The rarely occurring vaccine failure in sars-cove-2 vaccinee

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ISSN: 0005-2523
Volume 63, Issue 01, January, 2023
6735
THE RARELY OCCURING VACCINE FAILURE IN
SARS-COV-2 VACCINEES
ALI J ALKHAFAGY1, IBRAHIM M S SHNAWA2
Department of Anasthesia, Hilla University College, Babylon/IRAQ1
College of Biotechnology University of Qasim, And Hilla University College Babylon. IRAQ2
Keywords:
ABSTRACT
Breakthrough, covid-19, failure,
infection, pandemic, vaccine,
vaccinee.
Vaccine failure VF is a type of vaccine adverse effects VAE encountered
in human mass vaccination programs all over the world. VF originated
either from an inborn vaccine defects or due to defects in immune
responsiveness of human vaccinee and is expressed as breakthrough
infections including covid-19. The VF determination criteria were; I –
reported by the en-charge interviewing physician in vaccination unit as
normal subject before vaccination, ii – enrolled in fixed two doses
vaccination schedule iii – vaccinee subject should be lived away from
excessive virus exposure areas and iv – The onset of the infection 5-42
days or more after vaccination. Covid-19 pandemic is still circulating,
emergency approval of covid-19 vaccine versions are in use a year after
the start of the pandemic all over the world. Covid-19 vaccine failure
though it is rare but is being reportable all over the globe. The objective
of the present work was to report on covid -19 vaccine failure in
Babylon province –Iraq. Mild, moderate, severe and critical infection
forms of the pulmonary patho-type of covid-19 were reported in an
observable ratio of 0.017 per thousand vaccinee. Severe and critical
forms were associated with co-morbidity and/or ageing. The reported
breakthrough found in Pfizer, Astrazinica and synopharm vaccine
makes.
This work is licensed under a Creative Commons Attribution Non-Commercial 4.0
International License.
1. Introduction
Vaccines of the infectious communicable agents including covid-19 are the non-pathogenic versions of the
original pathogen or their subunit pathogenicity associated immune-dominant epitopes. Vaccines can be
either; I - preventive applicable for mass vaccination programs pre-exposure or during pandemic spread, or
ii – therapeutic for treatment of an individual cases [1]. The immune protective efficacy of any known
vaccine would not be in 100%. There are low limits for the approved vaccines to fail (break through
infection). Vaccine failure can be due to an inborn error in vaccine itself or due to defective host vaccinee
immune system function to the applied vaccine to overcome the burden of the infectious agent [1- 8]. VF
can happened after first or second covid-19 vaccine shots within 5-42 days or more in post-vaccination
period [3], [9]. The objective of the present work was to report on the rarely occurred covid-19 vaccine

A. J. ALKHAFAGY and I. M. S. SHNAWA, 2023 Azerbaijan Medical Journal
6736
failure.
2. MATERIALS AND METHODS
A special information case sheet was designed to match the covid-19 vaccine failure in this area. The
attendance patients of Mergan Teaching and ALSadik hospitals /Babylon to the period of Oct.2021 to
March 2022 were interviewed by special medical internist in these hospitals and the main author medical
internist among which 14 were vaccine failure covid-19 breakthrough infections. Patients consents were
made before application of the information sheets. Cough, fever, chest pain, shorten breath were the most
reportable symptoms 5 to 42 days post second vaccine shots. Clinical investigations were performed
including; I – PCR for the virus RNA genes, ii – D dimer, iii-CBC and iv- CT scan [10- 14].
3. RESULTS
3.1 Demography
The male-female ratio was 11:3(3.7: 1). The age range of the vaccinee patients were; 30-39= 1, 40-49 = 3,
50-59=3, 60-69 =5, 70-79= 1 and 80-90= 1. The clustering of the cases was around 50-90 years old. Half of
the patients were aged and one with arteriosclerosis comorbidity. The remaining were with no co-
morbidities.
3.2 Pre-vaccination Immune State
The routine followed by interviewing physicians within the vaccination programs including interviews for
the to be vaccinated subjects to prove that he or she was normal subject. Otherwise have co-morbidity. The
risk factors were ageing in seven cases and one arteriosclerosis case.
Figure – 1. Pie diagram showing the pre-vaccination immune state.
3.3 Vaccine Version
Twelve of the fourteen cases were vaccinated with two shots of Pfizer, one with two shots of Asrazinica and
one with two shots of Synopharm versions.
3.4 Vaccine Coverage
The overall covid-19 vaccine coverage of Babylon province to the period of Dec.2021 to March 2022 was
808389 vaccine with full vaccine shots [15,16].
Aged
50%
Nocomorbid
ity
40%
Comorbidity
10%

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6737
3.5 Vaccine Failure
The observable vaccine failure cases were 14 out of 808389 vaccinee. This stands as 0.017 per thousands of
vaccine. These expressed as breakthrough infections.
3.6 Breakthrough Infections
The complains of the patients were flu-like symptoms with fever, cough, chest pain and/or shortness of
breath. The investigations were showing; PCR positive for the virus RNA genes, D dimer levels ranges
from 550 to 11000, leukocytosis was up to 11000. Cell per/ul. CT scan confirming pathology were with
range of 20 to 90% Figure- 2. The onset of the post-vaccination infection was 14 days to six months. The
infection was of pulmonary mild, moderate severe and/or critical consistent with pulmonary covid-19
patho-type. The severe and critical cases were with aging and comorbidity. These cases were in both Pfizer
and synopharm makes of the vaccine, Table - 1.
Figure -2. Scattered diagram showing the CT scan covid-19 confirming pathology .X axis showed CT scan
and Y axis showed number of patients.
Table – 1: Characteristics of The Breakthrough infected Covid-19 vaccinee.
Feature
Observations
Demography
Male to Female Ration
Age Ranges in years
30-39
40-49
50-59
60-69
70-79
80-89
11:3 (3.7: 1 )
1:14
3:14
3:14
5:14
1:14
1:14
Risk factors
No underlying disease
Ageing
Arteriosclerosis
6:14
7:14
1:14
Vaccine Coverage at Babylon Dec.2021-March
2022
808389 vaccinee in full vaccination
Vaccine Versions
Pfizer
Astrazinica
Synopharm
12:14
1 : 14
1 : 14
Laboratory Investigations
0
0.5
1
1.5
2
2.5
3
3.5
020 40 60 80 100
CT scan %
No of
Patients

A. J. ALKHAFAGY and I. M. S. SHNAWA, 2023 Azerbaijan Medical Journal
6738
PCR virus RNA genes positive
D-dimer
Leukocytosis
14:14
510-11000
8000-1000 cell/ul.
CT Scan Confirming Pathology
20%
30%
50%
60%
75%
80%
90%
2:14
3:14
1:14
3:14
1:14
3:14
1:14
Infection Spectrum
Mild
Moderate
Severe/critical
Prognosis
Survivors
Deaths
3:14
3:14
8:14
12:14
2 : 14
4. DISCUSSION
Vaccine adverse effects VAE is one of the most vital areas of human vaccination programs. Covid-19
vaccines are not an exception to this theme. Covid-19 occupied the forefront area in the current vaccination
research. It broadly categorized into simple and complex. The complex VAE type can be ramified into
vaccine enhancement of the disease VAED and Vaccine failure [1- 8]. The present work was aimed at
tracing the observable vaccine failure cases among vaccinee during post-vaccination period. The followed
criteria for identification of breakthrough infection were in covid-19 full vaccinee were; i- the reviewing en-
charge physician reported that the to be vaccinated subject was normal before vaccination, ii-the
interviewed subject enrolled in fixed vaccination schedule of two doses, a month apart between them, iii-
the onset of the infection happened 14 to 42 days or more after vaccination and iv – the vaccinee subject
live in an area away from virus exposure niche [2], [9]. The notable signs and symptoms of the ill vaccinee
subjects were consistent with the pulmonary pathotype of covid-9 [18]. The infection course was spanning
between mild, moderate, severe and critical [19], [20]. The noted breakthrough infections, Table – 1 were
grouped in accordance with National Institute of health grading of covid-19 spectrum [21] and to mild-
moderate group A as well as severe-critical group B [22], Table – 2;
Spectrum of Severity
NIH[ 21]
[22]
Mild
3:14
Mild-Moderate 6:14
Moderate
3:14
Severe-Critical 8:14
Severe-Critical
8:14
Severe and critical cases were associated with ageing whereby CT scan covid-19 confirming pathology was
rated from 60 to 90 % in an age range of 50 to 79 years old. Though exception was noted to this finding,
that young vaccinee reported 90% and aged of 90 years old reported lower 20 % pathology. The
breakthrough infected vaccinee prognosis was 12 survivors and two deceased (The critical cases), Tables 1
& 2 [21- 29]. The observable vaccine failure cases were rated as 0.017 per thousand of vaccinee a
proportion that seemed to be low as compared to that reported abroad, Table – 3 [9], [21- 29]. This can be
an impact of underreporting due to those infected vaccine whom sneaking out reporting by managing to
cure in the special respiratory disease clinics. A situation being an familiar in abroad clinical practice. In
comparison, the high reported vaccine failure ratios per thousand in UK, USA, Italy and India [9], [21- 29],
attributed to most of studied populations were either health care workers [22], or those with underlying

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6739
comorbidities [24].
Table -3: Global Covid-19 vaccine failure(Breakthrough infections)Reports.
Area
Vaccine Failure per thousand
vaccines
References
United Kingdome
54
[21]
United Kingdome
26
[22]
Unite States of America
23.11(Comorbidity)
[24]
United States of America
5
[9]
India
12
[28]
India
93.7
[29]
IRAQ/Babylon
0.017(observable)
This study
5. CONCLUSIONS
The observable vaccine failure in this area is rare as it accounts for 0.017 per thousand vaccinee. VF was
reported among vaccinee with Pfizer, Asrazinica and synopharm vaccine makes. The breakthrough
infection form was of pulmonary patho-types. The infection severity spectrum was spanning between; mild,
moderate, severe and critical. Severe and critical cases were noted mainly among aged vaccinee.
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