Komisja Europejska wydała dziś warunkowe pozwolenie na dopuszczenie do obrotu szczepionki przeciwko COVID-19 opracowanej przez firmę Moderna. Jest to druga szczepionka przeciwko COVID-19 dopuszczona do obrotu w UE. Komisja wydała to zalecenie w porozumieniu z państwami członkowskimi oraz po otrzymaniu zalecenia i pozytywnej opinii naukowej od Europejskiej Agencji Leków (EMA), przygotowanych w oparciu o dogłębną analizę bezpieczeństwa, skuteczności i jakości tej szczepionki.
Jak podkreśliła przewodnicząca Komisji Europejskiej Ursula von der Leyen: Zapewniamy Europejczykom więcej szczepionek przeciwko COVID-19. Dzięki szczepionce Moderna, drugiej szczepionce dopuszczonej do obrotu w UE, będziemy dysponować kolejnymi 160 milionami dawek. I na tym nie koniec, wkrótce pojawią się kolejne szczepionki. Europa zabezpieczyła do dwóch miliardów dawek potencjalnych szczepionek przeciwko COVID-19. Będziemy dysponować wystarczającą liczbą bezpiecznych i skutecznych szczepionek, aby chronić wszystkich Europejczyków.
Z kolei Stella Kyriakides, komisarz ds. zdrowia i bezpieczeństwa żywności, oznajmiła: Obecna sytuacja dotyczy nas wszystkich. Działamy wspólnie, zjednoczeni. Właśnie dlatego wynegocjowaliśmy dla wszystkich państw członkowskich najszerszy portfel szczepionek na świecie. Dziś dopuszczamy drugą bezpieczną i skuteczną szczepionkę. Zapewni nam to łącznie 460 mln dawek, dostarczanych przez przedsiębiorstwa Moderna i BioNTech-Pfizer, oraz szybszą ich dystrybucję w UE. I ta liczba jeszcze wzrośnie. Państwa członkowskie muszą teraz zadbać o to, by tempo szczepień nadążało za podażą. Będziemy nadal dokładać wszelkich starań, by każdy mieszkaniec UE miał dostęp do szczepionki.
30 listopada 2020 r. Moderna złożyła do EMA wniosek o pozwolenie na dopuszczenie szczepionki do obrotu. EMA rozpoczęła przegląd etapowy danych już w listopadzie i dzięki temu oceniała jakość, bezpieczeństwo i skuteczność szczepionki na bieżąco, w miarę jak pojawiały się nowe dane. Komitet ds. Produktów Leczniczych Stosowanych u Ludzi (CHMP) Europejskiej Agencji Leków dogłębnie ocenił dane i zalecił w drodze konsensusu udzielenie formalnego warunkowego pozwolenia na dopuszczenie do obrotu. Warunkowe pozwolenie na dopuszczenie do obrotu jest jednym z unijnych mechanizmów regulacyjnych ułatwiających szybki dostęp do leków stanowiących odpowiedź na niezaspokojone potrzeby medyczne, w tym w sytuacjach nadzwyczajnych, takich jak obecna pandemia.
Na podstawie pozytywnej opinii EMA Komisja zweryfikowała wszystkie elementy pozwalające na dopuszczenie szczepionki do obrotu. Przed wydaniem warunkowego pozwolenia na dopuszczenie do obrotu skonsultowała się także z państwami członkowskimi.
Szczepionka Moderna opiera się na cząsteczkach informacyjnego RNA (mRNA), które jest odpowiedzialne za przekazywanie instrukcji z DNA do mechanizmu wytwarzania białek w komórkach. Ten rodzaj szczepionki zawiera część instrukcji, na podstawie których organizm produkuje nieszkodliwe fragmenty wirusa, które są wykorzystywane do wytworzenia reakcji immunologicznej w celu uniknięcia choroby lub jej zwalczenia. Po podaniu szczepionki danej osobie, komórki w jej ciele zapoznają się z otrzymanymi instrukcjami genetycznymi i wytwarzają białko szczytowe – białko na zewnętrznej powierzchni wirusa, które pozwala wirusowi dostać się do komórek organizmu i wywołać chorobę. Układ odpornościowy danej osoby rozpoznaje, że to obce białko nie powinno znajdować się w organizmie i reaguje na nie, wytwarzając naturalną ochronę: przeciwciała i limfocyty T.
Dalsze kroki
Moderna, z którą Komisja podpisała umowę 25 listopada, dostarczy w okresie od pierwszego do trzeciego kwartału 2021 r. łącznie 160 mln dawek szczepionki. Przedsiębiorstwa BioNTech i Pfizer, które opracowały pierwszą szczepionkę, która została dopuszczona do obrotu w UE – co miało miejsce 21 grudnia 2020 r. – dostarczą łącznie 300 mln dawek.
Kontekst
Warunkowe pozwolenie na dopuszczenie do obrotu jest pozwoleniem na dopuszczenie do obrotu produktów leczniczych na podstawie mniej kompletnych danych niż w przypadku zwykłego pozwolenia na dopuszczenie do obrotu. Udzielenie warunkowego pozwolenia na dopuszczenie do obrotu jest brane pod uwagę, jeżeli korzyści wynikające z natychmiastowej dostępności leku dla pacjentów wyraźnie przewyższają ryzyko związane z faktem, że nie wszystkie dane są jeszcze dostępne. Po przyznaniu warunkowego pozwolenia na dopuszczenie do obrotu przedsiębiorstwa muszą jednak dostarczyć w określonych terminach dalsze dane, w tym dane z trwających lub nowych badań, aby potwierdzić, że korzyści nadal przewyższają ryzyko.
Firma Moderna złożyła do EMA wniosek o warunkowe pozwolenie na dopuszczenie do obrotu swojej szczepionki 30 listopada 2020 r. EMA pracowała już nad dokonaniem oceny danych dotyczących bezpieczeństwa, skuteczności i jakości szczepionki oraz wyników badań laboratoryjnych i badań klinicznych w kontekście przeglądu etapowego. Przegląd etapowy i ocena warunkowego pozwolenia na dopuszczenie do obrotu umożliwiły EMA szybką ocenę bezpieczeństwa, skuteczności i jakości szczepionki. EMA zaleciła przyznanie warunkowego pozwolenia na dopuszczenie do obrotu, ponieważ korzyści płynące ze szczepionki przewyższają ryzyko.
Komisja Europejska sprawdziła, czy wszystkie niezbędne elementy (uzasadnienia naukowe, informacje o produkcie, materiały edukacyjne dla pracowników służby zdrowia, etykietowanie, obowiązki posiadaczy pozwolenia na dopuszczenie do obrotu, warunki stosowania itp.) są jasne i rzetelne. Komisja skonsultowała się również z państwami członkowskimi, ponieważ są one odpowiedzialne za wprowadzanie szczepionek do obrotu i stosowanie produktu w ich krajach. Po zatwierdzeniu przez państwa członkowskie i na podstawie własnej analizy Komisja postanowiła udzielić warunkowego pozwolenia na dopuszczenie do obrotu.
Dodatkowe informacje
Strategia UE dotycząca szczepionek przeciwko COVID-19
Pytania i odpowiedzi: Warunkowe pozwolenie na dopuszczenie do obrotu szczepionek przeciwko COVID-19
Bezpieczne szczepionki na COVID-19 dla Europejczyków
Prawodawstwo UE dotyczące produktów leczniczych
EMA i szczepionki przeciwko i COVID-19
Zestawienie informacji: Jak działają szczepionki?
Zestawienie informacji: Korzyści zdrowotne dzięki szczepionkom
Zestawienie informacji: Procedura udzielania pozwolenia
Zestawienie informacji: Bezpieczeństwo długoterminowe
Druga bezpieczna i skuteczna szczepionka przeciwko COVID-19 Pobierz (50.122 kB – PDF)
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