Tozinameran: Razlika med redakcijama

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'''Tozinameran'''<ref name="INN">{{cite journal |author=World Health Organization |title=International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 124 – COVID-19 (special edition) |journal=WHO Drug Information |date=2020 |volume=34 |issue=3 |page=666 |url=https://www.who.int/medicines/publications/druginformation/issues/WHO_DI_34-3_PL124-SpecialEdition.pdf |access-date=23. 11. 2020 |archive-date=27. 11. 2020 |archive-url=https://web.archive.org/web/20201127075410/https://www.who.int/medicines/publications/druginformation/issues/WHO_DI_34-3_PL124-SpecialEdition.pdf |url-status=live }}</ref> ([[mednarodno nelastniško ime|INN]]), pod zaščitenim imenom '''Comirnaty''', je cepivo proti [[covid 19|covidu 19]], ki ga je razvilo podjetje [[BioNTech]] v sodelovanju s [[Pfizer]]jem. Gre za prvo cepivo proti covidu 19, ki so ga nekatere zahodne agencije za zdravila dovolile za uporabo v izjemnih razmerah<ref name="ukgov12-2">{{cite press release |title=UK medicines regulator gives approval for first UK COVID-19 vaccine |url=https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine |publisher=[[Medicines and Healthcare products Regulatory Agency]] (MHRA) |access-date=2. 12. 2020 |date=2. 12. 2020}}</ref><ref name="boseley">{{cite news |first1 = Sarah | last1 = Boseley |first2 = Josh | last2 = Halliday |title=UK approves Pfizer/BioNTech Covid vaccine for rollout next week |url=https://www.theguardian.com/society/2020/dec/02/pfizer-biontech-covid-vaccine-wins-licence-for-use-in-the-uk |access-date=14. 12. 2020 |work=The Guardian |date=2. 12. 2020 |name-list-style=vanc}}</ref> ter prvo odobreno cepivo s strani teh agencij.<ref name=let19>{{Cite news|date=19. 12. 2020|title=Swissmedic autorise un premier vaccin contre le coronavirus|url=https://www.letemps.ch/suisse/swissmedic-autorise-un-premier-vaccin-contre-coronavirus|access-date=19. 12. 2020|publisher=[[Le Temps]]|language=fr}}</ref>
 
Daje se v obliki [[intramuskularna injekcija|intramuskularnih injekcij]] (injiciranje v [[mišica|mišico]]). Gre za [[RNK-cepivo]], ki vsebuje [[informacijska RNK|informacijsko RNK]] (mRNA) s spremenjenimi [[nukleozid]]i, z mutiranim zapisom [[koničasti protein|koničastega proteina]] virusa [[SARS-CoV-2]]. mRNA je enkapsulirana v lipidnih [[nanodelec|nanodelcih]].<ref name="pmid33053279">{{cite journal | vauthors = Walsh EE, Frenck RW, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Şahin U, Gruber WC | display-authors = 6 | title = Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates | journal = The New England Journal of Medicine | date = oktober 2020 | volume = 383 | issue = 25 | pages = 2439–50 | pmid = 33053279 | pmc = 7583697 | doi = 10.1056/NEJMoa2027906 | doi-access=free }}</ref> Potrebno je cepljenje z dvema odmerkoma v razmiku treh tednov.<ref name="NCT04368728">{{ClinicalTrialsGov|NCT04368728|NCT04368728: Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals}}</ref><ref name="palca" /><ref name="herper" /> Učinkovitost preprečevanja hude oblike okužbe pri otrocih, nosečnicah in bolnikih z imunsko pomanjkljivostko ni znana, prav tako ni znano trajanje zaščite.<ref name=herper/><ref name=edwards/><ref name=bbc>{{cite news|url=https://www.bbc.com/news/health-54873105|title=Covid vaccine: First 'milestone' vaccine offers 90% protection|vauthors=Gallagher J|work=BBC News|date=9. 11. 2020|access-date=9. 11. 2020|archive-date=26. 11. 2020|archive-url=https://web.archive.org/web/20201126013146/https://www.bbc.com/news/health-54873105|url-status=live}}</ref>
 
S [[klinično preskušanje|kliničnim preskušanjem]] cepiva so začeli aprila 2020, do aprila 2020 pa je bilo preskušeno že na več kot 40.000 posameznikih.<ref name="BioNTechUpdate"/> Vmesna analiza podatkov preskušanja je pokazala več kot 90-odstotno učinkovitost preprečevanja okužbe po sedmem dnevu po drugem odmerku.<ref name="palca">{{cite web |vauthors=Palca J |title=Pfizer says experimental COVID-19 vaccine is more than 90% effective |url=https://www.npr.org/sections/health-shots/2020/11/09/933006651/pfizer-says-experimental-covid-19-vaccine-is-more-than-90-effective |work=NPR |date=9. 11. 2020 |access-date=9. 11. 2020 |archive-date=9. 11. 2020 |archive-url=https://web.archive.org/web/20201109130110/https://www.npr.org/sections/health-shots/2020/11/09/933006651/pfizer-says-experimental-covid-19-vaccine-is-more-than-90-effective |url-status=live }}</ref><ref name="herper">{{cite web |vauthors=Herper M |title=Covid-19 vaccine from Pfizer and BioNTech is strongly effective, early data from large trial indicate |url=https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/ |work=[[Stat (website)|STAT]] |access-date=9. 11. 2020 |date=9. 11. 2020 |archive-date=9. 11. 2020 |archive-url=https://web.archive.org/web/20201109114554/https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/ |url-status=live }}</ref> Najpogostejši [[neželeni učinek|neželeni učinki]] blago do zmerno [[bolečina|bolečino]] na mestu injiciranja, utrujenost in [[glavobol]].<ref>{{cite journal | vauthors=Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC | display-authors=6 |title=Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine |journal=N Engl J Med |volume= 383|issue= 27|pages= 2603–2615|date=december 2020 |pmid=33301246 |doi=10.1056/NEJMoa2034577 | pmc=7745181 |doi-access=free }}</ref><ref>{{cite web | title=Questions and Answers About Pfizer-BioNTech COVID-19 Vaccine | publisher=Pfizer | url=https://www.cvdvaccine-us.com/faqs | access-date=16. 12. 2020}}</ref> Poročila o hudih neželenih učinkih, kot je alergijska reakcija, so bila zelo redka, o dolgoročnih zapletih pa niso poročali (podatek za december 2020).<ref name="nhs-cvac">{{cite web |publisher=National Health Service |url=https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/ |title=Coronavirus vaccine |date=7. 12. 2020 |access-date=7. 12. 2020 |archive-date=7. 12. 2020 |archive-url=https://web.archive.org/web/20201207150116/https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/ |url-status=live }}</ref>
 
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