The Flawed COVID-19 Vaccine Testing Programs

There doesn’t appear to be much difference between the testing protocols of the dozens of pharmaceutical companies that are working on developing a vaccine for the elusive (and therefore dubious) SARS virus that has not actually yet been isolated in the lab, much less been reproducibly-grown in living tissue cultures. 

The evidence for the existence of the new SARS-CoV-2 virus in any given patient has mostly been assumptive in the current alleged pandemic which has relied on testing with the equally dubious PCR test kits that have been manufactured by any number of fly-by-night outfits which are making unreliable test kits.

The “case” incidence and death statistics of the current alleged pandemic must therefore be also regarded as dubious because the PCR test’s inventor has repeatedly asserted that his test CANNOT be used for diagnostic purposes.

However, the aggressively Big Pharma/Big Media-promoted “conventional  wisdom”  says that if the PCR test turns out to be positive (even if the PCR-positive individual is totally asymptomatic, always wore the masks and never ever developed Covid symptoms) that subject must be assumed to be so infectious that he must be quarantined for weeks. If the subject does not comply with the quarantine order, he or she can– in certain jurisdictions – be arrested and imprisoned.

What should be of concern to thinking people is the fact that some of these pharma companies (not to mention that many of the PCR test kit manufacturers) are indeed just “start-ups” – like the National Institutes of Health’s (and Anthony Fauci’s) favorite vaccine company Moderna, whose business only involves vaccine development – not manufacture.

Yet Moderna is deeply involved in the race for FDA approval, and its stock price has sky-rocketed on hopes that it might massage its test results enough to get its Covid-19 vaccine approved (or at least be given Emergency Use Authorization [EUA] by the FDA).

Despite its sky-high stock price ($67 per share as of October 30, 2020), Moderna has yet to earn a single penny from the sale of any of its handful of experimental vaccines. It has, not surprisingly, developed its protocol for testing its 2-dose experimental Covid-19 vaccine that is essentially the same as the announced protocols of Johnson & Johnson, AstraZeneca and Pfizer’s Covid-19 vaccines in that half of the approximately 30,000 volunteers that they have amassed will be injected with two doses of its active vaccine (each of which contains uncertain-to-be-safe ingredients). The other half will be injected with a placebo. (Interestingly, in the past, some vaccine-testing companies have added a tissue-toxic ingredient that will cause injection-site symptoms presumably so that the placebo group won’t know if they got the vaccine or not.)

There are reportedly any number of start-up and established pharmaceutical corporations world-wide that are also trying to be the next block-buster vaccine-seller on the planet, but NONE of them, much less the four experimental vaccine companies listed below, have been following time-honored methods of testing its experimental drugs and vaccines on lab animals, a serious breach of protocol that has become the “new normal” in order to comply with President Trump’s Operation Warp Speed, agenda which Trump has been pushing in order to produce a vaccine – any vaccine – before his re-election bid is decided!!

Of course, the fast-tracking (aka, “short-circuiting”) of normal vaccine safety and efficacy studies has been condemned by all ethical scientists that don’t have economic or professional “conflicts of interest” that guarantee profitable results from the dangerous pseudoscientific pro-vaccine stances that Big Pharma shills like those in the Trump administration and the current HHS, NIH, CDC, NIAID and FDA has taken over the past 10 months.

Conditional, tentative, Emergency Use Authorization (EUA) from the already corporate-compromised FDA is likely to be granted even if the data that is presented to the FDA regulatory commissions are flawed and/or statistically insignificant – which means that the vaccine has not been proven to be safe and effective, especially in the long-term, which, by definition, can’t be safely assessed for many years. Sadly, the members of most standard “regulatory” commissions are often corporate shills that have ulterior motives.

There are 30,000 volunteers in each drug company’s study groups and they are essentially healthy, essentially middle-aged, eager and “patriotic” volunteers. Half of the 30,000 will be injected with a series of two immunologically-active vaccines. The other 15,000 members of the group will get two shots of a placebo that is supposed to be immunologically-inactive. None of the 30,000 will be informed as to which group they are in.

The approximately 30,000 total human guinea pigs that signed up for the Moderna study will be monitored until a paltry 53 of the 30,000 volunteers gets positive (and very dubious) PCR test results! The 53 may not have – and may never develop – SARS signs and symptoms for them to be included in the study!

Of course, false-positive PCR tests are extremely common and can happen to anybody, especially people who have had a common cold, which is often caused by simple, benign coronaviruses.

The designers of the Moderna study – just like the other drug companies that are in the race – will argue that their study should be considered relevant, reportable to the FDA as theoretical proof of effectiveness but they cannot claim that their vaccine is either safe or effective long-term.

However, these short-term studies can only be partially relied upon for short-term safety and effectiveness if 13 or fewer of the 53 PCR-positive “cases” occurred in the vaccinated population while at the same time 40 or more of the positive PCR “cases” occurred in the placebo group. What won’t be discussed will be the fact that over 14,900 of both the placebo group and the vaccine group also didn’t have positive PCR tests Covid-19 symptoms!

It is totally appropriate for legitimate doubters of America’s Big Pharma-co-opted drug and vaccine regulatory agencies to ask the question, “What kind of Big Pharma-influenced, profit-oriented, junk science is behind the studies that are being hastily approved by the likes of the obviously co-opted HHS, NIH, CDC, NIAID and FDA?

It is also totally appropriate for the public to have full information about what kind of coercive pro-vaccine influence is coming from such Trump appointees as his HHS director (and non-physician) Alex Azar, who came into Trump’s administration from a $2 million dollar per year CEO post at Big Pharma/Big Vaccine giant Eli Lilly. Azar also is part of Trump’s Operation Warp Speed, which is the impetus behind the fast-tracking of vaccine development, which is certain to be a disaster.

There will surely be dubious conclusions coming from all of the other provably untrustworthy pharmaceutical corporations that are in the race to develop an Emergency Use Authorized-vaccine that will not have been proven to be either safe or effective long-term – but will certainly be unaffordable.

Suspiciously, the major investment partner of start-up Moderna is actually the US government regulatory and funding body called the National Institutes of Health (including the CDC and the NIAID) which reportedly has a 50% financial stake in the company.

One can safely assume that – given the corrupt capitalist system that has thoroughly taken over our nation – that every Moderna shareholder (even our government bureaucracies) will do everything they can do to promote its products.

One must suspect also that these government agencies and their buddies in the corporate world are doing everything they can to keep the sheeple from noticing the most important data points in the studies discussed.

And one of those bits of information is that at least 29,800 of the 30,000 volunteers in Moderna’s vaccine trials, will likely not become infected whether the got the placebo or the vaccine. What could easily happen long-term is that a significant number of the 15,000 in the vaccine group, are at risk of developing disabling chronic illnesses such as autoimmune disorders.

What About the Vaccine Trials of Pfizer, Johnson & Johnson, AstraZeneca, et. al.?

The other significant statistical realities that won’t be pointed out in the corporate-controlled medical journals (or the corporate-controlled media) are the concepts of “Actual Vaccine Efficacy” and “Relative Vaccine Efficacy”, which are akin to the likewise purposely hidden-from view Actual Risk Reduction (AAR) and Relative Risk Reduction (RRR) that are often ignored in drug efficacy trials.

For Moderna, 13 positive PCR tests in the 15,000 member vaccine arm of their trial 13/15,000 = 0.00086) is an arbitrarily chosen data point that, when compared to the placebo trial may represent some sort of significance. 0.00086 is an obviously miniscule number that is the same as a percentage figure of 0.086 %.

And 40 or more positive PCR tests in Moderna’s placebo group of 15,000 subjects (40/15,000 = 0.0027) likewise represents a similarly miniscule percentage figure of 0.27 %. Subtracting 0.086 % from 0.27 % will obtain the “actual” miniscule benefit of being vaccinated (0.086 %) with Moderna’s potentially toxic vaccine vs. receiving the presumably innocuous placebo.

However, the falsely-inflated “relative” vaccine effectiveness numbers means that in calculating the Moderna results takes the fraction 13/40 (which = 0.325 in decimal terms, and which is 32.5% in percentage terms. The corporation’s mathematicians, in the standard method of calculating relative risk reduction (RRR), subtracts the 0.325 from “1”, resulting in a decimal number of  0.675 (which, in percentage terms is 67.5%).

So Moderna statisticians – who may, incidentally, own shares in the company – will then report to his bosses at corporate headquarters the “relative” effectiveness rate of 67.5 %, which the bosses will receive as positive, whereas it is a actually a deceptively inflated figure when it is put side-by-side with the actual vaccine effectiveness number of 0.184.

Note that Pfizer’s experimental vaccine trial also uses the PCR positivity number of 32 in the 30,000 group, 25 in the 15,000 placebo group, and 7 in the 15,000 vaccine group as starting statistical analysis points.

Using those numbers, Pfizer’s statisticians are actually reporting out the falsely-inflated Relative Risk Reduction/Relative Vaccine Effectiveness numbers (rather than the Actual Risk Reduction (ARR) numbers to America’s easily propagandized press corps and medical professionals, who can be relied upon to report – over and over again – the inflated benefits to their listeners, viewers and patients.

Predictably, Johnson & Johnson is also using the same mathematical trickery as the other Gang of Four, using as their arbitrary PCR-positivity break-points the following numbers: 77 PCR-positive tests among the 30,000 total group; 59 PCR-positive tests in the 15,000 person placebo group, and17 PCR-positive tests in the 15,000-person vaccine group.

AstraZeneca is doing the same, just using slightly different numbers of PCR-positivity: 50 in the 30,000 group, 38 in the15,000 placebo group and 12 in the 15,000 vaccinated group.

What we seem to have is well expressed in my version of Mark Twain’s famous quote: “There are 3 (or 4) kinds of lies: Lies, Damned Lies, Statistics and Covid Statistics”.

Discuss.

Dr Gary G. Kohls lives in the USA and writes a weekly column, entitled Duty to Warn, for the Duluth Reader, Duluth, Minnesota’s alternative newsweekly magazine. His columns deal with the dangers of American Friendly Fascism, corporatism, Oligarchy, militarism, racism, malnutrition, and Big Pharma’s over-drugging and over-vaccinating agendas as well as other movements that threaten the environment, democracy, civility, health and the sustainability and livability of the planet and the future of the children. Dr. Kohls is a frequent contributor to Global Research 

Many of Dr Kohls’ columns have been archived at a number of websites, including:

http://duluthreader.com/search?search_term=Duty+to+Warn&p=2; 

http://www.globalresearch.ca/author/gary-g-kohls;

http://freepress.org/geographic-scope/national;

https://www.lewrockwell.com/author/gary-g-kohls/?ptype=article; and

https://www.transcend.org/tms/author/?a=Gary%20G.%20Kohls,%20MD

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