Regulativni zahtjevi za odobravanje cjepiva protiv bolesti COVID-19 u Europskoj uniji

professional thesis

• Author: Tea Ćurković
• Mentor: Ivan Pepić (mentor)
• Mentor: Nikica Mirošević Skvrce (mentor)
• Committee member: Ivan Pepić (predsjednik povjerenstva)
• Committee member: Vesna Bačić Vrca (član povjerenstva)
• Committee member: Krunoslav Capak (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmaceutical technology); Zagreb
• Defense date and country: 2022-05-17, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Cilj istraživanja
Cilj istraživanja je detaljnije objasniti ulogu nadležnih institucija, postupke i vrste davanja
odobrenja za cjepiva protiv bolesti COVID-19.
Hipoteze istraživanja temelje se na utvrđenim propisima i postupcima nadležnih institucija u
Europskoj uniji kako bi se čim prije proizveli i odobrili lijekovi i cjepiva protiv bolesti COVID19 u svrhu sprječavanja širenja bolesti. Također, prate se i načini i posljedice cijepljenja na nivou
Europske unije kako bi se skupilo što više informacija o bolesti COVID-19.
Materijali i metode
Provedeno je detaljno istraživanje postojeće literature i svih službeno dostupnih podataka koja se
odnose na odobravanje cjepiva unutar Europske unije, s posebnim naglaskom na ubrzani postupak
davanja odobrenja. U svrhu boljeg razumijevanja potrebe za hitnim odobrenjem cjepiva, također
je istražena odobrena i dostupna literatura koja se odnosi na porijeklo i nastanak bolesti COVID19. Ovaj dio istraživanja proveden je pretraživanjem objavljenih zakona, uredbi i pravilnika na
stranicama Europske agencije za lijekove (EMA), Europske komisije (EK), Hrvatske agencije za
lijekove i medicinske proizvode (HALMED), Hrvatskog zavoda za javno zdravstvo kao i
akreditiranih baza podataka npr. ScienceDirect, PubMed, Elsevier koristeći sljedeće pojmove:
COVID-19, koronavirus, SARS-CoV-2, COVID-19 cjepivo i sl. Nadalje, pojašnjene su razlike
Regulativni zahtjevi za odobravanje cjepiva protiv bolesti COVID-19 u Europskoj uniji
odobrenih cjepiva protiv bolesti COVID-19 u Europskoj uniji iz regulativne perspektive kao i
predložene strategije i plan distribucije istih.
Rezultati
Ovo istraživanje osigurava detaljan uvid u stroge zahtjeve farmaceutske kakvoće, sigurnosti
primjene i djelotvornosti kako bi se odobrilo cjepivo protiv bolesti COVID-19 po ubrzanom
postupku u svrhu sprečavanje daljnjeg širenja zaraze. Također, istraživanje je prikazalo i
analiziralo najnovije prikupljene podatke o odobrenim cjepivima te daljnje korake regulativnih
institucija u Europskoj uniji.
Zaključak
Trenutačno pandemijsko širenje bolesti COVID-19 predstavlja globalnu krizu s velikim
zdravstvenim, socijalnim i ekonomskim utjecajem. Stoga je bilo potrebno uložiti iznimne napore
u razvoj i proučavanje cjepiva protiv bolesti COVID-19 kako bi učinkovita cjepiva ispunila
zahtjeve za ishođenje odobrenja i bila što prije dostupna. Trenutno su u Europskoj uniji odobrena
sljedeća cjepiva protiv bolesti COVID-19 različitih proizvođača: Comirnaty, Spikevax (prijašnji
naziv: COVID-19 Vaccine Moderna), Vaxzevria (prijašnji naziv: COVID-19 Vaccine
AstraZeneca) i COVID-19 Vaccine Janssen. Također, nastavno na dogovorene strategije i plan
cijepljenja u Europskoj uniji, EMA prikuplja sve nuspojave odobrenih cjepiva, dok Europski
centar za prevenciju i kontrolu bolesti prati učinkovitost cjepiva protiv bolesti COVID-19. Time
Regulativni zahtjevi za odobravanje cjepiva protiv bolesti COVID-19 u Europskoj uniji
se omogućuje identifikacija i procjena novih informacija kojima se osigurava otkrivanje
potencijalnih rizika te njihove prevencije.

Abstract (english)

Objectives
The aim of the study is to explain in more detail the role of competent institutions, procedures and
marketing authorisation types for COVID-19 vaccines. The research hypotheses are based on the
established rules and procedures of the competent institutions in the European Union in order to
produce and approve COVID-19 medicinal products and vaccines as soon as possible to prevent
the spread of disease. The vaccination administration and consequences of vaccination at the level
of the European Union are also monitored to gather as much information as possible about
COVID-19.
Material and Methods
Detailed study of the existing literature and any officially available data concerning the vaccine
authorisations within the European Union has been carried out, with a particular focus on the
conditional marketing authorisation procedure. For the purposes of a better understanding of the
need for an urgent fast-track vaccine approvals, the approved and available literature relating to
the origin and emergence of COVID-19 disease has also been investigated. This part of the
research was carried out by searching published laws, regulations and ordinances on the pages of
the European Medicines Agency (EMA), the European Commission (EC), the Croatian Agency
for Medicinal Products and Medical Devices (HALMED), the Croatian Public Health Agency as
well as accredited databases, e.g. ScienceDirect, PubMed, Elsevier using the following terms:
COVID-19 disease, coronavirus, SARS-CoV-2, COVID-19 vaccine, etc. Furthermore, the
Regulativni zahtjevi za odobravanje cjepiva protiv bolesti COVID-19 u Europskoj uniji
differences of the approved COVID-19 vaccines in European Union from the regulatory
perspective and the proposed strategies and the distribution plan have been clarified.
Results
This research provides a detailed insight into the strict pharmaceutical quality requirements, safety
and efficacy requirements in order to approve COVID-19 vaccines following urgent fast-track
vaccine approvals procedures to prevent further contagion spread. The research also presented and
analysed the most recent data about approved vaccines and further steps of the regulatory
institutions in the European Union.
Conclusion
The current pandemic COVID-19 disease spread is a global crisis with a major health, social and
economic impact. Therefore, it was necessary to make exceptional efforts to study and develop
vaccines against COVID-19 in order to meet the requirements for marketing authorisation and
availability as soon as possible. The following COVID-19 vaccines of different producers are
currently authorised in the European Union: Comirnaty, Spikevax (previous product name:
COVID-19 Vaccine Moderna), Vaxzevria and COVID-19 Vaccine Janssen. In addition, following
the agreed strategy and vaccination plan in the European Union, the EMA shall collect all side
effects of authorised vaccines, while the European Centre for Disease Prevention and Control shall
monitor the efficacy of COVID-19 vaccines. Above written enables identification and assessment
of new information to ensure the detection of potential risks and their prevention.

• Keywords: COVID-19; koronavirus; SARS-CoV-2; cjepivo
• Keywords (english): COVID-19; coronavirus; SARS-CoV-2; vaccine
• Language: croatian
• URN:NBN: urn:nbn:hr:163:018631
• Study programme: Title: Drug development; Study programme type: university; Study level: postgraduate specialist; Academic / professional title: sveučilišni magistar/sveučilišna magistra razvoja lijekova (sveučilišni magistar/sveučilišna magistra razvoja lijekova)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2022-05-27 08:25:42