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Extending the shot to babies

TGA “EVALUATING” MODERNA SHOTS FOR BABIES AND TODDLERS.  WHAT’S THE RUSH?

Despite conclusive evidence that young children are at virtually no risk at all of severe complications or death from the virus, the TGA announced last month it is evaluating an application from Moderna to inject its experimental mRNA shots into the arms of babies as young as six months.

Currently, Israel is the only country that has approved the shots for this age cohort, although the US Advisory Committee is voting on the issue this week.

I can’t find anything online about Moderna running any clinical trials for this age bracket, although there Moderna was reported as saying last year that they were hoping to carry out their baby and toddler trials here in Australia.

Pfizer’s baby trials are being run in the US and according to reports, these have not been completed yet and the clinical trial group was fairly small.

According to the TGA’s media release: “the authorisation (for Moderna shots) would be for a two-dose regimen, with the possibility of extending it to a third dose”.

Why is this even being considered here in Australia, given the risks involved?

It is well-known that the messenger RNA-based injections have been linked to heart conditions such as myocarditis and pericarditis, particularly in young men.

Some countries have even said they won’t even consider shots in this age group “after some studies showed it was tied to a higher risk of the heart inflammation”, according to a report in the West Australian yesterday:

The FDA itself said recently that myocarditis is a known risk and that the clinical trials for these age groups WERE NOT LARGE ENOUGH TO QUANTIFY THE FREQUENCY OF THE INFLAMMATION.”

Moreover, the FDA has revealed that early trial data for 2-5-year-olds showed an efficacy rate of just 36.8% using the CDC case definitions, and 50.6% for the 6-23 month group.

So again, what on earth is the rush here?

Historically, young children and pregnant women were always excluded from early human trials, irrespective of the drug.

As I mentioned, children are virtually at zero risk of dying from this virus. They may test positive and even develop symptoms, but they get through it the same way they get through any other cold or flu.

There is simply no justification for the TGA to even consider extending the shot to a group this young.

Especially when we are talking about a radically new treatment that has never been tested on animals and for which there is no long term safety data.

The risk of harm to these vulnerable babies is just too great.

(This is NOT medical advice – Just my opinion!!)

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We were sold a huge lie

HUNDREDS OF LIFE-SAVING DRUGS HAVE EITHER RUN OUT, OR ARE ABOUT TO RUN OUT – WHY?

Australia is experiencing crippling mass shortages of hundreds of life-saving medications and a range of other healthcare products.

Since 2020, the TGA has listed in excess of 700 medicines as in limited supply.  Today, there are 290 medicines that are either ‘unavailable’ or in short supply.

Why is this happening?

Well it turns out that virtually all the world’s active pharmaceutical ingredients (APIs) and chemicals needed to manufacture essential medicines, are made in China.

In some cases, they are produced by just one Chinese factory!

Take piperacillin-tazobactam.  It is a critically important antibiotic that is made by a single factory in Hubei.

In 2016, an explosion destroyed it, causing a worldwide shortage that was later blamed for multiple deaths across Africa and Brazil.

Then there’s the single factory in Shanghai that makes a contrast dye needed for MRIs, CT scans and other life-saving diagnostic x-rays.

That factory has been shut down for months, again causing an ongoing worldwide shortage, including here in Australia.

The world is now over 90% dependent on China’s APIs for most of its essential medicines, including antibiotics, anti-cancer drugs and medications that treat cancer, HIV, asthma, heart problems, blood pressure, Alzheimer’s, Parkinson’s, depression and seizures.

Even India, a major pharmaceutical manufacturer, relies on China for around 80% of the active ingredients used in its products.

As one researcher put it: “it’s the nightmare scenario”, with the world starting to run out of drugs with no easy alternative sources.

A lot of the problem is secrecy.

Regulators don’t even know the full picture of where all the ingredients in our medications actually come from.

And that’s because companies consider their API manufacturers to be proprietary information.

In February, the FDA announced that one drug was in short supply but wouldn’t say which, because naming it would have revealed “supply chain trade secrets”.

Many companies even hold plant locations as a closely held trade secret.

According to the Senior Director of a US Pharmacist Association that tracks shortages, it’s the murkiness of the supply chain that makes it hard to prevent shortages.

“And again, we don’t know where a lot of those drugs are made” he said.

The implications of all this for Australia’s national security are simply staggering.

AS Air Vice-Marshall Blackburn said at a Joint Standing Committee in 2020:

“We import about 90 per cent of our liquid fuels, 90 percent of our medicines and we rely on foreign-owned and flagged ships for about 98 per cent of our trade.  The import dependency has been further compounded by the failure of past governments to mandate stockholding levels for any of these imports.”

Those “past governments” have left Australia in an utterly untenable position.

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