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Speaker at Pharmaceutics and Drug Delivery Systems 2022 - Merita Kucuku
Freelance consultant, Albania
Title : Vaccines against rotavirus, data based on a study for safety and efficacy


Vaccines and vaccination are important for the prevention of infectious diseases. In the history of vaccination, we have savings of lives of people of different ages from children aged 0 days and the very old people. The vaccine against rotavirus: Before using the rotavirus vaccines the situation in the USA was: - 4 or 5 children had symptomatic rotavirus gastroenteritis, - 1 in 7 required a clinic or emergency department visit, - 1 in 70 was hospitalized, - 1 in 200000 would die from this disease, within the first 5 years of life . The cost of the situation was estimated: - 410000 physician visits, - 205÷272 000 emergency department visit and 55- 70000 hospitalizations was estimated to be approximately $ 1 billion. Approximately 20- 60 deaths per year among children aged < 5 years. The situation in developing countries related to rotavirus gastroenteritis continues to be a major cause of severe childhood morbidity, approximately half a million deaths per year among children aged < 5 years [4]. Of the estimated 8.795 million deaths in children younger than 5 years worldwide in 2008, infectious diseases caused 68% (5.970 million), with the largest percentages due to pneumonia (18%, 1.575 million, uncertainty range [UR] 1.046 million-1.874 million), diarrhea (15%, 1.336 million, 0.822 million-2.004 million), and malaria (8%, 0.732 million, 0.601 million-0.851 million). 41% (3.575 million) of deaths occurred in neonates, and the most important single causes were preterm birth complications (12%, 1.033 million, UR 0.717 million-1.216 million), birth asphyxia (9%, 0.814 million, 0.563 million-0.997 million), sepsis (6%, 0.521 million, 0.356 million-0.735 million), and pneumonia (4%, 0.386 million, 0.264 million-0.545 million). 49% (4.294 million) of child deaths occurred in five countries: India, Nigeria, the Democratic Republic of the Congo, Pakistan, and China [5]. Rotavirus disease burden globally and in India, Children < 5 years old are risked from rotavirus infectious. According to Rao, TS et al. Vaccine, 2014 1 in 260 children die and in all world 453.0000 deaths, 2, 5 million hospitalizations which means 1 in 58 children and 24 million outpatient visit 1 in 5 children. The situation in India: The risk is 1 in 256 die and a total of 99,000 deaths. 1 in 31-59 hospitalization and in total are 456,000- 884,000 deaths. 1 in 13 children outpatients visit and in total 12 million outpatients visit according to Rao, TS et al. Vaccine, 2014. Route of rotavirus infectious transmission- The transmission of rotavirus infectious is fecal-oral route, through close person to person contact and through fomites [6].


Merita Kucuku studied Master degree: “Chemical Analysis and Determination of the structure by Instrumental Analysis” and Master theses:” Validation and optimization of the determination method of merthiolate in the vaccine by spectrophotometer by means of Factorial Design “Studied Ph. D: “Study and chemical- analytical evaluation of some vaccines used in Albania”. More than 10 years of experience in the field of safety and efficacy and regulatory issues of vaccines, Head of National Regulatory Authority of Vaccines & Immunobiological Products in Albania, and experience as Head of Control Laboratory of medicines in the National Agency for Medicines & Medical Devices (NAMMD). Trained in international agencies and organizations for: Safety, efficacy, AEFI and quality control of vaccines, and GMP. Quality Control/ Quality assurance of laboratories (ISO 17025). Environmental issues as: Environmental Impact Assessment (EIA) and Strategic Environmental, Assessment (SEA),Strategies for chemicals management”, (Pharmaceutical waste management). Training for instrumental analysis as GC, GC- MS. Basic toxicology. National expert on the identification of populations at risk and gender dimensions under MIA project, UNDP. Expert in the project:” Strengthening of capacities for chemical management in Albania”, arranged from UNITAR.