Widespread Vaccine Failure is the Reproducibility Crisis in Public Health - Will They Adopt Science or Continue a Failing Denialist Agenda?

The Costly Taboo Against Expecting Rational Criticism from Public Health is Ending

In my podcast, “Unbreaking Science”, my initial goal was to bring guests on who were willing to discuss the perils of continuing down a path on which data manipulation and other less egregious problems with observational studies as conducted in public health. The goal was not iconoclastic; rather, it was to help nudge Science into a position in which critical analysis of individual studies - and sets of studies if need be - was again considered normal and healthy - even if the consequence of that analysis was to draw vaccine safety into question.

The goal of science - understanding and discovery - are at complete odds with taboo against rational criticism of vaccines. Rational criticism is usually conducted via peer-review; however, CDC’s main publication outlet, Morbidity and Mortality Weekly Report, is not peer-reviewed.

What has happened in the public health literature is an inversion of rational thought. Studies (like mine) that identify potential problems with vaccines are targeted for retraction. If Science is a way of knowing, then the quest of scientists should be the truth, that is, reality. The quest to have our knowledge match reality as closely as possible is not possible when the goal of those who claim they are conducting science is to prevent rational criticism at all costs - as if the vaccine science literature is thorough, complete, and finished, at least on the question of benefits and risks - and also as if each and every vaccine recommended by ACIP is the same entity year after year.

Clinical science that sought to seek to use cell lines to understand cancer have been criticized based on somatic evolution - the evolution of cells lines away from the ancestral tumor tissue from which they were derived - as well as evolutionary shifts along the way, making comparisons of results using the same-named cell lines irreproducible given the effects of evolution during serial propagation.

This has been well-documented in the literature with a bombshell study by Ben-David et al. (2018) (see Literature Cited, Evolving Cell Lines). The response to the empirical evidence that cells lines cannot be counted on to reflect the native tissue from which they were derived was met with shock by the cancer research community, which then set about establishing protocols to help ensure similarity between cell lines used in cancer research and actual, bona fide tumors. In other words, reason prevailed following rational discourse about unwelcome news.

The precise mechanisms that made cell lines less useful than they could be have afflicted vaccines given the time between the present day and the time the pathogen was isolated to create a given vaccine. Bacteria like Pertussis evolve most slowly, then DNA viruses like Varicella, and then RNA viruses like the SARS-CoV-2 virus. Acellular Pertussis vaccines have been announced to be failures due to their failure to prevent asymptomatic infection that can lead to transmission by James Cherry; SARS-CoV-2 vaccines have escaped vaccines to the point where immunogenicity has waned and now vaccines and boosters can only be expected to yield detectable antibodies for 3-4 months. SARS-CoV-2 placed vaccine failure due to vaccine selection into a highly visible process witnessed by everyone in a short enough period of time for the public to understand that available SARS-CoV-2 vaccines target (extinct) ancestral virus, the Wuhan-1 variant. Example:

“This study found a similar viral load in vaccinated and non-vaccinated HCWs infected by SARS-CoV-2 variant B.1.1.7, suggesting potentially reduced efficacy of BNT162b2 in preventing transmission of B.1.1.7.” (Ioannou et al., 2021)

I wrote about the problem of waning immunogenicity prior to COVID in an article on Medium, a platform that thanked me with a ban from publishing there again. I republished my article in April 2019 on jameslyonsweiler.com, with a face-to-face promise from that webhost provider to never censor articles on vaccines.

(See: “WANING IMMUNOGENICITY, VACCINE-DRIVEN EVOLUTION AND HYPERIMMUNIZATION: WE CAN NO LONGER DENY THE OBVIOUS” on jameslyonsweiler.com)

The problem is not an “anti-vax” or “pro-vax” problem. The problem is that evolution in cultured pathogens used in live attenuated vaccines is inevitable, and evolution in the wild-type pathogen guarantees loss of waning immunogenicity.

See also “Eberhardt, C. S., & Siegrist, C. A. (2017). What Is Wrong with Pertussis Vaccine Immunity? Inducing and Recalling Vaccine-Specific Immunity” and articles by James Cherry (below).

Sadly, the failure to address vaccine selection in Polio in Pakistan has resulted in a vaccine escape variant of the poliovirus, which has now made its way to Africa (See Science Magazine: In new setback for eradication campaign, poliovirus from Pakistan shows up in Africa).

As we return to remembering what we had learned before COVID-19, we will remember that schools filled with vaccinated children had clinical mumps outbreaks; that the US Navy USS Fort McHenry had to quarantine a ship for four months as mumps spread throughout the sailors on board - all of whom were up-to-date on mumps vaccination (See Business Insider).

We also remember that the Disneyland outbreak involved a large percentage of “vaccine type” clinical measles cases (See Roy et al.).

The issues of vaccine selection and vaccine escape cannot be solved by additional boosters. These issues must be addressed frankly and objectively. Evidence of the inability to be objective on this issue includes personal attacks on reputations and “credibility”, which of course does nothing to address the coming crisis of widespread vaccine failure.

The solution is that wild-type pathogens should be sequenced annually and compared to the vaccine-target type with special focus on mutations in the epitopes involved in antibody production. FDA should permit substitution of more recent pathogens to be included or to replace extinct variants.

This is not a radical, out-of-the-box solution; in fact, it was called for in the 1950s by scientists who recognized that measles vaccines would evolve away from the measles virus (and vice versa). They predicted that efficacy would be too low in 2022, and now we’re here. We’re masking kids in school for COVID-19, and it’s hard to tell if that is preventing a mass measles outbreak. However, the expectation is that we will start to see measles in adults, and that CDC will start pushing for vaccination against measles (and mumps) via the MMR vaccine.

Everything, however, seems to be on hold until a ruling is made in the Merck MMR whistleblower case in which two virologists allege that their supervisors told them to spike human samples with rabbit antibodies to make the MMR appear sufficiently protective (95% efficacy) to compete with other vaccines that were being proposed. One of the whistleblowers was threatened with jail time (See 2015 article on Biospace), and there appears to be a media black-out on the case since 2015 (See Reuters, 2015).

A related problem with live attenuated virus-based vaccines is the evolution of new functions, including the potential for new pathologies, including (potentially) measles inclusion body encephalitis (MIBE) and subacute sclerosing panencephalitis (SSPE) (See Beaty & Lee, 2016).

While the FDA is at it, they should require the removal of unsafe epitopes: those that are likely to cause autoimmunity.

And they should embrace the fact that HPV Vaccine Failure is worse than mere failure: the rare, more lethal non-vaccine-targeted types have emerged since the vaccine has reduced the frequency of vaccine-targeted HPVs, as I and others predicted: the type replacement data were all published during the last two years, during COVID-19. I gave a presentation of this issue in Ohio, and published evidence of HPV type replacement in CDC’s own data in Mary Holland et al.’s book “HPV Vaccine on Trial”.

The analysis is also here:

(See: “WANING IMMUNOGENICITY, VACCINE-DRIVEN EVOLUTION AND HYPERIMMUNIZATION: WE CAN NO LONGER DENY THE OBVIOUS” on jameslyonsweiler.com)

Will they adopt Science? Or will they continue supporting CDC’s agenda of vaccine failure, vaccine risk, vaccine injury and vaccine death denial?

Hasn’t that cost us all enough?

Literature Cited

Evolving Cell Lines

Ben-David U, Siranosian B, Ha G, Tang H, Oren Y, Hinohara K, Strathdee CA, Dempster J, Lyons NJ, Burns R, Nag A, Kugener G, Cimini B, Tsvetkov P, Maruvka YE, O'Rourke R, Garrity A, Tubelli AA, Bandopadhayay P, Tsherniak A, Vazquez F, Wong B, Birger C, Ghandi M, Thorner AR, Bittker JA, Meyerson M, Getz G, Beroukhim R, Golub TR. Genetic and transcriptional evolution alters cancer cell line drug response. Nature. 2018 Aug;560(7718):325-330. doi: 10.1038/s41586-018-0409-3. Epub 2018 Aug 8. PMID: 30089904; PMCID: PMC6522222.

Do Cancer Cell Lines Really Resemble Tumors? Now Researchers Can Tell (MSKCC.org) https://www.mskcc.org/news/do-cell-lines-really-resemble-tumors-now-researchers-can-tell

Evolving Pathogens and Evolving Cultured Pathogens Used In Vaccines

Beaty, S. M., & Lee, B. (2016). Constraints on the Genetic and Antigenic Variability of Measles Virus. Viruses, 8(4), 109. https://doi.org/10.3390/v8040109

Why Do Pertussis Vaccines Fail? (Cherry)

Epidemic Pertussis and Acellular Pertussis Vaccine Failure in the 21st Century (Cherry)

Eberhardt, C. S., & Siegrist, C. A. (2017). What Is Wrong with Pertussis Vaccine Immunity? Inducing and Recalling Vaccine-Specific Immunity. Cold Spring Harbor perspectives in biology, 9(12), a029629. https://doi.org/10.1101/cshperspect.a029629

Ioannou P, Karakonstantis S, Astrinaki E, Saplamidou S, Vitsaxaki E, Hamilos G, Sourvinos G, Kofteridis DP. Transmission of SARS-CoV-2 variant B.1.1.7 among vaccinated health care workers. Infect Dis (Lond). 2021 Nov;53(11):876-879. doi: 10.1080/23744235.2021.1945139. Epub 2021 Jun 26. PMID: 34176397; PMCID: PMC8240538.

Roy F, Mendoza L, Hiebert J, McNall RJ, Bankamp B, Connolly S, Lüdde A, Friedrich N, Mankertz A, Rota PA, Severini A. Rapid Identification of Measles Virus Vaccine Genotype by Real-Time PCR. J Clin Microbiol. 2017 Mar;55(3):735-743. doi: 10.1128/JCM.01879-16. Epub 2016 Nov 16. PMID: 27852670; PMCID: PMC5328441.

Science Magazine: In new setback for eradication campaign, poliovirus from Pakistan shows up in Africa