Months and months after their primary series by either Moderna, Pfizer or J&J, Americans began anticipating an answer to waning antibody titers. Health authorities like the FDA, NIH, even pharmaceutical giant Pfizer, began to propagate a narrative they believed would ameliorate tension and be the answer to declining immunity. BOOSTERS. Thus, on 11/19/21 the FDA granted EUA (emergency use authorization) to Pfizer and Moderna so booster doses could be given to EVERY AMERICAN 18+ across the board. Is there enough evidence to support this reductionistic decision/methodology? Is this what other countries are doing? Will this really slow the spread like the professionals claim? The answers respectively, no🚫, no🚫, and of course, a resounding no🚫.
Let’s explore the first question. Is there enough evidence to support this reductionistic decision/methodology?
Before I elaborate, Let me make something very clear for you. There are no appropriate randomised, double-blind, placebo, controlled studies that show efficacy for boosting all individuals 18+ with either Moderna (50 ug) or Pfizer (30 ug).
💉Regarding Moderna, an FDA analysis justified boosters based on only small sample sizes comparing antibody titers of at best 156 individuals who received booster doses against individuals only having their primary series. That is bad because you can’t possibly extrapolate side effects from such small numbers (156). To elaborate, side effects like myocarditis or pericarditis are seen in 1/4000, 1/5000 persons. Clearly, the data from only 156 booster recipients couldn’t be reflective of side effects, or a large scale population, let alone justify boosters for the entirety of individuals 18+ living in the USA. Moreover, the aforementioned FDA analysis only defines “effectiveness” as the quality of antibody response against the SARS-CoV-2 virus. Yet again, an inappropriate metric to measure effectiveness of additional doses. Why? You see, if your definition of effectiveness is simply based on a blood test, that test is not taking into account side effects, hospitalization, and suffering experienced by the person(s) who received the treatment. Explained differently, by definition, you could technically have an “effective” vaccine based on a blood test, but it could simultaneously be harmful to the individual receiving it- we need to be very careful how we define things in medicine. Considering all salient facts, the definition of effectiveness needs to be based on not only LAB METRICS, BUT ALSO, SIDE EFFECTS, HOSPITALIZATION, AND DEATH when trying to expand the use of any drug, therapy, or vaccine- most certainly novel technologies to humans like mRNA vaccines. Finally, you can’t forget the fact that there is no data to show myocarditis risk after receiving Moderna’s booster in recipients aged 18-30 (see picture of FDA’s own data below). However, it is likely to be greater than 1 which may offset any benefit from people aged 18-30. To sum this up, the previously mentioned analysis is just that, an analysis. It is not adequate enough to justify making a sweeping medical change for so many people (boosters for all). Additionally, the data used by the FDA to justify boosters is not based on appropriate randmoised, double-blinded, placebo, controlled clinical trials. It’s based on a hundred and a half booster recipients with questionable endpoints. So, what about the other mRNA vaccine company?
💉Now, regarding Pfizer. Is there enough evidence to support giving 30 ug boosters? Interestingly enough, Pfizer’s own recent randomised, placebo, controlled trial of over 10,000 participants even says no. Two things. Much like the Moderna data analyzed by the FDA (see previous paragraph), the data in Pfizer’s phase 3 clinical trial supporting boosters only defines effectiveness as “…the reduction in disease occurrence…”. Again, defining effectiveness on only 1 metric (recurrence of disease), without also including harm done by the intervention, hospital admission, severity of side effects, and death is problematic as I detailed in the previous paragraph. Second, according to all current data, Pfizer’s mRNA booster doesn’t provide a net benefit compared to the effectiveness of Moderna overall. As Moderna and Pfizer are the same mRNA technology, with essentially the same mechanism of action, allowing boosters from the less effective jab (Pfizer) that provides no net benefit in protection compared to the other (Moderna primary series 2 doses 100 ug each), is not sound science. That is to say, the benefit from the Pfizer’s booster is unlikely to even match, let alone exceed the overwhelming effectiveness of competitor Moderna’s primary series. So to approve Pfizer boosters on such shaky ground implies we’re just approving treatments to approve them, even if they’re less effective to comparable pharmaceuticals. So what’s with all the lax regulation? As a side note, I will answer that question in two parts, BUT FIRST look at the images directly below.
💡Why the laxed regulation? Based on the previous pictures, two reasons are obvious.
👉🏻Number one, you don’t approve the use of a drug/therapeutic for everyone 18+ simply because it’s less confusing for the general populace. Dealing with the confusion is a job for regulatory agencies and healthcare professionals like the FDA, CDC, nurses, doctors, PA’s and NP’s etc. It seems these regulatory agencies are deflecting onus of responsibility because they truthfully don’t know what to do about currently waning immunity from the primary series of COVID-19 vaccines. Again, not sound science. All this is in response to the first picture I posted above. Essentially, it’s a quote from Peter Marks M.D. Ph.D, director of the FDA’s Center for Biologics Evaluation and Research. He explains why he gave the green light on boosters for everyone 18+, because it’s less confusing.
👉🏻Number two, the second picture is telling. Based on unknown myocarditis risk from Moderna boosters, approval should never have been granted to all individuals above the age of 18. Conversely, approval should have been granted only to specific groups of people 18+. To quickly explain, we know the risk of myocarditis is much larger in males aged 17-30. So is risk worth the benefit for this group? Likely no. Again, no data to support this sweeping public health change regarding COVID-19 vaccination. It seems these regulatory agencies lack data, so change is being based on speculation in leu of appropriate double-blind, randomised, placebo controlled clinical trials.
Now, let’s look at the second question. Is this what other countries are doing? The answer is no 🚫.
Other countries are not allowing all individuals to receive Moderna and Pfizer. Below I will provide the evidence (feel free to click the links).
👉🏻 In Germany, only Pfizer is recommended to people under 30 or women who are pregnant - NOV 10th 2021
👉🏻 In Canada, specifically Ontario, Pfizer is recommended over Moderna for individuals 18-24 - SEPT 29th 2021
👉🏻 In Sweden and Denmark, Moderna has been paused for any individual under the age of 30 - OCT 6th 2021
👉🏻 In France, Moderna is not advised for any individual under the age of 30 - NOV 9th 2021
👉🏻 In Norway, health experts advise Pfizer be used over Moderna in men aged 30 or younger - OCT 6th 2021
👉🏻 In Finland, Moderna was paused for men aged 30 or younger - OCT 7th 2021
What does that tell you? Considering global trends and health policy, we’re clearly doing things very very wrong in the USA.
Finally, the 3rd question. Will this really slow the spread like the professionals claim? Again, no 🚫.
To specify, giving boosters to already vaccinated individuals will not slow down, contain, curtail, or eradicate SARS-CoV-2. However, It needs to be understood that the virus will inevitably become something more manageable, and endemic. Please check out my previous medical publication that lays out the facts on this. Getting back on subject, boosters are for already vaccinated individuals. To quickly explain, many claim this is a pandemic of the unvaccinated. Well, pushing those boosters on vaccinated individuals shifts attention away from unvaccinated people. That is bad because boosters are not providing immunity for the unvaccinated which is theoretically needed to slow the spread of SARS-CoV-2. Wasn’t the point of all this to get the un-jabbed jabbed?
Some final thoughts 💭
First, if you’re reading this, you should probably watch my Youtube video where I explain how mRNA vaccines like PFIZER and MODERNA work by clicking here.
Second, you should also considering watching my YouTube video on the new COVID-19 vaccine named NOVAVAX as it will soon be used in America.
Third, thank you for reading my publication, it means a lot to me. If you think someone could benefit from this information, please share the link.
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