The New Covid Vaccine Trials. Has Moderna Just Crossed an Ethical Line?

New clinical trials raise questions we must ask but are unlikely to have answered.

Here’s the usual, now obligatory, disclaimer, before some anti-vaxxer nutcase gets a hold of this post and conflates it into something it isn’t. Medika Life fully supports the use of Covid vaccines to offer protection to at-risk sectors of our communities. Got it? Okay, now to the issue at hand, which relates to Moderna’s revelation yesterday. They have commenced a second round of vaccine trials, this time on children, some as young as six months.

The question, two actually, which immediately came to mind on seeing this, was the following.

  • What is the clinical justification for these trials? In other words, does the SARS-CoV2 virus pose a significant and proven threat to this demographic that would justify the risk?
  • What is the ethical justification for using an unproven EUA vaccine — remember no Covid vaccines have been granted a full license as they have been unable to comply with the rigorous trials required — on children and babies?

How does Moderna describe this trial?

Let’s establish first of all exactly what the trials entail and the demographic of the participants? In a press statement released on the 16th of March, Moderna announced the following.

Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participants have been dosed in the Phase 2/3 study, called the KidCOVE study, of mRNA-1273, the Company’s vaccine candidate against COVID-19, in children ages 6 months to less than 12 years. The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

As to specifics of the participants and the trial endpoints, Moderna goes on to say;

This Phase 2/3 two-part, open label, dose-escalation, age de-escalation (Part 1) and randomized, observer-blind, placebo-controlled expansion study (Part 2) will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart. The Company intends to enroll approximately 6,750 pediatric participants in the U.S. and Canada ages 6 months to less than 12 years.

In Part 1, each participant ages two years to less than 12 years may receive one of two dose levels (50 μg or 100 μg). Also in Part 1, each participant ages six months to less than 2 years may receive one of three dose levels (25 μg, 50 μg and 100 μg). An interim analysis will be conducted to determine which dose will be used in Part 2, the placebo-controlled expansion portion of the study. Participants will be followed through 12 months after the second vaccination. Vaccine effectiveness will either be inferred through achieving a correlate of protection, if established, or through immunobridging to the young adult (ages 18–25) population. Evaluation of vaccine safety and reactogenicity is also a primary endpoint of the study.

You can read the full contents of the Moderna release by following this link.

Establishing Risk. Is there any?

My initial response is based on being a parent. It is quite simply this and has nothing to with science, but rather logic and a desire to protect my children. Would I, if I were in possession of a six-month-old, knowingly expose that infant to unnecessary risk.

It’s important to establish facts here first before we go any further. Despite the turmoil surrounding Covid, the vaccine, and all the misinformation floating around on the internet, we still have a relatively good idea of what is fact and what is fiction. Figures don’t lie.

What percentage of Covid-19 deaths comprise children?

Surprisingly, or perhaps unsurprisingly, this data isn’t easy to come by. To assess risk from the SARS-CoV2 virus in children aged 12 years and under we’ve looked for data for this age demographic. One article quotes the following official figure of 172 children who had died as of Dec. 17.

The American Academy of Pediatrics (AAP) provides some useful US-based data that would on the surface appear to be reliable, taking into consideration how deaths are recorded and state-by-state data fragmentation which seriously hampers the collection of reliable health data across the US.

These state-level data are the most recent available, 3/11/21. The age limits that apply to the definition of a child vary from state to state. The link above will allow you to download the reports.

Hospitalizations (24 states and NYC reported)

  • Children were 1.3%-3.0% of total reported hospitalizations, and between 0.1%-2.1% of all child COVID-19 cases resulted in hospitalization

Mortality (43 states, NYC, PR and Guam reported)

  • Children were 0.00%-0.19% of all COVID-19 deaths, and 10 states reported zero child deaths
  • In states reporting, 0.00%-0.03% of all child COVID-19 cases resulted in death

By comparison, a total of 186 pediatric deaths from influenza had been reported to CDC during the 2017–2018 influenza season. In 2018, over 21,000 infants died in the United States. According to the Centers for Disease Control and Prevention (CDC), the leading causes were birth defects, low birth weight and preterm birth, maternal pregnancy complications, sudden infant death syndrome (SIDS), and unintentional injuries.

While Covid does pose a very small, but undeniable risk to some children, it is most certainly not their health that it impacts the most, but rather their levels of poverty. Unicef has this to say on the matter in a statement issued in 2020.

The global socio-economic crisis caused by the pandemic could push 142 million more children into monetary poor households in developing countries by the end of the year, according to projections as of November 2020. The total number of children living in poor households globally could reach just over 725 million in the absence of any mitigating policies. Nearly two-thirds of these children live in sub-Saharan Africa and South Asia.

So in terms of actual deaths, it is really difficult to form an accurate picture from pandemic data in the US. Data is hugely fragmented and methods of collection vary from state to state, so much so, that one year and a month into the pandemic, we still can’t say conclusively which blood groups are most at risk from serious covid. We also cannot ascertain beyond doubt, the age breakdowns for mortality, comorbidities, and other conditions that could have contributed to these children’s deaths,

The CDC tries to quantify the risk of hospitalization and death by age group in this chart, published in Feb 2021.

Chart courtesy of the CDC

So there would appear to be no exact way of determining specific and accurate numbers for the risk children face from Covid. We never expected to find any, given the data shambles, but what is clear, even if not precise, is that the risk is minuscule in terms of actual numbers.

And what about the safety of the vaccines?

We have to go there, don’t we, as the safety of the Covid vaccines is key to the whole debate. There are issues, or we wouldn’t be having this discussion. Some of the issues are based on ignorance, conspiracy nonsense, and a general mistrust of pharma and governments. Others are justified and an indictment of our desperate societies.

mRNA Technology

Much is written about this medical revolution that has the potential to change the efficacy of many drugs and the way we treat disease. The most important term in all these documents is the word “novel”. It refers to the fact that we are dealing with a new and as yet, unproven (long term) method for delivering, in this case, an instruction to our body’s cells to produce a programmed response. Both Pfizer/BionTech and Moderna have opted for this route for their “vaccines”.

Johnson and Johnson have opted for a more traditional approach for their vaccine and while I would still question the need to extend trials at this point to children using their vaccine, I would be far less concerned. My reasons are again, not based on science, but rather in simple logic and known facts.

The novel mRNA method of delivering instructions to our cells has not been thoroughly tested to its logical conclusion. Emergency Use Authorization or EUA, which is the status currently awarded to all Covid vaccines indicates the following.

The FDA appreciates the fact that these products have not been tested properly, but given the interests of public health and the weighted risk, have decided to allow the public early access to them.

We are all now part of a large global trial revolving around the long-term impact of mRNA as a delivery mechanism for medication. Hopefully, for the sake of the participants and the long-term future of this promising technology, things don’t go wrong between now and the next two to three years. You see, it can potentially take that long for side effects to become apparent, and that’s when dealing with conventional vaccines. It’s the reason vaccines take so long to achieve FDA approval. Time. There is no shortcut.

When it comes to mRNA-based medicines, we haven’t a clue what a safe safety window might be. That’s a fact not even the most brilliant virologist can argue. We are in largely unchartered waters, dealing with cutting-edge technology that impacts us on a genetic level. We are fiddling with biological systems we have barely begun to understand properly and hell yes, there is risk.

There always is, for anything new, and these are risks worth taking.

The future benefits of mRNA delivery to medicine are enormous. The potential applications of the technology are almost limitless. It is an exciting and daunting time to be alive, especially if your interests lie in the sciences. This does not however mean to say we can lose sight of the risks and simply throw caution to the wind.

It does not mean we unnecessarily endanger patient populations simply for the sake of testing new technology, which is suspiciously what the new Moderna trials look like.

Based on the available evidence, it makes no logical sense to expose a young child’s developing physiology to this kind of trial, where we are not merely testing the efficacy of a vaccine, but the tolerance of young systems to a novel medical intervention. The ethics of these trials are highly questionable as are the motivations of the supporting bodies that have actively requested the trials.

Updated on May 23, 2024 9:01 pm
Updated on May 23, 2024 9:01 pm
Updated on May 23, 2024 9:01 pm
The article lives hereThe New Covid Vaccine Trials. Has Moderna Just Crossed an Ethical Line?
Robert Turner, Founding Editor
Robert Turner, Founding Editor
Robert is a Founder of Medika Life. He is a published author and owner of MedKoin Healthcare Solutions. He lives between the Philippines and the UK. and is an outspoken advocate for human rights. Access to basic healthcare and eradicating racial and gender bias in medicine are key motivators behind the Medika website and reflect Robert's passion for accessible medical care globally.

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