COVID-19 Vaccines and Therapies: An Advisory from Liselo Labs.

David Jarvis, Molecular Biologist, and CTO – Liselo Labs, Dr. Joey Moodley, Molecular Virologist – Liselo Labs, Dr. Mike Jarvis, Zoologist – Liselo Labs

May 2021

COVID-19 vaccines represent some of the best technologies currently available for the large-scale pre-exposure prophylaxis (protection) of people from severe forms of the disease. Although vaccines will not produce protective immunity in all patients (to all variants), they are by far the best tools that are presently available to prevent this infectious disease.

There is very little merit in vaccine hesitancy, as it is typically driven by those with peripheral understandings of immunology, and a poor understanding of the global benefits and risks of large-scale vaccination programs that have been a cornerstone of infectious disease management for more than a century.

It is easy to find shortcomings in vaccine strategies, but what is considerably more challenging is finding viable therapeutic alternatives. Many research facilities, such as Liselo labs, are currently working on such alternatives which can address some of the shortcomings of vaccination strategies. Therefore, the effective management of COVID-19 infections requires viable alternatives to supplement the use of vaccines during this pandemic.

At Liselo labs we are acutely aware of the risks of antibody dependant enhancement (ADE) and vaccine-associated hypersensitivity (VAH) (vaccines making the disease worse), however, no supporting evidence indicating this as a significant factor for SARS-CoV-2 infections is available to date.  Even if this changes and the evidence emerges, vaccines will remain effective against severe forms of the disease caused by all previous variants.  

COVID-19 FAQs

Why does COVID-19 affect the elderly more severely? 

COVID-19 is a disease caused by an infection with the SARS-CoV-2 virus.  Severe forms of the disease are essentially driven by the immunopathology triggered by the viral infection. This severe pathology is triggered by the patient’s immune system and in particular its reaction to infection known as an immunopathological response. The patient’s immune system-driven immunopathology is a key factor that leads to diseases like asthma, irritable bowel syndrome, diabetes, auto-immune diseases, hypertensive (high blood pressure) conditions, and many other inflammatory-related conditions. As people age, their immune system becomes biased towards an “over-reactive” response to infection. In scientific terms, this is referred to as an imbalanced Th1/Th2 polarization in the immune system that is skewed towards Th1 responses in patients predisposed to immunopathology, and in older patients (Uciechowski et al. 2008). A polarization (bias) towards Th1 leads to a more severe disease presentation in COVID-19 patients and reduced outcomes for recovery.

In summary, in older patients the immune system is typically not balanced and tends to be more polarized toward a Th1 response resulting in detrimental outcomes particularly for diseases like COVID-19.

Should  Ivermectin be used for COVID-19 treatment or prevention?

Ivermectin is registered in many developing countries and has been used as a therapy for parasitic infections in animals and humans for several years. Although it is not an approved drug for COVID-19, it has seen significant public popularity; particularly in the absence of any clinically proven alternative therapies. Whilst studies evaluating the modes of action that impact COVID-19 disease have been conducted , data is still limited and inconclusive (Chaccour et al. 2021). https://www.covid19treatmentguidelines.nih.gov/tables/table-2c/

Recent publications demonstrating the value of a beneficial microbiome, including helminths, as modulators of host immunity and pathology are raising concerns about the use of ivermectin. Its expanded use as a pre-exposure prophylaxis may introduce a range of host immune responses, predisposing patients to immunopathology. This may include COVID-19-induced immunopathology mediated at the mucosal surfaces of the small intestine. Helminths that establish themselves in the gastrointestinal tract can exert counter-inflammatory influences on the host immune system and there are no known probiotics for helminths. (Varyani et al. 2017; Zheng et al. 2020).

Care should also be taken with dosage as side effects are possible for patients if the regimen is not followed. It is registered as a prescription drug because of the side effects that can occur and these can be more problematic when ivermectin is used for prolonged periods. Adverse side effects can include life-threatening reactions.

In summary, ivermectin, especially taken prophylactically for COVID-19, may predispose patients to more severe forms of COVID-19 disease and adverse side effects. In addition, there is no evidence of its efficacy in clinical trials, therefore, its use is not without significant risk.

How safe and effective are COVID-19 vaccines?

The COVID-19 pandemic has driven more funding, scientific study, and global effort applied to solving a single disease challenge within such a short amount of time than any other disease in history. The large-scale rollout of vaccines and the data collected to date is also unprecedented compared to any other vaccine development. The volume and statistical relevance of data collected by multiple researchers in many countries is considerable.  

The safety data reported to date is encouragingly high compared to other vaccines for previous pandemics and outbreaks. The vaccine efficacy against initial SARS-CoV-2 variants is higher than typically expected for new vaccines, let alone vaccines developed within such a short time.  It is important to consider that much of the research work resulting in vaccines for SARS-CoV-2, started in 2003 after the SARS outbreak, therefore, the vaccines for SARS-CoV-2 have benefited from more than 17 years of research into vaccines against SARS-CoV. SARS-CoV-1 is nearly identical to the SARS-CoV-2 virus except for mutations that facilitate its transmissibility. SARS-CoV-1 infections caused SARS disease and had a higher mortality rate than COVID-19, although the virus was less transmissible.

In summary, the scientific data on safety and efficacy for multiple different SARS-CoV-2 vaccines is thorough and statistically relevant, and outside of the parameters of long-term observation, undeniably favorable.

https://www.health.harvard.edu/blog/covid-19-vaccines-safety-side-effects-and-coincidence-2021020821906

There is still a lot of research needed on several topics, but these are not valid reasons to avoid the use of COVID-19 vaccines. These include:

  • Untested/reduced efficacy for newly emerging variants of SARS-CoV-2.
  • Untested efficacy of a COVID-19 vaccine strategy to generate herd immunity (particularly given large-scale vaccine hesitancy)
  • Limited information on ADE or VAH which may become a factor in future variants.
  • New therapies may become available for those who don’t respond well (immunologically) to vaccines (Frediansyah et al, 2021).

Is “big pharma” abusing the global pandemic for profit?

Big pharmaceutical companies are about profit and they need a few ingredients to be profitable i.e.:

  1. A trusted brand that consumers will use and/or purchase that is driven by:
    1. Efficacy of drugs
    2. Pricing/affordability
    3. Marketing/Consumer awareness.
  2. Regulatory approvals are required including clinical trial data, which typically takes years and significant funding to complete.
  3. Patentable/protectable innovations are required to secure the investments.
  4. Peer-reviewed publications supporting the product efficacy are required to ensure that companies are not held liable for harmful effects resulting from poor/negligent scientific methods.

The notion that not only big pharmaceutical companies but also the entire scientific community is somehow part of a conspiracy to promote a few companies’ vaccines and discount affordable drugs like ivermectin, is just nonsensical.  

There are very few scientists who directly benefit from any of the COVID-19 vaccines that are currently in circulation (outside of receiving the jab). This ensures that independent peer-review of the vaccine safety and efficacy data is ongoing, and this is evidenced in new scientific publications that are published almost daily on these topics by well-respected researchers in journals.  

The notion that “big pharma” can silence negative peer-review by the scientific community is also not factual.  Critical and independent peer-review is the holy bible of academia. It is not practically possible to suppress scientifically sound and independent peer-review globally.

References:

Chaccour, C., et al. “The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with non-severe COVID-19: A pilot, double-blind, placebo-controlled, randomized clinical trial.” The Lancet – EClinical Medicine, vol. 32, 2021, https://doi.org/10.1016/j.eclinm.2020.100720.

Varyani, F., et al. “Helminths in the gastrointestinal tract as modulators of immunity and pathology.” American Journal of Physiology, vol. 312, no. 6, 2017, https://doi.org/10.1152/ajpgi.00024.2017.

Frediansyah et al. “Antivirals for COVID-19: A critical review.” Clin Epidemiol Glob Health., vol. 9, 2021, pp. 90-98, https://dx.doi.org/10.1016%2Fj.cegh.2020.07.006.

Zheng, D., et al. “Interaction between microbiota and immunity in health and disease.” Nature – Cell Research, vol. 30, 2020, pp. 492–506, https://www.nature.com/articles/s41422-020-0332-7.

Uciechowski P, et al.  TH1 and TH2 cell polarization increases with aging and is modulated by zinc supplementation. Exp Gerontol. 2008 May;43(5):493-8. DOI: 10.1016/j.exger.2007.11.006. Epub 2007 Nov 28. PMID: 18166287.