Covid Vaccines Are Not ‘Robust’
To have a truly robust vaccine it must afford long-lasting immunity. It is with this category that the Covid countermeasures fall well short of any definition that can be equated to robust
According to a Science Translational Medicine paper, mRNA vaccines targeting Covid elicit robust antibody responses in the circulation, which support protection from morbidity and mortality.
The commentary fails to highlight the significant limitations of the mRNA-based countermeasures, a two-prong problem of durability and a mutating viral pathogen, meaning by month three or four the benchmark of protection, a surge in antibodies, wanes substantially.
The authors of the paper wanted to better understand mRNA vaccine mucosal response, and specifically, the extent to which mRNA vaccines, which are delivered intramuscularly, would bolster mucosal immune protection.
Enter this Science Translational Medicine assessment. Reviewing two bodies of research documented and published by Declercq et al. and Lasrado et al., involved the use of human nasal swab samples in both studies.
Declercq et al. demonstrate that repeated vaccination for COVID-19 promotes neutralizing antibodies in the nose. However, Lasrado et al. report no obvious increase in neutralizing antibody titers after booster vaccination.
It is a conflict for which the explanation, according to the papers and an editorial by Courtney Malo, Ph.D., senior editor, suggests may differ due to the number of SARS-CoV-2 vaccinations or exposures, time since last exposure and experimental approaches.
But undoubtedly, there is a conflict when it comes to mRNA vaccines administered intramuscularly and the subsequent mucosal immune response in humans.
Represented by Dan Barouch, Beth Israel Deaconess Medical Center, Harvard Medical School in Boston and colleagues, the authors of this paper were funded by the National Cancer Institute and the Massachusetts Consortium on Pathogen Readiness.
The authors continue to claim that the “current COVID-19 vaccines provide robust protection against severe disease but minimal protection against acquisition of infection,” yet TrialSite would raise a question about the definition of “robust protection.”
We do so because durability limitations have to impact the definition of robust.
Here, we must challenge Barouch and colleagues. TrialSite has covered numerous Barouch studies and acknowledges he and his colleagues are brilliant impactful researchers.
But it’s time to call out the required template Baroch and all the results must use to get published. It is similar to the way all authors addressing the present COVID-19 vaccines must refer to them as “robust.”
But these Covid countermeasures are certainly not meeting the criteria of what describes a truly robust vaccine.
Why do we say that?
Well, defining a vaccine’s impact as “robust” involves several interrelated factors that collectively assess its efficacy, durability, safety and public health influence. The primary factors include high efficacy and effectiveness.
This means efficacy in trials, meaning the vaccine afforded strong protection against the pathogen (SARS-CoV-2) in controlled clinical trials.
High efficacy rates, typically above 80-90% for severe outcomes, indicate that a vaccine performs well in ideal conditions. We must remember that the U.S. Food and Drug Administration did not require clinical trials for successive COVID-19 vaccines, only the first batch.
But we must also weigh effectiveness in real-world conditions to determine whether a vaccine is robust. After deployment, a robust vaccine shows strong effectiveness in diverse populations and real-world conditions, which can include different demographics, preexisting health conditions and environmental factors.
Next, to have a truly robust vaccine it must afford long-lasting immunity. It is with this category that the COVID-19 countermeasures fall well short of any definition that can be equated to robust.
A robust vaccine offers long-term protection, reducing the need for frequent booster doses. Longer-lasting immunity often signifies a vaccine’s capacity to establish a strong immune memory, which is especially important for endemic diseases or pathogens with seasonal patterns, such as influenza.
If boosters are necessary, a robust vaccine demonstrates a predictable and potent immune response to booster doses. Yet even with booster doses, study after study we have chronicled at TrialSite suggests the COVID-19 countermeasures are anything but robust.
Also, the definition of robust necessitates broad protection across populations. This means effective protection across all age groups, including vulnerable populations like the elderly, infants and immunocompromised individuals, who may have weaker immune responses.
Moreover, for viruses that mutate rapidly, such as SARS-CoV-2, a robust vaccine shows cross-protection against multiple variants or strains, providing broad immunity even when the pathogen evolves.
We have seen conflicting evidence of this latter point at best, yet the durability problem remains.
Another key measure of robustness is the product’s safety profile and need for low adverse event incidence. The vaccine should demonstrate a high safety profile with minimal and mild adverse events.
In addition, robust post-marketing surveillance that shows continued low incidence of adverse effects contributes to the perception of the vaccine as safe and effective. Here, we have seen an unprecedented surge of side effects.
It is true that this could be deemed proportional to the massive vaccination push during Covid, deploying countermeasures to a population of over 330 million people. Over 240 million would be deemed “fully vaccinated.”
Yet acknowledged problems of myocarditis alone in young men raise alarm; incidence of anaphylaxis, and neurological problems which are not yet formally acknowledged as a problem.
As part of the React19 Board now, I am privy to lots of information. We helped organize the Scientific Publications Directory which features over 3,600 peer-reviewed studies documenting severe side effects from the COVID-19 vaccines.
There are now over 10,000 papers covering some aspect of problem outcomes associated with the COVID-19 countermeasures.
At TrialSite, we estimate anywhere from 400,000 to just over two million injuries in the U.S.
To make matters worse the U.S. federal government under the Countermeasures Injury Compensation Program has given out less money to vaccine injuries than React19, a startup nonprofit only a few years old and with a limited budget.
This is beyond the pale of failure.
Yesterday, React19’s founders Dr. Joel Wallskog and Brianne Dressen discussed at an X Space event among other things, the dearth of support for persons struggling with severe chronic conditions associated with Covid vaccines.
Yes, a robust vaccine must have a strong favorable benefit-risk ratio, offering a clear health benefit that significantly outweighs any risk, making it especially suitable for widespread administration.
What’s ironic is the American people representing the “market” already know that the product does not fit this category. That’s why the uptake rates are so low now, routinely 20 percent or under.
But the experts just don’t get it. They think they are smarter than the public, but that’s really debatable.
The National Institutes of Health will allocate money to study why people don’t want the product and the answer lies right in front of them.
Other measures of robustness when it comes to vaccines include sterilization or that the vaccine reduces transmission, and in this way, the vaccines failed. True blame could be defected on the pathogen itself, that it mutates.
But we at TrialSite called out very early on, well before the vaccines were approved, this problem.
We raised the question, “How can a novel vaccine eradicate an ever-mutating pathogen?” It’s as if the scientists forget the basics, given the pressure to produce the antidote for Covid.
And, of course, the economic prize for success was instrumental, with about $4 trillion in total spent across the pandemic, and in the aggregate hundreds of billions on countermeasures.
Other measures we would include at TrialSite include adaptability and scalability for global use, Here again, the success of the countermeasures is questionable. Robust vaccines are easier to manufacture at scale and distribute globally, especially in low-resource settings.
Formulations that are stable at higher temperatures, for example, are easier to transport and store. This was NOT the case with mRNA vaccines that needed expensive, high-end refrigeration, and for the majority of a global population that resides in warm tropical low-and moderate-income country settings.
This author could go on and on with more requirement elements of what actually defined a truly robust vaccine.
From cultural and social acceptance to overwhelming cost-effectiveness, the vaccines produced by BioNTech and Pfizer as well as Moderna do not fit the category of a robust vaccine.
These authors are being disingenuous to keep repeating that mantra. It becomes a collective lie we tell ourselves.
What we can say is that these countermeasures were deployed in an emergency setting and they temporarily primed the immune system to help protect people against more severe bouts of Covid.
Anti-vax groups hate TrialSite for acknowledging that there is no question that the Covid mRNA vaccines helped save lives. And no, they are not bioweapons — that’s a myth created by some agitators out there looking for attention.
However, countering any COVID-19 vaccine positivity was the top-down dictatorial approach to medicine employed by the federal government during the pandemic, blocking early treatment off-label, embracing policies less any real evidence, a rush to standardize methods such as intubation and other factors that cost lives in the aggregate.
So, the COVID-19 vaccines helped, but the policies and procedures in the aggregate may have hurt more than helped the population, and the vaccines, at least the current ones, have likely outlived their shelf life.
The durability of the COVID-19 countermeasures, combined with the mutating pathogen — meaning waning protection, combined with most certain safety issues, cost and production and distribution challenges as well as social response equals something far less than robust.
That’s just the truth.
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Editor’s note: PSI would disagree with TrialSite and argue the Covid ‘vaccines’ did far more harm than good. As vaccines they were pretty much useless, but they do seem to be rather good at causing life-threatening medical conditions.
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