Given what we know now - not what we don't know or may never know - it is time to dispense with the pseudo-science definitions of what qualifies as a vaccine and focus on the vaccine's impact on disease burden.
by Robert Nelson, MD
Forum for Healthcare Freedom
March 27, 2021
For those who don’t want to take the vaccine, just say, “NO.” But let’s stop pretending the objections are due to a conspiracy to enrich Bill Gates or Dr. Fauci; or some Orwellian twist of reason designed to trick us into being injected with a gene therapy masquerading as a vaccine.
Full disclosure: I’m not a fan of either man’s position on the issues in play. Nor am I an advocate for the current vaccine policy, nor do I advocate vaccinating the entire population. I favor a more targeted approach geared to vaccinate individuals who are at greatest risk of hospitalization and death; and then following cohort groups who have had the natural disease compared to groups that have had the vaccine to determine if we have immunity gaps.
But vaccines are what vaccines do. And what exactly do they do? Here is a definition that encompasses all types of vaccines.
“A preparation of a weakened or killed pathogen, such as a bacterium or virus, or of a portion of the pathogen’s structure that upon administration to an individual stimulates antibody production or cellular immunity against the pathogen but is incapable of causing severe infection.”vaccine – definition and meaning (wordnik.com)
Notice the underlined section which states, “or of a portion of the pathogen’s structure…” which is precisely what m-RNA vaccines are designed to replicate.
Components and the technology used to design vaccines vary widely. Some use live-attenuated pathogens. Some others are conjugated to other proteins to “present” the antigen. Some are adsorbed to other transport vehicles or inactivated viruses. Some are made from purified antigens. Others are inactivated whole virus vaccines while others use sub-units. m-RNA vaccines utilize small synthesized sections of RNA which signal our ribosomes to produce a specific portion of non-replicable COVID spike protein to include the antibody binding site. The presence of this protein triggers our immune system to produce antibody that attacks the receptor binding domain site (RBD) if we are exposed to native virus in the future which prevents the virus from binding to entry receptors.
The outcome generated by our immune system varies depending on the strategy used to attack the disease and the desired outcome. Some vaccines are “sterilizing” which means the totally eradicate the invader. Some don’t prevent infection at all, but target toxins. The tetanus vaccine, for example, doesn’t prevent infection by the causative bacteria; it stimulates antibody production against the toxin produced by the bacteria which causes the syndrome we call Tetanus. The latter is an example of an “infection-permissive vaccine” because it doesn’t prevent infection yet protects against the symptoms/syndrome that lead to severe disease. Another version of an infection-permissive vaccine is the disease-modifying vaccine, an example of which is the Pertussis (Whooping Cough) vaccine.
Viruses and bacteria routinely enter and “infect” our bodies. Yet our immune system fights off the invader or the indirect deleterious effects of the invasion. Either way, we are protected from harm.
It is no different with vaccines. A vaccine does NOT have to prevent infection, necessarily, to be be effective at preventing disease or preventing morbidity. In a similar fashion, a vaccine can significantly reduce symptoms by slowing viral replication in our cells and simultaneously reducing viral shedding and risk of transmission.
One criticism of the m-RNA vaccines is that they don’t prevent the virus from entering every cell by immediately “neutralizing” the virus. But as the discussion above indicates, having a complete neutralizing effect is not necessary for a vaccine to be effective. Even so, m-RNA vaccines act on several levels of our immune system. There is also evidence of significant neutralizing antibody of several SARS-CoV-2 vaccines, including the m-RNA vaccines, as this quote from a review article in Nature emphasizes.
According to the reported results, all of these vaccines induced antibodies against the spike protein (S protein) and the receptor-binding domain (RBD), including antibodies that neutralized pseudotyped and live SARS-CoV-2. Some reports have shown that NAb titres were strongly correlated with the concentration of RBD-binding IgG15,16.
To be balanced and fair, a low level of neutralizing antibody induced by some viral vaccines has occasionally lead to a serious complication referred to as Vaccine Associated Disease Enhancement (VADE). This was a problem that plagued the early SARS-1, MERS and early RSV vaccine trials. However, in SARS-CoV-2 there doesn’t appear to be significant binding to cells that express the fc-receptors for the immune complexes which are known to trigger antibody-dependent enhancement.
Another concern is labeled as “immune escape”. In this scenario, virus not killed by neutralizing antibody or cellular immune responses could “escape” and eventually infect others or mutate. Of course, this phenomenon can occur naturally even in the absence of vaccines.
A third criticism of the m-RNA vaccines is related to immune escape. Because the vaccines don’t prevent “infection”, but only modify the severity of disease, they may allow asymptomatic transmission of the virus. Based on what we know about the hierarchy of contagiousness of natural COVID-19, those with no, or few, symptoms are not likely to be a significant source of transmission. This argument instantiates the concept of “majoring in the minors”; i.e. this small risk is not of a magnitude that would off-set the benefits of the vaccine.
Here is what Vinay Prasad, MD, MPH had to say about this issue in his editorial in MedPageToday.com.
What about asymptomatic infection and so-called silent spread? In the Moderna trial, swabs taken from asymptomatic participants as they were receiving dose 2 showed a roughly 60% reduction in PCR positivity. It is likely that a second dose and longer asymptomatic period will result in greater reduction in PCR positivity. Preliminary data from AstraZeneca’s ChAdOx1 vaccine also showed reduced in asymptomatic PCR detection. In short, it is highly likely that receipt of vaccination and a 14-day asymptomatic period afterward results in both personal protection and reduced likelihood of ongoing viral propagation.
The bottom line is, there are no perfect vaccines. But the impact of vaccines on the disease burden on COVID-19 should not be underestimated. From his article in MedPage, W. Robert Graham, MD cites this:
Take for example the Moderna vaccine trial, published in the New England Journal of Medicine beginning in November with follow-up publications extending through February. In that trial they randomized 15,210 people to the vaccine and 15,210 people to placebo. Of those who got the placebo, 185 developed COVID-19. Therefore, 1.2% got COVID-19. Thirty of those became very ill. Of those who got the vaccine, 11 developed COVID-19. None of them got very ill. Therefore, 0.07% got COVID-19. So, the vaccine was effective: it prevented illness and it prevented serious illness.
The efficacy of the vaccine is quoted as 94%. That figure is arrived at by dividing 0.07 by 1.2, which equals 6%. Subtracting that from 100% equals 94%.https://www.medpagetoday.com/infectiousdisease/vaccines/91298?xid=nl_secondopinion_2021-02-23&eun=g1093365d0r
What about effectiveness against the variant strains? Data released by Pfizer from the Israeli Ministry of Health speaks to that question:
“Findings from the analysis were derived from de-identified aggregate Israel MoH surveillance data collected between January 17 and March 6, 2021, when the Pfizer-BioNTech COVID-19 Vaccine was the only vaccine available in the country and when the more transmissible B.1.1.7 variant of SARS-CoV-2 (formerly referred to as the U.K. variant) was the dominant strain. Vaccine effectiveness was at least 97% against symptomatic COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths. Furthermore, the analysis found a vaccine effectiveness of 94% against asymptomatic SARS-CoV-2 infections. For all outcomes, vaccine effectiveness was measured from two weeks after the second dose.”
“These new data build upon and confirm previously released data from the MoH demonstrating the vaccine’s effectiveness in preventing symptomatic SARS-CoV-2 infections, COVID-19 cases, hospitalizations, severe and critical hospitalizations, and deaths. The latest analysis from the MoH proves that two weeks after the second vaccine dose protection is even stronger – vaccine effectiveness was at least 97% in preventing symptomatic disease, severe/critical disease and death.”
When it comes to vaccines, safety and preservation of health are the metrics which with we should be concerned; not the case count or asymptomatic spread. Let’s not descend further into COVID chaos by becoming a victim of paralysis by analysis. Given what we know now – not what we don’t know or may never know – it is time to dispense with the pseudo-science definitions of what qualifies as a vaccine and focus on the vaccine’s impact on disease burden.