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[title] => Svijet će se prvi put u povijesti cijepiti ovom vrstom cjepiva: mRNA tehnologija tijelo transformira u tvornicu za uništavanje virusa
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Bez obzira na to koja će od dvije farmaceutske kompanije – Moderna ili Pfizer – izaći prva na tržište sa svojim cjepivom protiv COVID-19, svijet će se prvi put u povijesti cijepiti mRNA-a cjepivom namijenjenim ljudima.
Riječ je u potpunosti o novom i revolucionarnom cjepivu, koje umjesto klasičnog ubrizgavanja umrtvljenog virusa ili njegovog dijela sadrži upute za izradu jednog proteina koji se nalazi u virusu.
Tradicionalna cjepiva, naime, poput onih protiv gripe ili ospica, aktiviraju imunološki sustav uštrcavanjem malih količina virusa. Nova tehnologije koja transformira tijelo u tvornicu za uništavanje virusa velika je novina kad je riječ o cjepivu za široku primjenu, ali nipošto nije nešto neprovjereno i nepoznato u medicini. Moderna i BioNTech primjenjuju tehnologiju mRNA i na eksperimentalne lijekove protiv raka. U drugoj fazi je i testiranje mRNA protiv melanoma sa švicarskim Rocheom. Među najnaprednijim projektima Moderne, osim cjepiva protiv COVID-19, nalaze se i mRNA spojevi za liječenje raka jajnika ili ishemije miokarda, koji su također u drugoj fazi ispitivanja.
Postupak ocjene
Povjerenstvo za humane lijekove (CHMP) pri Europskoj agenciji za lijekove (EMA) započelo je u utorak postupnu ocjenu dokumentacije za cjepivo nazivom mRNA-1273, koje razvija Moderna i Biotech.
Početak postupka postupne ocjene dokumentacije znači da je CHMP započeo s ocjenom prvih dostupnih podataka o cjepivu dobivenih iz laboratorijskih ispitivanja, međutim zaključak o sigurnosti i djelotvornosti ovog cjepiva bit će moguće donijeti tek nakon što se Povjerenstvu dostavi preostali, veći dio dokaza.
Antivakseri su zbog ovog cjepiva odavno na nogama. Tumače kako se mRNA cjepiva mogu koristiti za genetsku modifikaciju ljudi, što znanstvenici u potpunosti odbacuju.
Prema uobičajenom shvaćanju pojma genetskih modifikacija promjena genetskog materijala domaćina mora biti trajna i nasljedna. Korištenjem sintetske RNA i njezinim unosom u ljudski organizam ili ljudske stanice nije moguće izazvati trajne ili nasljedne promjene genetskog materijala u ljudskim stanicama. Znanstvenici ponavljaju kako se mRNA, a samim time i mRNA cjepivo, ne ugrađuje u genom domaćina te ni na koji način ne može promijeniti genetski materijal domaćina.
Pristajanje na rizik
Tal Brosh, šef odjela za zarazne bolesti sveučilišne bolnice Assuta Ashdod u Izraelu djelovanje mRNA cjepiva opisao na primjeru računala.
– To je više kao da na računalu pokrenete program s vanjskog uređaja za pohranu podataka (disk, USB stick i slično). Dakle, on ne utječe na hard disk računala, već obavlja određeni zadatak u operativnom sustavu računala – tumači izraelski liječnik.
No, Brosh navodi da ipak postoje i nepoznati rizici korištenja mRNK cjepiva, koji uključuju lokalne i sustavne upalne reakcije koje mogu onda dovesti i do autoimunih uvjeta.
– U tijeku je utrka da se stanovništvo cijepi, stoga smo i spremniji riskirati više. Svijet ne može čekati klasično cjepivo deset godina – istaknuo je Brosh za Jerusalem Post.
Njegova kolegica Michal Linial, profesorica biokemije na Hebrejskom sveučilištu u Jeruzalemu uvjerava kako razloga za brigu oko mRNK cjepiva nema. Pojašnjava da cjepiva Moderne i Pfizera od tijela traže da rade nešto što ionako radi svakodnevno, da sintetizira proteine u stanicama. Ona više brine da mRNK možda neće ući u stanice te se tako dezintegrirati bez ikakvog učinka.
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Bez obzira na to koja će od dvije farmaceutske kompanije – Moderna ili Pfizer – izaći prva na tržište sa svojim cjepivom protiv COVID-19, svijet će se prvi put u povijesti cijepiti mRNA-a cjepivom namijenjenim ljudima.
Riječ je u potpunosti o novom i revolucionarnom cjepivu, koje umjesto klasičnog ubrizgavanja umrtvljenog virusa ili njegovog dijela sadrži upute za izradu jednog proteina koji se nalazi u virusu.
Tradicionalna cjepiva, naime, poput onih protiv gripe ili ospica, aktiviraju imunološki sustav uštrcavanjem malih količina virusa. Nova tehnologije koja transformira tijelo u tvornicu za uništavanje virusa velika je novina kad je riječ o cjepivu za široku primjenu, ali nipošto nije nešto neprovjereno i nepoznato u medicini. Moderna i BioNTech primjenjuju tehnologiju mRNA i na eksperimentalne lijekove protiv raka. U drugoj fazi je i testiranje mRNA protiv melanoma sa švicarskim Rocheom. Među najnaprednijim projektima Moderne, osim cjepiva protiv COVID-19, nalaze se i mRNA spojevi za liječenje raka jajnika ili ishemije miokarda, koji su također u drugoj fazi ispitivanja.
Postupak ocjene
Povjerenstvo za humane lijekove (CHMP) pri Europskoj agenciji za lijekove (EMA) započelo je u utorak postupnu ocjenu dokumentacije za cjepivo nazivom mRNA-1273, koje razvija Moderna i Biotech.
Početak postupka postupne ocjene dokumentacije znači da je CHMP započeo s ocjenom prvih dostupnih podataka o cjepivu dobivenih iz laboratorijskih ispitivanja, međutim zaključak o sigurnosti i djelotvornosti ovog cjepiva bit će moguće donijeti tek nakon što se Povjerenstvu dostavi preostali, veći dio dokaza.
Antivakseri su zbog ovog cjepiva odavno na nogama. Tumače kako se mRNA cjepiva mogu koristiti za genetsku modifikaciju ljudi, što znanstvenici u potpunosti odbacuju.
Prema uobičajenom shvaćanju pojma genetskih modifikacija promjena genetskog materijala domaćina mora biti trajna i nasljedna. Korištenjem sintetske RNA i njezinim unosom u ljudski organizam ili ljudske stanice nije moguće izazvati trajne ili nasljedne promjene genetskog materijala u ljudskim stanicama. Znanstvenici ponavljaju kako se mRNA, a samim time i mRNA cjepivo, ne ugrađuje u genom domaćina te ni na koji način ne može promijeniti genetski materijal domaćina.
Pristajanje na rizik
Tal Brosh, šef odjela za zarazne bolesti sveučilišne bolnice Assuta Ashdod u Izraelu djelovanje mRNA cjepiva opisao na primjeru računala.
– To je više kao da na računalu pokrenete program s vanjskog uređaja za pohranu podataka (disk, USB stick i slično). Dakle, on ne utječe na hard disk računala, već obavlja određeni zadatak u operativnom sustavu računala – tumači izraelski liječnik.
No, Brosh navodi da ipak postoje i nepoznati rizici korištenja mRNK cjepiva, koji uključuju lokalne i sustavne upalne reakcije koje mogu onda dovesti i do autoimunih uvjeta.
– U tijeku je utrka da se stanovništvo cijepi, stoga smo i spremniji riskirati više. Svijet ne može čekati klasično cjepivo deset godina – istaknuo je Brosh za Jerusalem Post.
Njegova kolegica Michal Linial, profesorica biokemije na Hebrejskom sveučilištu u Jeruzalemu uvjerava kako razloga za brigu oko mRNK cjepiva nema. Pojašnjava da cjepiva Moderne i Pfizera od tijela traže da rade nešto što ionako radi svakodnevno, da sintetizira proteine u stanicama. Ona više brine da mRNK možda neće ući u stanice te se tako dezintegrirati bez ikakvog učinka.
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10. svibanj 2024 23:56
