Public health decision makers, COVID Task forces, and their governments would be dangerously misguided and negligent if they continue to ignore the fully vaccinated as a major source of transmission

It was our hope given what we were initially told by the COVID-19 vaccine developers Pfizer and Moderna and the CDC, NIH, and NIAID, that the vaccines and the elevated vaccine rates would end the COVID emergency.  While not expressing support for the current vaccines in this op-ed given the existence of alternative public health measures and early outpatient treatment that should have been applied instead of vaccines, if one did develop vaccines capable of inducing sterilizing immunity in the first place, then this op-ed would not have been written. Why? It is our opinion that these vaccines were not needed in the vast majority of the low-risk population (definitely not in young persons or children) and if properly developed originally and properly tested with declarative safety, then and only then, with proper ethical informed consent, do we think that high risk vulnerable persons were candidates. The latter is still debatable given what we know about the high-risk group and the existence of effective treatment and methods to properly strongly protect them, absent of vaccine.

The views expressed here are ours and are meant to drive deeper urgent reflection and debate. Why this concern by us? Key is we have disregarded the evolutionary capacity of the virus to adapt to the immune pressure due to these vaccines. It is clear now that the vaccines have (are) largely failed against the Delta variant and boosting when the Delta variant is predominant and not the initial Wuhan strain, is only going to prolong and broaden population-level immune pressure and, therefore, promote dominant circulation of increasingly infectious immune escape variants. The resulting increase in viral infection rates enhances adaptation of more infectious variants to the vaccinated population while further driving immune escape in unvaccinated, previously asymptomatically infected individuals. This basically leads to a self-amplifying vicious circle.  

Basic immunology teaches us that you can only end the pandemic if you cut the chain of transmission and you do this with population-level herd immunity. We became very concerned when we learnt that the vaccines were sub-optimal, imperfect, and ‘leaky’ in that they did not sterilize the virus and thus they allowed for infection and transmission. Sterilization can be achieved by neutralizing antibodies. However, if neutralizing capacity is insufficient, the virus can still be sterilized thanks to cytotoxic immune cells capable of killing virus-infected cells.

We learnt that the vaccines were designed only to reduce mild symptoms of COVID and were not geared to reduce death or hospitalization or serious disease. We knew that you never ever use nonliving vaccines that cannot block viral transmission during an ongoing epidemic or pandemic. As was done in this case for COVID-19. We thus began warning the global community that you must not use conventional vaccines to conduct mass vaccination campaigns when there is widespread circulating pathogen. Experience told us that we must only vaccinate when the infectious pressure is low enough to not break through the innate immune response.

So as the vaccinal antibodies need time to achieve protective antibody titers, vaccinees will exert suboptimal immune pressure on the virus when exposed to the latter prior to having achieved full-fledged immunity. During an epidemic or pandemic, there is of course a high likelihood for vaccinees becoming infected while not yet being endowed with protective antibody titers.  In other words, you are already on the battle field and yet, at high risk of being attacked by the virus while still preparing your defences. We feel strongly that with these COVID vaccines, we would never ever be able to reach herd immunity as the chain of transmission could never be cut.

Remember, we came to know that the vaccine could not stop infection or transmission. On the contrary, mass vaccination only generates a widespread immunological environment that provides more infectious variants with a fitness/competitive advantage in the vaccinated population. We will, therefore, never be able to vaccinate ourselves out of this pandemic with these sub-optimal, i.e., leaky vaccines, and the virus will not spontaneously transit into endemicity as mass vaccination with Covid-19 vaccines will never generate herd immunity. In addition, sustained immune pressure on spike protein is even at risk of enabling the virus to cross species barriers, thereby potentially generating animal reservoirs that serve as a source of viral transmission to humans (as spike protein is also responsible for viral spillover events).   

By inoculating the host with a sub-optimal vaccine and applying such a vaccine for large-scale immunization programs (e.g., across all age groups), the risk of viral immune escape can only be increased. By placing widespread immune pressure on spike protein (mass vaccination with S-based vaccines!) of a virus that exerts high infectious pressure (dominant circulation of more infectious variants), mass vaccination during a pandemic of more infectious variants is adding fuel to the fire in that it enables the population to exert more and more pressure on viral infectiousness (as S spike protein is responsible for viral infectiousness).  Consequently, stakeholders of these campaigns have gravely underestimated and discounted the evolutionary capacity of the virus to naturally select highly infectious variants and adapt them to an environment of high but suboptimal population-level immune pressure.  Widespread rising levels of non-sterilizing immunity provides more infectious variants with a fitness advantage they would not normally have during the evolution of a natural pandemic (i.e., in the absence of massive S-directed immune pressure). As vaccination of large cohorts of the population provides a breeding ground for more infectious variants, the latter will now expand in prevalence and become dominant.

The purpose of this brief op-ed is therefore to warn the very same public health decision makers who implemented this flawed vaccine program using imperfect non-sterilizing vaccines that if they continue, they run the risk of driving the emergence of highly infectious variants that may eventually lead to more frequent and more pronounced pathogenicity as it is reasonable to assume that CoVs are amenable to escaping from all neutralizing antibodies by promoting variants capable of using alternative receptors on the surface of permissive host cells. As this would not affect epitopes recognized by previously neutralizing antibodies, antibody-opsonized virions would be suspicious of causing enhanced/ exacerbated pathogenicity. This is a very dangerous situation and particularly so if we move to vaccinate our children who do not need these vaccines and bring a near statistical zero risk of severe outcome to the table. The vaccines offer all risk and no benefit to children who have the gift of innate immunity that serves them usually as their first line of immune defense, and which is very potent. Why subvert this?

We warn again that mass vaccination as it is occurring now with these vaccines can potentially accelerate development of further variants as well as antibody-dependent enhancement (ADE) of disease. We thus state emphatically here that it is very misguided of public health, the CDC, and NIH, to discount the impact of the mass vaccination and to disregard the role of the vaccinated populations in the transmission of COVID virus, both to the vaccinated and the vulnerable unvaccinated persons. We argue that the vaccinated has a potentially equal if not superior role in the transmission of COVID virus than the unvaccinated based on the published data out of UK, Israel, US and elsewhere. The fully vaccinated must be considered as a source of transmission, and while it is no fault of their own and they must not be stigmatized as much as the unvaccinated must not be stigmatized, it is a consequence of a combination of immune pressure, infectious pressure, and the mass vaccine program during the midst of a pandemic with massive circulating pathogen.

The evidence is strong that the fully vaccinated can become infected, colonize, and transmit the virus and particularly heavy loads of virus and this opens the door for an unvaccinated person with a fully intact functional immune system to be potentially overwhelmed by such massive viral load from the vaccinated. The vaccine has failed against Delta. Disregarding the vaccinated as a source of pathogen and spread, could be catastrophic. We point to the following more recently published evidence and call on decision makers to urgently consider this data and adjust their control measures. One will not be able to avoid infection or disease by staying away from vaccinees. We are that what counts rather is improving your immune defence, first by declining the shot and second, by improving innate immunity (via healthy life style, nutrition etc.).

What is the key evidence that underpins this warning? How do we know that the vaccine has failed against the Delta and there is a real serious problem? As an example, Gazit et al., Acharya et al.,    Riemersma et al., Chemaitelly et al., Subramanian and Kumar, Chau et al., Shitrit et al., Hetemaki et al., Levin et al., Rosenberg et al., Suthar et al., Nordström et al., Yahi et al., Goldberg et al., Singanayagam et al., Keehner et al., Juthani et al., Embi et al. at the CDC , Eyre et al., Levine-Tiefenbrun et al., Puranki et al., Saade et al., Canaday et al., Israel et al., Salvatore et al., Eyran et al., Andeweg et al., and Di Fusco et al. have shown us that the vaccinated can become infected, can harbour the virus, and potentially transmit. We are looking at not only potentially more infectious variants, but more lethal ones due to these sub-optimal non-sterilizing vaccines. This is a huge problem and Kampf as well as Masre et al. (alternative receptors for SARS‐CoV‐2 viral entry into host cell) provides us further warnings. Kampf echoes a key warning of ours: “It appears to be grossly negligent to ignore the vaccinated population as a possible and relevant source of transmission when deciding about public health control measures.”

It is very likely that the vaccinated do transmit. They can harbour elevated viral loads and thus can potentially spread to the vaccinated and unvaccinated. We now have consistent credible reports (as above) of no significant difference in PCR cycle count threshold values between vaccinated and unvaccinated, asymptomatic and symptomatic groups infected with SARS-CoV-2 Delta, no difference in viral loads when comparing unvaccinated individuals to those who have vaccine “breakthrough” infections, and waning efficacy (antibody responses and T cell immunity) by the 4th to 6th months. Vaccinated are showing on average much more virus in their nose than the unvaccinated who were infected. Alarmingly, secondary transmission in nosocomial outbreaks are occurring from nurses with symptomatic infections in spite of the use of personal protective equipment and masks. Also of concern is the finding in the UK data (reports 42, 43, 44, 45, 46, 47) of elevated infection in the vaccinated and depressed N antibody levels in persons who acquire infection following 2 doses of vaccination.

Based on the presented evidence above that must include a simultaneous consideration of the adverse events and deaths reported to the CDC’s VAERS vaccine adverse reporting database, then we cannot support this mass vaccination. The COVID vaccines have proven to be too ineffective and unsafe at this time to warrant support of mass vaccination. This must be stopped and not even applied to vulnerable persons and definitely to our children. For the latter, the costs are unacceptable particularly as that these sub-optimal non-sterilizing vaccines would damage and subvert the potent polyspecific innate immune system response in children that is their first line of immunological defence (that they come with) and which serves them so potently to fight SARS-CoV-2, including all its variants (specific high-affinity vaccinal antibodies could outcompete polyspecific low-affinity innate antibodies). This could potentially create asymptomatic super-spreaders of highly infectious variants, but alarmingly, leave children in a highly vulnerable position to other viruses and pathogens due to a subverted ‘first line of defense’ innate immune system. None of this defense mechanisms can be replaced by vaccinal antibodies from which the virus is now increasingly escaping.    

To close, we are bypassing fully capable and sterilizing innate immune systems in our populations (and also natural adaptive/acquired immune systems) and eroding them by inducing non-sterilizing immune responses with an ever-decreasing capacity to recognize the target pathogen (antigen).  This can have catastrophic consequences for populations and humanity. This deserves very serious consideration as we move forward. Moreover, repeated natural boosting due to high rates of viral re-exposure (circulation of highly infectious variants) will prevent vaccinal antibody titers from declining and is, therefore, at risk of continually suppressing the innate immune system, which could have devastating consequences (for adult and child). It is our opinion that a hard stop to this vaccine program is the only path forward, with an equally acute pivot to the use of chemoprophylaxis antivirals as well as for treatment if infected. These current COVID vaccines are proving to be too unsafe with rapidly waning immunity to justify use. Ostracizing, stigmatizing, and attacking unvaccinated persons (including COVID-recovered) is not only morally wrong and unethical, it has no credible medical or scientific basis.

Paul Elias Alexander, MHSc, MSc, PhD, Geert Vanden Bossche, DVM, PhD