The document presents a critical appraisal of the reported efficacy measures for the Pfizer/BioNTech and Moderna COVID-19 mRNA vaccines. Using epidemiological tools and data from the vaccine clinical trials, the author calculates that the absolute risk reduction for the Pfizer vaccine is 0.7% and for the Moderna vaccine is 1.1%. These measures of absolute risk reduction are much lower than the reported relative risk reduction measures of 95.1% and 94.1%, respectively. The author argues that reporting absolute risk reduction is essential to prevent outcome reporting bias and allow for informed decision making about vaccine efficacy.
The Spartacus Letter – Rev. 2 (2021-09-28) | SpartacusGuy Boulianne
An anonymously posted document by someone calling themselves “Spartacus” of the Institute for Coronavirus Emergence Nonprofit Intelligence (ICENI) has been gaining widespread attention. Zero Hedge called the letter “simply the best document I’ve seen on COVID, vaccines, etc. Whoever Spartacus is, they have a very elaborate knowledge in ‘the field’.”
The Spartacus Letter – Rev. 2 (2021-09-28) | SpartacusGuy Boulianne
An anonymously posted document by someone calling themselves “Spartacus” of the Institute for Coronavirus Emergence Nonprofit Intelligence (ICENI) has been gaining widespread attention. Zero Hedge called the letter “simply the best document I’ve seen on COVID, vaccines, etc. Whoever Spartacus is, they have a very elaborate knowledge in ‘the field’.”
The Life After COVID-19: A Frontliner's Perspective.MaMonicaRivera
These slides are uploaded for information and as partial requirement of Philippine Women's University in Master of Nursing (MAN); Subject: Nursing Practicum
By: Ma. Monica Rivera, BSN, RN
Selon une étude, publiée en décembre 2020, la population de la ville de Manaus (Brésil) aurait atteint l’immunité collective. Laurent AVENTIN, PhD – Consultant en santé publique, fait le point pour Le Courrier des Stratèges…
Pneumonia and diarrhoea: tackling the deadliest diseases for the world’s poor...UNICEF Publications
Pneumonia and diarrhoea are leading killers of the world’s youngest children, accounting for 29 per cent of deaths among children under age 5 worldwide – or more than 2 million lives lost each year. This report makes a remarkable and compelling argument for tackling pneumonia and diarrhoea, two of the leading killers of children under age five. The data in this report highlight a critically important point – children living in the poorest households are less likely than the children living in the richest households to benefit from preventive measures and, when they do become ill, to receive lifesaving treatments.
Contributors are students, faculty, and alumni located in a variety of geographic locations from Yale, Tulane, and Sacred Heart Universities. It provides information gathered from situation reports, government and non-governmental organization, media reporting, and a variety of information sources, verifies and synchronizes the information and provide real-time information products to federal, state, local, nongovernmental and international response organizations.
Contributors are students, faculty, and alumni located in a variety of geographic locations from Yale, Tulane, and Sacred Heart Universities. It provides information gathered from situation reports, government and non-governmental organization, media reporting, and a variety of information sources, verifies and synchronizes the information and provide real-time information products to federal, state, local, nongovernmental and international response organizations.
This report specifically looks at the impact COVID-19 has had on nursing homes and the nursing home industry. Contributors are students, faculty, and alumni located in a variety of geographic locations from Yale, Tulane, and Sacred Heart Universities. It provides information gathered from situation reports, government and non-governmental organization, media reporting, and a variety of information sources, verifies and synchronizes the information and provide real-time information products to federal, state, local, nongovernmental and international response organizations.
Die britische Regierung räumt ein, dass Impfstoffe das natürliche Immunsystem von Doppelgeimpften geschädigt haben. Die britische Regierung hat zugegeben, dass Sie nach einer Doppelimpfung nie wieder eine vollständige natürliche Immunität gegen Covid-Varianten – oder möglicherweise gegen andere Viren – erlangen können. Sehen wir also zu, wie die „echte“ Pandemie jetzt beginnt! In seinem „COVID-19 Vaccine Surveillance Report“ (Woche 42) räumt das britische Gesundheitsministerium auf Seite 23 ein, dass „die N-Antikörperspiegel bei Menschen, die sich nach zwei Impfdosen infizieren, niedriger zu sein scheinen“. Es heißt weiter, dass dieser Rückgang der Antikörper im Wesentlichen dauerhaft ist. Was bedeutet das? Wir wissen, dass Impfstoffe eine Infektion oder Übertragung des Virus nicht verhindern (tatsächlich zeigt der Bericht an anderer Stelle, dass geimpfte Erwachsene jetzt viel wahrscheinlicher infiziert werden als ungeimpfte). Die Briten stellen nun fest, dass der Impfstoff die Fähigkeit des Körpers beeinträchtigt, nach einer Infektion Antikörper zu bilden, nicht nur gegen das Spike-Protein, sondern auch gegen andere Teile des Virus. Insbesondere scheinen geimpfte Personen keine Antikörper gegen das Nukleokapsid-Protein, die Hülle des Virus, zu bilden, das ein entscheidender Teil der Reaktion bei ungeimpften Personen ist. Langfristig sind die Geimpften deutlich anfälliger für eventuelle Mutationen im Spike-Protein, auch wenn sie bereits einmal oder mehrmals infiziert und geheilt wurden. Die Ungeimpften hingegen werden eine dauerhafte, wenn nicht sogar dauerhafte Immunität gegen alle Stämme des angeblichen Virus erlangen, nachdem sie auch nur einmal auf natürliche Weise damit infiziert wurden. Quelle: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1027511/Vaccine-surveillance-report-week-42.pdf Die
The Life After COVID-19: A Frontliner's Perspective.MaMonicaRivera
These slides are uploaded for information and as partial requirement of Philippine Women's University in Master of Nursing (MAN); Subject: Nursing Practicum
By: Ma. Monica Rivera, BSN, RN
Selon une étude, publiée en décembre 2020, la population de la ville de Manaus (Brésil) aurait atteint l’immunité collective. Laurent AVENTIN, PhD – Consultant en santé publique, fait le point pour Le Courrier des Stratèges…
Pneumonia and diarrhoea: tackling the deadliest diseases for the world’s poor...UNICEF Publications
Pneumonia and diarrhoea are leading killers of the world’s youngest children, accounting for 29 per cent of deaths among children under age 5 worldwide – or more than 2 million lives lost each year. This report makes a remarkable and compelling argument for tackling pneumonia and diarrhoea, two of the leading killers of children under age five. The data in this report highlight a critically important point – children living in the poorest households are less likely than the children living in the richest households to benefit from preventive measures and, when they do become ill, to receive lifesaving treatments.
Contributors are students, faculty, and alumni located in a variety of geographic locations from Yale, Tulane, and Sacred Heart Universities. It provides information gathered from situation reports, government and non-governmental organization, media reporting, and a variety of information sources, verifies and synchronizes the information and provide real-time information products to federal, state, local, nongovernmental and international response organizations.
Contributors are students, faculty, and alumni located in a variety of geographic locations from Yale, Tulane, and Sacred Heart Universities. It provides information gathered from situation reports, government and non-governmental organization, media reporting, and a variety of information sources, verifies and synchronizes the information and provide real-time information products to federal, state, local, nongovernmental and international response organizations.
This report specifically looks at the impact COVID-19 has had on nursing homes and the nursing home industry. Contributors are students, faculty, and alumni located in a variety of geographic locations from Yale, Tulane, and Sacred Heart Universities. It provides information gathered from situation reports, government and non-governmental organization, media reporting, and a variety of information sources, verifies and synchronizes the information and provide real-time information products to federal, state, local, nongovernmental and international response organizations.
Die britische Regierung räumt ein, dass Impfstoffe das natürliche Immunsystem von Doppelgeimpften geschädigt haben. Die britische Regierung hat zugegeben, dass Sie nach einer Doppelimpfung nie wieder eine vollständige natürliche Immunität gegen Covid-Varianten – oder möglicherweise gegen andere Viren – erlangen können. Sehen wir also zu, wie die „echte“ Pandemie jetzt beginnt! In seinem „COVID-19 Vaccine Surveillance Report“ (Woche 42) räumt das britische Gesundheitsministerium auf Seite 23 ein, dass „die N-Antikörperspiegel bei Menschen, die sich nach zwei Impfdosen infizieren, niedriger zu sein scheinen“. Es heißt weiter, dass dieser Rückgang der Antikörper im Wesentlichen dauerhaft ist. Was bedeutet das? Wir wissen, dass Impfstoffe eine Infektion oder Übertragung des Virus nicht verhindern (tatsächlich zeigt der Bericht an anderer Stelle, dass geimpfte Erwachsene jetzt viel wahrscheinlicher infiziert werden als ungeimpfte). Die Briten stellen nun fest, dass der Impfstoff die Fähigkeit des Körpers beeinträchtigt, nach einer Infektion Antikörper zu bilden, nicht nur gegen das Spike-Protein, sondern auch gegen andere Teile des Virus. Insbesondere scheinen geimpfte Personen keine Antikörper gegen das Nukleokapsid-Protein, die Hülle des Virus, zu bilden, das ein entscheidender Teil der Reaktion bei ungeimpften Personen ist. Langfristig sind die Geimpften deutlich anfälliger für eventuelle Mutationen im Spike-Protein, auch wenn sie bereits einmal oder mehrmals infiziert und geheilt wurden. Die Ungeimpften hingegen werden eine dauerhafte, wenn nicht sogar dauerhafte Immunität gegen alle Stämme des angeblichen Virus erlangen, nachdem sie auch nur einmal auf natürliche Weise damit infiziert wurden. Quelle: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1027511/Vaccine-surveillance-report-week-42.pdf Die
A broad perspective on COVID-19: a global pandemic and a focus on preventive ...LucyPi1
Abstract Coronavirus 2019 has become a highly infectious disease caused by severe acute respiratory syndrome coronavirus-2, a strain of novel coronavirus, which challenges millions of global healthcare facilities. Coronavirus are sub-microscopic, single stranded positive sense RNA viruses that leads to multi organ dysfunction syndrome, severe acute and chronic respiratory distress syndrome and pneumonia. The spike glycoprotein structure of the virus causes the viral protein to bind with the receptors on the lung and gut through angiotensin-converting enzyme 2. In some cases, the infected patients become hyper to the immune system because of the uncontrolled production of cytokines resulting in “cytokine storm”, a devastating consequence of coronavirus disease 2019. Due to the rapid mutant strain and infective nature of severe acute respiratory syndrome coronavirus-2, discovering a drug or developing a vaccine remains a global challenge. However, some anti-viral agents, certain protease inhibitor drugs, non-steroidal inflammatory drugs and convalescent plasma treatment were suggested. The containment and social distancing measures only aim at reducing the rate of new infections. In this view, we suggest certain traditional herbs and complementary and alternative medicine as a supporting public healthcare measure to boost the immune system and also may provide some lead to treat and prevent this infection.
Các nguyên tắc thẩm định vaccine chống Coronavirus SARS-CoV-2 theo tiêu chuẩn GMP Nhật Bản. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
The word "vaccine" originates from the Latin word “vacca”, meaning “cow” a virus (cowpox) which manly effect the cow. which Edward Jenner demonstrated in 1798 could prevent smallpox in humans.
Assignment on Covid 19 | Tutors India.pptxTutors India
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Treatment of COVID-19; old tricks for new challengesLuisaSarlat
Coronavirus disease (COVID-19), which appeared in December 2019, presents a global challenge, particularly in the rapid increase of critically ill patients with pneumonia and absence of definitive treatment. To date, over 81,000 cases have been confirmed, with over 2700 deaths. The mortality appears to be around 2%; early published data indicate 25.9% with SARS-CoV-2 pneumonia required ICU admission and 20.1% developed acute respiratory distress syndrome
Impact of population mixing between vaccinated and unvaccinated subpopulation...Guy Boulianne
Impact of population mixing between vaccinated and unvaccinated subpopulations on infectious disease dynamics: implications for SARS-CoV-2 transmission
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
2. Medicina 2021, 57, 199 2 of 8
“There may be much more complexity to the ‘95% effective’ announcement than
meets the eye—or perhaps not. Only full transparency and rigorous scrutiny of
the data will allow for informed decision making. The data must be made public.”
As was also noted in the BMJ Opinion, Pfizer/BioNTech and Moderna reported the relative
risk reduction of their vaccines, but the manufacturers did not report a corresponding
absolute risk reduction, which “appears to be less than 1%” [9]. Absolute risk reduction
(ARR) and relative risk reduction (RRR) are measures of treatment efficacy reported in
randomized clinical trials. Because the ARR and RRR can be dramatically different in the
same trial, it is necessary to include both measures when reporting efficacy outcomes to
avoid outcome reporting bias. In the present article, a critical appraisal of publicly available
clinical trial data verifies that absolute risk reduction percentages for Pfizer/BioNTech
vaccine BNT162b2 [7] and Moderna vaccine mRNA-1273 [8] are, respectively, 0.7%; 95% CI,
0.59% to 0.83%; p = 0.000, and 1.1%; 95% CI, 0.97% to 1.32%; p = 0.000. The same publicly
available data, without absolute risk reduction measures, were reviewed and approved
by the roster of members serving on the U.S. Food and Drug Administration’s (FDA’s)
Vaccines and Related Biological Products Advisory Committee (VRBPAC) for emergency
use authorization (EUA) of the mRNA vaccines [10]. Ironically, the omission of absolute
risk reduction measures in data reviewed by the VRBPAC overlooks FDA guidelines for
communicating evidence-based risks and benefits to the public [11]. The FDA’s advice for
information providers includes:
“Provide absolute risks, not just relative risks. Patients are unduly influenced
when risk information is presented using a relative risk approach; this can result
in suboptimal decisions. Thus, an absolute risk format should be used.”
The New England Journal of Medicine also published clinical trial data on safety and efficacy
for the BNT162b2 vaccine [12] and the mRNA-1273 vaccine [13], but with no mention of
absolute risk reduction measures.
The present article uses epidemiologic tools to critically appraise absolute and relative
risk reduction measures for vaccine efficacy in phase III clinical trials of the COVID-19
mRNA vaccines. Microsoft Excel was used to analyze data and chart risk reduction out-
comes. The article further clarifies how selective reporting of vaccine efficacy measures can
cause a type of outcome reporting bias that misrepresents health information disseminated
to the public.
2. Critical Appraisal of Vaccine Efficacy
The application of epidemiologic and biometric methods to clinical diagnosis and
treatment is known as clinical epidemiology [14]. Clinical epidemiologic tools can be
applied in evidence-based medicine (EBM) to critically appraise research evidence for
validity, size of effect, and usefulness in clinical practice [15]. Clinical treatment effects in
groups of participants are measured by comparing probabilities of an event, known as
event rates [16].
Figure 1 shows an example of a vaccine clinical trial for an infectious disease. The
vaccine and placebo groups in Figure 1 each have 100 randomly assigned individuals with
no history of infection, and an event is defined as the incidence of infection among all
individuals during the course of the trial. The percentage of events in the vaccine group is
the experimental event rate (EER) or the risk of infection in the vaccine group (1/100 = 1%),
and the percentage of events in the placebo group is the control event rate (CER) or the risk
of infection in the placebo group (2/100 = 2%). Absolute risk reduction (ARR) is the disease
risk difference between the placebo and vaccine groups, i.e., the CER minus the EER (2% −
1% = 1%). The ARR is also known as the vaccine disease preventable incidence (VDPI) [17].
Relative risk reduction (RRR) or vaccine efficacy (VE) is the reduced risk from vaccination,
the ARR or VDPI, relative to or divided by the risk in unvaccinated individuals, the CER
(1%/2% = 50%) [18].
3. Medicina 2021, 57, 199 3 of 8
Medicina 2021, 57, x FOR PEER REVIEW 3 of 9
duced risk from vaccination, the ARR or VDPI, relative to or divided by the risk in un-
vaccinated individuals, the CER (1%/2% = 50%) [18].
Figure 1. Example of a vaccine clinical trial for an infectious disease.
3. 2 × 2 Contingency Tables and Epidemiologic Equations
The following 2 × 2 contingency tables for SARS-CoV-2 infection are based on re-
ported clinical trial data for the Pfzier/BioNTech BNT162b2 vaccine [12] and the Moderna
mRNA-1273 vaccine [13]. The table rows, shown in Table 1, list the vaccine and placebo
groups and the table columns list the participants’ outcomes of either SARS-CoV-2 in-
fection or no infection. Table 2 and Table 3 list the clinical trial data for the
Pfzier/BioNTech and Moderna vaccines, respectively. As shown in Table 1, the total
number of participants in a group, known as n, is represented by a + b for the vaccine
group and c + d for the placebo group.
Table 1. 2 × 2 contingency table for SARS-CoV-2 infection in vaccine clinical trials.
Infection No Infection
Vaccine a b a + b
Placebo c d c + d
Table 2. 2 × 2 contingency table for SARS-CoV-2 infection in Pfzier/BioNTech vaccine clinical trial.
Infection No Infection
BNT162b2 8 21,712 21,720
Placebo 162 21,564 21,726
Table 3. 2 × 2 contingency table for SARS-CoV-2 infection in Moderna vaccine clinical trial.
Figure 1. Example of a vaccine clinical trial for an infectious disease.
3. 2 × 2 Contingency Tables and Epidemiologic Equations
The following 2 × 2 contingency tables for SARS-CoV-2 infection are based on reported
clinical trial data for the Pfzier/BioNTech BNT162b2 vaccine [12] and the Moderna mRNA-
1273 vaccine [13]. The table rows, shown in Table 1, list the vaccine and placebo groups
and the table columns list the participants’ outcomes of either SARS-CoV-2 infection or no
infection. Tables 2 and 3 list the clinical trial data for the Pfzier/BioNTech and Moderna
vaccines, respectively. As shown in Table 1, the total number of participants in a group,
known as n, is represented by a + b for the vaccine group and c + d for the placebo group.
Table 1. 2 × 2 contingency table for SARS-CoV-2 infection in vaccine clinical trials.
Infection No Infection
Vaccine a b a + b
Placebo c d c + d
Table 2. 2 × 2 contingency table for SARS-CoV-2 infection in Pfzier/BioNTech vaccine clinical trial.
Infection No Infection
BNT162b2 8 21,712 21,720
Placebo 162 21,564 21,726
Table 3. 2 × 2 contingency table for SARS-CoV-2 infection in Moderna vaccine clinical trial.
Infection No Infection
mRNA-1273 11 15,199 15,210
Placebo 185 15,025 15,210
4. Medicina 2021, 57, 199 4 of 8
The following epidemiologic equations use data from the 2 × 2 contingency tables
(Tables 1–3) to calculate relative and absolute measures of COVID-19 mRNA vaccine efficacy.
Risk ratio (RR):
RR =
a/(a + b)
c/(c + d)
(1)
The risk ratio, also known as the relative risk, in a randomized controlled trial is the
ratio calculated by dividing the experimental event rate (EER), a/(a + b), by the control
event rate (CER), c/(c + d) [19]. Dividing the EER by the CER equals 1 if the rates do not
differ, in which case the RR has the null value 1. RRs below 1 indicate a protective effect
and a decreased risk (EER CER), and RRs above 1 indicate an increased risk (EER CER).
Risk ratio 95% confidence interval (CI):
CI = eˆ(Ln(RR) ± 1.96 ∗ SE) where SE =
s
b/a
(a + b)
+
d/c
(c + d)
or
s
1
a
−
1
(a + b)
+
1
c
−
1
(c + d)
(2)
The risk ratio 95% confidence interval predicts the range of probable risk ratios if the
experiment or trial was repeated 95 out of 100 times. The narrower the range between
the upper and lower CI values, the more precise the CI. If the range includes the RR null
value, 1, the risk ratio is considered statistically insignificant. The equation calculates the
standard error (SE) [20,21], and the natural logarithm (Ln) is used, along with the antilog
expressed as an exponent of the base e, to normally distribute the data when calculating
the 95% probability.
Absolute risk reduction (ARR):
ARR (%) =
c
(c + d)
−
a
(a + b)
(3)
The absolute risk reduction is a percentage equal to the arithmetic difference when
subtracting the EER from the CER [19]. The difference equals zero if the rates do not differ,
in which case the ARR has the null value zero. The difference is negative if the EER is
higher than the CER.
Absolute risk reduction 95% confidence interval (CI upper, lower):
ARR CI = ARR ± 1.96 ∗ SE, where SE =
s
EER∗(1 − EER)
(a + b)
+
CER∗(1 − CER)
(c + d)
(4)
The standard error in the absolute risk reduction 95% confidence interval measures
the square root of the sum of the group variances [22]. If the ARR CI includes the null
value zero, the ARR is not statistically significant.
Number needed to vaccinate (NNV):
NNV =
1
ARR
(5)
The NNV, or the number needed to vaccinate to prevent one infection, is the reciprocal
of the ARR [17]. Note that the numerator is multiplied by 100 when the ARR is expressed
with a percentage sign. The NNV is also usually rounded up to the next individual.
NNV 95% confidence interval (CI):
NNV CI =
1
ARR CI
(6)
The CI of the NNV is calculated by dividing 1 by the ARR CI [22], again multiplying
by 100 in the numerator when the ARR is expressed with a percentage sign.
Relative risk reduction (RRR) or vaccine efficacy (VE):
RRR, VE (%) = 1 − RR (7)
5. Medicina 2021, 57, 199 5 of 8
The relative risk reduction is the same as vaccine efficacy (VE) [17]. The RRR is
calculated by subtracting the RR from the null value 1, or by dividing the ARR by the
CER [22].
RRR, VE 95% confidence interval (CI):
RRR, VE CI = 1 − RR CI (8)
The CI for the relative risk reduction is calculated by subtracting the RR CI from the
null value 1.
Pvalues, which measure the probability that a trial result occurred by chance, can be
calculated from the confidence interval for the difference between two proportions, as in
the ARR, and from the confidence interval for a ratio, as in the RRR [23]. Online calculators
are also available that compare group proportions [24] and calculate epidemiological
equations [25], which are useful for measuring vaccine efficacy. Figure 2 shows a chart of
the present critical appraisal of mRNA COVID-19 vaccine efficacy. Note that the vertical
axis of the chart is a logarithmic scale, base 10.
Medicina 2021, 57, x FOR PEER REVIEW 5 of 9
Relative risk reduction (RRR) or vaccine efficacy (VE):
RRR, VE (%) = 1 − RR (7)
The relative risk reduction is the same as vaccine efficacy (VE) [17]. The RRR is cal-
culated by subtracting the RR from the null value 1, or by dividing the ARR by the CER
[22].
RRR, VE 95% confidence interval (CI):
RRR, VE CI = 1 − RR CI (8)
The CI for the relative risk reduction is calculated by subtracting the RR CI from the
null value 1.
Pvalues, which measure the probability that a trial result occurred by chance, can be
calculated from the confidence interval for the difference between two proportions, as in
the ARR, and from the confidence interval for a ratio, as in the RRR [23]. Online calcula-
tors are also available that compare group proportions [24] and calculate epidemiological
equations [25], which are useful for measuring vaccine efficacy. Figure 2 shows a chart of
the present critical appraisal of mRNA COVID-19 vaccine efficacy. Note that the vertical
axis of the chart is a logarithmic scale, base 10.
Figure 2. The chart shows critical appraisal results of mRNA COVID-19 vaccine efficacy.
Clinical epidemiologic tools can be used to critically appraise the efficacy of new
COVID-19 vaccines having biological mechanisms that differ from the mRNA vaccines,
such as AstraZeneca-Oxford’s ChAdOx1 adenoviral vector vaccine [26] and Johnson
Johnson’s Janssen Biotech Ad26.COV2.S vaccine [27]. (As this article goes to press, the
FDA VRBPAC is scheduled to review the Janssen Biotech vaccine for EUA.) As well, re-
ported efficacy for randomized clinical trials involving any treatment, intervention, dis-
ease, disorder, or illness can be critically appraised using clinical epidemiologic tools. In a
similar manner, observational studies that report vaccine and other treatment effective-
Figure 2. The chart shows critical appraisal results of mRNA COVID-19 vaccine efficacy.
Clinical epidemiologic tools can be used to critically appraise the efficacy of new
COVID-19 vaccines having biological mechanisms that differ from the mRNA vaccines,
such as AstraZeneca-Oxford’s ChAdOx1 adenoviral vector vaccine [26] and Johnson
Johnson’s Janssen Biotech Ad26.COV2.S vaccine [27]. (As this article goes to press, the
FDA VRBPAC is scheduled to review the Janssen Biotech vaccine for EUA.) As well, re-
ported efficacy for randomized clinical trials involving any treatment, intervention, disease,
disorder, or illness can be critically appraised using clinical epidemiologic tools. In a
similar manner, observational studies that report vaccine and other treatment effectiveness
in reducing disease incidence within a population can also be critically appraised using
clinical epidemiologic tools.
6. Medicina 2021, 57, 199 6 of 8
4. Discussion
Medical and public health experts continue to stress the need to include measurements
of absolute risk reduction and number needed to treat when reporting results of clinical
interventions [28]. Currently, differences between relative effect measures and absolute
effect measures in studies are “poorly understood by health professionals, and even more
poorly understood by patients.” [29] In addition,
“ . . . critical appraisal knowledge and skills are limited among physicians,”
and “use of relative effect measures was associated with greater perceptions
of medication effectiveness and intent to prescribe, compared with the use of
absolute effect measures.” [29]
Reporting relative measures may be sufficient to summarize evidence of a study for com-
parisons with other studies, but absolute measures are also necessary for applying study
findings to specific clinical or public health circumstances [22]. Omitting absolute risk
reduction findings in public health and clinical reports of vaccine efficacy is an example of
outcome reporting bias, which ignores unfavorable outcomes and misleads the public’s
impression and scientific understanding of a treatment’s efficacy and benefits [30]. Fur-
thermore, the ethical and legal obligation of informed consent requires that patients are
educated about the risks and benefits of a healthcare procedure or intervention [31].
Similar to the critical appraisal in the present article, critical appraisals of reported
vaccine efficacy in other studies reveals clinically significant insights. For example, a 2018
review of 52 randomized trials for influenza vaccines that studied over 80,000 healthy
adults reported an overall influenza vaccine EER of 0.9% and a 2.3% CER, which calculates
to a RRR of 60.8% [32]. This vaccine efficacy is consistent with a 40% to 60% reduction in
influenza reported by the Centers for Disease Control and Prevention (CDC) [33]. However,
critically appraising data from the 2018 review shows an overall ARR of only 1.4%, which
reveals vital clinical information that is missing in the CDC report. A 1.4% ARR works out
to a NNV of approximately 72 people, meaning that 72 individuals need to be vaccinated
to reduce one case of influenza. By comparison, Figure 2 of the present article shows that
the NNV for the Pfzier-BioNTech and Moderna vaccines are 142 (95% CI 122 to 170) and 88
(95% CI 76 to 104), respectively.
The mRNA vaccine manufacturers reported that infections in most subgroups in
phase III clinical trials were similar for both vaccines after two doses. Vaccine clinical trial
case definitions for SARS-CoV-2 infection included COVID-19 clinical symptoms; thus
the trials were not designed to provide evidence of vaccine efficacy for protection against
asymptomatic infections. In addition to outcome reporting bias, information bias may have
also affected COVID-19 vaccine trial outcomes due to misclassification of SARS-CoV-2
infections as mild adverse effects of the vaccines. For example, several COVID-19 clinical
symptoms are similar to the vaccines’ adverse effects such as fever, pain, and fatigue, which
could potentially lead to missed diagnoses of viral infections.
A limitation of this article is that it only critically appraised mRNA vaccine efficacy
in healthy individuals who were randomized to two groups under strictly controlled
conditions. The critical appraisal did not include vaccine safety and effectiveness outcomes
within a general population that includes unhealthy people and that lacks control over
confounding factors. For example, healthy vaccinee bias occurs when people who are in
better health are more likely to follow vaccination recommendations in order to protect
their health [34].
5. Conclusions
A critical appraisal of phase III clinical trial data for the Pfizer/BioNTech vaccine
BNT162b2 and Moderna vaccine mRNA-1273 shows that absolute risk reduction measures
are very much lower than the reported relative risk reduction measures. Yet, the manufac-
turers failed to report absolute risk reduction measures in publicly released documents.
As well, the U.S FDA Advisory Committee (VRBPAC) did not follow FDA published
guidelines for communicating risks and benefits to the public, and the committee failed
7. Medicina 2021, 57, 199 7 of 8
to report absolute risk reduction measures in authorizing the BNT162b2 and mRNA-1273
vaccines for emergency use. Such examples of outcome reporting bias mislead and distort
the public’s interpretation of COVID-19 mRNA vaccine efficacy and violate the ethical and
legal obligations of informed consent.
Funding: This research received no external funding.
Institutional Review Board Statement: Not applicable.
Informed Consent Statement: Not applicable.
Data Availability Statement: Data for Pfzier/BioNTech BNT162b2: https://doi.org/10.1056/nejmoa2
034577; data for Moderna mRNA-1273: https://doi.org/10.1056/NEJMoa2035389 (accessed on 10
January 2021).
Acknowledgments: Special thanks to Richard J. Cook from the University of Waterloo, whose
foundational work with David L. Sackett in clinical epidemiology is cited in this manuscript.
Conflicts of Interest: The author declares no conflict of interest.
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