Kaj je v cepivu proti covid19?

Objavil/a G Z, dne 2020-12-22 ob 02:43:59

Magistar farmacije i diplomirani inženjer medicinske biokemije Stribor Marković na Facebooku je u jednoj grupi koja se bavi pitanjima i nedoumicama o cjepivu objasnio sastav Pfizerovog cjepiva protiv Covida-19, a koje je u nekoliko zemalja već u upotrebi.


U poduljem statusu na Facebooku, Marković navodi da pojedinačna doza Pfizerova cjepiva iznosi 0,3 mL te da je kvantitativni sastav u miligramima sastav u toj dozi. Potom je pobrojao što se nalazi u cjepivu i čemu služe pojedini sastojci.

"U cjepivu se nalaze anorganske soli: 0,36 mg natrij klorida, 0,01 mg kalij klorida, 0,07 mg natrij hidrogenfosfat dihidrata i 0,01 mg kalij dihidrogenfosfata. Funkcija tih tvari je održavanje stabilnog pH (kiselosti) i optimalne koncentracije soli koja ne šteti ljudskom tkivu i koja istovremeno stabilizira lipidne nanočestice koje ćemo objasniti u daljnjem tekstu. Osim anorganskih soli cjepivo sadrži i 6 mg šećera sukroze (saharoze) koja služi kao stabilizator,  napisao je Marković i dodao kako cjepivo sadrži 0,03 mg mRNA.

Cjepivo sadrži lipidnu (masnu) komponentu koja omogućuje ulazak mRNA u stanice. Zajedno s mRNA one tvore lipidne nanočestice skraćenog naziva LNP (lipid nano-particles). Koje su to lipidne komponente? Prva je kolesterol, lipid koji nalazimo u ljudskom tijelu u normalnim, zdravim membranama. U jednoj dozi nalazi se 0,2 mg kolesterola. On stabilizira dvoslojnu lipidnu strukturu lipidnih nanočestica sličnu staničnim membranama. Kolesterol je farmakopejski ekscipijens (pomoćna tvar) koja ima jasno definiranu čistoću i kvalitetu. Drugi lipid je 1,2-distearoil-sn-glicero-3-fosfokolin kojeg ima 0,09 mg po dozi. To je lipid koji nastaje i u živim organizmima, a prepoznajete ga pod grupnim nazivom lecitin. Kao i kolesterol, on stabilizira dvoslojnu lipidnu strukturu lipidnih nanočestica. Dvoslojna lipidna struktura koja sliči našim staničnim membrana omogućuje ulazak mRNA u stanice. Ova dva spoja su neophodna jer sljedeća dva lipida koja spominjemo u tekstu imaju tendenciju da grade jednoslojne lipidne strukture, a ne dvoslojne lipidne strukture. Ovdje i stajemo sa sastojcima iz bakine kuhinje (osim mRNA), navodi Marković u objavi na Facebooku.

ALC-0315, (4-hidroksibutil)-azanedil)-bis-(heksane-6,1-diil)-bis-(2-heksildekanoat), je kationski lipid. U cjepivu ga ima 0,45 mg. „Kationski“ znači da ima pozitivan naboj na fiziološkom pH (kiselosti) ljudskog tijela. Zašto je potrebno da naboj bude pozitivan? mRNA molekula je pri fiziološkom pH organizma negativno nabijena. Pozitivno nabijeni kationski lipid stupa u interakciju s negativno nabijenom mRNA molekulom jednostavnim zakonima elektrostatskog privlačenja. Tako se mRNA inkapsulira (ugradi) u stabilne lipidne nanočestice. Kako je moguće da tako čvrst kompleks oslobodi čistu mRNA molekulu? Da bi cjepivo bilo djelotvorno, mRNA mora na neki način izaći iz tog čvrstog zagrljaja s ALC-0315 jednom kad uđe u stanicu. Tu u pomoć pozivamo staničnu biologiju. mRNA lipidne nanočestice ulaze u endosome, malene „mjehuriće“ okružene membranom lipida. Endosomi se nalaze u citoplazmi stanice. I dok je pH citoplazme oko 7,0 (neutralna), pH endosoma je prilično kiseliji, sve do pH 4,5. Kada LNP uđu u kiseli sadržaj staničnih endosoma, dolazi do promjene naboja mRNA – ona prestaje biti negativno nabijena. Zbog toga dolazi do oslobađanja slobodne mRNA iz lipidnih nanočestica u citoplazmu i dolazak do ribosoma gdje će mRNA odigrati svoju fiziološku funkciju, napisao je magistar farmacije.

Posljednja lipidna komponenta je ALC-0159, 2-[(polietilen glikol)-2000]-N,N-ditetradecil-acetamid) koje ima 0,05 mg po dozi. Čemu ona služi? Injektiranjem cjepiva u mišićno tkivo, lipidne nanočestice bi mogle reagirati s proteinima koje nalazimo na membranama stanica i u međustaničnom prostoru. ALC-0159 stabilizira kompleks lipidnih nanočestica i mRNA i sprječava nespecifično vezanje za proteine. Potencijalno vezanje lipidnih nanočestica za proteine moglo bi smanjiti efikasnost ulaska mRNA u stanice. ALC-0315 i ALC-0159 su novi ekscipijensi (pomoćne tvari) koje su se pojavile s RNA lijekovima. Polietilen glikol nalazi se u sastavu niza oralnih i injekcijskih lijekova.

U Pfizerovom  cjepivu nalazi se i voda za injekcije.  S druge strane, navodi Marković, cjepivo ne  ne sadrži konzervanse, proteine jaja, gluten, orašide i sjemenke niti se te tvari koriste u procesu proizvodnje.

Vrlo rano u procesu proizvodnje koristi se jedan od derivata kravljeg mlijeka, no u konačnom proizvodu se ne očekuje njihov nalazak. U ranoj fazi proizvodnje koristi se antibiotik kanamicin, kojeg ne očekujemo u konačnom proizvodu u količinama koje možemo detektirati analitičkim tehnikama. U cjepivu se ne nalaze penicilin, neomicin i drugi antibiotici".

Istaknuo je kako alergija na penicilin nije prepreka cijepljenju. 

"Alergija na lateks nije prepreka jer čepovi bočica nisu napravljeni od lateksa već od bromobutila. Alergija na jaja, soju, orašide te celijakija nisu prepreka cijepljenju. Trenutne smjernice u Ujedinjenom Kraljevstvu upozoravaju samo na osobe koje su imale povijest anafilaktičke reakcije na druga cjepiva, prvu dozu SARS-CoV-2 cjepiva te hrane. Anafilaktička reakcija je snažan tip alergijskog odgovora (http://bit.ly/38fxu6B). Takvi ljudi kao lijek u slučaju nužde sa sobom nose lijek EpiPen (adrenalin). Iste smjernice upozoravaju na osobe s prethodnom anafilaktičkom reakcijom na polietilen-glikol (PEG, makrogol) iz drugih lijekova. U SAD-u upozoravaju na osobe koje su imale ozbiljne reakcije na komponente cjepiva. Vrlo skoro Europska agencija za lijekove dat će i precizna upozorenja koja će vrijediti i za našu zemlju", zaključuje Marković.

Nakon diplome kratko je radio na zavodu za organsku kemiju Farmaceutsko-biokemijskog fakulteta, a potom se zaposlio u istraživačkom institutu Pliva. Godine 2011. zaposlio se u Imunološkom zavodu, najprije na Zavodu za transfuzijsku medicinu, a potom i kao direktor kvalitete cjepiva.

Podsjetimo, Pfizerov/BioNTechovo cjepivo već je odobreno U SAD-u i u Velikoj Britaniji koje su počele s cijepljenjem, a sljedeći tjedan očekuje se i odobrenje Europske agencije za lijekove.

EK je u četvrtak objavila da je zaključila preliminarne razgovore s tvrtkom Novavax o kupnji 100 milijuna doza cjepiva s opcijom još dodatnih sto milijuna doza. EK je dosad zaključio šest ugovora s različitim proizvođačima o kupnju gotovo dvije milijarde doza.

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