The truth about the vaccination “success” in Israel – a study dissected

BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting

One page summary (see details on next pages)

The study recognizes the severe limitations of the Randomized Controlled Trial for the EUA 

The study is limited in quality and scope, with many limitations, and biases 
The study is not independent with potential conflicts of interests 
The study uses questionable matching criteria, resulting in the risk of confounding bias 
The study’s findings on efficacy on mortality reduction is not statistically significant 
The study’s suggestion on efficacy on mortality reduction’s lower border is low (19%) 
Background

Clalit, the largest of Israel's four state-mandated health service organizations, with combined public and
semi-private interest, conducted a study.

Since the “gold standard” of evidence-based medicine, a RELEVANT double-blinded randomized

controlled trial (RCT) is missing for the Pfizer BioNTech vaccine, much is being done to try to prove the
value of this vaccine by other means.

It is now claimed that a study done by Clalit, BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass
Vaccination Setting, is proof of this.

But what does the study really say?

See : https://www.nejm.org/doi/10.1056/NEJMoa2101765

Don’t forget to look in the appendixes, they “hide” the important “details”.

For the protocol, see:

https://www.nejm.org/doi/suppl/10.1056/NEJMoa2101765/suppl_file/nejmoa2101765_protocol.pdf

The study recognizes that the original RCT, that lead to Emergency Use Authorization (EUA), was very
limited

1. “notable limitations of sample size and subgroup analysis”

2. “restrictive inclusion criteria”
3. “highly controlled setting that may not be replicated in a mass vaccine rollout”
4. “permitted estimates of vaccine efficacy in only a small number of subpopulations”
5. “patients with chronic diseases were included only if the conditions were deemed stable by the
investigators”
6. doesn’t take “suboptimal adherence to vaccination schedules and vaccine-handling logistics
influence vaccine effectiveness” into account

In fact this RCT was largely irrelevant as it focusses on efficacy of non-severe covid-19 positive testing in
healthy people with low risk of disease. It is flawed because of many reasons discussed elsewhere in my
posts, including:

 It was not a fully blinded study and testing was initiated subjectively
 Testing didn’t take into account variable disease prevalence (in spite of the WHO official
communication, see : https://www.who.int/news/item/20-01-2021-who-information-notice-for-
ivd-users-2020-05 ) resulting in poor accuracy
This CLALIT “patch-up” study was also limited in quality, time and scope

1. It’s not a prospective study

2. There is no (double-)blinding
3. It’s not a RCT
4. It’s an observational study with severe limitations that relies heavily on “matching” (see later)
5. It only takes people vaccinated during the period from December 20, 2020, to February 1, 2021
into account, thus it is a best a short snapshot in time, not taking emerging new variants into
account
6. Many of the most important groups were artificially excluded from this study:
a. People with previously documented positive SARS-CoV-2 polymerase-chain-reaction
(PCR) test were excluded
i. And thus risks like lower efficacy in previously infected people, Vaccine
Associated Enhanced Disease (VAED) and Antibody Disease Enhancement (ADE)
have been artificially excluded
b. Several other groups, with “variability in the probability of exposure” like patient-facing
health care workers in dedicated Covid-19 wards, persons not having a documented
geostatistical living area, those who have had interactions with the health care system
during the preceding 3 days that may indicate the start of symptomatic disease and may
preclude vaccination, nursing home residents, persons medically confined to the
home, or health care workers, were excluded

Independence and conflicts of interests

Based on the Disclosure information submitted, (see

https://www.nejm.org/doi/suppl/10.1056/NEJMoa2101765/suppl_file/nejmoa2101765_disclosures.pdf
) most of the authors and the corresponding author (Ran D. Balicer) do have relevant conflicts of
interest and receive grants from Pfizer.

Matching

The matching is crucial because it’s here that it’s attempted to exclude confounding factors that lead to
“correlation without causation”.
As you can see, the “count of pre-existing conditions by the CDC as risk criteria” contain elements that
aren’t risk Covid-19 factors. E.g. according to several specialized studies1, Asthma is not a risk factor. In
contrast, elements that are well established risk factors have been left out. Examples include:
chromosomal abnormalities, deficiencies with a strong association with severe disease and mortality, like
vitamin D3 deficiency, immune compromised status, and being overweight.

Furthermore the “count” of pre-existing conditions assumes that each of the factors contributes as much
risk as the others. This is untrue. As a result, study subjects may be matched inappropriately because in
reality their risk is significantly different.

Conclusion: matching may not be appropriately strong (depending on the statistical significance).
Confounding factors that make this observational study biased cannot be excluded.

1
Prevalence and characterization of asthma in hospitalized and nonhospitalized patients with COVID-19
https://www.jacionline.org/article/S0091-6749(20)30840-X/fulltext and The Impact of Asthma on Mortality in
Patients With COVID-19 https://journal.chestnet.org/article/S0012-3692(20)31645-7/fulltext and Prevalence of
comorbid asthma in COVID-19 patients https://www.jacionline.org/article/S0091-6749(20)30745-4/fulltext
Findings

I look mostly at the reduction in mortality because in a retrospective study with so many exclusions and
no blinding, it’s the probably the least subjective.

As you can see, the pink and light blue (confidence intervals) overlap. This means that at least statistically,
the efficacy of mortality reduction is uncertain and unproven.

Still the study’s summary suggests that vaccination may prevent death from Covid-19 at 72% (95% CI, 19
to 100). This means it can be as low as 19%. The 72% claimed is clearly a cherry-picked result, given the
above.
Overall conclusion.

The Clalit study, while recognizing the many flaws of the RCT, still contains a lot of weaknesses and biases.
This makes the conclusions of this study highly suspect. It is unable to fully rectify the fatal flaws of the
RCT study design.

The study’s summary suggests that vaccination may prevent death from Covid-19 at 72% (95% CI, 19 to
100). This means it can be as low as 19%. But, as shown, there are still confounding biases in this study.

It also doesn’t take into account the effect of physical prevention measures.

Giving the event sample size and the confounding bias, evidence level is currently LOW that this vaccine
reduces mortality MODERATELY (less than 0.02% ARR).

The main problem remains the probable continued spread, also via asymptomatically infected (as that is
at the core of the pandemic after all – otherwise isolation measures of the sick could have quickly dealt
with it, like SARS1)

There is no proof that herd immunity will be attainted in this way, nor that this strategy of mass
vaccination will not lead to immune escape variants. So at best the Clalit study shows some (temporary)
efficacy.