Dear President Biden, Mayor De Blasio, Dr. Collins, and President Bollinger,

As you  know, many workplaces and colleges in the US are mandating COVID-19 vaccinations with an effective start date on or near September 1st. Given my family medical history, I recently conducted a weeks-long extensive research to decide whether the benefits of vaccination outweigh the risks, or whether I should seek an exemption. Towards this end, I applied my almost 20 years background and training in biomedical and clinical informatics, data science, applied statistics, as well as previous experience in epidemiology and microbiology research. I am a research scientist and assistant professor at Columbia University Irving Medical Center. 

https://www.columbiapsychiatry.org/profile/spiro-pantazatos-phd ​

https://www.researchgate.net/profile/Spiro-Pantazatos

Based on my research, I decided I should not get vaccinated. I also discovered that the benefits of being vaccinated at this point do not outweigh the risks, especially for younger and middle age groups who are at much lower risk of dying from or being impaired by COVID. Therefore, I felt a moral and ethical imperative to report my findings to you during this critical time in which vaccine mandates are being considered or have already been recently implemented throughout the city and state. 

The mandates are based on (now) outdated beliefs that the current vaccines will: 
1.  reduce community spread of the coronavirus
2.  reduce one’s chances of being infected with coronavirus 
3.  reduce likelihood of severe COVID symptoms and death if infected with the coronavirus 

Recent findings undermine and contradict each of these beliefs. We now know the vaccines do not reduce community spread[1] and they do not appear to confer protection against currently circulating variants of the virus[2] (despite misleading reports that we are experiencing a “pandemic of the unvaccinated”), and they will likely be completely ineffective against newer variants currently circulating in other parts of the world[3].  There do not appear to be enough protective benefits of vaccination to justify the non-trivial risk of death and (alarmingly) higher risk of life-altering injury[4]. Emerging evidence from Israel suggests vaccination may paradoxically increase the rate of spread and risk of infection, symptom severity and death both during vaccination and also after full vaccine protection has worn off[5]. Given the much lower risks of COVID in younger adults relative to older adults [6] and the low benefits of vaccination, continuing the vaccine mandates may take or impair more lives than save from COVID in these age groups.

Why isn’t this advice coming from government agencies? 

The virus evolves quickly as does the current state of knowledge on the pandemic. Many academics, scientists and clinicians are too busy to adequately research the current state of knowledge, and we must resort to taking guidance and recommendations from the CDC. At this time, I strongly feel this is the wrong approach. Rather than promptly inform public officials and other agencies to swiftly lift the vaccine mandates and adjust public health policy accordingly, it appears that officials at the CDC still believe 100% vaccine coverage is the best way to beat the virus. They appear to be trying to paint mass vaccination in a positive light no matter what.  A cynic might speculate these actions are related to financial conflicts of interest or efforts to mitigate culpability or liability stemming from the higher than normal vaccine-related deaths and injuries out of fear of professional retributions. However, where they have dropped the ball, others have the opportunity to pick it up. 

Dr. Robert Malone[7], credited as the early pioneer and inventor of mRNA vaccine technology[8], [9], also says young adults should not be vaccinated because the risk-benefit ratio analyses have not been done[10]. The risks and adverse events observed with the current vaccines (estimates of vaccine related deaths are well in the thousands and life-altering injuries in the tens or even hundreds of thousands[11], [12]) appear to be mediated by the (unintended) cleaving of spike protein from transfected cells leading to biodistribution in organs outside the injection site[13], [14].   

The mandates in NYC colleges and workplaces should be lifted ASAP until risk-benefit ratio analyses can be done for younger age groups and according to COVID risk status. Mandating vaccination with the current vaccines in groups at low risk for severe COVID without fully informed consent about the benefits vs. risks, especially when they will not reduce community spread of the virus, and when there are alternative and safer forms of prophylaxis with a growing evidence base such as Ivermectin[15] and other vaccines that may prove safer such as Novavax[16], is highly unethical. 

It is also foolhardy. It is in the best interest of Columbia University, NYC, NIH and NYS to lift the mandates as soon as possible. The sooner the mandates are lifted the less likely there are to be future repercussions in the form of lawsuits stemming from adverse events or injuries. I just recently spoke with my martial arts instructor from childhood. His young adult son suffered acute appendicitis within a week after vaccination and his previously healthy young adult niece was diagnosed with Reyes syndrome following vaccination. When adjusting for likely underreporting to the CDC’s Vaccine Adverse Events  Reporting System (VAERS)[11], [12], hundreds of thousands of serious, life-altering vaccine-related injuries may have already occurred in the US. 

It is only a matter of time (weeks or months?) before problems with the current vaccines surface to greater public awareness. At this critical juncture, the NIH, NYC, NYS, and Columbia University have an opportunity to get out  ahead of it, set a precedent, and swiftly learn from the mistakes of countries where mass vaccinations have already been implemented. 

Heavily vaccinated countries like Iceland[17] (where >90% adults 16 and over are vaccinated) and Israel are currently experiencing new COVID surges [18]. Iceland’s chief epidemiologist now believes that herd immunity can not be achieved through high vaccination coverage. The country will appear to adopt the Swedish approach of achieving herd immunity through natural infection, while administering vaccine boosters to high risk groups [19]. 

Below I elaborate each of the above points in more detail. 

1. Vaccination does not appear to significantly reduce infectivity, community spread or transmissibility of the virus, especially with current and future variants of the virus[1]. 

A recent CDC study reported an outbreak of SARS-CoV-2 infections associated with large public gatherings in Barnstable County, Massachusetts among fully vaccinated people in July 2021[1]. While “vaccination coverage among eligible Massachusetts residents was 69%, approximately three quarters (346; 74%) of cases occurred in fully vaccinated persons (those who had completed a 2-dose course of mRNA vaccine [Pfizer-BioNTech or Moderna] or had received a single dose of Janssen [Johnson & Johnson] vaccine ≥14 days before exposure).”

Mass vaccination efforts have been supported by evidence from real world studies that suggest vaccination reduces symptomatic infections for both alpha and delta variants. For example, a large-scale UK study linked vaccination status with community testing (RT-PCR) results. Data on all symptomatic sequenced cases of Covid-19 in England were used to estimate the proportion of cases with either variant according to the patients’ vaccination status using a test-negative case control design [20]. The approach suggested 93.7% (88.0%) vaccine effectiveness (VE) among people with the alpha (delta) variant.  

However, the authors themselves note “The findings are observational and should be interpreted with caution. Low sensitivity or specificity of PCR testing could result in cases and controls being misclassified, which would attenuate the estimates of vaccine effectiveness.“ In addition, the study extracted data between October 26, 2020, and May 16, 2021, and it is not clear how or whether their adjusted VE estimates take into account the fact that the UK’s first COVID wave occurred in November, and vaccination did not start until late December. This could bias more cases to occur among their unvaccinated group which would also attenuate VE estimates.  Finally, the paper does not appear to address or attempt to adjust for the fact that vaccinated people are less likely to seek testing when experiencing symptoms consistent with COVID symptoms, because they are less likely to believe they have COVID due to having been vaccinated. Such cases would be excluded from the vaccinated group, thus further attenuating the VE estimates. 

I have not had the time to review other real world studies on VE with the alpha and delta variants, but I suspect they have similar issues and limitations. 

2. State government reports comparing rates of infection, hospitalization and death among unvaccinated use misleading statistics. Where details are lacking, there appears to be cherry-picking or a lack of transparency and access to the underlying data. 

A report from the Washington State Department of Health[21] dated August 11th, 2021 highlighted the following key findings from data obtained between February and July 2021:

“– 95.5% of COVID-19 cases were in those not fully vaccinated
 – 95.4% of hospitalizations among COVID-19 cases were in those not fully vaccinated 
 – 94.3% of deaths related to COVID-19 were in those not fully vaccinated.”

Similar statistics are reported in another report across 24 states published July 30, 2021 [22]. The reporting periods for all but a few of the states begin in January 2021. However, the reports do not adjust their figures for the base rate of vaccination over time. Vaccination campaigns began Demember, 2020. In WA state for example, by March 1st only 8% of the state’s population had been fully vaccinated, increasing to 33% by May 1st [23]. Most states, including WA, were coming off of a large wave of infection which peaked on Jan 1st, 2021 (see infections panel in [24]). Given the time course from COVID infection to symptom onset to hospitalization and death (~2-4 weeks)[25], the majority of the cases, hospitalizations and deaths would be expected in January and February, 2021. Therefore the majority of COVID cases, hospitalizations and deaths are expected to be among the unvaccinated, because the majority of cases, hospitalizations and deaths occurred when the states were mostly still unvaccinated. The statistics are an example of the base rate fallacy and are highly misleading.

An NBC news report on July 30th, 2021 reported at least 125,000 fully vaccinated Americans tested positive for COVID and that 1,400 of those cases had died [2]. This translates to roughly a 1.1% infection fatality ratio (IFR). This is likely to undershoot the actual rate since those cases are still on-going and we do not know who will recover vs. eventually die (in other words the rate can only go up after those 125K either recover or die). 

For comparison the estimated US national average IFR pre-vaccination campaigns was between 0.35-0.5%[26]. Obtaining accurate estimates of the IFR among vaccinated people, across multiple age groups and adjusting for co-morbidities, in comparison to the IFR in unvaccinated people, is critical in order to learn whether vaccines mitigate COVID symptom severity and likelihood of death following infection. Perplexingly, however, this does not appear possible, since the CDC stopped tracking breakthrough infections on May 1[27] . I speculate that the CDC stopped tracking breakthrough infections because they found no differences in infection rates between vaccinated vs. unvaccinated people with the recent delta variant.

Other news reports such as one titled “Symptomatic breakthrough COVID-19 infections are rare, CDC estimates” use misleading maths[28] : 

“Statewide in Massachusetts, state health officials report there have been at least 5,166 breakthrough infections as of July 17. More than 4,800 of these infections resulted in no hospitalization or death. A total of 80 of these breakthrough cases resulted in death, representing 0.0015% of individuals fully vaccinated -- and 272 cases resulted in hospitalization, representing 0.006% of those fully vaccinated.”

The authors divide the number of breakthrough COVID deaths (80), by the total number of people who were vaccinated (vaccinees), to arrive at a very low percentage number (0.0015%). However, the denominator of interest is the number of breakthrough infections. This gives an estimated IFR in vaccinees of 80/5,166 = 1.5%. Information such as age composition and co-morbidities of these cases is needed to understand how this IFR compares to those who are unvaccinated and the pre-vaccination estimated national average IFR of 0.35-0.5%[26]. However,  such information is not readily available because the CDC stopped tracking breakthrough infections on May 1st (see above).   

For the above reasons, I do not trust or take at face value many of the current circulating reports claiming that unvaccinated people form the overwhelming majority of those hospitalized or treated for severe COVID. 

3. Basic calculations using publicly available data strongly suggest the benefits of current vaccines do not outweigh the risks, especially for healthy young adults. 

The COVID IFR depends highly on age and other co-morbidities. Up to 90% of the variation in population wide IFR is explained by age composition and extent to which older age groups were exposed to the virus[6]. According to the meta-analysis the IFR for age 18 years is 0.005%, 25 years is about 0.01%, 45 years 0.1 %, 55 years 0.4%, 65 years 1.4%, 75 years 5%, and 15% >85 years.[6]   

The risk of dying from COVID can be readily compared to the risk of dying from or suffering life-altering injuries from vaccination using the CDC Vaccine Adverse Events Reporting System (VAERS)[4]. The VAERS is a publicly searchable database of adverse events including death following vaccination.   

Table 1. VAERS data adjusted for completed vaccinations obtained from the CDC[29] 

(Change.org does not allow tables or figures. Click link above to view the table.)

Although these counts do not adjust for age, the table already makes clear that vaccination probably does not make sense for adolescents who are ages 18 or younger (i.e. the estimated vaccination death rate of ~0.004% is similar to the COVID IFR in this age group as estimated in [6]). Given that VAERS only accepts (not collects) adverse event reports from healthcare workers, vaccine manufacturers, and the public, the events are likely to be underreported. An early analysis from 2010 estimated that only about 1% of adverse events are reported[12], so the above estimates are likely to be higher. 

An individual’s risk of COVID is also a function of infection risk, which is based on lifestyle, location, and occupation. This will also factor into whether the benefits of vaccination outweigh the risks. Infection risk calculators based on county across can allow someone to estimate their risk of infection based on attending an event of a certain size[30]. An individual attending a social gathering with an infection risk of 10% would therefore have an overall risk of death from COVID that is 1/10th the IFR for their age group. 

For example, a healthy 45 year old attending events with a 10% infection risk would have a 0.1*0.1%=0.01% chance of dying from COVID, which is similar to the odds of dying from vaccination (i.e. if one assumes that VAERS under-reports vaccine-related deaths by a factor of 3 then the calculated odds are ~0.01%). Note that the total counts of vaccine related deaths in VAERS in July went from ~12K to 6K within a week, ostensibly because the agency had decided to remove foreign reports of death [31]. According to reports about a CDC whistleblower, the number of vaccine related deaths reported to VAERS may be as high as 45K [32]. My calculations based on the VAERS data are consistent with other more detailed reports [33]. For a more comprehensive analysis and detailed report of the July, 2021 VAERS dataset broken down by age, sex, vaccine manufacture and types of adverse events see [11]. Of note, the latter analysis found that 2,346 cases were women who were documented as pregnant at time of vaccination. Of these, 4.1% experienced a congenital anomaly or birth defect, while over 36% experienced some type of pregnancy disorder when expanding search terms to include fetal death, heart abnormality, growth abnormality, cardiac arrest, cerebral haemorrhage, abortion, premature baby death, premature delivery, rupture of membranes, separation of placenta, or vaginal haemorrhage in pregnancy. 

A recent study suggests that the current vaccines may be completely ineffective against new variants of interest such as lambda (currently circulating in South America)[3]. At this point vaccine mandates appear to incur no benefit and only risk.

4. The NIH’s emphasis on personalized medicine seems to have been thrown out the window in its insistence and recommendation of vaccine mandates for everyone. However, with risk there must be choice and fully informed consent. Unfortunately, research into and awareness of alternative therapeutics and prophylactics have been largely ignored.

Monoclonal antibodies as early treatment for COVID positive cases has just been FDA approved [34]. A substantial global evidence base suggests hydroxychloroquine is an effective treatment for COVID-19 [35]. Ivermectin has a growing evidence base supporting its use as a therapeutic and prophylactic against COVID [15]. The repurposed drug  is central to the Frontline COVID-19 Critical Care Alliance protocol [36] that is being used in low-resources countries. In terms of its mechanism, “Multiple coexisting or alternate mechanisms of action likely explain the clinical effects observed, such as the competitive binding of ivermectin with the host receptor-binding region of SARS-CoV-2 spike protein, as proposed in 6 molecular modeling studies. In 4 of the studies, ivermectin was identified as having the highest or among the highest of binding affinities to spike protein S1 binding domains of SARS-CoV-2 among hundreds of molecules collectively examined, with ivermectin not being the particular focus of study in 4 of these studies.” One meta-analysis suggests a relative risk reduction of ~60% which suggests its effectiveness is comparable to the J&J vaccine [37].  

5. Emerging evidence suggests vaccination may paradoxically increase the likelihood of hospitalization and death following coronavirus infection. 

A straightforward re-analysis of public data provided by the Israeli Ministry of Health (initially published with the intent to evidence support for the mass vaccinations) suggests that vaccination with the Pzifer vaccine may actually increase the infectivity, severity, and IFR from following coronavirus  infection [5]. I was in disbelief when I came across the report, but the calculations appear to be correct. In order to reap life saving benefits, the Pzifer vaccine would need to offer 27 months of stable perfect vaccine protection against a mutable RNA coronavirus in order to make up for excess deaths, likely caused by a weakening of the immune system, between the 1st dose until  ~7 days after the 2nd dose. Twenty seven months of stable protection against a mutable RNA virus is highly unlikely with the current vaccines.  

The report also suggests vaccines may contribute towards a higher IFR even after the full vaccination period (see Table 1 in [5] ). If true, the mechanism for this may be due to antibody dependent enhancement (ADE) [38] . “ADE is a special case of what can happen when low, non neutralizing levels of either specific or cross-reactive antibodies against a virus are present at the time of infection. These antibodies might be present due to prior exposure to the virus, exposure to a related virus, or due to prior vaccination against the virus. Upon reinfection, antibodies in insufficient numbers to neutralize the virus nevertheless bind to the virus. These antibodies then dock at the Fc receptor on cell surfaces, facilitating viral entry into the cell and subsequently enhancing the infectivity of the virus [39]. 

Thank you very much for your time and consideration in reading this letter. Please let me know if I can help any further. I can offer to prepare a short 5-10 minute slideshow presentation explaining the above material in layman’s terms in order to further help you as you make your decisions regarding the vaccine mandates. An up-to-date preprint manuscript with additional analyses and citations, including critical reviews of vaccine clinical trial studies, can be accessed at https://researchers.one/articles/21.08.00008.

Sincerely,

Spiro Pantazatos, PhD
Assistant Professor of Clinical Neurobiology
Columbia University Irving Medical Center
New York, NY USA

                                                           References

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