Description
Critical Thinking Assignment: Write an Introduction
This Critical Thinking (CT) assignment builds on the assignments from Modules 4 and 6.
Write an Introduction based on the references identified in the Module 4 CT assignment and the annotated bibliography created in the Module 6 CT assignment. The Introduction should provide an overview, background, and explanation of the research topic you chose. Include an overview of your research question, what software might be used in your analysis, and ethical principles in research. Week 9’s module lecture provides guidance on writing introductions for research papers.
Your introduction should meet the following requirements:
Be three paragraphs in length (1-2 page maximum), not including the title or reference pages.
Be formatted according to Saudi Electronic University and APA writing guidelines.
Provide support for your statements with in-text citations from the scholarly articles you have gathered.
Follow APA and Saudi Electronic University writing standards.
Review the grading rubric to see how you will be graded for this assignment.
You are strongly encouraged to submit all assignments to the Originality Check prior to submitting them to your instructor for grading.
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1
Vaccines: COVID-19 Vaccines and their Effects on Different Trial Groups globally
Annotated Bibliography
Ghady Alayad
Colorado State University – Global Campus, and Saudi Electronic University
HCM 505: Research Methodology in Health Care Management
Dr. Mary Moor
13 October, 2023
2
Vaccines: COVID-19 Vaccines and their Effects on Different Trial Groups globally
Annotated Bibliography
Chemaitelly, H., AlMukdad, S., Ayoub, H. H., Altarawneh, H. N., Coyle, P., Tang, P., Yassine,
H. M., Al-Khatib, H. A., Smatti, M. K., Hasan, M. R., Al-Kanaani, Z., Al-Kuwari, E.,
Jeremijenko, A., Kaleeckal, A. H., Latif, A. N., Shaik, R. M., Abdul-Rahim, H. F.,
Nasrallah, G. K., Al-Kuwari, M. G., & Al-Romaihi, H. E. (2022). Covid-19 Vaccine
Protection among Children and Adolescents in Qatar. New England Journal of Medicine,
387(20), 1865–1876. https://doi.org/10.1056/nejmoa2210058
The authors of this study used three groups of retrospectives, and target-trial
methods to collect data, to compare the prevalence of COVID-19 in the vaccinated group
and the unvaccinated group in Qatar. The aim of this research study is to assess the
effectiveness of the BNT162b2 vaccine against Covid 19 in children 5 to 11 years old
and adolescents 12 to 17 years old. In the research, the first group was children 5 to 11
years old after the B.1.1.529 (omicron) variant spread. The second group is adolescents
12 to 17 years of age before the spread of the omicron variant, and the third group is
adolescents 12 to 17 years of age after the spread of the omicron variant. The vaccinated
group received a 10-μg dose of the BNT162b2 vaccine among children and a 30-μg dose
of the BNT162b2 vaccine among adolescents. The Cox proportional-hazards regression
model was used to compare percentages and statistics among the three trial groups.
Chin, E. T., Leidner, D., Lamson, L., Lucas, K., Studdert, D. M., Goldhaber-Fiebert, J. D.,
Andrews, J. R., & Salomon, J. A. (2022). Protection against Omicron from Vaccination
and Previous Infection in a Prison System. New England Journal of Medicine, 387(19),
1770–1782. https://doi.org/10.1056/nejmoa2207082
3
The authors of this paper used a retrospective cohort design research to conduct
their study by collecting data from December 24, 2021, through April 14, 2022, which is
the period of the omicron outbreak. The research was focused on two high-risk groups:
the staff and residents of California State Prison. The aim of this study is to evaluate the
protection level by vaccination and previous infection against the omicron variant of
COVID-19. The Weighted Cox models were used to compare the effectiveness of
protection between the group who had a previous infection, secondly, the group who was
vaccinated before with two doses, and lastly the group who was vaccinated with a third
booster dose. Also, a rolling matched-cohort design was used as a secondary analysis
method to compare the effectiveness of two, and three doses of vaccination.
Dai, L., Gao, L., Tao, L., Hadinegoro, S. R., Erkin, M., Ying, Z., He, P., Girsang, R. T., Vergara,
H., Akram, J., Satari, H. I., Khaliq, T., Sughra, U., Celi, A. P., Li, F., Li, Y., Jiang, Z.,
Dalimova, D., Tuychiev, J., & Turdikulova, S. (2022). Efficacy and Safety of the RBDDimer–Based Covid-19 Vaccine ZF2001 in Adults. New England Journal of Medicine.
https://doi.org/10.1056/nejmoa2202261
The method used by researchers in this study was a randomized, double-blind,
placebo-controlled, phase 3 trial to investigate the efficacy and safety of the ZF2001
vaccine against COVID-19. The research was conducted at 31 clinical centers across
Uzbekistan, Indonesia, Pakistan, and Ecuador, and additionally, a center in China was
included in the safety analysis only. A random allocation of three 25 g doses, 30 days
apart from ZF2001 or placebo, was given to adult participants 18 years of age or older in
a 1:1 ratio. Symptomatic symptoms of the Covid19 that were confirmed in a polymerase
chain reaction assay not less than 7 days after initiation of 3 doses, were an important
4
endpoint. Serious to critical COVID-19 events at least seven days after administration of
the 3rd dose were a crucial second efficacy endpoint.
Halasa, N. B., Olson, S. M., Staat, M. A., Newhams, M. M., Price, A. M., Pannaraj, P. S., Boom,
J. A., Sahni, L. C., Chiotos, K., Cameron, M. A., Bline, K. E., Hobbs, C. V., Maddux, A.
B., Coates, B. M., Michelson, K. N., Heidemann, S. M., Irby, K., Nofziger, R. A., Mack,
E. H., & Smallcomb, L. (2022). Maternal Vaccination and Risk of Hospitalization for
Covid-19 among Infants. New England Journal of Medicine.
https://doi.org/10.1056/nejmoa2204399
The method used by researchers in this study is a case-control test-negative design
to assess the effectiveness of maternal vaccination in pregnancy against hospitalization
for COVID-19 among infants aged less than 6 months; as they are considered at high risk
for Covid 19 and not eligible for vaccination. Researchers are trying to test if the
transplacental transfer of antibodies in vaccinated pregnant ladies can offer protection
against COVID-19 for infants. Researchers included infants hospitalized for COVID-19
(case infants) and infants hospitalized without COVID-19 (control infants) at 30 hospitals
in 22 states between July 1, 2021, and March 8, 2022. Researchers calculated vaccine
efficiency by comparing the likelihood of full maternal immunization (two doses of
mRNA vaccine) among case and control newborns during the B.1.617.2 (delta) and
B.1.1.529 (omicron) variants’ circulation.
Muñoz, F. M., Sher, L. D., Sabharwal, C., Gurtman, A., Xu, X., Kitchin, N., Lockhart, S.,
Riesenberg, R., Sexter, J. M., Czajka, H., Paulsen, G. C., Maldonado, Y., Walter, E. B.,
Talaat, K. R., Englund, J. A., Sarwar, U. N., Hansen, C., Iwamoto, M., Webber, C., &
Cunliffe, L. (2023). Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger
5
than 5 Years of Age. New England Journal of Medicine, 388(7), 621–634.
https://doi.org/10.1056/nejmoa2211031
The method used by researchers in this study is an ongoing phase 2-3,
randomized, placebo-controlled trial to investigate the efficacy, safety, and
immunogenicity of the BNT162b2 vaccination in children aged 6 months to 4 years. The
BNT 162b2 vaccine (three dosages, 3 μg) was given as 2:1 ratio to give two injections,
21 days apart, to 1776 children aged 6 months to 2 years and 2750 children aged 2 to 4
years. A third dose was given at or after 60 days from the second dose. To check the
effectiveness of the vaccine, the ratio of the geometric mean titer (GMT) of neutralizing
antibodies against COVID-19 was used to compare children at 1 month after the third
vaccine dosage as opposed to the GMT at 1 month after the second dose of 30 μg for
people aged 16 to 25.
Pavord, S., Scully, M., Hunt, B. J., Lester, W., Bagot, C., Craven, B., Rampotas, A., Ambler, G.,
& Makris, M. (2021). Clinical Features of Vaccine-Induced Immune Thrombocytopenia
and Thrombosis. The New England Journal of Medicine.
https://doi.org/10.1056/NEJMoa2109908
The method used by researchers in this paper is a prospective cohort study. An
anonymous electronic method was used to collect data from hospitals in the United
Kingdom between March 22 and June 6, 2021. The aim of this research is to provide risk
factors, indicators, course of treatment, and information about the prognosis of VaccineInduced Immune Thrombocytopenia and Thrombosis (VITT) which is a new syndrome
associated with the Oxford-AstraZeneca Covid19 vaccine. Based on predetermined
criteria, incidents were classified as either definite or probable VITT. Researchers found
6
170 definite and 50 probable cases of VITT among the 294 individuals that were
assessed. All of the patients showed up 5 to 48 days (median, 14) after receiving the first
dose of the ChAdOx1 nCoV-19 vaccine. There was no sex predominance and no clearcut medical risk factors, and the age range was 18 to 79 years (median, 48).
Pittet, L. F., Messina, N. L., Orsini, F., Moore, C. L., Abruzzo, V., Barry, S., Bonnici, R.,
Bonten, M., Campbell, J., Croda, J., Dalcolmo, M., Gardiner, K., Gell, G., Germano, S.,
Gomes-Silva, A., Goodall, C., Gwee, A., Jamieson, T., Jardim, B., & Kollmann, T. R.
(2023). Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care
Workers. New England Journal of Medicine, 388(17), 1582–1596.
https://doi.org/10.1056/nejmoa2212616
In this publication, the researchers’ method that was used is a multinational,
double-blind, randomized, placebo-controlled trial to assess the efficacy of the BCG
Denmark Vaccine against COVID-19 in Health Care Workers. A total of 3988
individuals were randomly assigned of which 1703 were in the BCG group and 1683
were in the placebo group. These healthcare workers have never tested positive for
COVID-19 and were assigned to receive a (0.1 ml) of BCG Denmark Vaccine
intradermally, be assessed after 6 months, and followed for 12 months.
Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L.,
Pérez Marc, G., Moreira, E. D., Zerbini, C., Bailey, R., Swanson, K. A., Roychoudhury,
S., Koury, K., Li, P., Kalina, W. V., Cooper, D., Frenck, R. W., Hammitt, L. L., &
Türeci, Ö. (2020). Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New
England Journal of Medicine, 383(27), 2603–2615.
https://doi.org/10.1056/nejmoa2034577
7
The method used by researchers in this study is a multinational, placebocontrolled, observer-blinded, pivotal efficacy, randomized trial, in which people 16 years
of age or older were assigned in a 1:1 ratio to receive two doses, 21 days apart, of either
placebo or the BNT162b2 vaccine (30 μg per dose). There were 43,448 participants who
received intramuscular injections: 21,720 with BNT162b2 and 21,728 with placebo and
were followed for around 2 months to assess the efficacy of the vaccine.
Tan, S. H. X., Cook, A. R., Heng, D., Ong, B., Lye, D. C., & Tan, K. B. (2022). Effectiveness of
BNT162b2 Vaccine against Omicron in Children 5 to 11 Years of Age. New England
Journal of Medicine, 387(6), 525–532. https://doi.org/10.1056/nejmoa2203209
The method conducted by researchers in this study is data analysis from January
21, 2022, through April 8, 2022, for 255,936 children who were between the ages of 5 to
11 in Singapore during an outbreak of the omicron strain. The objective of this study is to
report on the efficacy of the BNT162b2 messenger RNA (mRNA) vaccine (PfizerBioNTech) against COVID-19 in 5 to 11-year-old children. Data were collected and
assessed among all, unvaccinated children, partially vaccinated, and fully vaccinated
children. From the incidence rate ratio of outcomes, the Poisson regression model was
utilized to evaluate vaccine effectiveness.
Winokur, P., Gayed, J., Fitz-Patrick, D., Thomas, S. J., Diya, O., Lockhart, S., Xu, X., Zhang,
Y., Bangad, V., Schwartz, H. I., Denham, D., Cardona, J. F., Usdan, L., Ginis, J., Mensa,
F. J., Zou, J., Xie, X., Shi, P.-Y., Lu, C., & Buitrago, S. (2023). Bivalent Omicron BA.1–
Adapted BNT162b2 Booster in Adults Older than 55 Years. New England Journal of
Medicine, 388(3), 214–227. https://doi.org/10.1056/nejmoa2213082
8
The method used in this research is phase 3, a randomized trial to evaluate the
effectiveness of different sequences of BNT162b2 Booster vaccine against Omicron
BA.1 in Adults Older than 55 Years. 1846 participants were assigned to six treatment
groups to receive their fourth dose, and all participants had previously received three 30μg doses of the BNT162b2 vaccine. The six groups will receive the fourth dose as follow:
either 30 μg or 60 μg of BNT162b2, 30 μg or 60 μg of (monovalent BA.1 which is a new
adaptive vaccine), 30 μg or 60 μg of (bivalent BA.1 which is also new and adaptive
vaccine).
1
Vaccines: COVID-19 Vaccines and their Effects on Different Trial Groups globally
Ghady Alayad
Colorado State University – Global Campus, and Saudi Electronic University
HCM 505: Research Methodology in Health Care Management
Dr. Mary Moor
7 October, 2023
2
Vaccines: COVID-19 Vaccines and their Effects on Different Trial Groups globally
Globally, the COVID-19 virus began in late 2019 in the Chinese city of Wuhan as a few
cases of pneumonia patients who did not respond successfully to treatment (Centers for Disease
Control and Prevention, 2022). Furthermore, when the coronavirus 2 (SARS-CoV-2) infection
known as COVID-19 started, there was a global pandemic that demanded immediate action and
effective vaccines. This paper will list a number of empirical research papers that discuss COVID19 vaccines and their effects on different trial groups globally.
Table 1
The Name of the Empirical Research Study and the Reason for Selection Each Research Paper
The study
Reason for selection
Covid-19 Vaccine Protection among
The
Children and Adolescents in Qatar.
effectiveness of the BNT162b2 vaccine against
researchers
in
this
paper
assess
the
coronavirus disease in children 5 to 11 years old and
adolescents 12 to 17 years old in Qatar.
Protection against Omicron from The researchers in this paper evaluate the protection
Vaccination and Previous Infection level by vaccination and previous infection against
in a Prison System.
the omicron variant of COVID-19 in the residents
and staff of California state prison.
Efficacy and Safety of the RBD- The researchers in this paper investigate the efficacy
Dimer–Based Covid-19 Vaccine and safety of the ZF2001 vaccine against COVID-19
ZF2001 in Adults.
in adults in clinical centers in Uzbekistan, Indonesia,
Pakistan, and Ecuador, and also in a Chinese center
that was only for safety analysis.
3
Maternal Vaccination and Risk of The authors of this study evaluate the effectiveness of
Hospitalization for Covid-19 among maternal vaccination with mRNA vaccines (Pfizer–
Infants.
BioNTech and mRNA-1273 Moderna) during
pregnancy against COVID-19 hospitalization in
infants younger than 6 months of age.
Evaluation of BNT162b2 Covid-19 The authors of this study conducted research to assess
Vaccine in Children Younger than 5 the efficacy, safety, and immunogenicity of the
Years of Age.
BNT162b2 vaccine in children between 6 months
old to 4 years old.
Clinical Features of Vaccine-Induced The authors of this paper conducted research in the
Immune
Thrombocytopenia
Thrombosis.
and United Kingdom about Vaccine-Induced Immune
Thrombocytopenia and Thrombosis (VITT) which is
a new syndrome associated with the OxfordAstraZeneca Covid19 vaccine and its risk factors
and prognosis.
Randomized Trial of BCG Vaccine to In this publication, the researchers evaluate the
Protect against Covid-19 in Health effectiveness of the BCG Denmark Vaccine against
Care Workers.
Covid-19 in Health Care Workers.
Safety and Efficacy of the BNT162b2 The authors of this paper conducted a generalized
mRNA Covid-19 Vaccine.
multinational study to assess the effectiveness of the
BNT162b2 mRNA COVID-19 vaccine on people 16
years and older.
Effectiveness of BNT162b2 Vaccine The authors of this study conducted research in
against Omicron in Children 5 to 11 Singapore to assess the efficacy of the BNT162b2
Years of Age.
vaccination against Omicron in children aged 5 to 11
years.
Bivalent Omicron BA.1–Adapted The
researcher
in
this
paper
evaluates
the
BNT162b2 Booster in Adults Older effectiveness of different sequences of BNT162b2
than 55 Years.
Booster vaccine against Omicron BA.1 in Adults
Older than 55 Years.
4
References
CDC. (2022, August 16). CDC Museum COVID-19 Timeline. Centers for Disease Control and
Prevention; CDC. https://www.cdc.gov/museum/timeline/covid19.html
Chemaitelly, H., AlMukdad, S., Ayoub, H. H., Altarawneh, H. N., Coyle, P., Tang, P., Yassine,
H. M., Al-Khatib, H. A., Smatti, M. K., Hasan, M. R., Al-Kanaani, Z., Al-Kuwari, E.,
Jeremijenko, A., Kaleeckal, A. H., Latif, A. N., Shaik, R. M., Abdul-Rahim, H. F.,
Nasrallah, G. K., Al-Kuwari, M. G., & Al-Romaihi, H. E. (2022). Covid-19 Vaccine
Protection among Children and Adolescents in Qatar. New England Journal of Medicine,
387(20), 1865–1876. https://doi.org/10.1056/nejmoa2210058
Chin, E. T., Leidner, D., Lamson, L., Lucas, K., Studdert, D. M., Goldhaber-Fiebert, J. D.,
Andrews, J. R., & Salomon, J. A. (2022). Protection against Omicron from Vaccination
and Previous Infection in a Prison System. New England Journal of Medicine, 387(19),
1770–1782. https://doi.org/10.1056/nejmoa2207082
Dai, L., Gao, L., Tao, L., Hadinegoro, S. R., Erkin, M., Ying, Z., He, P., Girsang, R. T., Vergara,
H., Akram, J., Satari, H. I., Khaliq, T., Sughra, U., Celi, A. P., Li, F., Li, Y., Jiang, Z.,
Dalimova, D., Tuychiev, J., & Turdikulova, S. (2022). Efficacy and Safety of the RBDDimer–Based Covid-19 Vaccine ZF2001 in Adults. New England Journal of Medicine.
https://doi.org/10.1056/nejmoa2202261
Halasa, N. B., Olson, S. M., Staat, M. A., Newhams, M. M., Price, A. M., Pannaraj, P. S., Boom,
J. A., Sahni, L. C., Chiotos, K., Cameron, M. A., Bline, K. E., Hobbs, C. V., Maddux, A.
B., Coates, B. M., Michelson, K. N., Heidemann, S. M., Irby, K., Nofziger, R. A., Mack,
E. H., & Smallcomb, L. (2022). Maternal Vaccination and Risk of Hospitalization for
5
Covid-19 among Infants. New England Journal of Medicine.
https://doi.org/10.1056/nejmoa2204399
Muñoz, F. M., Sher, L. D., Sabharwal, C., Gurtman, A., Xu, X., Kitchin, N., Lockhart, S.,
Riesenberg, R., Sexter, J. M., Czajka, H., Paulsen, G. C., Maldonado, Y., Walter, E. B.,
Talaat, K. R., Englund, J. A., Sarwar, U. N., Hansen, C., Iwamoto, M., Webber, C., &
Cunliffe, L. (2023). Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger
than 5 Years of Age. New England Journal of Medicine, 388(7), 621–634.
https://doi.org/10.1056/nejmoa2211031
Pavord, S., Scully, M., Hunt, B. J., Lester, W., Bagot, C., Craven, B., Rampotas, A., Ambler, G.,
& Makris, M. (2021). Clinical Features of Vaccine-Induced Immune Thrombocytopenia
and Thrombosis. The New England Journal of Medicine.
https://doi.org/10.1056/NEJMoa2109908
Pittet, L. F., Messina, N. L., Orsini, F., Moore, C. L., Abruzzo, V., Barry, S., Bonnici, R.,
Bonten, M., Campbell, J., Croda, J., Dalcolmo, M., Gardiner, K., Gell, G., Germano, S.,
Gomes-Silva, A., Goodall, C., Gwee, A., Jamieson, T., Jardim, B., & Kollmann, T. R.
(2023). Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care
Workers. New England Journal of Medicine, 388(17), 1582–1596.
https://doi.org/10.1056/nejmoa2212616
Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L.,
Pérez Marc, G., Moreira, E. D., Zerbini, C., Bailey, R., Swanson, K. A., Roychoudhury,
S., Koury, K., Li, P., Kalina, W. V., Cooper, D., Frenck, R. W., Hammitt, L. L., &
Türeci, Ö. (2020). Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New
6
England Journal of Medicine, 383(27), 2603–2615.
https://doi.org/10.1056/nejmoa2034577
Tan, S. H. X., Cook, A. R., Heng, D., Ong, B., Lye, D. C., & Tan, K. B. (2022). Effectiveness of
BNT162b2 Vaccine against Omicron in Children 5 to 11 Years of Age. New England
Journal of Medicine, 387(6), 525–532. https://doi.org/10.1056/nejmoa2203209
Winokur, P., Gayed, J., Fitz-Patrick, D., Thomas, S. J., Diya, O., Lockhart, S., Xu, X., Zhang,
Y., Bangad, V., Schwartz, H. I., Denham, D., Cardona, J. F., Usdan, L., Ginis, J., Mensa,
F. J., Zou, J., Xie, X., Shi, P.-Y., Lu, C., & Buitrago, S. (2023). Bivalent Omicron BA.1–
Adapted BNT162b2 Booster in Adults Older than 55 Years. New England Journal of
Medicine, 388(3), 214–227. https://doi.org/10.1056/nejmoa2213082
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