Tag Archives: Nicole Shanahan

Vaccines poorly-tested because FDA is funded by Big Pharma?!

Nicole Shanahan : Vaccines Poorly-Tested Because FDA Is Funded By Big Pharma!

Vice Presidential candidate, and Robert F. Kennedy Jr.‘s running mate, Nicole Shanahan just claimed or suggested (archive) that vaccines are poorly tested because the US FDA is partly funded by pharmaceutical companies!

Our only protection from poorly tested vaccines is our regulatory agencies like the FDA. Yet, 46% of the FDA’s total operating budget is funded by pharmaceutical companies. This is what is meant by AGENCY CAPTURE.

A Kennedy-Shanahan administration will end the rampant conflicts of interest in the regulation of the medicines and vaccines we need. We can reverse the explosion of chronic diseases in our population by demanding that drugs and vaccines undergo proper, long-term testing. We will make manufacturers responsible for the damage caused by their products, so they are again incentivized to make them as safe as possible.

Truth : Vaccines Are Properly Tested Even Though FDA Is Funded By Big Pharma!

This is unfortunately more misinformation by the Vice Presidential candidate, and Robert F. Kennedy Jr.‘s running mate, and here are the reasons why…

Fact #1 : Vaccines Are Not Poorly Tested

Let me start by pointing out that there is no evidence that the FDA ever approved any “poorly-tested” vaccine. Nicole Shanahan certainly provided no evidence that the FDA has ever done that, although the insinuation appears to be that there is “rampant conflicts of interest” due to “AGENCY CAPTURE”.

Even the COVID-19 vaccines, which were accused of being “rushed”, underwent massive clinical trials, and were only approved after they were shown to be safe and effective. To date, there has been no evidence that those clinical trials were compromised in any way by the pharmaceutical industry’s funding of the US FDA.

Fact #2 : FDA User Fees Improve Efficiency

In her post, Nicole Shanahan shared a screenshot of an article titled Why is the FDA Funded in Part by the Companies It Regulates?, but oddly enough did not provide a direct link to the article itself.

Perhaps that’s because the May 2021 article by C. Michael White of the UConn School of Pharmacy explained how user fees have helped to improve efficiency at the US FDA.

Because of the additional funding generated by user fees and performance measures that the FDA has to meet, the FDA is quicker and more willing to discuss what it wants to see in an application with manufacturers. It also offers clearer guidance for manufacturers.

The author also pointed out that FDA user fees are “a viable way to shift some of the financial burden to manufacturers who stand to make money from the approval and sale of drugs in the lucrative U.S. market.”

Fact #3 : User Fees Don’t Affect Regulations

The user fees that the US FDA charges go towards paying people and other related costs of assessing and either approving or denying new drugs, vaccines, and medical devices.

They don’t affect its review process, as the FDA explained in its article that has been around since October 2022:

For products where premarket review is required, there are standards for FDA product review that are written into law and that the agency follows regardless of the source of funding. The FDA’s work, high standards, and decisions are guided by science and focused on protecting and promoting the public health.

Importantly, there is no direct connection between a fee paid to submit an application and the review outcome for that application. The fees are not a “fee-for-service” payment. Rather, the user fees, including application fees, are authorized by Congress to help the FDA fund payroll and related costs to deliver on program goals.

User fees provide the FDA with supplemental resources for reviewing product applications based on the scientific and clinical evidence, and for conducting related activities.

While the agency strives to meet the review timeline goals established as a part of the user fee program agreements, the timeline does not force the FDA to decide on a product application before the agency’s work is complete. If additional work is necessary, the FDA continues working past the applicable goal date. The user fee performance goals anticipate this may happen and do not count on meeting the timeline 100% of the time.

Arguably, user fees help FDA improve its review of new drugs and vaccines, not the other way around.

Fact #4 : There Are Other Regulatory Agencies

I should point out that even if the US FDA is somehow compromised by its funding by pharmaceutical companies, there are other regulatory agencies in other countries like the European Medicines Agency (EMA), Health Canada, the Australian Therapeutic Goods Administration (TGA), the Japanese Ministry of Health, Labour, and Welfare (MHLW), etc.

Vaccines that are approved by the US FDA are only approved for use in the United States. They still need to undergo assessment by each country’s regulatory agency. All those foreign regulatory agencies are not funded by the pharmaceutical industry, and therefore, provide a kind of verification for the regulatory work done by the US FDA.

Fact #5 : FDA User Fees Are Used For Specific Purposes

FDA also pointed out that it is required by law to spend user fees only on specific activities:

The FDA is required by law to spend user fee funds only on specified activities. For example, human prescription drug user fee funds can only be used for activities specified in the law, which include monitoring of research, review of human drug applications and post-market safety activities.

Similarly, medical device user fee funds can only be used for activities specified in the law, which include monitoring of research, review of device applications, and a defined set of post-market activities.  

In short – FDA user fees are used to fund its critical regulatory and review activities, which would otherwise by paid for by taxpayers, instead of pharmaceutical companies.

Fact #6 : FDA User Fees Are Reauthorised By Congress

The user fees came about after the FDA was too slow in studying and approving experimental HIV drugs during the height of the AIDS crisis in the 1980s and early 1990s.

The US Congress then passed the Prescription Drug User Fee Act in 1992, which was signed into law by President George H.W. Bush. Since then, it has to be reauthorised every five years by Congress, before being signed into law by the President of the United States.

So even if the Kennedy-Shanahan administration does come to pass (which appears to be highly unlikely), it is highly unlikely that Congress would agree to provide additional funding to make up for the shortfall should user fees be eliminated.

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Nicole Shanahan is wrong about VAERS + vaccine injury payouts!

Nicole Shanahan : VAERS Is Organisation That Determines Vaccine Injury!

Vice Presidential candidate, and Robert F. Kennedy Jr.‘s running mate, Nicole Shanahan just claimed (archive) that VAERS is the organization that determines if someone was injured by a vaccine, and can be compensated.

In the United States, VAERS is the body that determines if someone injured by a vaccine can be compensated. Here’s the dirty truth: Tax payers cover all expenses for this (all legal fees and the payout), not the pharmaceutical company actually responsible for the injury.

That means these companies can make you sick, get paid huge profits from selling the injections, and the taxpayers are the ones on the hook for their mistakes. As the Covid vaccine is proven to be responsible for more and more injuries, this scheme promises to take our country even further into debt.

The correct course of action is to return to standard tort liability for all vaccine developers. It is the right thing for our country, for our budget, and is even in the best interest of the vaccine developers who will be held to a higher standard in safety.

Nicole Shanahan made those comments in response to a PeterSweden post about AstraZeneca facing $255 million in compensation for admitting that its COVID-19 vaccines can cause blood clots.

When told that she was wrong, Shanahan chose not to apologise for the mistake and post a correction. Instead, she doubled down (archive), insisting that VAERS is an organisation that defines vaccine injuries that can be compensated:

Seeing people want more information – GREAT! VAERS is an organization that defines what injuries can be compensated – yes it is a database. The payout, and the lawyers who represent the injured are paid by taxpayers via a sister organization VICP.

Truth : VAERS Is Not Organisation That Determines Vaccine Injury!

It is unfortunate that someone running to be Vice President of the United States not only responded to a known peddler of fake news, she appeared to be agreeing with him.

As the running mate of Robert F. Kennedy Jr., who is notoriously anti-vaccine, Nicole Ann Shanahan may be trying to impress him, or his supporters – many of whom espouse the same anti-vaccine rhetoric and opinions.

However, in doing so, she demonstrated her profound lack of knowledge. Here is what Nicole Shanahan needs to know about VAERS…

Fact #1 : VAERS Is A Reporting System

Let me start by pointing out that VAERS is an an acronym for the Vaccine Adverse Event Reporting System used by the United States Department of Health and Human Services (HHS).

VAERS is not a body that “determines if someone injured by a vaccine can be compensated”, as Nicole Shanahan claimed. It is an early warning system design to collect adverse event reports, to detect possible safety problems in U.S. licensed vaccines.

Fact #2 : VAERS Data Is Unverified

I should point out that VAERS is a passive reporting system similar to the British Yellow Card system, and it relies on individuals or healthcare professionals to submit reports of potential adverse reactions to vaccines.

While its open, catch-all design lets scientists catch very rare adverse events that even large clinical trials may not catch, VAERS is open to abuse as anyone from anywhere in the world can submit a report, and write anything they want.

In other words – VAERS data is unverified, and cannot be used to determine whether a vaccine injury has occurred, never mind determine whether someone should be compensated for that vaccine injury!

Fact #3 : VAERS Is Managed By CDC + FDA

VAERS is also not an independent or separate organisation. It is a database that is co-managed by the Centers for Disease Control and Prevention (CDC), as well as the U.S. Food and Drug Administration (FDA).

For Shanahan’s benefit, both the CDC and the FDA are agencies of the U.S. Department of Health and Human Services (HHS).

Hence, the official VAERS website is https://vaers.hhs.gov – it is using a subdomain under the official HHS government website domain.

Fact #4 : VICP Determines Vaccine Injury Compensations

As many people have pointed out to Nicole Shanahan, it is not VAERS – a database of unverified reports of vaccine adverse events, that determines whether someone should be compensated for a vaccine injury.

That job belongs to the National Vaccine Injury Compensation Program (VICP), which is under a completely different HHS agency – the U.S. Health Resources & Services Administration (HRSA). VICP is a program offering an alternative to the tort system for resolving vaccine injury petitions.

In fact, the VAERS FAQ specifically pointed out that the VICP is a separate program from VAERS.

Is VAERS involved in the Vaccine Injury Compensation Program?

No. The Vaccine Injury Compensation Program (VICP) is a separate program from VAERS and is administered by the Health Resources and Services Administration (HRSA). Reporting an adverse event to VAERS does not constitute filing a claim with the VICP. For more information about the VICP, call (800) 338-2382 or visit the VICP Web site.

VICP compensation is funded through excise taxes on covered vaccines, while expenses are paid through annual funding by Congress.

Fact #5 : COVID-19 Vaccines Are Covered By CICP

While Nicole Shanahan tried to cover her mistake by claiming that VAERS “defines” what injuries can be compensated, but it is VICP that pays the compensation, that’s not accurate since she was referring to COVID-19 vaccines.

Community Notes on X (formerly Twitter) are also inaccurate when it comes to vaccine injury compensation for COVID-19 vaccines, which are not covered by the VICP, but a separate Countermeasures Injury Compensation Program (CICP).

It is the 2005 Public Readiness and Emergency Preparedness Act (PREP Act) that authorises the CICP to provide benefits / compensation to people “who sustain a covered serious physical injury as the direct result of the administration or use of covered countermeasures” that were “administered or used under a PREP Act declaration“.

The PREP Act declaration for COVID-19 does not only cover COVID-19 vaccines, but also antiviral and biologic drugs, as well as diagnostic tools, used to diagnose, mitigate, prevent, treat, or cure COVID-19, or the transmission of the SARS-CoV-2 virus.

In addition to COVID-19, the CICP also covers compensation for:

acute radiation syndrome
anthrax
botulinum toxin
Ebola
Marburg
nerve agents and certain insecticides
pandemic influenza
Smallpox and other orthopoxviruses like mpox
Zika

The CICP is funded through separate Congressional appropriations that must occur each time a new countermeasure is designated.