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Running head: EVALUATIONS OF VACCINES

Evaluations of Vaccines
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EVALUATIONS OF VACCINES

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Evaluations of Vaccines
Evaluation of how vaccines can be studied in the midst of an epidemic
Vaccination is the most effective measure of preventing both virus and bacterium
infections such as Ebola and influenza. When vaccines are available during a break of an
epidemic majority of the countries will try their best to vaccinate the population considered as
riskier. However, the strategies used in production and distribution of the vaccine may take
longer time hence making it difficult during the first stages of the infection. Also, there is limited
capacity in the production of adequate the vaccine to meet the demand in the midst of an
epidemic. For example between the years 2014 and 2016 when there was an increase in Ebola
cases mainly in West Africa, three partners Merck & Co. Inc., Kenilworth, NJ USA and New
Link Genetics conducted studies to determine and license the V920 vaccine (Coller et al., 2017).
However, the vaccine had to undergo different clinical trials in different phases to determine the
safety, efficiency, and immunogenicity of the vaccine. The researchers also have to determine
the variations in Ebola infections in the participants using either placebo or vaccine. The World
Health Organization (WHO) has a responsibility to study the patterns of the infections in
different regions early enough to ensure the vaccines are readily available in different
hemispheres. Moreover, when studying the vaccines it is necessary to look at the mutations
during the egg-based manufacturing process as opposed to the antigenic drift during the spread
of the virus. The randomized controlled trial is used in the evaluation of the efficacy of the
vaccine in two phases, developmental and pre-licensure.

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When studying vaccines in the midst of an epidemic, it is also necessary to discuss the
strategies that are necessary to address the issue of efficacy. Research and technological
developments are essential for the study of vaccines to enhance efficient methods of large-scale
manufacturing and deployment in the midst of an epidemic (Laskowski et al., 2015). The
production of the cell-based vaccines is through the growth of viruses in cultured animal cells.
On the other hand, the egg-based technique uses the cell cultures. The benefit of this method is
the flexibility that allows the cells to be cryopreserved and scaled up and reduces the number of
mutations during the production process. Both the egg-based and cell-based methods produce
vaccines with similar characteristics such as safety, immunogenicity, and efficacy. However, the
cell-based technique is more costly (Boyd, 2017).
The Deoxyribonucleic acid (DNA) technology is also another concept to consider when
studying vaccines in the midst of an epidemic. It involves the injection of the DNA expression
vectors in the host’s cell for the purposes of evoking an immune response. The application of the
technology facilitates the production of the Ebola vaccines that can be multivalent. The clinical
trials indicate that the application of DNA technology in the midst of an epidemic because of its
ability to provide an increased immunological protection as compared to the other methods such
as egg-based and cell-based vaccines. However, when studying the application of DNA
technology in the midst of an epidemic it is necessary to evaluate how the amount required in the
production of adequate levels of proteins impacts on the efficacy of the vaccine. The DNA
required is dependent on the DNA transported into the different target cells through
intramuscular injection.
The other important technology to consider when studying vaccines in the midst of an
epidemic is Virus-like particles (VLPs). Compared to the other technologies the protein structure

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of VLPs lacks the genomic components which make it hard to replicate. This method is less
costly and effective since it contains similar features like viruses which can elicit an immune
response in the host. There are much more approaches that are in different stages of research and
clinical trials to increase the production of vaccines for different epidemics such as Ebola, Zika,
and influenza among others (Fellner, 2016).
Phases of Clinical Trials
When determining the technology or methods of vaccination to adopt, it is necessary to
consider the different phases of clinical trials which are important components during the study
of vaccination in the midst of an epidemic. Understanding the four phases of clinical trials is
important during an epidemic in developing the vaccines. Phase 1 includes the initial trials of the
safety of the vaccines. When studying the vaccines the first phase will determine the application
of the vaccine in either severely ill patients or less ill patients when dealing with the
pharmacokinetic problems. The Phase II is important for the study of vaccine by evaluating the
efficacy and safety of the population having the epidemic that has to be diagnosed, treated, and
controlled (Gire et al., 2014). Through studying the different characteristics of efficacy and
safety of the vaccine such as the dose-response and the frequency of the dosing, it is easier to
determine the applicability of the vaccine in the midst of an epidemic. The second phase involves
controlled and randomized trials. For example, the subjects are given the experimental drug and
the control group is given a placebo. Studying of phase II of vaccine trial during an epidemic is
essential for the determination of the correct dosage. Therefore, the importance of analyzing the
second phase is to provide information on the safety of the experimental vaccine, the required
dosage to man...