Management of Hospital Overcrowding during the Second Wave of COVID-19 Pandemic in Pisa (Italy) before Vaccination Campaign: from Medical Stays to Low and Intermediate Cares by Angelo Baggiani in Open Access Journal of Biogeneric Science and Research

Management of Hospital Overcrowding during the Second Wave of COVID-19 Pandemic in Pisa (Italy) before Vaccination Campaign: from Medical Stays to Low and Intermediate Cares by Angelo Baggiani in  Open Access Journal of Biogeneric Science and Research 

ABSTRACT

Background: After the summer season, in Italy, a second wave of COVID-19 pandemic involved all the Italian Regions. From September to December 2020, in Tuscany Region COVID-19 cases increased from 15.000 to 110.000.

Methods: This occurrence led to a sharp raise of hospitalized patients, in the Azienda Ospedaliero-Universitaria Pisana (AOUP) (Pisa, Tuscany), a highly specialized teaching, with 1082-bed hospital. In this perspective we describe the application of a structural plan in AOUP for the management of hospital overcrowding during the second wave of COVID-19 pandemic.

Results: From November 16th, AOUP COVID hospital has been organized in different areas: Intensive Care Units intended for critical patients; Medical Stays intended for medium critical patients; a Low care structure intended for low critical patients needing continuous cares; an Intermediate care structure intended for patients needing nursing cares; and a COVID hotel intended for still positive patients in discharge.

Conclusion: This strategy may improve the COVID patients flow during the epidemic, allowing a quickly beds release and a continuous patient path from one level of care to another.

Keywords: COVID-19, low cares, intermediate cares, second wave

Introduction

In Italy COVID-19 emergency evolved in a first wave in the period between February and  May 2020 with over 200.000 cases [1]. Italian hospitals managed the increase of hospitalizations in terms of COVID and not COVID areas. In North West Tuscany, the Azienda Ospedaliero-Universitaria Pisana (AOUP), began their preparedness. The AOUP is a highly specialized, tertiary, 1082-bed hospital. COVID clinical wards were divided into infectious disease and pulmonology units. Further clinical wards and operating rooms were repurposed to realize 160 additional beds in COVID medical stays and 83 COVID beds in Intensive Care Units (ICUs) [2,3]. This response induced the stop of the scheduled surgical activities, which were partly resumed from June 2020.

After the summer season, a second wave of COVID-19 emergency involved in Italy. From September 01st to November 24th, in Tuscany Region COVID-19 cases increased from 14.827 to 96.990 [4]. This occurrence led to a sharp raise of hospitalized patients, which increased in AOUP from 11 to 214, in almost 50 days. During the first wave the peak of hospitalized COVID patients was achieved in March 30th, with 187 patients.

Methods and Results

Considering this epidemiological trend, from October 15th the regional task force was set up in order to coordinate a new preparedness plan of the AOUP health services, providing a new procedure for hospital reorganization.

In a first moment, we dedicated 23 beds of infectious disease unit; 19 beds in pulmonary ward and 20 beds in a new COVID-19 pavilion [5].

In this second wave, a critical point consisted in the difficulty in converting of operating rooms and its ICUs in COVID areas, as performed in March 2020. This limit is due to the slowdowns in surgical activities, which were caused by the first wave. AOUP is a high specialized hospital, where surgical activities cover almost 65% of all healthcare services.In this plan, the AOUP may guarantee all the high specialized surgeries (transplants, oncologic and cardiac surgeries). Emergency interventions and 80% of all further surgeries were maintained. From October 15th, new clinical wards (endocrinology, geriatric, urology, internal medicine) were gradually converted in COVID area, with a total of 217 beds (132 beds in medical stays; 43 beds in sub-ICUs and 42 beds in ICUs).

This new reorganization resulted not-sufficient and a rapid beds exhaustion was obtained in few days. Considering the choice of not further reducing surgeries and clinic wards and considering the fast hospitalizations in COVID medial stays, on November 16th the task force teams implemented a plan to integrate the intermediate and low cares in AOUP. COVID-19 hospital emergency needs an “intermediate structure” suitable for patients in discharge from medical stays, needing a protected environment having medical devices and a continuous nursing surveillance [6].

The importance of these cares during COVID-19 pandemic, described by Regional Decree (7) may be useful for:

1. avoiding the inappropriate hospitalization;
2. ensuring the continuous cares;
3. promoting the patients discharge and the homecare.

From November 16th, in AOUP, COVID hospital has been organized in different areas (Figure 1), including:

1. 42 beds in ICUs and 43 beds in sub-ICUs, intended for critical patients (including which needing C-PAP therapy);
2. 132 beds in Medical Stays intended for medium critical patients (including which needing C-PAP therapy) and Operating room unit;
3. 16 beds in “Low care structure” intended for low critical patients needing continuous cares (from November 16th).
4. 32 beds in “Intermediate care structure” intended for patients needing nursing cares (from November 16th);
5. 90 beds in “COVID hotel” intended for still positive patients in discharge.
6. Intermediate and low care structures were implemented after the evaluation of structural requirements (number of beds, ambulatories); organizational requirements (continuous nursing cares); technological requirements (equipments, medical devices).
7. Organizational model provides a “Low Care Team” composed by:
8. Medical staff (internist, geriatrician and anesthetist) with a 24/7 service;
9. Nursing staff (nurse and a social health operator) with a 24/7 service;
10. Rehabilitation staff (physiotherapist).

Figure 1: Planimetry of different healthcare levels reorganized in Azienda Ospedaliero Universitaria Pisana (AOUP) during the second wave of COVID-19 pandemic.

With a daily basis, medical and nursing staff check COVID Medical Stays in order to detect the patients which may be transferred in low care area. These evaluations are applied following the requirements defined by the Regional Decree (8) (blood oxygen saturation >94% in 48h; slow relaxed diaphragmatic breathing <22 breath per minute; absence of dyspnea; absence of non-invasive ventilation in 78h; hemodynamic stability).

The same evaluation is performed in low care structure, in order to identify patients needing the only continuous nursing assistance in intermediate care structure.

Conclusion

These implementations improve the COVID patients flow during the epidemic, allowing a quickly beds release and a continuous patient path from one level of care to another. Patient discharge may be enhanced throughout the addition of different healthcare levels, from the high to the low care units, present in AOUP. In this way the most surgical activities are guaranteed and the risk of COVID hospital overcrowding may be reduced.

Acknowledgments

The authors acknowledge the efforts of healthcare workers and essential workers during the COVID-19 pandemic.

Conflict of Interest

All authors report no conflicts of interest relevant to this article.

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Nutritional Status of Subjects with Celiac Disease (CD) at a Tertiary Care Hospital in Saudi Arabia - A Retrospective Cross-Sectional Study by Kavita Sudersanadas in Open Access Journal of Biogeneric Science and Research

Nutritional Status of Subjects with Celiac Disease (CD) at a Tertiary Care Hospital in Saudi Arabia - A Retrospective Cross-Sectional Study by Kavita Sudersanadas in Open Access Journal of Biogeneric Science and Research 

ABSTRACT

Introduction: Celiac disease (CD) is chronic gluten-sensitivity enteropathy. Due to the inflammatory reactions, it is known to cause malnutrition. Objective: The study aimed to assess the nutritional status of subjects with CD by anthropometric, biochemical methods.

Subjects and Methods: The study followed a retrospective cross-sectional design-seventy-one subjects with CD registered in a tertiary care teaching hospital from 2008 to 2018. Data concerning demography, clinical manifestations, and the biochemical and iron profile of the selected subjects were collected by using IRB-approved data collection form from the Best Care Hospital Information system. The data were analyzed by using SPSS Version 22. Categorical variables and continuous variables were expressed respectively by frequencies and percentages and by mean ± Comparison of mean values was done with student's t-test. The IRB of KAIMRC approved the study.

Results: The age of the subjects ranged from 3 to > 60 years. The majority (78.9%) of them were females. Moderate to severe underweight was found respectively among female and male children of 3-12 years. Adequate nutrition was reported among 13-18 years. According to BMI for age percentile, the prevalence of malnutrition among children was 8.7%, whereas 26.1% of the children with CD were either overweight or obese. BMI of adult subjects indicated that 29.6% were with energy deficiency and 32.4 % were overweight or obese. Iron deficiency was the most prevalent micronutrient deficiency found among the subjects, especially among females.

Conclusion: Those with CD are at risk of iron efficiency anemia and loss of lean mass. Loss of lean mass and severe undernutrition results in growth retardation. The study indicates the importance of nutrition monitoring and follow up and nutrient supplementation to those with CD.

 

KEYWORDS: Celiac disease; Nutritional status; Anthropometry; Biochemical profile; Iron profile

Introduction

Celiac disease, known as gluten-sensitivity enteropathy, is a chronic autoimmune inflammatory disease in the small intestine. It is characterized by permanent gluten intolerance and malabsorption syndrome. The etiology of CD could be due to environmental factors such as the ingestion of gluten and genetic factors such as HLA and tTG auto-antigen. Therefore, CD affects genetically susceptible individuals. Gluten is recognized as a protein found in prolamine fragments of barley (hordein), wheat (glutenin and gliadin), or rye (secalin) [1–5].

CD could be associated with autoimmune diseases such as diabetes, type 1, and hypothyroidism. Over the previous decades, the prevalence rate of celiac disease in different parts of the world was underestimated by relatively 1 in 1000 individuals. It was considered an uncommon disease that mainly affects children, and typical symptoms, gastrointestinal manifestations. The gastrointestinal manifestations are chronic diarrhea, vomiting, bloating, abdominal pain, abdominal distention, and steatorrhea. The recent introduction of susceptible serological tests led to increased screening. The subjects with CD are diagnosed by serological tests such as tTG, anti-gliadin, and EMA. They can be diagnosed by small intestinal mucosal biopsy, which is treated as the golden standard for CD diagnosis (5-11). Accordingly, the prevalence of CD is increased continuously at the rate of 1 in 100 or 200 individuals. High rates of prevalence were reported among females than males (2.8:1) [2,4, 12-14]. In KSA, it was reported that females have a high prevalence of CD than among males [12].

The CD is classified into typical (with gastrointestinal manifestations), atypical (extra-intestinal manifestations), and asymptomatic [1, 2, 14-16]. Extra-intestinal manifestations include fatigue, dermatitis herpetiform, and bone problems such as osteopenia, hematological abnormalities such as anemia; leukopenia; thrombocytopenia; and thrombocytosis.

The inflammatory reaction causes morphological changes in the proximal small intestine, which ate villous atrophy, abnormal surface epithelium, typical flat mucosa, and hyperplastic crypts. These morphological changes occur primarily in the duodenum and jejunum and because malabsorption leads to nutrient deficiencies [2, 4,13,14,17,18]. There is much evidence that the macronutrients and micronutrients deficiency among individuals with CD is higher than those without CD [4, 18]. Iron deficiency anemia (IDA) due to iron deficiency is the main hematological magnification found in subclinical cases of CD and could be the only manifestation observed with CD subjects. Iron deficiency can result from iron malabsorption, gastrointestinal bleeding, or iron loss via diarrhea or steatorrhea. IDA is usually considered as presenting feature of CD. 0.5%-6% cases of IDA result from CD.

Numerous studies documented the impact of nutrient malabsorption caused by CD in both children and adults. Although gluten sensitivity is temporary and resolves with the healing of the small intestine, additional restrictions to a gluten-free diet increase the risk of overall nutritional deficiencies. This study aimed to assess the nutritional status of subjects with CD as depicted by biochemical and iron profiles.

SUBJECTS AND METHODS

The study was conducted at the gastroenterology department of King Abdulaziz Medical City from 2008 to 2018. KAMC is one of the biggest hospitals in KSA located in Riyadh. It has 690 beds tertiary care, and it is a teaching hospital.

Subjects

All patients, irrespective of gender, registered in King Abdul-Aziz Medical City and referred to the gastroenterology department with a diagnosis of celiac disease were included in this retrospective cross sessional study. Exclusion criteria included those with pregnancy or lactating mothers, patients with apparent blood loss (not caused by celiac disease) such as hypermenorrhea, Melena, hemoptysis, those with gastrointestinal abnormalities such as irritable syndrome, chronic liver disease, chronic kidney disease, and Crohn's disease, those with febrile diseases such tuberculosis, those with cancer of intestine/ colon/ or any organ in the gastrointestinal tract and those who have metabolic disorders. Accordingly, 71 patients were selected for the study by using the convenience sampling technique.

Data Management and Analysis

Data were collected from the hospital information system, Best Care of KAMC. Data concerning demography, clinical manifestation, and biochemical and iron profile of the subjects were taken using IRB Approved Data collection charts.

The nutritional status of the subjects was assessed by anthropometric and variables related to the biochemical and iron profile. For children, Body Mass Index (BMI) for age percentile based on CDC growth chart was used to conclude anthropometric data. Those with less than the fifth percentile were considered underweight, 5- 85th percentile as normal BMI, 85 < 95th percentile as overweight, and equal to or ≥95th percentile as obese [19]. In addition, the subjects' weight and height were used to calculate BMI and classified as per universally accepted classification of BMI. The ideal body weight and percent of ideal body weight was calculated using MediCalc online calculator [20].

The collected data was entered in MS excel. After proper cleaning of the data, it was exported in SPSS version 20 for further statistical analysis. Prior to statistical analysis, the normality of the data was tested by Shapiro Wilk’s test. Categorical variables were presented by frequencies and percentages while for continuous variables mean ± SD was used. Mean values were compared by using an independent t-test. Statistical significance of the test was assumed with p-value of <0.05 [21].

RESULTS

A total of 71 subjects with confirmed celiac disease diagnosed by duodenum biopsy and serological tests were identified and included in the study. Table 1 details the demographic characteristics of the subjects.It was observed that the majority of the subjects were in the age group of 30-60 years (35.2%), followed by those in the age group of 18-29 years (29.6%) and more than ¾th of them (78.9%) were females. The important gastrointestinal manifestations reported were diarrhea (29.6%), abdominal pain (26.8%), and vomiting (25.5%). In addition, around 26.8% were diagnosed with extra-intestinal manifestations such as skin lesions.

Table 1: Demographic Characteristics of the Subjects with CD

*Some Subject Presented with More Than One Clinical Manifestation

The nutritional status of the subjects based on anthropometric data is given in Table 2. It was observed from Table 2 that there was significant gender variation in height, current body weight, and ideal body weight of the subjects of age 19-50years. In addition, the percent of ideal body weight (%IBW) was 21.4 and 24.3 respectively for adult females and males, and there is a significant gender difference in % of IBW. A significant difference in IBW was observed among females and males of 13-18year old subjects. Severe underweight observed among the subjects of age group 2-12years and 19-50years. CD is one of the etiological factors for malnutrition among adults and children.

Table 2: Nutritional status of the subjects as depicted by anthropometry

Prevalence of energy deficiency among the subjects as indicated by Body Mass Index is given in Figure 1 and 2.

It was found that the prevalence of energy deficiency as indicated by Body Mass Index (BMI) ranges among children aged 2-19 years old with CD was 8.7%. Most child subjects (65.2%) had normal BMI; however, 17.4% were overweight, and 8.7% were obese. Among the adults, 29.6 percent had energy deficiency, whereas 38 % were of normal BMI (Figure 2). The biochemical profile of the subjects with CD is given in Table 3. The biochemical profile of the subjects indicated that compared to males, female subjects are at risk of low biochemical values. The majority (25%) of the subjects were presented with lower blood urea and serum creatinine (25.35%). In addition, there was a significant difference between blood urea and serum creatinine values of females and males. Table 4 details the iron profile of subjects with Celiac Disease. Results of the study indicated that compared to male subjects, female subjects are at greater risk of iron deficiency. Around 41.07 % of females presented low hemoglobin levels (Table 4). A significant difference existed between the hemoglobin values of male and female subjects (p= 0.001). The majority (73.21%) of the female subjects showed low serum iron levels. Low serum ferritin levels were found among 33.33% of males and 19.64 % of females. There was a significant difference (p= 0.012) between the serum ferritin values among both genders. Females with high total iron-binding capacity were at a higher percentage (78.57%) than males with CD (73.33%).

Table 3: Biochemical profile of the subjects with Celiac Disease

Figure 1 : Energy deficiency among subjects of 3-18 years as per BMI for age percentile

Figure 2: Energy deficiency among subjects of >18 years as per BMI

 

Table 4: Iron profile of the subjects with Celiac Disease

DISCUSSION AND CONCLUSION

Celiac disease (CD) is a chronic autoimmune inflammatory disease. In the present study, adults formed a significant proportion of the sample (64.8%), followed by 31% of children. Gender-wise distribution of the study subjects showed that females (78.9%) were more affected with CD. In addition, meta-analysis studies based on the seropositive diagnosis of CD from KSA showed that seropositive females are more common than males [22].

CD causes morphological changes in the duodenum and jejunum, which are the main sites of nutrient absorption. Gastrointestinal manifestations such as diarrhea (29.6%), abdominal pain (26.8%), and vomiting (25.4%) were reported by the subjects of the current study. These clinical manifestations interfere with the digestion and absorption of food and nutrients, resulting in nutritional deficiencies. Many studies support the evidence that, the macronutrient and micronutrient deficiency among individuals with CD is higher than those without CD [4,10]. The main finding of our study showed that the subjects experienced malnutrition due to chronic energy and iron deficiency.

Based on %IBW, children of 3-12 years of age were more affected with malnutrition than other age groups. They were categorized as moderate (females) to severely (males) underweight. Other age groups under the study were with good, overweight, and obese category of %IBW.

BMI for age percentile of the children was low for 8.7%. On the contrary, in a retrospective study conducted in Iran, the prevalence of malnutrition among child subjects with CD was 43% [23]. BMI of those above 18 years indicated that most (32.4%) of them were obese or overweight, whereas 29.6% were underweight. It was reported that overweight and obesity could co-exist with CD [24].

The loss of villi and surface epithelium due to CD increases the plasma protein leakage in such patients [25]. About 9.86 percent of the subjects of the study were presented with low serum albumin levels indicative of protein-losing enteropathy. Moreover, 35.21 % of the subjects had low serum urea, representing protein malnutrition or a low protein diet. Low muscle mass due to malnutrition is the leading cause of low creatinine levels. In the present study, 25.35% of the subjects were with low serum creatinine values. Iron is the major micronutrient depleted in subjects with CD caused by iron malabsorption, reduced duodenal iron absorption, gastrointestinal blood loss, autoimmune diseases, and microcytic anemia. The frequency of Iron Deficiency Anemia (IDA) among those with CD ranged from 12% to 69% [25]. This study found that 38.03% of subjects had low hemoglobin levels, and 67.61 % had low serum iron levels. Low serum ferritin, the marker of iron stores in the body, was observed among 22.54% of the subjects. It was stated that the depletion in body iron storage and reduced hemoglobin levels were observed among patients with celiac disease [26].

With the reduction in the body iron stores, there will be an elevation in the iron-binding capacity of the iron transporting protein transferrin. We found that 77.46 percent of the study subjects had elevated Total Iron binding Capacity (TIBC). In addition, females with CD are at higher risk for iron depletion in the body than males.

The strength of our study is that, it is the first study in KSA which indicates the nutritional status of subjects with CD by anthropometric, biochemical and iron profile for all ages. However, this study had certain limitations. The design of the study was retrospective. The samples with incomplete file records were excluded; hence the sample size was drastically reduced, and the sample size was very low for specific age and gender groups.

Celiac disease is chronic gluten-sensitivity enteropathy with varying clinical manifestations. Due to the inflammatory reactions and morphological changes at the micro and macronutrient absorption sites, the patients are at risk of nutrient deficiencies. Furthermore, nutrition and food consumption pattern in Saudi Arabia largely depends on cereal groups, with wheat as the most popular staple food. Therefore, improper nutritional management of CD may result in an unchanged or increased risk of having complications due to multiple nutrient deficiencies. In this regard, the changes in biochemical and iron profile due to iron depletion require more attention and follow-up. In addition, the results of our study indicated the importance of nutritional and lab assessments, Gluten-Free Diet, diet counseling, iron supplementation, and continuous follow-up and monitoring of the interventions with CD subjects during nutrition rehabilitation.

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Structuring Virtual Teams by Ecler Jaqua* in Open Access Journal of Biogeneric Science and Research

Structuring Virtual Teams by Ecler Jaqua* in Open Access Journal of Biogeneric Science and Research 

ABSTRACT

The primary purpose of the virtual team is to address a specific problem at hand from different locations, which could either be locally, regionally or internationally. It implies that while working from diverse settings, it is vital for leadership to create a favorable environment where every member is afforded the opportunity for showcasing their skills and knowledge while at the same time demonstrating that they can be relied upon for the accomplishment of organizational purposes.

Introduction

The virtual team is created to share information about their operations to offer a review of the corporate hence ensuring that it continues with its success trajectory while at the same time eliminating the foreseeable challenges. In this regard, the team's togetherness is best described through linear approach, intuitive approach, and finally componential approach.

In the linear approach, the virtual team members accept the cultural diversity enabling the creative process, which involves defining and clarifying the work and solution to the challenge. It implies that the team's togetherness is created by the top-level management who, through induction, introduces the team's objectives and outlines this approach which primarily deals with elaboration of the steps guiding the development of the solution. It illustrates that togetherness is enhanced through three crucial steps: problem finding, fact-finding, and problem defining. On the other hand, the intuitive approach, a significant factor determining the team, is also best described through the intuitive approach, which encourages creativity among the team (Nemiro, 2004) [4]. It is one of the critical stages which holds the team together and can easily break the same. Finally, it implies that the team's togetherness is best described through the ability to recognize each member to contribute to the study discussion without being judged. The access the open communication is an indication that eliminates doubt within the team, thus making each member feel comfortable, which overall facilitates the attainment of the purpose. When virtual team members can communicate without being judged, they experience a sense of belonging and remain committed to organizational aims.

In the same way, the team's creativity is demonstrated through the componential approach, which mainly emphasizes the social psychology of creativity. Accordingly, this is an approach best described through three critical factors comprising a combination of factual knowledge, creativity, and task motivation. Again, and as demonstrated, the team's togetherness is promoted by setting rules, clarifying the purpose, showing respect and trust alongside the ability of effective communication.

In contrast, the apartness of the team is described through the personal differences happening in the context of personal issues, cultural barriers, time zone, and lack of effective leadership. This issue causes the absence of unity of purpose. Each member focuses on their problem whose conflict of interest makes the overall attainment of the virtual team objective incredibly impossible. Accordingly, the cultural barriers are a challenge that requires the virtual team leadership to provide an approach to attaining the primary goal. It could entail looking for a professional translator to break down the communication barriers making the information accessible to all the people. Specifically, given that the team is working from different geographical areas, it is possible to have other working times, making the team unable to stick together and attain its objective within the specified time. It implies that the leadership should create a timetable when all people should increasingly participate in the virtual meeting, thus enabling the group's goals. The team apartness, also best described via lack of effective communication, shows a lack of leadership, thus making the team lack direction on how to execute their objectives. This overall enables negative analysis and communication within the team. Notably, there is no sequence for idea generation, development, finalization, and closure.

 The Options for Work Design and Leadership of Virtual Teams

The available options for the work design and leadership in the virtual team comprise the wheel, modular and iterative approaches that guide and shape the team members from the idea generation to development, finalization, and closure. The wheel approach mainly entails the leader communicating what will be accomplished, how, and when to the whole team. The higher status or the manager is the communication through which all the information must pass from the low-level members. Thus, it eliminates the communication gaps and inconsistencies and assures the whole team to have an efficient flow of information. Finally, all the team members propose the ideas to the team leader, who, as a result, ends up making the requisite decision on tabling the various views to the whole team, which discusses the matter extensively, thus enabling the leader to make the right choices.

On the other hand, the modular approach involves the team member's ability to meet together to decide on the task, need, and purpose to be pursued. After agreeing on the goal, the team members divide the amount of work based on expertise. After each member has completed their pie, they consolidate and revise before finalizing the same and the successful implementation. This approach for work design plays an instrumental role that overall facilitates impressive work, which illustrates the ability to continue better and improved outcomes on the assigned tasks by the management.

The iterative approach, on the other hand, contains the use of e-mail. This approach requires adequate time, an open communication system, honesty, work-sharing technology, and increased task interaction alongside the willingness to accept feedback and continue with cooperation (Delice, Rousseau & Feitosa, 2019) [3]. The team members are provided with the tasks which they should accomplish within specific timelines. Therefore, once a team member works on a particular task within a specified time, they share the same with the management from which they are provided with feedback. From this, they work on the areas they have been advised to before submitting the same to the management. Accordingly, this creates a favorable environment that encourages more creativity, improving the work for the whole project. In essence, all this demonstrates that the leadership of a virtual team is instrumental during the work design. Furthermore, this indicates that the leadership creates a supportive environment and culture that makes all the employees feel valued and, at the same time, valid for the accomplishment of the corporate objectives. Accordingly, this signifies that a leader encourages creativity, employs open communication, embraces cultural diversity, and, most of all, offers direction while regulating the behavior among the team.

How Task Requirements and Team Characteristics Affect Work to Design and Leadership

Often, the virtual team works on a project needed to be accomplished within the specified time. From this project, the leader gauges the team members' capability based on the outcome they provide. Arguably, having a hierarchy within the virtual team may significantly alter the team to deliver on its mandate. Furthermore, as severally indicated, the team members are working from different places, and therefore reaching the team leader may be a challenge due to the various time zones. It implies that decision-making becomes impaired, increasingly affecting the ability of the corporate to attain its objectives.

In the same way, some tasks may be challenging for some members, thus requiring rotation which increasingly becomes the onset of bad blood within the team members. Often, the member whose work has been transferred to another individual within the team could have worked on the same for a considerable time. Still, since they cannot complete the same as anticipated, they get transferred to another capable member. This aspect affects the work design and the ability to lead the whole team since they need to accomplish their purposes.

In the same way, the issue of different time zones also affects the ability of the leadership to design the work effectively. Accordingly, when the other members are up, the other member could be asleep. Therefore, the variance of time overall affects the ability to have better and improved performance, thus wasting time and resources alongside inconveniencing the whole team (Davidaviciene, Majzoub & Meidute-Kavaliauskiene, 2020) [1]. In the same way, the team members have different attitudes and approaches towards each other. Therefore, the task at hand, which also considering they are working virtually, becomes impossible to consolidate the objective, thus increasingly facilitating the attainment of the corporate goals. Conversely, given that the team should work based on standardized procedures, following the same virtually can be challenging within the team, illustrating the challenge for the attainment of the group purposes.

Assessment of the Effectiveness of the Structures/Practices Covered by the Readings in this Module for Virtual Teaming.

Given the above task requirements and team characteristics affecting the choices of work design and leadership, it is easily possible to argue that virtual teaming is a flop. Because of the ability to create the physical human relations needed within the team, the communication barrier occasioned by the different time zones, and eventually, personal differences within the team. In contrast, these are challenges found within the virtual team but require effective communication and the establishment of a flat hierarchy of communication where all the members increasingly have access to open communication. Furthermore, it implies that the team first does the induction process, which outlines the expectations of each member while at the same time setting out the rules and regulations which should be followed within the team. Overall, this clearly indicates that once the team gets provided with training and development, they elevate communication and acceptance amongst themselves, thus changing the direction that should be employed. All this signifies the possibility for the continuation of open communication while at the same time increasingly enhancing cultural diversity within the whole team, which promotes a sense of purpose.

Conclusion

In this regard, I am convinced that virtual teaming works out provided there is effective leadership that offers communication, training, and development and, importantly, outlines the steps that should be followed for the team relations while encouraging open communication and subsequent feedback (Malhotra, Majchrzak & Rosen, 2007) [2]. Regarding timeframe, the team leader communicates a specific time that favors everyone but is equal to the team, following the team members. Since the COVID-19 outbreak, the reality of virtual teaming proved effective, with also immense literature supporting the view that it is practical. Virtual teaming requires building trust, appreciating diversity, managing the work cycle adequately, and enhancing the visibility of team members. Also, it requires adequate monitoring of the team members, ensuring that each member stands to benefit from the whole group.

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The Importance of the Cold Chain Logistics in the Pandemic: The Transport of Covid-19 Vaccines

The Importance of the Cold Chain Logistics in the Pandemic: The Transport of Covid-19 Vaccines by Mesut Selamoglu* in Open Access Journal of Biogeneric Science and Research 

ABSTRACT

Pharmaceutical and medical products play a major role in the cold chain and its logistics, especially in temperature-sensitive products. Cold chain logistics are referred to as supply chain systems consisting of series of protocols including multi-level processing, transportation, storage, distribution and retail sale of products. All these procedures are indispensable to maintain a temperature-controlled environment for the pharmaceutical products such as drugs vaccines and to minimize deterioration and maintain quality standards. Therefore, with advancement in technologies in the industrial sector, cold chain logistics have made remarkable progress.

Keywords: Pandemic, Vaccines, Covid-19, Logistics, Cold chain, Cold chain logistics, Smart health technology

Introduction

Human history has witnessed many pandemics and significant impacts caused by these pandemics on health, economy and even global security. Such a pandemic situation has infected millions of people, caused massive diseases outbreak and deaths. Pandemics also threaten global security which directly influences economic stability and lives. The mortality and morbidity rates can be controlled by a prompt, efficient and effective emergency response to reduce long term social and economic impacts. The term ‘Pandemic’ is referred to the outbreak of a fatal disease at a global level irrespective of regions and climates such as the Black Death, HIV-AIDS and SARS and plague. In the 21st century, infections of avian influenza (bird flu) and SARS emerged and they cause pandemic which arose from Asia and caused millions of death and infected people all around the world. The emergence of new and virulent viral strains cause global pandemics and the spread of such infectious viral diseases is easy. Such infectious diseases lead to high rates of transmission, mortality and morbidity as the human population do not show immunity against the virus [1].

The outbreak of infectious diseases spreads very quickly and can cross borders very easily, which threatens not only economies but also the regional stabilities as was witnessed in the pandemic and epidemic of H1N1, H5N1, HIV and SARS. Such health emergencies caused by infectious diseases threaten public health as well as global stability. During December 2019, there were many reports of pneumonia type incidences caused by some unidentified viral strain outbroke Wuhan, China. The disease clinically resembled some new type of viral pneumonia and Flu. After the isolation of the virus and several analyses of its genomic sequence, a novel strain of coronavirus was identified which was designated as ‘severe acute respiratory syndrome-Related Coronavirus-2’ or SARS-CoV-2. The respiratory diseases were caused by this newly discovered ‘SARS-CoV-2’ which was later declared as ‘Coronavirus disease 2019’ (Covid-19) by World Health Organisation [2-4]. The virus originated from bats and then transmitted to human beings. This Covid-19 pandemic has been threatening human health all around the world and its chain is not yet been broken as humans are spreading it. This pandemic situation has lime lighted the worth of laboratory medicines. The clinicians, laboratories and medical scientists have played a very critical part and responded very promptly to this health emergency of SARS-CoV-2. Currently, the laboratory medicine services are required to take care of the rapid diagnosis and medical solution of this viral infection, serological and biochemical monitoring of infected the hospitalized patients and epidemiological surveillance. The immune responses of post-infection patients are detected by antibody assays against pathogens. Serological investigations are pivotal in determining the efficiency of vaccines and also in evaluating the immune response of patients. Especially, the federal drug authority takes an average of 12 years to approve a drug or vaccine for any disease. However, there are great efforts worldwide on the developing of vaccines against the Covid-19. Therefore, there are 5 different platforms for Covid-19 vaccines and about 16 different vaccines developed. The platforms and vaccines in each platform are as follows [5]:

1. RNA based vaccine eg Pfizer, Moderna, CureVac G
2. Viral Vector (adenovirus-non-replicating) eg AstraZeneca, CanSino, Sputnik, Janssen
3. Inactivated Virus eg Sinopharm, Sinovac etc.
4. Protein subsunit eg Novavax
5. DNA based Vaccine eg Zydus Cadila

There was rapid progress and scientific efforts to develop vaccines for Covid-19 and from initial trials to the approval of vaccines the hopes were alive to break this chain of virus and stop the pandemic. The global distribution of the coronavirus vaccines required a huge setup of their transport and the logistic challenges in air transportation are fundamental. This present paper will encompass all key considerations regarding vaccination and its role in recovering international travels. The worldwide transportation of Covid-19 vaccines requires some stringent and safe means. After successful trials, the Covid-19 vaccines enlightened the hopes all around the world to get rid of the pandemic situation and returning to the normality of life. The global transportation of vaccines require international travels and this process must be standardized and consistent to minimize complexities and wastage of doses. Moreover, a clear roadmap plan is needed to implement and manage the vaccination process, especially during roll-out periods of different countries which are going at a different pace to access vaccine supplies. This is very crucial to maintain the vaccination process while there is an overlap between testing and vaccination [6]. The transportation and handling of life-saving pharmaceutical products demand stringent and careful handling conditions. During the transportation of potential medicines may lose their potency and become ineffective. The most critical issue while transporting pharmaceutical products is the maintenance of quality which cannot be compromised. The impacts of logistic constraints and their strategies are mitigated by dealing with pharmaceutical logistics. The operational challenges of transporting vaccines across the borders are linked to the standardized prerequisites to be fulfilled. The training of transportation staff is highly necessary so as their prior knowledgeability about the issue. The risk assessment and reviewing to adjust any risk is the primary requirement that has to be dedicated to the types of equipment and infrastructure [7].

There are different economic and technical indicators aimed at ensuring product control due to the inability to restore quality losses. The final quality of the product is evaluated together with the time, temperature and tolerance of the product during storage. An effective shipment requires good coordination and time management. Any delay in the process of logistics activity of the product, a change in the degree of heat will both financially damage the enterprise, and, more importantly, a deterioration in pharmaceutical products subject to the cold chain will adversely affect health and may even lead to fatal consequences. In order to ensure that the product does not deteriorate and is not damaged during the cold supply chain process, the pharmaceutical and medical sectors require cold chain technology more and more. In this context, this study aimed to focus on the importance of the cold chain logistics related to the transportation of Covid-19 vaccines in the pandemic days.

Logistics

A network of entities to produce and distribute services or goods from the suppliers to end-users is designated as a supply chain. Logistic is a complex process to organize and implement any operation. Logistics and supply chain management are interlinked with the plans, control mechanism, implementation, the effectiveness of forward and reverse flow processes as well as the final storage of the services and goods. There is a continuous transfer of information from point of origin to the consumers to fulfil customer requirements. The main task of distribution logistics deals with the delivery of products from the manufacturer to distributors and finally to consumers. There is some basis operational step such as processing of orders, warehousing and the transportation to the destination. These distribution logistics are very important to maintain the standards of the process and depend on the time, place, and quantity of production and their consumption parameters. Management of resources in logistics maybe some tangible goods (materials, supplies or equipment etc.), food or other consumable products [8,9].

Cold Chain Logistics

The term ‘Cold chain’ refers to a series of actions and the equipment required to maintain the quality of products in a specific low-temperature range from their production to consumption. The supply chain in cold chain setup is strictly temperature-controlled and requires uninterrupted refrigeration during productions, storage and distribution operations. There are some other activities associated with the equipment and logistics to maintain low-temperature with a specific range. The whole process is required to ensure quality, preservation and extension of shelf life of the consumer products including agricultural produce, frozen food, seafood, photographic films, pharmaceutical products and other chemicals. The transport and transient storage of such products maintaining low temperatures is sometimes termed as cool cargo.  Moreover, the cold chain is considered as a science, technology and also process. It is considered as ‘science’ as the understanding of biological and chemical processes is associated with the perishability of products and goods. On the other hand, the cold chain is termed as ‘technology’ due to its reliance on physical means for ensuring desired thermal conditions. It is also a ‘process as it requires a series of tasks in manufacturing, storage, transportation and monitoring of temperature for all sensitive products [8].

Cold chains are among the common processes in the pharmaceutical, and food industries and also required for chemical shipments. The most common low-temperature range in pharmaceutical processing units is maintained between 36 to 46 °F (2 to 8 °C), but the temperature range can be specific depending on the needs of products to be shipped. Some other parameters are also considered while shipping fresh products to maintain a specific environment including air quality in terms of oxygen, carbon dioxide, humidity. These requirements complicate the operation and maintenance of cold chain processes [10]. Unlike other merchandise, cold chain goods are endangered to perishability and disability so these products always require safe and quick transportation towards end-users. These goods are transported temporarily maintaining a low-temperature environment so also termed as cold cargo during entire logistics [11].

Cold chain logistics in the transport of the Covid 19 Vaccines

Some 80 potential vaccines for Covid-19 have been launched in the market until now, but still, many research programmes are underway. To transport these vaccines from the production place to the destination, the air freight industry has to respond accordingly for efficient global transportation and delivery. Transportation and handling of Covid-19 vaccines introduced some other dimensions to supply chains. These highly sensitive and valuable vaccines require not only a temperature-controlled environment but also have to follow international regulations published by ‘EU Good Distribution Practices’, ‘US Federal Drug Administration’ and also World Health Organization (WHO) about temperature control [12].

The capacity in airfreight logistics is generated in such a way to meet all existing programmes to transport vaccines all around the world. Both the resources and infrastructure are very critical as every country was prepared to respond for massive vaccination against Covid-19 as this virus has impacted all territories to a different extent. There are some upcoming challenges for supply chain stakeholders in planning and executing delivery mechanism at the global network for Covid-19 vaccines. Collaborations are much needed in this scenario to build trust and confidence, and the integrity of sensitive vaccines is required strict maintenance throughout the process of transportation. The demand for the vaccine is increasing worldwide and to respond to this situation the ‘traditional manufacturing’ approach could be replaced with ‘distributed manufacturing’. Thus, it can be said that the decentralization approach would create multiple manufacturing units and load would be distributed among them. This would also facilitate the end-users and reduce constraints of supply chain logistics. This goal could only be met for Covid-19 vaccines if the newly developed companies ensure access to their products and compounds. Nowadays, this situation is very challenging due to the imposition of export restrictions on Covid-19 vaccines by government authorities. Such life-saving and essential medical supplies require different approvals and certification policies [13].

Covid-19 Vaccines and Smart Health Technologies in the Pandemic

The Covid-19 disease outbreak is putting a greater emphasis on protracted technological and medical advancements. Firms who are unable to provide a rich experience to their employees and clients are at risk as they traverse the new work-from-home reality. Cloud computing and cybersecurity have become key parts of organization based as companies navigate the new work-from-home reality. In the field of medicine, attempts to find a cure or better therapies are refocusing emphasis on some of the most recent advances in genetics and immunology. Significantly, innovations resulting from the imminent pandemic issue are not transient; it can be proposed entrepreneurs should broaden their horizons to see the long-term implications of current issues. Covid-19 unpredictability drives healthcare and technology innovations [7].

Vaccinations are a significant new tool to combat over Covid-19, and the fact that far too many vaccines are proven to be effective and are being developed is quite promising. Scientists from everywhere in the globe are researching and creating as swiftly as they can to deliver us diagnostics, cures, and vaccinations that would save lives and ultimately lead to the end of this pandemic [14]. There are different platforms for Covid-19 vaccines and many different vaccines developed with their various conditions (Figure 1). To speed healthcare innovation and combat the coronavirus, organizations all across the world are implementing considered trying technology as well as inventing new ones. The goal of smart healthcare is to transport data rather than people. All that is left is to hope that this future answer arrives soon, and that the promise afforded by the interplay of technological advancements is completely realized [7].

Figure 1: Different Covid-19 Vaccines with their conditions [14].

Every year, vaccines protect millions of people's lives. Vaccines function by retraining and strengthening the body's natural defenses, the immune system, to detect and combat the viruses and bacteria they are designed to combat. If the body is exposed to such disease-causing microorganisms after vaccination, the body is prepared to kill them right away, minimizing sickness. Effective and reliable vaccinations will improve the future, but for the time being, we should start wearing masks, keep a safe distance, and avoid crowds. Getting vaccinated does not imply that we may disregard prudence and put yourself and others at danger, especially because the extent to which vaccinations can defend not just against sickness but also against infection is yet unknown [14].

The temperature of most vaccinations must be kept within 1 degree Fahrenheit of their optimal temperature. Traditional immunizations are normally kept between 35- and 46-degrees Fahrenheit. Although most Covid-19 vaccinations must be maintained at temperatures below 32 degrees Fahrenheit, several of the most popular Covid-19 vaccinations must be kept at significantly lower temperatures. Pfizer's vaccine candidate needs a preservation temperature of - 94 degrees Fahrenheit, while Moderna's vaccine needs minus 4 degrees Fahrenheit. It's not simple to keep these temps consistent [14].

Once a Covid-19 vaccine is manufactured, it will mostly certainly be delivered by vehicle towards the next suitable airport. Because a Covid-19 vaccine is so important and time-sensitive, it will almost certainly be flown around across nation or over the world via air. Following the unloading of these planes, the vaccinations will be transported by truck to suitable stockroom storage facilities for distribution. Several vaccines may be shipped straight from the warehouses to the health-care institutions where they will be administered. Following the unloading of these planes, the vaccinations will be transported by truck to suitable stockroom storage facilities for distribution. Several vaccines may be shipped straight from the warehouses to the health-care institutions where they will be administered [7].

The very first stage should be to figure out where vaccinations will be manufactured. Industries might have to use vehicles and airplanes for transportation inside their own nations and for broader marketing to others if manufacturing is mostly done elsewhere. There's also some doubt regarding which Covid-19 vaccination will be licensed initially. Depending on the vaccination, different temperatures and processing protocols may be required. As a result, distinct instruction would be required for personnel across the cold chain about how to manage each vaccination [7]. Getting the right vaccines into the right people at the right time during a global pandemic is, unsurprisingly, proving to be a logistical challenge. Numerous large logistics businesses, such as UPS and DHL, are indeed making significant investments in the cold chain processing facilities. Near UPS aviation centers in Louisville, Kentucky, and Atlanta, Georgia, UPS is establishing frozen farms with 600 freezers capability of attaining - 80 degrees Celsius. The Netherlands is a country in Europe. Also every freezer would contain 48,000 vaccine bottles and so will be capable of storing whether the Pfizer or the Moderna vaccines at the required low temperatures [7]. In several localities, establishing freezers appropriate of the cold temperatures required by the Pfizer vaccine is not feasible, thus systems must be put in place to ensure that such locations receive a sufficient quantity of such vaccine. Aviation and logistical firms are assessing whether they would handle this demand. The outcome will have to wait and see. Ever other vaccination created has the potential that can save a world and gives the globe closer to routine, but delivering the vaccinations to where they are needed will be difficult. Establishing and strengthening the storage conditions for vaccine delivery would assist the globe avoid wasting vaccines and help these people overcome the pandemic quicker [7,14]. Nowadays, the globe can produce and distribute around 6.4 billion flu vaccinations each year. Analysts claim that firms will manufacture roughly 9 billion Covid-19 vaccines in 2021, and the cold storage will need to be capable of managing this massive increase on edge of the vaccines that should currently be supplied each year. According to research published in 2019, 25% of vaccinations are damaged either by time they reach their ultimate targets. When a vaccine is exposed to high temperature beyond its normal operating range and that this is discovered, the vaccinations are often discarded. A temperature error is occasionally made, and one of these vaccinations is given. According to researchers, these vaccinations have no side effects, but they may provide less immunity and need an individual to really be revaccinated. Vast majority of individuals in the United States and billions throughout the world may eventually require a coronavirus vaccination – maybe two doses. This massive immunization campaign will necessitate a complicated vaccine cold chain on a never-before-seen scale. The present vaccine cold storage is inadequate, and increasing the distribution network will be difficult [7].

So, how do businesses and government entities provide vaccinations for those that need them?

The solution is the vaccine freezing chain, which is a distribution network that can retain vaccinations at precise temperatures from the time they are manufactured until the time they are delivered to a person. A further concern is how often delivery to sites of care will be required. This will be determined by the refrigeration capacity of healthcare institutions and hospitals, personnel resources, vaccine distribution sites, and a variety of other criteria, as well as the vaccine's storage period. Finally, there is also the straightforward issue of how to increase transport and storage capability (7). Regular restaurant freezers also have range of temperatures of 5 to minus 10 degrees Fahrenheit, which is insufficient to meet the requirements needed by the Pfizer vaccine. It is necessary to use specialized equipment. It was investigated that the vulnerable product distribution networks in the pharmaceutical business and also how they relate to quality of product as just an operations management scholar. Considering trillions of vaccines required to combat the pandemic, a high spoiling rate could result in a tremendous loss of revenue as well as a significant delay in immunizations, perhaps leading to fatalities and a lengthier worldwide closure. Covid-19 vaccinations are estimated to be required in the range of 12 billion to 15 billion globally, according to experts. Vaccines are consumable products that must be stored at extremely low temperatures. The bulk of Covid-19 vaccines in production, such as those developed by Moderna and Pfizer, are RNA-based vaccines. They will spoil if they become too hot or too cold. A rotten vaccination, like damaged seafood, must be discarded. WHO is collaborating with Gavi and UNICEF to guarantee that the infrastructure as well as technical assistance are in place in order to ensure that Covid-19 vaccinations are securely given to all individuals who require them [7,14].

At minimum seven distinct vaccinations across three platforms have already been put out in nations as of February 18, 2021. Vaccination is prioritized for vulnerable groups in all nations. Simultaneously, more than 200 other vaccine candidates are being developed, with more than 60 of them in clinical trials. COVAX is a component of the ACT Accelerator, which WHO and partners introduced in 2020. COVAX, the ACT Accelerator vaccines cornerstone hosted by CEPI, Gavi, and WHO, intends to stop the Covid-19 pandemic's acute phase by; accelerating the production of safely and effectively Covid-19 vaccines; facilitating the development of production facilities; and collaborating with governments and producers to guarantee that vaccinations are distributed fairly and equally to all nations – the only global program to do so. A Covid-19 epidemic is sweeping the globe. WHO and collaborators are scrambling to develop and implement safely and effectively vaccinations while they work together over the reaction — monitoring the epidemic, consulting on essential measures, and sending important medical supplies to individuals in need [7].

Pharmaceutical and biochemical engineering items must be handled and transported under strict guidelines, otherwise the drug may lose its efficacy and become useless. This adds to the present constraints of restricted aviation freight capacity and worldwide connection as a result of the cancellation of roughly two-thirds of the commercial network. Handling and delivering vaccinations adds a new layer to the logistics of the supply chain - it's not simply a box! Such elevated and delicate items may necessitate not just a temperature-controlled development environment, but also must adhere to international regulatory criteria outlined in the Temperature Control Regulations [14].

The majority of temperature errors in the cold storage facilities are caused by ineffective transportation practices, with yearly losses approximated at $34.1 billion. However, that figure does not include the cost – both financially and physically – of any sickness that could've been avoided if high-quality vaccinations had been delivered on time. Aircraft, trucks, and cold storage facilities are all necessary components of the cold chain. The vaccine manufacturing sites and demand points determine how and why the infrastructure is interconnected and exploited [7]. Todays modern air cargo logistical capacity is geared to match each country's present scheduled immunization programs. As governments prepare for a huge vaccine reaction to Covid-19 that will affect all nations and territories, including infrastructure and manpower will be important. The supplier stakeholders' next task is to create and implement a worldwide network distribution strategy for the Covid-19 vaccines, which has never been done before. Would this temperature-controlled distribution network be able to handle, store, and transfer such a significant increase in vaccine quantities? -Certain transporters, ground handlers, forwarders, and transporters may be confused how to manage temperature-sensitive items successfully. Furthermore, because temperature-controlled life science medical supplies may not have been acceptable for travel in the passenger cabin, pharmaceutical producers may be less reluctant to have their precious goods handled in this fashion. As a result, before accepting or handling vaccine shipments, all suppliers must acquaint themselves with either the overall criteria for securely processing vaccine deliveries. It may be necessary to dedicate special or supplementary resources inside their networks, as well as assign additional and/or legally compliant vaccine storage capacity. It's possible that industry retraining and compliance certifications may have to be expanded [7,14].

Conclusion and Suggestions

The vaccine manufacturing industries are largely influenced by the contribution from intermediate industries in the locality end user’s destinations. The major portion of vaccines are imported from foreign countries, the bottleneck strategy may prevent pharmaceutical industries from maximizing their impact along the supply chains. In such a situation, domestic production could be boosted if the policymakers execute supportive policies which would, in turn, reduce the import of vaccines. This would also facilitate the pharmaceutical industry to flourish and its production would also increase manifolds. Expectedly, the producers of vaccines and vaccine services are the two most important industries which have globally influenced vaccine processing as they are major users of the supply chain during a pandemic. Cold chain logistics is the life of pharmaceutical products such as the Covid-19 vaccine products in the pandemic.

The continuous supply of vaccines could only be ensured by cooperation, collaboration and communication. Prompt actions are needed to initiate industrial transformation that could only be achieved through an efficient, integrated, and collaborative supply chain mechanism. Whether in alignment with globally harmonized standards or with the industrial collaborative efforts, by digitization, data sharing, risk assessment, or by tracking and tracing strategy. This improved approach will lead to growing expectations, transparency and high standardization across supply chains. The airfreight logistics is ambitious and must follow some workable plans for resilient solutions.

There has been a collaboration between logistics and pharmaceutical industries for many decades to improve the quality of products within realistic capabilities. The logistics in general and cold chain logistics, in particular, will continue their vital contribution in supplying life-saving products to help fight against the coronavirus and to diminish its impacts on humanity. It is highly believed that laboratory scientists with support from medical professionals, industries, and public health authorities will eventually overcome this pandemic.

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