AN INNOVATIVE MULTIDISCIPLINARY STUDY OF THE AVAILABILITY OF CORONAVIRUS VACCINES IN THE WORLD

. The article presents the results of the search for innovative technologies in a multidisciplinary study of the availability of COVID-19 vaccines of any type in the world. In the context of the coronavirus pandemic, multidisciplinary health research brings together the interdisciplinary links of scientists from around the world in medicine, pharmacy, law, economics on good medical practice, pharmaceutical provision and vaccination availability for all contingent of patients and postcovid health disorders. The aim of the research was to search for innovative technologies for the study of medically approved vaccines against COVID-19 in countries around the world using a multidisciplinary and integrated approach in the application of traditional and new methods of analysis. Content analysis was performed according to the range of licenses, permits for medical use and manufacturers by grouping them using the Sturgess formula, followed by construction of a discrete series of variations and distribution polygon. The results show satisfactory availability of vaccines against COVID-19 of any type. Doctors have a choice of appropriate vaccines and the manufacturer that corresponds to the social personalized vaccination taking into account the individual characteristics of patients.

cases of COVID-19 will only increase. Therefore, US health professionals have already decided that all adults (18 years of age and older) who have received at least Pfizer-BioNTech or Moderna should be revaccinated six months after the second dose. However, since April 2021, EU administrations have discussed and suggested the possibility of accelerating booster vaccinations, but recommended that it is important to distinguish between overdose for people with weakened immune systems and booster doses for people with normal immune systems. For example, in France, the official authorities emphasize that booster vaccination is available to all citizens over the age of 18, 5 months after receiving the second dose, i.e. -until mid-January 2022. The elderly has until mid-December 2021 to receive revaccination, otherwise citizens risk losing their sanitary pass (French passport for COVID -19).
Doctors in Israel have organized the process in such a way that more than 40% of citizens have already been vaccinated with the third dose [15]. A study published in the Lancet [16] also shows that revaccination with the 3rd dose is 81% more effective in preventing death than those who received only 2 injections at least 5 months later. It has been noted that SARS-CoV-2 infections are on the rise in many countries, despite successful vaccination campaigns, which are thought to be due to higher infectivity of the Delta variant and reduced immunity after earlier vaccination. Regardless of the cause, these early results suggest that a third dose of mRNA vaccine is effective in reducing the severe outcomes associated with COVID-19 for patients who received two doses at least 5 months earlier.
According to Barbash Gabi [17], Israel again needs to introduce mandatory masks for citizens not only indoors but also outdoors. He stressed the following measures, namely: the importance of introducing stricter checks when people from other countries arrive at Ben Gurion International Airport; impose severe penalties on those who have a forged vaccination or immunity certificate; require those who have been in contact with confirmed cases to be quarantined, even if the citizen is fully vaccinated, because half of those who are currently in critical condition in the country's hospitals have received both doses of the vaccine.
The COVID-19 pandemic and its consequences have three characteristic features of traumatic events [18]: unpredictability, uncontrollability, threat of death or serious injury according to ICD-11 (International Classification of Diseases) and DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition). Patients with COVID-19 tended to be at high risk for mental and social health problems. Although the epidemic apparently affected their overall health, leading to negative emotions or fears, it also had a positive effect, such as a more positive view of their relationships with families or other people and the emergence of more thoughts and views. for life. The study encouraged medical staff to take their time listening to patients and to pay more attention to specific psychological and social health problems in future treatment.
A technical document from the United Nations Health Agency for Member States has become the WHO's strongest warning about a new strain of coronavirus found in South Africa. The agency reported that preliminary evidence increases the likelihood that an unprecedented number of "adhesive mutations" may increase the strain's ability to spread among the population [19]. Health authorities in some countries (UK, Germany, Italy, Belgium, Israel, Spain, the Netherlands, Portugal, Sweden, Scotland, Austria, Canada, Denmark, Hong Kong) have already identified a new strain of Omicron and strengthened quarantine measures [20].
The World Health Organization presented a new edition of the International Classification of Diseases (ICD-11) at the World Health Assembly on May 20, 2019 in Geneva. ICD-11 is the most complete, systematic list of known and recognized evidence-based diseases and conditions. ICD-11 will enter into force after consultation with all WHO countries. WHO notes that the implementation of ICD-11 involves the interaction of classification with the rule of law, laws, national policies, health systems and information infrastructure of each country. Training methods need to be developed for a wide range of international health professionals [21,22].
In these conditions, the relevance of multidisciplinary innovative studies of the treatment of vaccines against coronavirus in the world for the selection of personalized vaccination of patients is growing.
The purpose of the work was to conduct multidisciplinary and comprehensive studies on the availability of vaccination in the context of the coronavirus pandemic, taking into account the production and availability of permits for the medical use of COVID-19 vaccines in the world.
Materials and methods. Innovative approaches to the study of vaccines in the prevention of COVID-19 consisted in the multidisciplinary and integrated application of traditional and new research methods. The multidisciplinary comprehensive study was based on the regulatory framework of health care, including regulatory norms of medical and pharmaceutical legislation, principles of evidence-based medicine, evidence-based pharmacy, forensic pharmacy, clinical pharmacy, pharmacy, marketing, management for different groups of patients [23][24][25][26][27][28][29][30].
The methodological basis of the study was based on the paradigm of organizational and legal, clinical, and pharmacological standards: ICD-11; international and national medical and technological documents on standardization of medical care; normative documents (standards of medical care, clinical protocols, forms of medicines, National list of essential medicines, instructions for medical use); scientific publications on the topic of work.
More than 700 legislative, normative, and legal, instructive, and methodical documents have been processed. The study was conducted from January 15, 2021 to February 20, 2022. The study focused on 33 vaccines in the world (197), which were approved, authorized, licensed, authorized for emergency use or provided for use outside clinical trials in any way by a regulatory body, national authority, or other organization as of January 2022.
The information base of the study consisted of scientific works of foreign and domestic scientists on the topic of the article. The review of scientific sources of literature was carried out taking into account the recommendations of the Cochrane Society for PICO: P (population)the population suffering from vaccines against COVID-19 of any type; I (intervention)vaccination and personification of patients; C (comparison)comparison in research technology, innovative experimental study; O (outcomes)research results. Based on a review of published qualitative strategy and management research, the author identifies highly innovative academic articles, that is, a study that demonstrates substantial novelty in every part of the research process. Author works through these articles in detail to demonstrate their novelty, highlighting concrete ways in which scholars have innovated three interconnected parts of the research process: data generation, data analysis, and presentation of findings. These principles are engaging in holistic innovation, being excruciatingly clear in the presentation of methods, developing theory and method together, and being reflexive in innovating methods. Our model demystifies the largely implicit process of innovating research methods [31][32][33][34][35][36][37][38][39].
Among the traditional research methods used are regulatory, documentary, normative and legal, retrospective, clinical and pharmacological, marketing, comparative, system, forensic and pharmaceutical and graphic.
In addition, content analysis was used. For the content analysis, the method of selection developed by the Department of Medical and Pharmaceutical Law, General and Clinical Pharmacy of the Kharkiv Medical Academy of Postgraduate Education was used. The methodology of content analysis was to qualitatively and quantitatively monitor the turnover of the COVID-19 vaccine market, taking into account our previous studies [40][41][42].
Microsoft Excel 2010 (descriptive characteristics: minimum and maximum value, average value) was used to process the results and determine the consistency between the studied parameters.
To conduct the analysis, for the first time developed its own method of content selection of vaccines against COVID-19, which included seven stages, presented in Fig. 1.  COVID-19 in the pharmaceutical markets of the world, selected countries for inclusion in the study. A total of 33 vaccines against COVID-19 in the pharmaceutical markets of 11 countries were studied. On the second phase, the registration of COVID-19 vaccines was monitored in selected countries. In the third phase, the availability of permits for the use of COVID-19 vaccines in selected countries was analyzed. On the fourth phase, force majeure was studied when, in emergencies, COVID-19 vaccines were authorized for medical use outside of clinical trials. During the Phase 5, we studied which COVID-19 vaccines were included in clinical protocols and treatment standards in the countries selected for the study. On Phase 6, the number of countries where COVID-19 vaccines were authorized and licensed was monitored. At the 7 th phase, the results of the research were systematized and generalized to form conclusions and proposals [43]. The grouping indicator refers to the number of countries where they have been approved, authorized, licensed, authorized for emergency use or granted for use outside clinical trials by any regulatory body, national authority, or other organization [44].
The research of the article is a fragment of research work of the Kharkiv Medical Academy of Postgraduate Education on "Improving the organizational and legal procedure for providing patients with drugs from the standpoint of forensic pharmacy, organization and management of pharmacy" (state registration number 0116U003137, terms 2016-2020) and "Pharmaceutical and medical law: integrated approaches to the system of drug circulation from the standpoint of forensic pharmacy, organization and management of pharmacy" (state registration number 0121U000031, terms 2021-2026).
Results and discussion. Innovative technologies in this study were used in a multidisciplinary and integrated approach using traditional and new methods of analysis. Among the latter, content analysis was applied. Content analysis is a systematic procedure aimed at objectively analyzing the content of any text. Americans are rightly considered inventors and leaders of content analysis. Content analysis was first used in 1640 in Sweden. Already in the late 1960s, content analysis became the most common methodology in research papers defended at American universities, and still remains the most popular methodology in the United States. Unlike questionnaires, content analysis does not measure what respondents write in the questionnaires, but what they actually did. Thus, with the help of content analysis, it is possible to conduct research of any document or set of documents in order to study both the laws of internal structure of the document, and what gave rise to it and what it is intended for. In general, it can be noted that today no study of the document can be carried out without the use of the method of content analysis. This method continues its development and combines the best features of qualitative methods with the advantages of formalized, quantified analysis. The essence of the method of content analysis is to list the quantitative indicators of textual information, as well as to quantify the data obtained. The specificity of the method of content analysis is the division of content analysis into quantitative and qualitative. It has been established that quantitative content analysis must include standardized procedures for calculating selected categories. Quantitative values are crucial for drawing conclusions, the bulk of the calculations of which can be performed using computer programs. Qualitative content analysis is aimed at indepth meaningful study of textual material, including in terms of the context in which the selected categories are presented. The results are formulated here taking into account the relationships of content elements and their relative importance (rank) in the structure of the text.
Depending on the objectives of the study, qualitative content analysis can be supplemented by some elements of quantitative content analysis. Also, content analysis can be divided into search, control, directed, undirected, direct, indirect, structural. The main types of documents for content analysis: text or mixed documents (texts with graphs, charts, tables), which analyze only textual materials in order to identify relevant information; mixed documents or tabular data that can be obtained from documents such as reports, statements, etc. The main characteristic of this type of documents is that they have a lot of tabular materials, on the basis of which secondary data are formed, which are part of various reports and other analytical materials (data are accompanied by textual materials). It should be noted that content analysis can be used in pharmacy, medicine, and other sciences, firstly, as an independent research method; secondly, in combination with other methods; thirdly, as an auxiliary method of processing data obtained by other methods.
It is possible to allocate kinds of application of the content analysis: 1) for processing and specification of the data received by other methods in researches; 2) to study the scientific literature [45][46][47][48].
There are three approaches to conduct content analysis: conventional, directed, and summative. All three approaches are used to interpret meaning from the content of text data and, hence, adhere to the naturalistic paradigm. The major differences among the approaches are coding schemes, origins of codes, and threats to trustworthiness. In conventional content analysis, coding categories are derived directly from the text data. With a directed approach, analysis starts with a theory or relevant research findings as guidance for initial codes. A summative content analysis involves counting and comparisons, usually of keywords or content, followed by the interpretation of the underlying context [49][50][51][52][53][54].
Consider the indicators of vaccination, approval, and testing of vaccines against COVID-19 of any type in the world [43,44]. The availability of COVID-19 vaccines of any type was monitored in official reports from countries that publicly announce the approval of at least one COVID-19 vaccine of any type. Patients who received all the doses recommended by the vaccination schedule were considered fully vaccinated. We monitored licenses, approvals and permits for medical use of vaccines against COVID-19 of any type from official reports of state health authorities. The indicator "approved vaccines" included vaccines that have been approved, licensed, authorized for medical use, have received emergency use status or are available for use outside of clinical trials in any way. The indicator "clinical trials of vaccines against COVID-19 of any type" included countries in which at least one clinical trial of a vaccine against COVID-19 of any type was registered. The "vaccine trials" indicator included those that have not yet been officially registered, whose trials are ongoing, completed or suspended.
An innovative study of vaccines against COVID-19 included the use of content analysis using the Sturgess formula, followed by the construction of discrete series of variations and the distribution polygon. The Sturgess formula used to calculate the number of vaccine groups against COVID-19 vaccines is as follows: where n is the number of variations; N is the number of COVID-19 vaccines. The step limits of certain groups of drugs were determined by the following formula: where h is the magnitude of the step of the group; X max is the maximum number of countries where COVID-19 vaccines have been approved; X min is the minimum number of countries where COVID-19 vaccines are approved.
As the primary data for content analysis, COVID-19 vaccines were selected that passed the stages 1-6 of the study, met the requirements of regulatory authorities, national authorities, or other organizations responsible for the circulation and medical use of COVID-19 vaccines in the national legislations of 14 selected countries. After further processing of these data, a roll of vaccines was stockpiled, which is available in 33 names in 11 manufacturing countries (Table 1). For content analysis, the studied vaccines were distributed according to the indicator for calculating the number of producing countries and countries in which their medical use is allowed in the context of a coronavirus pandemic [43,44,53,54].
To conduct a content analysis of vaccines by the number of countries in which they are approved, primary data on the number of countries where vaccines are approved from the list were selected and processed (Table 2). The Table 2 shows that 33 vaccines are used for coronavirus vaccination, which are approved by countries in the range of 1 to 137 positions.
When calculating the number of coronavirus vaccines according to the number of countries in which they are approved, according to the formula No. 1, determined the number of groups: n = 1 + 3,322 lgN = 1 + 3,322 lg33 = 6,05. We accept n=6 groups. According to the formula No. 2, the step of the group was determined. We accept h=22. The distribution of the step according to the groups is shown in Table 3. According to calculations, the studied COVID-19 vaccines divided by the number of countries where they are approved into six groups, as indicated in the Table  4. Based on the data obtained in the Table 4, we can analyze the pharmaceutical market of COVID-19 vaccines by country of origin. The first group included 23 vaccines from 23 manufacturers with 65 registrations and licenses authorized for medical use.
The range of the second group includes two vaccines from two manufacturers, which are approved for medical use in 56 countries.
Based on the data in the Table 4, the third group also includes 2 vaccines from 2 manufacturers, which are approved for medical use in 100 countries. This indicates that 2 manufacturers can manufacture COVID-19 vaccines in 100 countries that have been licensed CoronaVac and Covishield (Oxford/AstraZeneca formulation).
The fourth group includes three vaccines from three manufacturers, which have 247 licenses and registrations for medical use in the world.
The fifth group is represented by one vaccine (Ad26.COV2.S) from one manufacturer, which is used in 106 countries.
The sixth group is represented by two vaccines from two manufacturers with 274 licenses for medical use. At this stage, it can be concluded that the two COVID-19 vaccines of the sixth group Vaxzevria and BioNTech have the largest number of registrations and licenses for medical use in the world (each in 137 countries).
At the next stage of the study, the results of the content analysis of COVID-19 vaccines on the quantitative indicators of manufacturers and licenses for registration for medical use are systematized and summarized. Based on the received data statistical processing of results of research by construction of discrete variational series and polygons of distribution of the received data is carried out. Discrete variation range of the COVID-19 vaccines shown in table. 5. 115-137 2 The discrete variation series of vaccines against COVID-19 is an ordered division of units of the studied population into groups (based on the results of grouping using the Sturgess formula) by a certain variable (number of vaccines against COVID-19 produced by pharmaceutical companies and the number of approved, authorized, licensed issued authorizations for use in emergencies or granted for use outside clinical trials in any way by a regulatory authority, national authority or other organization). The obtained discrete variation in the distribution of vaccines against COVID-19 indicates that the studied quantitative indicator of vaccines approved in the world varies within the first group (range from zero to 22) with the highest frequency (f i =23). Graphically discrete variation series of the studied vaccines are presented in Fig. 2 in the form of a distribution polygon.