Covid jabs: new legal grounds for prosecution uncovered

Anyone who claimed the Covid jabs stopped infection or transmission, was making an off-label claim and should be made liable.

Remember when the Covid gene therapy injections came along, and we were all told to get them? How could we forget! And do you remember the reasons we were given for why this was so essential?

Here are a few reminders…

Protect, protect, protect

Ad campaigns appealed to your sense of duty and selflessness, with the implicit rationale that these Covid ‘vaccines’ would help ‘stop the spread’. There was even a point early on in the charade where people were led to believe that mass vaccination was the way out of lockdowns, masks and social distancing.

While exact percentages on the reason for getting injected vary, surveys show that many felt they had to get vaccinated due to external pressures, or to protect their loved ones.

Since 2021, your local authorities, GP, the media, and prominent public figures have consistently stressed the obligation to protect others through vaccination.

Dr. Anthony Fauci, for example, has highlighted that COVID-19 vaccines reduce virus transmission and are essential for controlling the pandemic, advocating for immunization to protect both individuals and the community. Justin Trudeau claimed that vaccinations safeguard not just individuals but also vulnerable populations like grandparents, while criticizing anti-vaccination views.

Emmanuel Macron emphasised the necessity of vaccines for public health, particularly for older people, and has promoted widespread vaccination efforts. Similarly, Olaf Scholz, the Chancellor of Germany, has supported vaccination campaigns to protect vulnerable groups. Ursula von der Leyen, President of the European Commission, has frequently discussed the critical role of vaccines in managing the pandemic and protecting those at higher risk.

But there’s a problem.

The vaccine manufacturers never said it would stop transmission

Manufacturers like Pfizer always stressed that their clinical trial was designed to evaluate only the efficacy of their COVID-19 vaccine in preventing diseases caused by the COVID-19 virus, which did not even include severe illness or death. Stopping transmission was not even an endpoint of the approvals studies. The product information of the manufacturers clearly does not mention any prevention of transmission.

That’s not all. Since these injections aim to produce antibodies when arriving in the bloodstream, vaccines against respiratory viruses will never prevent infection or spread as this happens via the nasal mucosa.

Even the FDA stated in a Dec. 11, 2020, press release announcing the authorization of Pfizer's COVID-19 vaccine that "at this time, data are not available to decide about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person."

But doesn’t the jab minimise symptoms?

Tragically, even the claim of a reduction of symptoms is only valid in certain age groups in the first few months after the injections and leads to a so-called negative efficiency. Later on, vaccination even increases the likelihood of infection as inefficient antibodies (IG G4) are generated. We now know that even the essential antibodies in the nasal mucosa (IG A) to create the first line of defense are reduced after the second shot. Long-term antibodies are not even created in the bone marrow, so unlike a measles infection, we have no further protection in later life.

A liability nightmare

At a committee meeting in 2021, Dr. Demetre Daskalakis, a senior CDC official, warned that administering the shot off-label could be dangerous for healthcare providers if something goes wrong. "Providers may not have immunity from [legal] claims," Daskalakis said. So health care providers administering the vaccine off-label were not to be granted liability protection under the Public Readiness and Emergency Preparedness Act (PHE, 2021), the agency said.

Dr Daskalakis: “Providers may not have immunity…”

That means providers could be sued by patients in the event of injury, or if something else goes wrong — legal actions they are protected from as long as they're administering shots by federal rules.

However, suppose a manufacturer seeks to promote a drug for off-label use in the US. In that case, they must submit a New Drug Application (NDA) or a Supplemental New Drug Application (sNDA) to obtain approval for that specific use. Suppose a company wishes to market a drug for an off-label indication in Europe. In that case, they must submit a Marketing Authorization Application (MAA) to the EMA, demonstrating that the product meets safety and efficacy standards.

Using a Covid gene injection to prevent infection or stop the spread is technically an off-label medical product use.

But what does this mean?

How prescribing off-label works

Imagine you have a medication approved to treat condition A. Still, your doctor thinks it might also help with condition B. That's off-label use in action! It's not unusual; studies suggest that about one in five prescriptions written today are for off-label uses. This can be a lifesaver when no approved treatments are available for a particular condition, but it raises some critical questions.

Legal requirements for off-label use

So, how does a healthcare provider navigate the murky waters of off-label prescribing?

Here are some key legal requirements they must consider:

1. Clinical judgment

First and foremost, physicians must ensure that the off-label use is in the patient's best interest. This means thoroughly assessing the available evidence supporting the off-label indication. It's all about making informed decisions that prioritize patient safety and well-being.

2. Insurance approval

Next up is the often-dreaded insurance approval. Health insurance companies may require prior authorization for off-label uses. Providers must demonstrate that the off-label use is medically necessary and backed by clinical evidence to get coverage. It's a bit of a bureaucratic dance, but one that's essential for ensuring patients receive the care they need.

3. Documentation

Finally, proper documentation is crucial. Physicians should meticulously document the rationale for off-label use in the patient's medical record, including any discussions about the risks and benefits. This not only protects the patient but also shields the provider from potential legal issues down the line.

Risks and consequences of off-label use

While off-label use can be beneficial, it's not without its risks. Here are some potential consequences:

A. Legal liability

If a patient experiences adverse effects from an off-label use, the individual illegally promoting it may face malpractice claims. Courts may scrutinize whether the physician, the politician, or the journalist acted within the standard of care, which can lead to severe legal headaches, such as:

• Criminal charges: individuals or companies can be charged with misdemeanors or felonies related to drug promotion laws. For instance, a company might plead guilty to a misdemeanor, resulting in significant financial penalties.

• Civil liability: there is potential for civil lawsuits from patients harmed by illegal off-label use, which can lead to compensatory damages awarded to those affected.

• Regulatory actions: regulatory bodies may impose sanctions, such as suspending or revoking licenses for healthcare providers or companies involved in illegal off-label promotion.

B. Promotion restrictions

Pharmaceutical companies are strictly prohibited from promoting their products for off-label uses. If they cross this line, they could face significant legal repercussions, including hefty fines and settlements for illegal marketing practices. It's a big no-no in the industry!

C. Punishments for misuse

Using a vaccine off-label, especially during public health emergencies like the Covid-19 pandemic, can have severe consequences. Healthcare providers promoting or administering vaccines outside their approved indications should face criminal charges.

Several settlements were reached with US authorities against pharmaceutical companies to resolve allegations of ‘off-label’ promotion of drugs in the past. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may be subject to civil liability under the False Claims Act as well as criminal penalties.

Patients have the right to take legal action

Off-label use of medical products do provide therapeutic benefits. In fact, this could have saved millions of lives in the pandemic through the use of ivermectin, hydroxychloroquine, and Zinc or even Vitamin D. However, healthcare providers should have navigated the legal landscape carefully. They had to ensure that the claim of using a Covid injection for anything but individual immunity was justified, documented, and compliant with insurance requirements to mitigate risks of legal repercussions.

This has never been done.

Promoting off-label uses, particularly for vaccines, must lead to serious legal consequences which enables the public to press legal charges against anybody who had or is still promoting or distributing the injections. All of us have the right to pursue legal action against healthcare providers, journalists, politicians, in fact anybody who promoted the use of Covid 19 injections for illegal or negligent off-label use. This applies especially if you’ve suffered harm as a result. This is necessary if we want to prevent a repeat of the Covid drama. The World Council for Health stands for a better way.

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Sources:

1. EEC, 2021; https://ec.europa.eu/health/documents/community-register/2021/20210311151284/dec_151284_en.pdf

2. EMA, 2024; https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/accreditation-conformity-assessment-bodies_en

3. Gelderloos AT, Verheul MK, Middelhof I, de Zeeuw-Brouwer ML, van Binnendijk RS, Buisman AM, van Kasteren PB. Repeated COVID-19 mRNA vaccination results in IgG4 class switching and decreased NK cell activation by S1-specific antibodies in older adults. Immun Ageing. 2024 Sep 14;21(1):63. doi: 10.1186/s12979-024-00466-9. PMID: 39272189; PMCID: PMC11401348.

4. HHS, 2021; https://www.hhs.gov/sites/default/files/pfizer-inc-covid-19-vaccine-contract.pd

5. https://apnews.com/article/fact-check-pfizer-transmission-european-parliament-950413863226

6. https://cdn.pfizer.com/pfizercom/2020-11/C4591001_Clinical_Protocol_Nov2020.pdf

7. Nguyen DC, Hentenaar IT, Morrison-Porter A, Solano D, Haddad NS, Castrillon C, Runnstrom MC, Lamothe PA, Andrews J, Roberts D, Lonial S, Sanz I, Lee FE. SARS-CoV-2-specific plasma cells are not durably established in the bone marrow long-lived compartment after mRNA vaccination. Nat Med. 2024 Sep 27. doi: 10.1038/s41591-024-03278-y. Epub ahead of print. PMID: 39333316.

8. Nordström, 2021; Risk of infection, hospitalisation, and death up to 9 months after a second dose of COVID-19 vaccine: a retrospective, total population cohort study in Sweden, Nordström, Peter et al., The Lancet, Volume 399, Issue 10327, 814 – 823

9. PHE 2021, https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx

10. Pollack, 2020; https://www.nejm.org/doi/full/10.1056/nejmoa2034577

11. Wikipedia, 2024; https://en.wikipedia.org/wiki/List_of_off-label_promotion_pharmaceutical_settlements

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