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Question
Details: Please reply to these 2 discussion posts and cosmic questions and provide 2 references and in-text citations that are from years (2016-2021) for each post reply.
Post 1 (Vittorio):
a) limitations and strengths of the study variable(s) The study is like any other study and it has strengths but is not perfect and it contains limitations. These limitations are also referred to as weaknesses or threats to internal and external validity (LoBiondo-Wood & Haber, 2018). The study stated it had limitations of who was included, they did not have data on children, pregnant women, or adolescents under the age of 16 (Polack et al, 2020, p. 9). It also mentions that it does not have data on adverse reactions 2-3.5 months after dose 2.
b)hypothesis(es)/research questions The article does not contain an outright hypothesis or research question but it does state on page 9 that A two-dose regimen of BNT162b2 (30 μg per dose, given 21 days apart) was found to be safe and 95% effective against Covid-19. They state that it met their predetermined criteria and it exceeded minimum FDA requirements.
c) theoretical framework-The article mentions at the beginning that was building off a study conducted in the US and Germany where the results supported the need to continue their 3-phase study of the mRNA vaccine (Polack et al, 2020, p. 2)
d) design- The study is designed in three phases. The setup of the study was an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial. The trial consists of two groups to either receive the vaccine or placebo with dose 1 and dose 2 being twenty-one days apart from one another.
e) sample- The sample was derived after a certain number of participants were screened. Some participants were lost along the way due to various reasons. The sample consisted of 43,448 Were injected with a vaccine or placebo 21,720 Were assigned to receive BNT162b2 21,728 Were assigned to receive the placebo (Polack et al, 2020, p. 4)
f) data collection procedures- Data collection procedures consisted of site staff who monitored the groups for thirty minutes after the injection and participant reporting through an electronic journal (Polack et al, 2020, p.2).
g) data analysis – A two-dose regimen of BNT162b2 (30 μg per dose, given 21 days apart) was found to be safe and 95% effective against Covid-19. The vaccine met both primary efficacy endpoints, with more than a 99.99% probability of a true vaccine efficacy greater than 30%. These results met their prespecified success criteria, which were to establish a probability above 98.6% of true vaccine efficacy being greater than 30% (Polack et al, 2020, p. 9)
h) generalizations – The study does not make broad generalizations as it states its limitations and mentions that the data does not state if the vaccine prevents asymptomatic infections (Polack et al, 2020, p. 12), and it also informs those who the study did not include (see limitations above).
i)conclusions- The study concludes that COVID-19 can be prevented by immunization. (Polack et al, 2020, p. 12)
j) recommendations for future research- The recommendations for future research is to produce data for those under 16 in regards to the vaccine and that mRNA-based vaccine are a great new approach in disease protection for humans.
2. After reviewing and evaluating the “Discussion” section of the article, discuss the strength of the evidence that supports a change in current practice. The article has good strength to further support the necessary expedited approval processes for vaccines in terms of the spread of viruses. I feel that pandemics can be prevented and stopped when they are at an epidemic level. The science behind mRNA viruses has been researched since SARS and MERS. The CDC reports that early-stage clinical trials for mRNA vaccines are decades old. These have been studied for influenza, ZIKA, rabies, and CMV (CDC.gov, December 2020).
3. My cosmic question is that with the new technology allowing us to further understand the biology of mRNA viruses and the presence of retrograde viruses like HIV will these new developments help to produce medicine such as preventatives or curative measures for diseases that will have yet to eradicate?
References:
Understanding mRNA Vaccines COVID-19 Vaccines. Retrieved from https://www.cdc.gov/coronoavirus/2019-ncov/vaccines/different-vaccines/mrna.html
LoBiondo-Wood, G. & Haber, J. (2018). Nursing research: Methods and critical appraisal for evidence-based practice, (9th ed.). Elsevier
Polack, F.P., Thomas, S.J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J.L., Perez Marc, G., Moreira, E.D., Zerbini, C., Bailey, R., Swanson, K.A., Roychoudhury, S., Koury, K., Li, P., Kalina, W.V., Cooper, D., French, R.W., Hammitt, . . . Gruber, W.C. (2020). Safety and efficacy of the BNT162b2 mRNA covid-19 vaccine. New England Journal of Medicine, 383, 2603-2615. DOI: 10.1056/NEJMoa2034577
Post 2 (Benedicta):
1. Evaluate the discussion section of the article attached and identify if the following was addressed.
a) Limitations and strengths of the study variable(s)
One of the limitations of the study variables that the discussion part of the article pointed out was that with a large number of participants the study had more than 83% probability of detecting at least one adverse event if the true incidence is 0.01%, but it was not large enough to detect less common adverse events (Absalon et al., 2020, pg 11).
One strength of the study was that it was able to meet the research question. Absolon et al. (2020) stated that the vaccine met both primary efficacy endpoints, with more than a 99.99% probability of a true vaccine efficacy greater than 30% (pg. 11).
b) Hypothesis(es)/research questions
Yes. I think the hypothesis of the study, although not clearly stated is whether a two-dose regimen of BNT162b2 and given 21 days apart can be safe and effective against Covid-19 (Absalon et al., 2020, pg 9). I believe this because Absolon et al. (2020) went on further to state that the results of the vaccine met the researcher’s prespecified success criteria (pg. 1).
c) Theoretical framework
Yes. The researchers stated that the data that they analyzed from the research showed a rise in Covid-19 cases (Absolon et al., 2020, pg 9). The authors also wrote about previous studies done both at home and in other countries and information used from the results of clinical trials (Absolon et al., 2020, pg 9). I think these helped them formed the theoretical framework for the study.
d) Design
Yes. However, the discussion does not make it clear what exactly the design was. According to Absolon et al. (2020), the study was not designed to assess the efficacy of a single-dose regimen but it was designed to follow participants for safety and efficacy for 2 years. (pg. 10 & 12).
e) Sample
No. The study was not powered to definitively assess efficacy by subgroups (pg. 2).
f) Data collection procedures
No. This was not in the discussion. But the researchers used an electronic diary daily to record findings every time they give participants doses of vaccine (Absalon et al., 2020, pg 8).
g) Data analysis
Yes. Absalon et al. (2020) stated that for all analyzed subgroups in which more than 10 cases of Covid-19 occurred, the lower limit of the 95% confidence interval for efficacy was more than 30% (pg. 9).
h) Generalizations
No. According to Absolon et al. (2020) the report does not address the prevention of Covid-19 in other populations such as younger adolescents, children, and pregnant women (pg. 12).
i) Conclusions
Yes. The article concluded with the findings of the study which seems to answer their research question. The authors of the article concluded that the results of the study demonstrate that Covid-19 can be prevented by immunization, which provides proof of concept that RNA-based vaccines are effective against infectious disease and show that with speed and resources RNA vaccines can be easily developed (Absolon et al., 2020, Pg 12)
j) Recommendations for future research
The recommendation for future research is that RNA vaccines can be developed more quickly if there are sufficient resources (Absolon et al., 2020, Pg 12). Also, the researchers did not design the study to assess the effectiveness of a single-dose regimen (Absolon et al., 2020, Pg 12)
2. After reviewing and evaluating the “Discussion” section of the article, discuss the strength of the evidence that supports a change in current practice
The article indicated that RNA-based vaccines are a promising new approach for protecting humans against infectious diseases (Absolon et al., 2020). According to the Center for Disease Control and Prevention (CDC) (2020) RNA vaccines are new but they are not unknown. Researchers have been studying it for years but it has only gotten known because they are easy to develop and because of their effectiveness in controlling infectious diseases (CDC, 2020).
3. What is your cosmic question? (This should be based on the chapter of the week. Pose a research question in the discussion section of the research).
Besides what l have listed, can you list another limitation of the study that the researchers discussed in the discussion section of the article?
Reference
Absalon, J., Bailey, R., Cooper, D., Dormitzer, P. R., Frenck, R. W., Gurtman, A.,
Gruber, W. C., Hammitt, L. L., Jansen, K. U., Kalina, W. V., Kitchin, N., Koury, K., Li, P., Marc, G. P., Mather, S., Moreira, E. D., Nell, H., Perez, J. L., Roychoudhury, S….Zerbini, C. (2020, December 21). Safety and efficacy of the BNT162b2 Mrna covid-19 vaccine. New England Journal of Medicine, 383(27), 1-3. https://doi.org/10.1056/nejmoa2034577
Center for Disease Control and Prevention. (2020, December 18). Understanding
mRNA Covid-19 vaccines. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html
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