TGA considers approving Moderna mRNA flu jab despite a 2.2% serious injury rate

By Alison Bevege

Moderna has a new influenza gene-vaccine that may seriously injure or kill 2.2 percent of recipients.

This sounds like an exaggeration. It’s not.

That is what Moderna’s own studies for mRNA-1010 “mFlusiva” show, as published in the New England Journal of Medicine.

Serious adverse events were reported in 2.2 percent of the recipients of mRNA-1010, during the Moderna-funded trial.

Here it is, see for yourself: Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults, by Leroux-Roels, I; et al.

Of the 20,350 people injected with mRNA-1010, 455 were seriously injured.

A “serious adverse event” is an injury that causes death, persistent disability, in-patient hospitalisation or other serious medical episode.

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The Moderna researchers hid the exact number of injuries from the published study, sticking with “2.2 percent”. It’s in a supplementary appendix that you can’t access without an institutional log-in.

But you can find it in a US Food and Drug Administration (FDA) memorandum here, in table 20 on page 54. Archived here.

You can also find tables with more granular descriptions of the injuries at that document.

Moderna reduced 455 down to 449 injuries in Table S8 of its paywalled supplementary document, included in journalist Maryanne Demasi’s analysis here.

Moderna’s trial investigators concluded only three of those 449 injuries were “vaccine-related”. The word “related” injects ambiguity, when there is none.

The investigators were a mix of Moderna employees and “independent” clinical trial investigators all of whom were directly funded by Moderna and Blackstone life Sciences, owned by Blackstone, the asset manager which spawned BlackRock.

The Moderna-funded trial used its direct employees on the same team as the independent investigators, ensuring that it was not independent at all.

The trial did not compare the Moderna product with an inert, saline placebo, but against a GSK flu vaccine: Fluarix (also known as Alpharix).

The GSK product harmed less people in the trial than the mRNA did: 392 died or were seriously maimed by GSK’s Fluarix out of 20,353 for 1.9 percent.

All participants in the trial were aged 50 or older.

For this level of risk, Moderna’s mRNA-1010 only gives an absolute risk reduction for influenza of 0.8 percent.

Australia is considering releasing mRNA-1010

Australia’s drug regulator the Therapeutic Goods Administration is now considering mRNA-1010 for authorisation in Australia.

You can see the landing page here.

The TGA ignored my media request asking whether they are going to approve a product with such an alarming potential risk of injury and death.

A better question would be: if they approve it, who is going to be liable for the injuries and deaths? Will the taxpayer again be on the hook as they were for the covid products?

The TGA refuses to publish the names of those within the agency who are directly responsible for approving these products.

Those people are known as the Delegate or Delegates of the Secretary of the Department of Health.

Under the Therapeutic Goods Act 1989, the Department’s Secretary is the one who holds the statutory power to decide whether to register a medicine. They have the legal power to delegate this authority, to the person who actually signs the approval decision.

It is important to know exactly who is responsible for signing these decisions.

Without knowing their names, you can’t know if they are compromised by ties to the companies involved, and you can’t take legal action for redress if injured.

This is the exact defense that was recently heard in Federal Court during the Covid Vaccine Class Action led by Whitsunday Doctor Melissa McCann.

Moderna jumps the queue at the FDA

Moderna used a Priority Review Voucher to force the US drug regulator, the Food and Drug Administration (FDA) into an expedited six-month review timeline instead of the standard 10-month review.

These vouchers are typically awarded to companies to expedite treatments for things like “neglected tropical diseases” for which there isn’t any existing help.

But once a company has a voucher they can sell it to Big Pharma and it can be used for anything.

They typically sell for up to US$100 million, which gives you an idea of what it’s worth to Big Pharma to shave four months off the safety review process.

Why the FDA chose to approve these shots with no true placebo and a hugely high injury rate is a question for Health and Human Services Secretary Robert F. Kennedy Jr, head of the over-arching body that oversees all the US health departments including the FDA, NIAID, NIH and Barda.

Kennedy has been increasingly isolated as his lieutenants have been forced out, one by one, and his reforms have been blocked in the courts.

For more on the controversial FDA authorisation of Moderna’s mRNA-1010 product and the isolation of HHS Secretary RFK Jr, see Highwire journalist Jefferey Jaxen’s analysis Is FDA’s New mRNA Flu Shot Approval Proof of Agency’s MAHA Purge?

The FDA’s Acting Commissioner is now Kyle Diamantas, the former Deputy Commissioner for Food who was Kennedy’s Senior Counselor. He replacedMarty Makary who resigned in May.

Journalist Maryanne Demasi has written that the FDA’s own briefing document “exposes clear regulatory malfeasance” because they used pooled data to hide the safety signal in her piece FDA’s botched review of Moderna’s flu mRNA vaccine.

20 years of evidence show flu vaccines don’t really work

Injected influenza vaccines are notoriously ineffective because they provoke blood-borne antibodies which are not useful for fighting off infections that come in through your mucosa.

They don’t stimulate mucosal immunity which is what you need to fight off respiratory-spread infections.

The Cochrane Collaboration was long regarded as the gold standard of science, the peer-reviewer of peer-reviewed studies.

Three separate Cochrane reviews over 20 years have looked at all the evidence for the traditional influenza vaccines, and have concluded there is little evidence that they do much of benefit at all.

“Current yearly registration of candidate influenza vaccines is based on their ability to trigger a good antibody response. But antibody responses are poor predictors of field protection. This is another example of the use of surrogate outcomes in biomedicine, where effects on clinically important outcomes remain unmeasured or unproven from randomised trials: complications and death by influenza,” the Cochrane reviewers wrote.

They are not even certain what causes “influenza-like illnesses”.

In the course of their reviews, Cochrane noted that influenza vaccines make you more (not less) likely to contract other respiratory illnesses.

Now, thanks to mRNA, we can add “dangerous” in addition to a shot that’s not really working.

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If you wish to voice your concerns about the mRNA technology directly to the TGA, their contact details are as follows. Be polite and factual only, please.

Therapeutic Goods Administration general line: 1800 020 653 call 9am to 5pm Australian Eastern Time, Monday to Friday only.

From overseas: +61 2 6289 4124 or Fax: (02) 6203 1605. Email: Email for general enquiries: info@tga.gov.au

Write a letter to: TGA, PO Box 100, Woden, ACT, 2606

TGA street address for couriers is the Gulgana Building, 27 Scherger Drive, Fairbairn ACT 2609, which houses the departments handling medical devices and prescription medications authorisation.

Or complain via their online complaints form: https://www.tga.gov.au/contact-us/complaints