Ez a téma mindannyiunkat érint, de kevesen veszik a fáradtságot, hogy mélyebben utánanézzenek a saját kérdéseiknek, ezért nem tudják mit is gondoljanak. Az alábbi összefoglaló a nálunk elsőként elérhető Pfizer-BioNTech vakcináról tartalmaz fontos információkat, megbízható, hiteles forrásokból, de a Moderna vakcina is ugyanezen elv alapján működik. Az oltás témában én továbbra sem szeretnék állást foglalni, de hasznos információkat tartalmazhat számodra is, amiket a facebookon nem találsz meg.
A cikk csak közölt tényeket tartalmaz, amiket én magam is ebben a formában találtam.
Köztudott, hogy a vírusok okozta fertőzések ellen védőoltásokkal lehet a leghatékonyabban védekezni (megelőzés). Ez igaz az új koronavírus (SARS-CoV-2) okozta fertőzésekre is.
Az oltóorvos az oltást megelőzően kérdőív segítségével kikérdez és megvizsgál. Az oltás beadásáról minden esetben az oltóorvos dönt.
A vakcina működési elve:
A vakcina a vírus molekuláris szerkezetén alapuló technológia segítségével jött létre. Az oltóanyag mRNS-alapú, egy lipid nanorészecskébe csomagolt, a stabilitás miatt módosított hírvivő RNS molekulát (mRNS) tartalmaz.
A Comirnaty (vakcina) mRNS molekulája “utasításokat” hordoz a COVID-19-et okozó vírus SARS-CoV-2 fehérje előállításához. Az oltás során néhány sejt “elolvassa” az mRNS utasításait, és ideiglenesen előállítja a tüskefehérjét. Az illető immunrendszere ezt követően felismeri ezt a fehérjét idegenként, antitesteket termel, és aktiválja a T-sejteket (fehérvérsejteket) annak megtámadására. A Comirnaty-t intramuscularisan kell beadni. A preferált beadási hely a felkar deltaizma.
A vakcina mRNS-e nem sokkal az oltás után lebomlik.
Ha később a személy kapcsolatba kerül a SARS-CoV-2 vírussal, immunrendszere felismeri és készen áll arra, hogy megvédje a fertőzéstől.
Az immunitás kialakulásához szükséges: 2 adag oltás, 21 nap különbséggel beadva. Az oltottak védelme csak a vakcina második adagját követő 7 napon belül alakul ki. Mint minden vakcinánál, a Comirnaty esetében is előfordulhat, hogy a 2 adagból álló oltási sorozat nem véd meg minden beoltott személyt (95%), valamint a biztosított védelem ideje egyelőre nem ismert, meghatározása folyamatban van a jelenleg is zajló klinikai vizsgálatok során.
A Comirnaty viszont nem tartalmazza magát a vírust, ezért nem okozhat COVID-19-megbetegedést.
Az oltást kizáró okok:
- Védőoltások vagy egyéb gyógyszerek beadását követő anafilaxiás reakció
- Magas lázzal járó akut betegség vagy akut fertőzés a szervezetben
- 3 hónapon belül igazolt SARS CoV-2 fertőzés történt
- 16 éves kor alatt nem alkalmazható
- Várandósság alatt nem alkalmazható
- Ha bármilyen egyéb vakcináció történt, a beadástól számított minimum 2 hét várakozási idő szükséges
- Bármilyen műtét után 1 hónapig
- Thrombocytopeniás, illetve véralvadási zavarban (például hemofíliában) szenvedő egyéneknél mérlegelendő, de nem ellenjavallt
- Autoimmun betegségek és immunsupresszív terápia, kemo-, radioterápia esetén az oltóorvos dönt, nem abszolút ellenjavallt
A Comirnaty hatásossága az immunszuppresszált személyek esetében kisebb lehet.
A várandósságot a második oltás után minimum 3 hónappal javasolt tervezni.
A szoptatás során nem ismert, hogy a vakcina kiválasztódik-e a humán anyatejben. Akik kockázati csoportba tartoznak és igénylik az oltást, a szoptatás ideje alatt is megkaphatják.
A COVID-19 betegség lezajlását követő 3 hónap múlva az oltások beadhatók.
A Comirnaty nem, vagy csak elhanyagolható mértékben befolyásolja a gépjárművezetéshez és a gépek kezeléséhez szükséges képességeket.
Mi az a feltételes forgalomba hozatali engedély?
Egy olyan engedélyezési folyamat az EU-ban, amely lehetővé teszi az EMA (European Medicines Agency) számára, hogy a normál esetben elvártnál kevésbé teljeskörű adatok alapján engedélyezzen hiánypótló gyógyszereket, megkönnyítve azok korai hozzáférhetővé válását. Erre olyan közegészségügyi vészhelyzetekben van szükség, mint amilyen a jelenlegi járvány is. Azonban ez csak akkor lehetséges, amennyiben a gyógyszer azonnali hozzáférhetővé tételének előnye a betegek szempontjából meghaladja azt a kockázatot, amit a részben hiányos adatmennyiség jelent. Miután a feltételes forgalomba hozatali engedélyt kiadták, a vállalatoknak előre meghatározott időszakonként újabb adatokat kell szolgáltatniuk a folyamatban lévő vagy újonnan indított vizsgálatok alapján, annak alátámasztására, hogy az előnyök továbbra is meghaladják az esetleges kockázatokat.
Hogy lett ilyen gyorsan kész, amikor minden más évekig tart?
Alapvetően a COVID vakcinák azért készülnek gyorsabban az átlagos eljárásnál, mert a gyógyszergyártók és kutatóintézetek minden költségét az államok finanszírozzák, így a gyártók nagyobb kapacitással gyakorlatilag költségmentesen tudnak dolgozni. Nem kellett megvárniuk a vizsgálatok eredményeit ahhoz, hogy elkezdjék kiépíteni a gyártósorokat, így amint megkapták az engedélyt indulhat a gyártás. Ha pedig nem kapták volna meg, nekik nincs pénzügyi veszteségük.
Másfelől a tesztalanyok felkutatásába sem kellett nagy energiát befektetni, mert rengeteg a fertőzött világszerte, ez is jelentősen felgyorsítja a munkát. A kötelező dokumentációkat sem egyben, hanem részenként is be lehetett adni az EMA számára, ahol jelenleg is mindenki csak ezzel foglalkozik, a világban uralkodó állapotok mielőbbi megoldására.
Összefoglalva, ez a vakcina is ugyanolyan klinikai tesztelési eljáráson esett át, mint az összes többi, csak a papírmunka és a gyártási idő lett a lehető legjobban megolajozva a cél érdekében.
Bármelyik védőoltás után jelentkezhet oltási reakció. Ezen lehetséges oltási reakciókra az oltóorvos külön fel fogja hívni a figyelmet.
Oltási reakciók lehetnek:
Fájdalom és duzzanat a beadás helyén, fáradtságérzés, fejfájás, izomfájdalom, ízületi fájdalom, hidegrázás, láz esetleg bőrpirosodás az injekció beadásának helyén, émelygés
Nagyon ritkán előfordulhat:
(1:10000) Megnagyobbodott nyirokcsomók, rossz közérzet, végtagfájdalom, álmatlanság, viszketés az injekció beadási helyén
A felsorolt reakciók enyhítésére fájdalomcsillapító és / vagy lázcsillapító gyógyszerekkel (pl. Paracetamolt tartalmazó termékekkel) tüneti kezelés alkalmazható. Ezek azonban átmeneti reakciók, melyek a klinikai vizsgálatok során bizonyítottan szövődmények nélkül megszűnnek.
Az oltás továbbra is ingyenes és önkéntes.
Az oltásra EZEN a linken tudsz jelentkezni.
Ha tovább olvasnál: https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_hu.pdf https://koronavirus.gov.hu/cikkek/gyakori-kerdesek-valaszok-vakcinarol-pfizer-biontech-vakcina https://koronavirus.gov.hu/sites/default/files/sites/default/files/imce/pfizer_oltoanyag_lakossagi_tajekoztato_1223_0.pdf https://www.pfizer.hu/hu/covid-19-elleni-vakcinafejleszt%C3%A9sr%C5%91l https://hu.wikipedia.org/wiki/COVID%E2%80%9319-vakcina https://www.ogyei.gov.hu/az_europai_gyogyszerugynokseg_a_moderna_oltoanyaganak_covid_19_vakcina_moderna_forgalomba_hozatalat_jovahagyja_az_eu_ban
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