://www.npr.org/2019/03/06/700617424/18-year-old-testifies-about-getting-vaccinated-despite-mothers-anti-vaccine-beli

During one of these hearings a stack of papers was presented to a committee chairman, and represented to be 2 or 3 of the required biannual reports that the HHS & NIH were unable to locate during ICAN’s FOIA request.   

One of the pundits on the freedom side claimed that ICAN had screwed up, and that the reports produced at the hearing were applicable. Of course, if that was true, it meant that HHS and NIH had violated FOIA laws by not returning accurate data when ICAN requested. That accusation of ICAN’s error caused me to dig in to see what I could find.

This section of the legislation acknowledges the understanding in the bill that by removing civil liability for injury the responsibility for safety shifts from the manufacturers to the Government, and this section is part of how that safety was supposed to be achieved.

Consider the composition of the Task Force. The members are top officials in each of the agencies- Directors of the CDC and NIH, and the FDA commissioner.

It doesn’t say, “The CDC / NIH / FDA will provide personnel to staff a task force”.

This conveys the contemporary, perceived importance of the section, “MANDATE FOR SAFER CHILDHOOD VACCINES”. The title of this section is again revelatory- a mandate to make vaccines safer indicates they are not currently safe enough.

These agency personnel designations also guarantee that had the Task Force been convened it is impossible it could have avoided documentation. These individuals all have calendars, and even if all they did was to get together and say, “We don’t see a problem”, that meeting would have been memorialized in multiple places- appointment books, location reservation, minutes, etc.

Two Agency Directors and a Commissioner could not meet anonymously.

Then NIH director James B. Wyngaarden was to chair the Task Force. The FDA Commissioner was Frank Young, and CDC Director James Mason were to man the task force.

Note there is no time limitation or expiration for the task force, making it a permanent component, like the Vaccine Adverse Event Reporting System, VAERS, and the National Vaccine Injury Compensation Plan, NVICP, also established in the NCVIA, HB 5546.

So, when a congressman or senator who was looking for reassurance that safety would not be lost with the removal of tort litigation market forces, were they told, “There is a top tier task force that will be taking over all aspects of safety”?

The “Mandate for Safer Childhood Vaccine Task Force” would not have been just those three agency heads getting together occasionally to talk shop.

The properly formed task force would have teams of staff from the three agencies, each specializing in their areas of expertise, and coordinating to create safer and safer product by fulfilling the requirements of (a) above:

(1) promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market

“make or assure improvements in, …, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines”…

This task force was supposed to be an active, significant organization, making, and then reporting their progress biannually to both the, “Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate”.

Perhaps a look at another multi-agency task force that was established during the negotiation period of the NCVIA could be instructive, as it might be what some legislators thought would be the model for the Safer Childhood Vaccine Task Force.

“The Organized Crime Drug Enforcement Task Forces (OCDETF) Program was established in 1982 to mount a comprehensive attack and reduce the supply of illegal drugs in the United States and diminish the violence and other criminal activity associated with the drug trade.” https://www.justice.gov/ocdetf  https://www.dea.gov/operations/ocdetf 

What does a multi-agency task force look like? For the OCDETF, it is almost 3,000 employees.

What could have happened had the “MANDATE FOR SAFER CHILDHOOD VACCINES” Task Force been convened, staffed at 10% or even 5% of the OCDETF – 150 – 300 employees- and operated in an honest and ethical manner?

One of the first tasks would be to establish the (then) current safety profile so that improvement could be quantified, determine the types of injuries and their various etiologies to know where effort and energy should be focused, etc.

What would have happened if the Task Force had done the work?

What would have happened if full time, dedicated employees from these 3 agencies took the direction of “MANDATE FOR SAFER VACCINES” Task Force seriously and modeled themselves after The Organized Crime Drug Enforcement Task Forces?

Imagine each agency aggressively, or even just competently, fulfilling the mandate?

Could that Task Force have been a multi-agency “red pill” nearly 40 years ago, pre-empting the most disastrous decline in children’s and national health we have experienced?

My takeaway from my research was that the Congress did not just recklessly abandon vaccine safety to the pharmaceutical companies in the legislation without an effort to mitigate the loss of the market forces.

The abandonment was later, when they failed to require the Secretary of the HHS to follow the law and convene the SCVTF.

The plain language of the bill details that an entire organization dedicated to the continual improvement of vaccine safety was supposed to have been stood up.

Regulatory oversight of this scope and type for the monitoring of a product that is required for children to attend school, a product that can cause possible adverse effects, is so common sense that most people assume something like this is already in place.

Any responsible person designing a vaccination program from the ground up would automatically include the components of the Safer Childhood Vaccine Task Force.

Most people are shocked to learn that vaccine safety is functionally voluntary for the vaccine manufacturers.

People mistakenly think the FDA has labs and performs independent testing when licensing a manufacturers’ product. This is false.

The FDA reviews the documentation of testing performed by the pharmaceutical manufacturers or their subcontractors. The challenge here is that the system is based on trust and honesty by the manufacturers.

The British Medical Journal recently published an article titled:

“Time to assume that health research is fraudulent until proven otherwise?”

“Health research is based on trust. Health professionals and journal editors reading the results of a clinical trial assume that the trial happened and that the results were honestly reported. But about 20% of the time, said Ben Mol, professor of obstetrics and gynaecology at Monash Health, they would be wrong.”

https://blogs.bmj.com/bmj/2021/07/05/time-to-assume-that-health-research-is-fraudulent-until-proved-otherwise/  

This reason is why the tort system is critical for keeping unsafe products off the market.

A future post will excerpt a documentary about how litigation was the only way to get the FDA to follow its own rules for adding black box warnings for drug safety about a conventional pharmaceutical. And how litigation is a vital part of the regulatory system, working in conjunction during the phase 4 market release of a new product.

As always, I am open to updates and corrections.

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