Praćenje sumnji nuspojava na cjepiva protiv bolesti COVID-19 prijavljenih Agenciji za lijekove i medicinske proizvode

Autor: Sabati, Klara
Přispěvatelé: Tomić, Siniša, Ratkaj, Ivana, Wittine, Karlo
Jazyk: chorvatština
Rok vydání: 2021
Předmět:
Popis: SARS-CoV-2 virus uzročnik je bolesti COVID-19. SARS-CoV-2 virus se preko proteina šiljka (engl. spike protein) veže na ACE-2 receptore u plućima čovjeka i uzrokuje bolest COVID-19. Infekcija SARS-CoV-2 virusa najčešće dovodi do razvoja težih respiratornih stanja, boli u grlu i suhog kašlja. Apliciranjem cjepiva imunološki sustav čovjeka prepoznaje virusni antigen čime se aktiviraju stanice imunološkog sustava koje stvaraju neutralizirajuća protutijela s ciljem uklanjanja virusnog antigena. Razvijena su cjepiva s ciljem sprječavanja bolesti COVID -19. U Europi najčešće primjenjivana cjepiva jesu mRNK cjepiva (engl. messenger ribonucleic acid; glasnička ribonukleinska kiselina) i adenovirusna cjepiva. U ovome su radu prijave sumnji na nuspojave cjepiva protiv COVID-19 analizirane prema životnoj dobi pacijenta, spolu pacijenta, ozbiljnosti prijave, kriteriju ozbiljnosti, vrsti prijavitelja, prijavljenoj reakciji te pripadnosti nuspojava prema klasifikaciji organskih sustava Medicinskog rječnika za regulatorne poslove (MedDRA). Analizirane prijave ocijenjene su u razdoblju od 27.12.2020. do 1.7.2021. godine. Ukupno je ocijenjeno 2932 prijava sumnji na nuspojave cjepiva protiv bolesti COVID-19, od kojih je njih 730 ocijenjeno ozbiljnima (24,9%). Od 730 ozbiljno ocijenjenih prijava, najveći broj prijava odnosi se na razvoj ostalih medicinski značajnih stanja, njih 583 (70,3%). Najveći broj prijava odnosi se na cjepivo Comirnaty, njih 1610 (54,9%). Zatim slijede prijave sumnji na nuspojave na cjepivo Vaxzevria sa 1098 prijava (27,4%) te Spikevax sa 206 prijava (7,0%). Najmanji broj prijava sumnji na nuspojave odnosi se na cjepivo COVID-19 Vaccine Janssen (15; 0,5%), dok za tri prijave sumnji na nuspojave nije poznato o kojem se cjepivo radi (0,1%).Smrtni ishod prijavljen je u 34 slučaja prijave sumnji na nuspojave, što iznosi tek 4,1% od ukupnog broja ozbiljnih prijava, odnosno 1,15% od ukupnog broja svih zaprimljenih prijava. Najčešće prijavljivane reakcije na cjepiva protiv bolesti COVID-19 bile su vrućica, glavobolja i zimica.
The SARS-CoV-2 virus is the cause of COVID-19 disease. The SARS-CoV-2 virus binds to ACE-2 receptors in the human lung via spike protein and causes COVID-19 disease. SARS-CoV-2 virus infection most often leads to the development of severe respiratory conditions, sore throat, and dry cough. By administering the vaccine, the human immune system recognizes the viral antigen, thereby activating immune system cells that produce neutralizing antibodies to remove the viral antigen. To combat the COVID-19 disease pandemic vaccines have been developed. Most commonly used vaccines in Europe are mRNA (messenger ribonucleic acid) vaccines and adenoviral vaccines. In this paper, suspected adverse reactions to the COVID-19 vaccine were analyzed according to patient age, sex, the severity of reporting, severity criteria, type of notifier, reported reaction, and adverse reactions according to the MedDRA classification of organ systems. Analyzed reports of suspected adverse effects were evaluated in the period from 27.12.2020. to 1.7.2021. A total of 2932 reports of suspected adverse reactions to the COVID-19 vaccine were analyzed, of which 730 were considered serious (24.9%). Out of 730 seriously evaluated reports, the largest number of reports refers to the development of other medically significant conditions, 583 of them (70.3%). The largest number of reports relates to the vaccine Comirnaty, 1610 of them (54.9%). This is followed by reports of suspected adverse reactions to Vaxzevria with 1098 reports (27.4%) and Spikevax with 206 reports (7.0%). The lowest number of suspected adverse reactions relates to Vaccine Janssen's COVID-19 vaccine (15; 0.5%), while for three suspected adverse reactions the vaccine is unknown (0.1%). 34 cases of suspected adverse reactions, which amounts to only 4.1% of the total number of serious reports, or 1.15% of the total number of all received reports. The most commonly reported reactions to COVID-19 vaccines were fever, headache, and chills.
Databáze: OpenAIRE
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