| Abstract | Pandemijsko širenje zaraze koronavirusom uzrokovalo je globalnu krizu obilježenu velikim zdravstvenim, socijalnim i ekonomskim utjecajem. Bolest COVID-19, uzrokovana SARS-CoV-2 virusom, može prouzročiti smrt ili pojavu daljnjih bolesti s još uvijek nepoznatim posljedicama na zdravlje ljudi svake životne dobi, uključujući i inače zdrave pojedince bez komorbiditeta. Zbog svega navedenog javila se hitna potreba za sigurnim i djelotvornim cjepivom kao glavnog sredstva prevencije bolesti COVID-19 i zaštite zdravlja, posebice zdravstvenih djelatnika te rizičnih skupina poput starijih osoba i kroničnih bolesnika. Dosadašnji istraživački napori i globalna koordinacija rezultirali su brzim razvojem cjepiva kandidata i započinjanjem kliničkih ispitivanja na ljudima. Istraživanje, razvoj te proizvodnja cjepiva protiv bolesti COVID-19 uključivale su konvencionalne tehnologije cjepiva kao što su virusni vektori, ali znanost svjedoči renesansi na polju RNA tehnologije cjepiva. Tehnologija temeljena na viralnim vektorima postala je uvriježen dio genske terapije i terapije karcinoma. Viralni vektor je bezopasni, oslabljeni virus koji je modificiran kako bi služio kao sustav isporuke genetičke upute u ljudske stanice koje će prema toj informaciji proizvoditi protein patogena od interesa i tako potaknuti stvaranje imunosnog odgovora te imunosne memorije. Nova tehnologija te zamisao korištenja mRNA kao cjepiva ili lijeka zapravo je prilično jednostavna: u stanicu je moguće unijeti laboratorijski proizvedenu mRNA koja donosi preciznu uputu stanici pacijenta za proizvodnjom proteina koji mogu spriječiti, liječiti ili izliječiti bolest. Trenutno postoji 320 kandidata za cjepivo protiv infekcije SARS-CoV-2 virusom, dok ih je 97 uključeno u klinička ispitivanja.
U ovom radu nalazi se pregled odobrenih cjepiva u prevenciji širenja SARS-CoV-2 virusa na području Europske Unije. U Europskoj uniji, pa tako i u Republici Hrvatskoj, odobrenje za stavljanje u promet imaju trenutno četiri cjepiva: cjepivo Comirnaty, cjepivo COVID-19 Vaccine Moderna, cjepivo Vaxzevria i cjepivo COVID-19 Vaccine Janssen. Jednako kao i svi ostali lijekovi, cjepiva protiv bolesti COVID-19 razvijaju se na način da ispunjavaju stroge zakonske zahtjeve farmaceutske kakvoće, sigurnosti primjene i učinkovitosti. S obzirom na tehnologiju njihove proizvodnje, sastav i posebnosti objedinjene su upute te smjernice za procjepljivanje specifičnih populacija poput osoba starijih od 65 godina, trudnica i dojilja, djece i imunokompromitiranih pacijenata. Aktualnost teme te iznimno brz i učinkovit odgovor znanosti na zahtijeve pandemije sa sobom povlači bezbroj pitanja. U ovom radu pruženi su odgovori na često postavljena pitanja pacijenata, s kojima će se susretati farmaceuti i medicinsko osoblje, a na njih moraju biti spremni sa sigurnošću odgovoriti.
Rad je pohranjen u Središnjoj knjižnici Sveučilišta u Zagrebu Farmaceutsko-biokemijskog fakulteta. |
| Abstract (english) | The pandemic spread of coronavirus infection has caused a global crisis accompanied by major health, social and economic impact. COVID-19 disease, caused by the SARS-CoV-2 virus, can cause death or the onset of further diseases with as yet unknown effects on the health of people of all ages, including otherwise healthy individuals without any comorbidities. Due to all obvious reasons, there was an urgent need for a safe and effective vaccine as the main tool for COVID-19 disease prevention and health protection, especially for health professionals and risk groups such as the elderly and the chronically ill. Last research efforts and global coordination have resulted in the rapid development of the candidate vaccine and the initiation of clinical trials in humans. Research, development, and production of COVID-19 vaccines have included conventional vaccine technologies such as viral vectors, but science is witnessing a renaissance in the field of RNA vaccine technology. Technology based on viral vectors has become a standard part of gene therapy and cancer therapy. A viral vector is a harmless, attenuated virus that has been modified to serve as a system for delivering genetic instruction to human cells that, according to that information, will produce a pathogen protein of interest and thus stimulate the immune response and immune memory. The new technology and the idea of using mRNA molecule as a vaccine or medicine is actually quite simple: it is possible to introduce laboratory-produced mRNA into a cell that provides precise guidance to the patient's cell to produce proteins that can prevent, treat or cure the disease. There are currently 320 candidates for the SARS-CoV-2 virus vaccine, while 97 are included in clinical trials.
This thesis provides an overview of approved vaccines for the prevention of the spread of SARS-CoV-2 virus in the European Union. There are currently four vaccines approved for sales and distribution in the European Union, including the Republic of Croatia: Comirnaty, COVID-19 Vaccine Moderna, Vaxzevria and COVID-19 Vaccine Janssen. Like all other medicines, COVID-19 vaccines are developed in a way that meets the strict legal requirements of pharmaceutical quality, safety and efficacy. This paper serves combined instructions and guidelines for vaccination of specific populations such as persons over 65 years of age, pregnant and lactating women, children and immunocompromised patients, with regard to the technology of different vaccine production, composition and specifics. Vitality of the topic and the extremely fast and effective response of science to the demands of this pandemic entails countless questions. This paper provides answers to frequently asked questions, which will be met by pharmacists and medical staff, who must be ready to answer them with certainty and take away patient's fears and doubts regarding vaccination. |
