by John Jones, JD, Ph.D., Vaxxter Contributor
Part II: What’s next for this tuberculosis vaccine?
In Part I of my review of a tuberculosis (TB) vaccine trial, reported in the New England Journal of Medicine (NEJM), among other things, I showed that statistically, we cannot say with any degree of certainty that the GlaxoSmithKline (GSK) vaccine M72/AS01E reduces TB disease rates.
Here in Part II, I flesh out more details about TB rates in Southern Africa. I’ll also show how the numbers generated by Tait et al. (2019) prove that the vaccine actually caused more illness than should have occurred if the subjects had no injections.
More About TB in Southern Africa
What do we know about the incidence of real cases of TB in Southern Africa?
A variety of organizations, institutes, and governments track and report on cases of tuberculosis at the national level. Using data readily available to the public, I found that of these three nations, Kenya, Zambia, and South Africa, perhaps Kenya has the highest rate of tuberculosis. Kenya rate is roughly 5.5 per 1000 in its adult population, although it is only about 2.9 across all ages. One 2016 study 2016 estimates that the rate TB disease for adults in Zambia to be around 4.5 per 1000 (with a range of 2.3 to 7.7). South Africa has about 5.2 TB cases per 1000 nationally. And in children under the age of 15, the incidence is only 7%.
Those numbers fall within the extremes of the results found by Tait et al. (2019). But recall, they only used test subjects who were HIV negative. So what is the estimated incidence of TB in that sub-national cohort? Using data from WHO, I factored out the comorbidity (TB and HIV+) and derived estimates for the TB rates of the HIV negative adult populations in each nation. Kenya reports that 27% of her TB cases are HIV+. So I estimate their HIV- TB rate at 3.8 per 1000. Tuberculosis in South Africa affects only 2.1 per 1000 who are HIV-. Within its HIV- population, Zambia sees a mere 1.6.
[Note: for the HIV negative populations of Zambia and South Africa, their TB disease rate is lower than those who received two injections in this GSK vaccine trial].
Vaccine Efficacy Protocol
These baseline numbers are important because they give us the means to evaluate the true efficacy of the vaccine protocol. But we should also consider the trends. In Kenya, the WHO says that TB peaked in 2006, at 6 per 1000 – and has dropped ever since. Conversely monitors for Bacille Calmette Guerin (BCG) Atlas said that in 2011, the TB rate in Kenya was only 2.3 per 1000 (i.e., lower than present-day). Taking a broad view then, if we can appreciate that in the recent past, the incidence of TB in Kenya has dropped, we have reason to expect that samples will exhibit variability. The numbers and estimates for disease rates go up and down, just like we find in the United States with outbreaks of measles, pertussis, parapertussis, and mumps.
South Africa saw its recent peak for TB infections in 2011, at 8.3 per 1000. Thus, when Kenya was at a nadir, South Africa was hitting a crest. Yet both countries were, and continue to, vaccinate babies with BCG. Is there any efficacy in giving the shots?
The adult subjects for this GSK vaccine trial were enrolled from August 2014 through November 2015. That is, the TB rates of the test subjects should reflect the national samples estimates which used data from 2018. Though Tait et al. fail to disclose the exact proportions of participants by gender in each group, we can make some estimates and re-evaluate the efficacy of the GSK injectable.
(Note: my evaluations are skewed because real-world data show that in these countries, men have much higher TB disease rates than women).
The Real Numbers
In Table 2, Tait et al. (2019) share the nationalities of those in the placebo group as: 1344 from South Africa; 71 from Zambia; and 248 from Kenya.
Putting the pieces together, using TB incidence rates for the HIV negative adult population in each country, we can estimate, over the course of about 2.7 years (the average number of years each test subject was in the study), how many in the placebo group, should have been diagnosed as ill with TB. We would expect 4.3 cases of active TB per 1000 people for the study’s duration of 2.7 years. Given these 1663 subjects endured 4463.07 person-years, the expected number of TB cases was 0.096 per 100 person-years!
Yes, you read that correctly.
By my analysis, the numbers for a true placebo group would have been far lower than what Tait et al. generated in their two-dose group. And by definition, via their experiment, Tait et al. made more than 20 people sick with TB, for no reason other than they injected them with an experimental vaccine and a so-called placebo.
What was in the vaccine? What was used as a placebo?
The injectable in the study is called M72/AS01E. According to the WHO,
“M72/AS01E is … comprised of an immunogenic fusion protein (M72) derived from two Mycobacterium tuberculosis (M.tb) antigens (MTB32A and MTB39A), and the [GSK] proprietary adjuvant AS01E.”
And just in case you – or anyone else – might be worried about the harms of the adjuvant, the WHO press release adds:
AS01E is the same adjuvant used in Shingrix, GSK vaccine for shingles, as well as in the new, experimental malaria vaccine RTS,S/AS01E.
To paraphrase the character Jack Torrance from the film, The Shining, “See, that adjuvant is okay. We’ve seen it used on other people.” But given that the expected TB numbers for the HIV negative adult populations of South Africa, Zambia, and Kenya who had no treatment, and were not in the study, was lower than the treatment group, what are we to conclude?
Ceteris paribus, because of this study, we now know that either the adjuvant, the fusion protein M72, and or the other unpublished ingredients in the vaccine, individually or synergistically, reduce real immunity and promote illness.
Avoiding Distraction and Looking Ahead
In their synopsis of Tait et al. (2019), the WHO admits that the researchers do not know how this vaccine works or whether stimulation of antibodies generates immunity. Obviously M72/AS01E does not reduce susceptibility to tuberculosis. But curiously, writers for WHO insist that the M72/AS01E vaccine provides protection. They write:
“The study has demonstrated protection approximately during two years of study follow up. The final analysis of the study is expected to provide data on protection during 3 years of follow-up.”
Keep in mind that their definition of “protection” is simply the presence of an antibody, which is the marker they will track for the next 3 years. But we know from the numbers that this vaccine does not prevent disease. And frankly, the research world knows it too.
Prevent Disease But Not Infection
In a 2015 article from the Journal of Clinical and Vaccine Immunology, Orme writes:
“At this time, a tuberculosis vaccine that could induce a form of immunity that, even years later, would prevent infection rather than disease is purely theoretical.”
So we know that theoretically, a TB vaccine might prevent disease, but none could prevent TB infection. Thus by injecting babies with BCG, millions of defenseless infants are needlessly infected each year with Mycobacterium bovis, a bacteria that causes tuberculosis in cows but can also infect humans. Nevertheless, the NEJM, GSK, and all the other stakeholders want us to put faith in their vaccines.
It turns out that years ago, in 1978 and 1981, two teams found the key to remediation for TB patients. They demonstrated that they could kill “strains of Mycobacterium tuberculosis” with “immunologically activated macrophages” when the macrophages were stimulated with hydrogen peroxide. See Grange et al. (1983), references 35 and 36.
And there it is. For forty years real scientists have known that no vaccine can eliminate a bacteria. But something as simple as a high pH environment, and an infusion of oxygen in the form of H2O2 (hydrogen peroxide) will provide the body the fuel it needs to kill off this harmful bacteria. See Grange et al. (1983), references 35 and 36.
These experiments and the resulting data show clearly: vaccines cause harm and vaccines are unnecessary for health and disease prevention.
This year, I urge you to start a new tradition: Read the studies. Check their numbers. Calculate the statistics yourself. Let big pharma and the mis-leadership class know, “We won’t get fooled again.”
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John C. Jones received his law degree (2001) and his Ph.D. is in political science (2003) from the University of Iowa. He has over 15 years of research and writing (both academic and journalistic) in fields of public policy and law, criminal and Constitutional law, and philosophy of science and medicine. His additional areas of expertise and specialized knowledge include applied statistics, etymology, political communications/public relations, litigation and court procedure. He has a particular interest in the science and history of vaccines.
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