Dragoş Damian, CEO Terapia Cluj, după anunţul lui Cîţu despre fabricarea vaccinului anti-COVID: ‘Nu există în țară tehnologie’

Dragoş Damian, CEO Terapia Cluj, cel mai mare producător local de medicamente, afirmă că România nu are în acest moment capacitatea de a produce vaccin anti-COVID, ci doar de a-l ambala. Dragoş Damian explică dificultăţile tehnologice care stau momentan în calea acestui deziderat, însă consideră că România are într-adevăr nevoie de investiţii într-o nouă fabrică de vaccinuri.

  • Premierul Florin Cîțu a fost întrebat de ziariști după ce a făcut a doua doză a vaccinului anti-Covid dacă România intenționează să cumpere vaccinul rusesc Sputnik. Prim-ministrul a anunțat că are o soluție mai bună. „Nu, România va face un lucru mult mai bun. Noi vom încerca să producem vaccinul la Cantacuzino. Ne-am arătat disponibilitatea, am trimis o scrisoare oficialilor europeni, așteptăm să aflăm ce vaccin am putea produce”, a dezvăluit premierul României. Răspunsul oficialilor europeni este așteptat cât de curând și în funcție de acesta va fi luată decizia privind fabricarea vaccinului anti-Covid în România.

„România deține fabrici care au tehnologie de etichetare și / sau ambalare unde pot fi manipulate inclusiv produse imunologice (deci și vaccinuri). Așadar, cel puțîn teoretic, orice sit de fabricație autorizat care îndeplinește stardardele de calitate impuse de agenția medicamentului ANMDMR și se conformează cerințelor producătorului care oferă licența de fabricație – pentru că presupun că vorbim despre transferul de licenţă şi tehnologie al unuia dintre vaccinurile deja aprobate de UE – ar putea ambala și eticheta vaccinuri.

Sunt câteva companii care au fluxuri tehnologice de fabricație pentru produse sterile (injectabile) în București, Cluj, Sibiu, Iași – validare prin media fill, umplere aseptică sau umplere și sterilizare terminală – deci este posibil ca și această etapă a procesului de fabricație să fie transferată în țară, cu condiția, repet, ca fabrica din țară să se conformeze cerințelor producătorului care face transferul tehnologic, asta însemnând desigur fabricație în lanțul frigului ‘cold-chain’; știm că vaccinurile anti SARS-CoV-2 se fabrică, depozitează, transportă și manipulează în condiții de ‘cold-chain’. Din câte știu, nu există în țară tehnologie de fracționare doze mici și umplere lichide sterile în flacoane – acele recipientele mici de sticlă cu capac metalic pe care le vedem la TV în unitățile de vaccinare – ci doar în fiole, așa cum spuneam.

Avantajul activării mai multor situri de fabricăție în țările din UE este că se pot fabrica mai repede cantități mai mari de vaccin, care pot ajunge mai repede la populația care trebuie vaccinată.

Așadar, nu este imposibil să transferăm în România în 2-3 luni unele etape din tehnologie de fabricăție a vaccinurilor anti SARS-CoV-2, dar este puțîn probabil, pentru că Ungaria, Bulgaria, Cehia, Polonia, au o tehnologie mult mai avansate în propriile fabrici și pot fabrica imediat.

În orice caz, România ar trebui să investească într-un sit nou de fabricație de vaccinuri, atât pentru a fabrica cantități suficiente în caz că mai apar pandemii, cât și pentru schemele de imunizare ale copiilor sau pentru diverse vaccinuri sezoniere, cum este cel antigripal”, a declarat Dragoş Damian.

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