Szczepionka menb
Epidemiologia
Choroba meningokokowa, szczególnie inwazyjna choroba meningokokowa (IMD), stanowi istotne zagrożenie zdrowia publicznego z wysoką śmiertelnością i ryzykiem powikłań. Epidemiologia IMD jest zmienna geograficznie i czasowo, z serogrupą B dominującą w Europie, Ameryce Północnej i wielu krajach Ameryki Łacińskiej. Zapadalność na meningokokową chorobę inwazyjną waha się od 0,01 do 4,26/100 000 osób, z najwyższą częstością wśród niemowląt (np. 11,1/100 000 w Australii). W USA w 2023 roku zgłoszono 415 przypadków, z dominacją serogrup B i C (25-40% przypadków każda). Szczepionki przeciwko MenB (4CMenB i MenB-FHbp) wykazują skuteczność 50-100% u osób od 2 miesięcy do 20 lat, a ich stosowanie w programach szczepień krajowych (np. Wielka Brytania, Irlandia, Australia) przyczynia się do spadku zachorowań. Jednak wskaźniki zaszczepienia, zwłaszcza wśród młodzieży, pozostają suboptymalne (np. w USA tylko 29,4% 17-latków otrzymało pierwszą dawkę MenB, a 11,9% dawkę drugą). Nadzór epidemiologiczny i monitorowanie pokrycia szczepów przez szczepionki są kluczowe dla oceny skuteczności i dostosowania strategii szczepień.
- Szczepionka MenB – Epidemiologia i nadzór
- Globalne trendy epidemiologiczne choroby meningokokowej grupy B
- Epidemiologia choroby meningokokowej grupy B w poszczególnych regionach
- Systemy nadzoru nad chorobą meningokokową
- Ogniska choroby i kontrola
- Wpływ pandemii COVID-19 na epidemiologię choroby meningokokowej
- Programy szczepień i ich wpływ
- Rodzaje szczepionek przeciwko meningokokom grupy B
- Strategie szczepień w różnych krajach
- Zalecenia dotyczące szczepień dla różnych grup wiekowych
- Skuteczność szczepionek MenB
- Wyzwania związane z realizacją programów szczepień
- Monitorowanie pokrycia szczepów i odpowiedzi na szczepionkę
- Metody oceny pokrycia szczepów
- Różnice w pokryciu szczepów przez różne szczepionki
- Nowe odkrycia na temat ochrony krzyżowej
- Przyszłe kierunki i wyzwania
Szczepionka MenB – Epidemiologia i nadzór
Choroba meningokokowa jest poważnym zagrożeniem dla zdrowia publicznego na całym świecie, charakteryzującym się nieprzewidywalną epidemiologią, która zmienia się w zależności od regionu i czasu. Inwazyjna choroba meningokokowa (IMD) ma wysokie wskaźniki śmiertelności i może powodować trwałe powikłania u osób, które przeżyją zakażenie. W ostatnich latach szczepionki przeciwko meningokokom grupy B (MenB) stały się ważnym narzędziem w zapobieganiu tej chorobie12.
Globalne trendy epidemiologiczne choroby meningokokowej grupy B
Na całym świecie zapadalność na inwazyjną chorobę meningokokową wykazuje zróżnicowane wzorce. W Europie, Ameryce Północnej i wielu krajach Ameryki Łacińskiej, serogrupa B jest obecnie jedną z głównych przyczyn zachorowań. W ostatnich latach odnotowano ogólny spadek zachorowań, nawet przed wprowadzeniem szczepień przeciwko meningokokom grupy B23.
Systematyczne badania wykazały, że częstość występowania meningokoków grupy B waha się od 0,01 do 4,26 przypadków na 100 000 osób, przy czym zauważalny jest trend spadkowy, szczególnie w krajach, gdzie dane są zbierane w sposób bardziej konsekwentny. W Ameryce Łacińskiej wskaźniki zachorowalności na chorobę meningokokową znacznie się różnią – od 0,1 przypadku na 100 000 w Meksyku, Peru, Paragwaju i Boliwii, do 2 przypadków na 100 000 w Brazylii, przy czym najwyższe wskaźniki obserwuje się u niemowląt2.
W Stanach Zjednoczonych w 2023 roku odnotowano wzrost przypadków choroby meningokokowej, szczególnie spowodowanych serogrupą Y. Według wstępnych danych, w 2023 roku zgłoszono 415 potwierdzonych i prawdopodobnych przypadków choroby meningokokowej, co odpowiada poziomowi z 2014 roku13.
Epidemiologia choroby meningokokowej grupy B w poszczególnych regionach
W Stanach Zjednoczonych serogrupy B i C są głównymi przyczynami choroby meningokokowej, każda odpowiada za około 25-40% przypadków. Serogrupy W i Y wraz z niegrupowalnymi meningokokami stanowią kolejne 5-15% przypadków. W 2018 roku zgłoszono 329 przypadków w USA, co stanowi zapadalność 0,10 na 100 000 mieszkańców2.
W okresie 2018-2022, serogrupa B była przyczyną większości przypadków choroby meningokokowej u pacjentów w wieku 16-23 lat w USA. Według danych CDC z 2021 roku, zgłoszono 46 przypadków serogrupy B (współczynnik zapadalności 0,01 przypadku na 100 000, czyli 1 przypadek na 10 milionów mieszkańców) oraz 108 przypadków serogrupy C, Y lub W12.
W Wielkiej Brytanii, w roku epidemiologicznym 2022-2023, UK Health Security Agency (UKHSA) potwierdziła 396 przypadków inwazyjnej choroby meningokokowej, w porównaniu do 205 przypadków w roku 2021-2022. Serogrupa B stanowiła 89,9% (356 z 396) wszystkich przypadków1.
W Australii, w latach 2006-2015, serogrupa B stanowiła 81% przypadków inwazyjnej choroby meningokokowej o znanej serogrupie. Najwyższą zapadalność odnotowano wśród niemowląt poniżej 12 miesiąca życia (11,1 na 100 000), dzieci w wieku 1-4 lat (2,82 na 100 000) oraz młodzieży w wieku 15-19 lat (2,40 na 100 000)1.
Systemy nadzoru nad chorobą meningokokową
Nadzór nad chorobą meningokokową jest kluczowy dla monitorowania wpływu strategii szczepień na obciążenie chorobą1. W Stanach Zjednoczonych funkcjonuje kilka systemów nadzoru, a choroba meningokokowa jest stanem podlegającym obowiązkowemu zgłaszaniu we wszystkich stanach11.
CDC zbiera informacje o chorobie meningokokowej za pośrednictwem National Notifiable Diseases Surveillance System (NNDSS). Ponadto, od 2015 roku prowadzony jest rozszerzony nadzór w celu zbierania bardziej kompletnych danych do monitorowania epidemiologii choroby. Departamenty zdrowia ze wszystkich 50 stanów i kilku dużych jurysdykcji zbierają rozszerzone dane dotyczące choroby meningokokowej i izolatów1.
Światowa Organizacja Zdrowia (WHO) opracowała globalny plan działania mający na celu pokonanie zapalenia opon mózgowych jako zagrożenia dla zdrowia publicznego do 2030 roku. Plan ten wymaga połączenia wielu wysiłków, w tym zapobiegania i kontroli epidemii, poprawy dostępności szczepionek, lepszej diagnostyki i leczenia, silnych krajowych systemów nadzoru, skutecznego wsparcia dla osób dotkniętych zapaleniem opon mózgowych oraz działań uświadamiających1.
Ogniska choroby i kontrola
W Stanach Zjednoczonych ogniska epidemiczne stanowią około 5% zgłaszanych przypadków choroby meningokokowej (czyli 95% przypadków ma charakter sporadyczny). Ognisko definiuje się jako ≥3 przypadki związane z ogniskiem (np. przypadki tej samej serogrupy, chyba że są uznane za genetycznie niepowiązane metodami typowania molekularnego) w organizacji (np. szkoła, college, zakład karny) w okresie trzech miesięcy, lub wiele przypadków związanych z ogniskiem z częstością choroby meningokokowej przekraczającą oczekiwaną częstość w społeczności w okresie trzech miesięcy2.
Od 2009 roku, siedem ognisk choroby meningokokowej serogrupy B wystąpiło na kampusach uniwersyteckich w USA. Od 2011 roku serogrupa B była odpowiedzialna za wszystkie ogniska choroby meningokokowej na amerykańskich uczelniach21.
Masowe kampanie szczepień mogą być wdrażane w celu kontroli ogniska choroby. Co ważne, szczepienie nie zastępuje zalecanej chemioprofilaktyki3. Doświadczenia z zastosowaniem szczepionki 4CMenB w kampaniach szczepień awaryjnych wykazały, że po wdrożeniu kampanii szczepień nie wystąpiły dalsze przypadki u osób zaszczepionych2.
Wpływ pandemii COVID-19 na epidemiologię choroby meningokokowej
Pandemia COVID-19 miała znaczący wpływ na epidemiologię choroby meningokokowej. Dane z USA, Anglii, Francji, Australii i Chile wskazują na odbicie się choroby meningokokowej po pandemii, szczególnie w krajach bez aktywnych programów szczepień przeciwko meningokokom2.
Środki ograniczające COVID-19 mogły doprowadzić do spadku bezobjawowego nosicielstwo-neisseria-meningitidis/” title=”nosicielstwo Neisseria meningitidis” class=”to-tag” data-termid=”61164″>nosicielstwa N. meningitidis lub blisko spokrewnionych gatunków, takich jak Neisseria lactamica, które, jak wykazano, zapewniają ochronę przed chorobą meningokokową, potencjalnie przyczyniając się do spadku ochrony populacyjnej w populacji ogólnej1.
W Anglii, po całkowitym wycofaniu środków ograniczających COVID-19 w lipcu 2021 roku, ogólna liczba przypadków inwazyjnej choroby meningokokowej zaczęła powracać do poziomów sprzed pandemii, głównie dzięki chorobie meningokokowej grupy B1.
Programy szczepień i ich wpływ
Rodzaje szczepionek przeciwko meningokokom grupy B
Obecnie dostępne są dwie szczepionki przeciwko meningokokom grupy B: MenB-FHbp (Trumenba) i MenB-4C (Bexsero), które zostały zarejestrowane w latach 2014-201511. Są to szczepionki białkowe, zawierające białka lub lipoproteiny znajdujące się na powierzchni bakterii1.
Szczepionka 4CMenB (Bexsero) zawiera cztery komponenty antygenowe i wymaga dwóch dawek w schemacie 0 i 1 miesiąc, podczas gdy szczepionka MenB-FHbp (Trumenba) zawiera dwa czynniki wiążące białko H i wymaga dwóch dawek w schemacie 0 i 6 miesięcy1.
Opracowanie tych szczepionek wymagało sekwencjonowania genomu bakteryjnego w celu znalezienia białek unikalnych dla ściany bakteryjnej Neisseria, które mogłyby być wykorzystane jako antygeny do stymulowania odporności u ludzi2.
Strategie szczepień w różnych krajach
W Europie programy szczepień przeciwko meningokokom są bardzo zróżnicowane. Szczepionka przeciwko MenC została po raz pierwszy wprowadzona do rutynowego programu szczepień dla dzieci w Wielkiej Brytanii w 1999 roku. Szczepionka MenB została po raz pierwszy wprowadzona w Wielkiej Brytanii w 2015 roku, a następnie we Włoszech w 2017 roku23.
W Wielkiej Brytanii niemowlęta otrzymują rutynowo szczepionkę MenB od 1 września 2015 roku. Najnowsze roczne szacunki dotyczące zasięgu szczepień w Anglii (1 kwietnia 2021 r. do 31 marca 2022 r.) dla niemowląt kwalifikujących się do szczepienia 4CMenB wynosiły 91,5% dla 2 dawek do 12 miesiąca życia i 88,0% dla dawki przypominającej po roku do 24 miesiąca życia2.
W Irlandii szczepionka MenB została wprowadzona dla wszystkich dzieci urodzonych po 1 października 2016 roku, ponieważ dzieci poniżej pierwszego roku życia są najbardziej narażone na chorobę meningokokową B. Wszystkie dzieci otrzymują szczepionkę MenB w wieku 2 i 4 miesięcy z dawką przypominającą w 12 miesiącu życia11.
W Australii szczepionka MenB jest zalecana dla niemowląt, dzieci, młodzieży i młodych dorosłych. Jest finansowana przez NIP (National Immunisation Program) dla osób z określonymi schorzeniami, które zwiększają ryzyko inwazyjnej choroby meningokokowej. Programy szczepień finansowane przez państwo zostały wprowadzone w Australii Południowej od 2018 roku i w Queensland od 2024 roku1.
W Kanadzie szczepionki meningokokowe są zalecane dla osób z wysokim ryzykiem choroby inwazyjnej, w tym dla osób z określonymi schorzeniami i dla osób o zwiększonym ryzyku ekspozycji12.
Zalecenia dotyczące szczepień dla różnych grup wiekowych
Amerykański Komitet Doradczy ds. Szczepień (ACIP) zaleca rutynowe podawanie szczepionek MenB niektórym osobom w wieku 10 lat lub starszym, które są narażone na zwiększone ryzyko zachorowania na chorobę meningokokową serogrupy B1.
Szczepionka MenB może być podawana młodzieży i młodym dorosłym w wieku 16-23 lat w celu zapewnienia krótkotrwałej ochrony przed większością szczepów choroby meningokokowej serogrupy B. Preferowany wiek do szczepienia MenB to 16-18 lat11.
ACIP zaleca również schemat dawki przypominającej dla szczepienia MenB u osób z wysokim ryzykiem choroby meningokokowej serogrupy B. Pierwsza dawka przypominająca jest zalecana rok po zakończeniu serii pierwotnej, z kolejną dawką przypominającą podawaną co 2-3 lata, tak długo jak ryzyko pozostaje5.
W Wielkiej Brytanii szczepionka MenB jest podawana jako część rutynowego programu szczepień NHS dla dzieci. Dzieci otrzymują 3 dawki szczepionki MenB – pierwsze dwie dawki w ramach szczepień podstawowych, a trzecią jako dawkę przypominającą1.
Skuteczność szczepionek MenB
Dane z 7 krajów dostarczają dowodów na skuteczność szczepionki 4CMenB w różnych warunkach i grupach wiekowych, w tym w krajowych/regionalnych programach szczepień, badaniach obserwacyjnych i kontroli ognisk epidemicznych1.
Podanie co najmniej 2 dawek szczepionki 4CMenB zmniejszyło inwazyjną chorobę meningokokową o 50-100% u osób w wieku od 2 miesięcy do 20 lat2. Pierwsza ocena skuteczności szczepionki u niemowląt została opublikowana w 2016 roku i opisała skuteczność i wpływ 2 dawek szczepionki 4CMenB podawanej w brytyjskim programie szczepień niemowląt. Ogólna skuteczność 2 dawek szczepionki 4CMenB przeciw chorobie meningokokowej grupy B wynosiła 82,9% (95% przedział ufności [CI] 24,1, 95,2)2.
W badaniu przeprowadzonym podczas ogniska choroby meningokokowej na Uniwersytecie Princeton w 2013 roku, szczepionka Bexsero wywołała odpowiedź immunologiczną u większości odbiorców, ale 34% nie miało odpowiedzi immunologicznej na szczep wywołujący ognisko. Dwa miesiące po otrzymaniu drugiej dawki szczepionki, tylko 66% badanych wykazało aktywność bakteriobójczą przeciwko szczepowi MenB, który zakażał studentów1.
Badania wykazały, że szczepionka MenB jest bardzo skuteczna w wywoływaniu odpowiedzi immunologicznej na określone szczepy meningokoków B powodujących inwazyjną chorobę meningokokową w Irlandii. Badania sugerują, że do 88% szczepów meningokoków B powinno być chronionych przez szczepionkę MenB2.
Wyzwania związane z realizacją programów szczepień
Pomimo dostępności szczepionek, wskaźniki zasięgu szczepień MenB pozostają suboptymalne, szczególnie wśród młodzieży. Według danych CDC z badania National Immunization Survey z 2022 roku, wskaźniki zasięgu wśród 17-latków dla MenACWY wynosiły 90,7% dla dawki 1 i 60,8% dla dawki 2. Dla szczepionki MenB, 29,4% otrzymało dawkę 1, a tylko 11,9% otrzymało dawkę 211.
W retrospektywnym badaniu bazy danych wskaźniki ukończenia serii MenB były suboptymalne w populacjach komercyjnych (56,7%) i Medicaid (44,7%), które rozpoczęły szczepienie MenB. Osoby, które otrzymały pierwszą dawkę MenB-4C, były znacznie bardziej skłonne do ukończenia serii niż te, które otrzymały pierwszą dawkę MenB-FHbp (komercyjne: 61,1% vs 49,8%; Medicaid: 47,8% vs 33,9%)1.
Wiele osób, które rozpoczęły szczepienie MenB, nie ukończyło serii. W badaniu, 40,2% populacji komercyjnej i 34,7% populacji Medicaid, które nie otrzymały dawki uzupełniającej szczepionki MenB w zastosowanych limitach czasowych, uczestniczyły w wizycie związanej z podaniem szczepionki lub wizycie profilaktycznej/wizycie kontrolnej dziecka w tych okresach. Gdyby otrzymali swoją dawkę uzupełniającą podczas takiej wizyty, wskaźniki ukończenia mogłyby być znacznie wyższe2.
Monitorowanie pokrycia szczepów i odpowiedzi na szczepionkę
Metody oceny pokrycia szczepów
W celu monitorowania skuteczności szczepionek MenB ważne jest ocenianie, w jakim stopniu szczepionki pokrywają różnorodne szczepy bakterii N. meningitidis. Właściwe przewidywanie pokrycia szczepów przez szczepionki białkowe jest bardziej złożone przy użyciu metody serum bactericidal assay with human complement (hSBA) niż w przypadku szczepionek skierowanych przeciwko polisacharydom otoczkowym, biorąc pod uwagę, że różnorodność sekwencji białek i zmienność poziomów ekspresji różnią się między różnymi szczepami powodującymi chorobę meningokokową1.
W badaniach nad szczepionką MenB-FHbp, aby wybrać szczepy o szerokiej różnorodności antygenowej i epidemiologicznej do testów klinicznych, zebrano ponad 1200 inwazyjnych izolatów choroby MenB z laboratoriów i agencji zdrowia w Stanach Zjednoczonych i Europie. Łącznie 14 testowych szczepów MenB reprezentuje większość rozpowszechnionych meningokokowych białek FHbp, z wariantami FHbp odpowiadającymi ~80% krążących izolatów powodujących chorobę inwazyjną w Stanach Zjednoczonych i Europie2.
W badaniu przeprowadzonym w Czechach wykorzystano sekwencjonowanie całego genomu (WGS) do badania obecności genów antygenów szczepionki MenB we wszystkich badanych izolatach B i nie-B N. meningitidis, co sugeruje, że szczepionka ma potencjał ochrony również przed meningokokami nie-B w Czechach2.
Różnice w pokryciu szczepów przez różne szczepionki
W badaniu we Francji, przeprowadzonym przed wprowadzeniem rutynowego stosowania szczepionek, wykorzystano analizę MenDeVAR do przewidzenia pokrycia szczepów przez obie szczepionki – 4CMenB i bivalent rLP2086. W analizie 1691 izolatów NmB, MenDeVAR przewidział pokrycie 973 izolatów (57,5%) dla szczepionki 4CMenB i 1268 izolatów (75,0%) dla szczepionki Bivalent rLP20862.
W badaniu tym pokrycie szczepionką 4CMenB wahało się, ale nieznacznie, w czterech okresach między 46,8% a 60,6%. Wskaźnik pokrycia przez bivalent rLP2086 wykazał wyższe pokrycie od 2010 roku2.
Wyniki sugerują, że nadzór nad pokryciem szczepów NmB przez szczepionki 4CMenB i bivalent rLP2086 może się znacznie zmieniać w czasie, nawet przed wprowadzeniem rutynowych programów szczepień2.
Nowe odkrycia na temat ochrony krzyżowej
Okazuje się, że szczepionki MenB mogą zapewniać ochronę krzyżową przeciwko innym chorobom, co jest obiecującym odkryciem. Niedawne badania wykazały, że szczepionka Bexsero (MenB-4C) zapewnia ochronę krzyżową przeciwko rzeżączce1.
Przegląd systematyczny i metaanaliza opublikowane w Journal of Infection wykazały, że skorygowana skuteczność szczepionki (VE) dla szczepionek OMV przeciwko rzeżączce wahała się od 22% do 46%. Łączne szacunki VE szczepionek OMV przeciwko jakiemukolwiek zakażeniu rzeżączką po całej serii szczepień wynosiły 33-34%11.
Autorzy badania stwierdzili, że chociaż zmienność skuteczności szczepionki (VE) i wpływu szczepionki (VI) można przypisać różnicom w programach szczepień, grupach docelowych wiekowych oraz regionalnej epidemiologii zakażeń gonokokowych, wyniki „dają pewność odnośnie ochrony krzyżowej zapewnianej przez szczepionki MenB”1.
Przyszłe kierunki i wyzwania
Nowe szczepionki i strategie szczepień
W październiku 2023 roku, po znacznym przeglądzie i dyskusji, Komitet Doradczy ds. Praktyk Szczepiennych (ACIP) zagłosował za zatwierdzeniem użycia Penbraya, pierwszej pięciowalentnej szczepionki meningokokowej skierowanej przeciwko serogrupom A, B, C, W i Y, głównym serogrupom prowadzącym do większości przypadków inwazyjnej choroby meningokokowej1.
Obecne zalecenia dotyczące szczepionek meningokokowych dla większości osób mówią, że szczepionka MenACWY powinna być podawana w wieku 11-12 lat z dawką przypominającą w wieku 16 lat. Dwudawkowa seria szczepionki MenB jest zalecana na podstawie wspólnego podejmowania decyzji klinicznych między 16 a 23 rokiem życia1.
Grupa robocza ACIP ds. meningokoków przyznała, że ten nowy produkt i jego obecne zalecenia wymagają dalszej dyskusji i mogą wymagać zmian w przyszłości w celu najlepszego wdrożenia1.
Wyzwania w ocenie efektywności kosztowej
Badania kliniczne skuteczności szczepionek nie są praktyczne ani możliwe ze względu na niską częstość występowania choroby2. Komitet ACIP szacuje koszt na rok życia skorygowany o jakość (QALY) na ponad cztery miliony dolarów2.
Badanie przeprowadzone we Włoszech wykazało, że chociaż nowa szczepionka MenB może potencjalnie zapobiec około jednej trzeciej przypadków choroby w populacji włoskiej, wyniki modelu pokazują, że strategia ta jest mało prawdopodobna, aby była opłacalna (wartość ICER powyżej 350 000 euro/QALY) przy szczepionce, która zapobiega tylko chorobie1.
Wprowadzenie nowej szczepionki do rutynowego programu szczepień musi być dokładnie ocenione. Nowa szczepionka MenB ma potencjał zmniejszenia obciążenia chorobą na poziomie populacji. Jednak z perspektywy włoskiej służby zdrowia program szczepień jest mało prawdopodobne, aby był opłacalny przy obecnych poziomach zachorowań i cenie szczepionki2.
Potrzeby badawcze i nadzoru
Konieczne są dalsze dane, aby ustalić współczesne czynniki ryzyka choroby meningokokowej (w tym działania i ustawienia związane z nabywaniem bakterii, nosicielstwem i transmisją) oraz oszacować prawdziwy koszt zakażeń, którym można zapobiec za pomocą szczepionek meningokokowych1.
Doświadczenie związane z oceną poszczepieniową szczepionki przeciwko meningokokom C udowodniło znaczenie dobrego nadzoru poszczepieniowego w celu monitorowania rzeczywistej skuteczności klinicznej leku. Dobry aktywny nadzór oparty na populacji umożliwiłby zebranie ważnych informacji również o zdolności 4CMenB do przerwania nosicielstwa i osiągnięcia odporności stadnej4.
Kontynuacja monitorowania genów antygenów szczepionki MenB w czeskich izolatach N. meningitidis jest potrzebna do wykwalifikowanego przewidywania skuteczności szczepionek MenB w Czechach2.
Kwestie związane z zasięgiem szczepień
Znaczne luki w szczepieniach meningokokowych pozostawiają większość starszych nastolatków w grupie ryzyka. Ważne jest, aby chronić starszych nastolatków w wieku 16 lat, zwłaszcza gdy wzrasta ryzyko choroby meningokokowej. Wskaźniki szczepień meningokokowych spadają do suboptymalnych poziomów wraz z wiekiem nastolatków1.
84,8% pracowników służby zdrowia zgadza się, że istnieje znaczna luka w zasięgu szczepień meningokokowych wśród nastolatków. Utrzymują się dysproporcje w szczepieniach meningokokowych wśród nastolatków, przyczyniając się do luk w zasięgu1.
Wśród osób w wieku 16-23 lat, wskaźnik ukończenia serii szczepień MenB różni się w przypadku osób w bazie danych Medicaid (44,7%) i osób z komercyjnymi planami opieki zdrowotnej (56,7%), wykazując większą nierówność w szczepieniach dla pacjentów objętych programem Medicaid1.
Adaptacja programów do zmieniającej się epidemiologii
Pomyślne programy szczepień muszą być dostosowane do lokalnej epidemiologii, która różni się geograficznie, czasowo oraz w zależności od wieku i serogrupy1.
Niedawna epidemiologia choroby meningokokowej podkreśla znaczenie szczepienia grup wiekowych zagrożonych przeciwko serogrupom powszechnie występującym w regionie; na przykład, komponent przeciwko serogrupie X niedawno prekwalifikowanej szczepionki MenACWXY prawdopodobnie zapewni ograniczoną ochronę poza afrykańskim pasem zapalenia opon mózgowych. W innych regionach bardziej odpowiednie wydaje się kompleksowe szczepienie przeciwko MenB i MenACWY, które mogłoby być usprawnione przez niedawno zatwierdzoną szczepionkę MenABCWY1.
Biorąc pod uwagę zróżnicowaną epidemiologię choroby meningokokowej, NACI ustaliło, że zalecanie pankanadyjskiego ukierunkowanego programu jest obecnie trudne i że programy regionalne mogą być lepiej dostosowane do zapobiegania chorobie meningokokowej w grupach populacyjnych uznawanych za zagrożone wysokim ryzykiem ekspozycji1.
Nasze badanie potwierdziło różnorodność krajowych programów szczepień, nawet w sąsiadujących krajach o podobnych czynnikach, takich jak zasoby ekonomiczne i ryzyko epidemiologiczne, podkreślając inne czynniki napędzające krajowe programy szczepień3.
Kolejne rozdziały
Zapraszamy do dalszego czytania naszego leksykonu.
Wybierz kolejny rozdział z menu poniżej, aby otworzyć nową podstronę kompedium wiedzy i uzyskać szczegółowe informację o leku, substancji lub chorobie.
Materiały źródłowe
- #1 Global epidemiology of serogroup B meningococcal disease and opportunities for prevention with novel recombinant protein vaccineshttps://pmc.ncbi.nlm.nih.gov/articles/PMC5989912/
Meningococcal disease (MD) is a major cause of meningitis and sepsis worldwide, with a high case fatality rate and frequent sequelae. Neisseria meningitidis serogroups A, B, C, W, X and Y are responsible for most of these life-threatening infections, and its unpredictable epidemiology can cause outbreaks in communities, with significant health, social and economic impact. Currently, serogroup B is the main cause of MD in Europe and North America and one of the most prevalent serogroups in Latin America. […] Two novel protein-based vaccines are a significant addition to our armamentarium against N. meningitidis as they provide broad coverage against highly diverse strains in serogroup B and other groups. Early safety, effectiveness and impact data of these vaccines are encouraging. These novel serogroup B vaccines should be actively considered for individuals at increased risk of disease and to control serogroup B outbreaks occurring in institutions or specific regions, as they are likely to save lives and prevent severe sequelae. Incorporation into national programs will require thorough country-specific analysis.
- #1 Meningococcal Disease Surveillance and Trends | Meningococcal | CDChttps://www.cdc.gov/meningococcal/php/surveillance/index.html
Rates of meningococcal disease in the United States increased in 2023. […] Public health officials track all meningococcal disease in the United States using multiple surveillance systems. […] CDC issued a Health Alert Network (HAN) Health Advisory on March 28, 2024, about the increase in serogroup Y meningococcal disease in the United States. […] Meningococcal disease is a reportable condition in all states. […] CDC collects national information about meningococcal disease through the National Notifiable Diseases Surveillance System (NNDSS). […] Health departments from all 50 states and several large jurisdictions collect enhanced meningococcal disease data and isolates. This enhanced surveillance began in 2015 in order to collect more complete data to monitor disease epidemiology.
- #1 Meningococcal Disease | BEXSERO (Meningococcal Group B Vaccine) HCPhttps://www.bexserohcp.com/meningococcal-disease/
According to CDC, serogroup B caused the majority of all US meningococcal cases in patients 16-23 years of age from 2018 to 2022. […] As of 2022, CDC survey data showed the MenB vaccination rate among adolescents was low. Only 29.4% of 17-year-olds had received at least 1 dose of a MenB vaccine. ONLY 11.9% of 17-year-olds had received 2 doses or more of a MenB vaccine. […] CDC recommends a primary series for adolescents not at increased risk, aged 16-23 years (preferred age 16-18 years), based on shared clinical decision-making. […] Your patients need more than 1 dose to complete a MenB vaccination series. Make sure your patients are fully vaccinated against MenB. […] BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals aged 10 through 25 years. […] BEXSERO may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains.
- #1https://www.gov.uk/government/publications/meningococcal-disease-laboratory-confirmed-cases-in-england-in-2022-to-2023/invasive-meningococcal-disease-in-england-annual-laboratory-confirmed-reports-for-epidemiological-year-2022-to-2023
This report presents data on laboratory-confirmed invasive meningococcal disease (IMD) for the epidemiological year 2022 to 2023. […] In England, the national UK Health Security Agency (UKHSA) Meningococcal Reference Unit (MRU) confirmed 396 cases of IMD in 2022 to 2023, compared to 205 cases reported in 2021 to 2022 when the country was emerging from COVID-19 pandemic restrictions. […] With the complete withdrawal of COVID-19 containment measures in England from July 2021, overall IMD case numbers began to return to pre-pandemic levels driven mainly by group B meningococcal disease (MenB). […] The distribution of IMD cases by capsular group in 2022/23 is summarised in Table 1, with MenB accounting for 89.9% (356 out of 396) of all cases. […] In 2022 to 2023, 356 individuals were confirmed with MenB invasive disease, compared to 179 cases in 2021 to 2022, and 61 in 2020 to 2021.
- #1 Epidemiology of invasive meningococcal B disease in Australia, 1999â2015: priority populations for vaccination | The Medical Journal of Australiahttps://www.mja.com.au/journal/2017/207/9/epidemiology-invasive-meningococcal-b-disease-australia-1999-2015-priority
Objectives: To describe trends in the age-specific incidence of serogroup B invasive meningococcal disease (IMD) in Australia, 1999-2015. […] The incidence of meningococcal serogroup B (MenB) disease declined progressively from 1.52 cases per 100,000 population in 2001 to 0.47 per 100,000 in 2015. During 2006-2015, MenB accounted for 81% of IMD cases with a known serogroup; its highest incidence was among infants under 12 months of age (11.1 [95% CI, 9.8-12.2] per 100,000), children aged 1-4 years (2.82 [95% CI, 2.5-3.15] per 100,000), and adolescents aged 15-19 years (2.40 [95% CI, 2.16-2.67] per 100,000). […] Based on disease incidence at its current low endemic levels, priority at risk age/population groups for MenB vaccination include all children between 2 months and 5 years of age, Indigenous children under 10 years of age, and all adolescents aged 15-19 years.
- #1 Epidemiology of Meningococcal Disease in Four South American Countries and Rationale of Vaccination in Adolescents from the Region: Position Paper of the Latin American Society of Pediatric Infectious Diseases (SLIPE)https://www.mdpi.com/2076-393X/11/12/1841
Surveillance of meningococcal disease (MD) is crucial after the implementation of vaccination strategies to monitor their impact on disease burden. […] The World Health Organization (WHO) has launched a global roadmap to defeat meningitis as a public health threat by 2030, which requires to combine multiple efforts that include prevention and epidemic control, including enhancement of accessibility to vaccines; improved diagnosis and treatment; strong national surveillance systems to document the effect of vaccines and the burden of disease; effective support and care for people affected by meningitis; and advocacy and engagement to raise awareness of meningitis and its impact to achieve its main objectives, and thus to eliminate epidemics of bacterial meningitis, reduce cases of vaccine-preventable bacterial meningitis by 50% and deaths by 70%, and finally to reduce disability and improve quality of life after meningitis of any cause.
- #1 Immunizations: Meningococcal Vaccines | Wisconsin Department of Health Serviceshttps://www.dhs.wisconsin.gov/immunization/meningvaccines.htm
Meningococcal disease is a Wisconsin Disease Surveillance Category I disease. […] Report it right away to the patients local public health department. […] The CDC recommends a MenB vaccine for people ages 16-23 years old, especially those at high risk of meningococcal disease. […] Multiple doses of MenB are needed for the best protection. […] The CDC recommends meningococcal vaccines for all preteens and teens. […] Three serogroups, or types, of Neisseria meningitidis cause most meningococcal illness in the United States. […] Vaccines can prevent almost all types of meningococcal disease.
- #1 Latest Research — American Society for Meningitis Preventionhttps://meningitisprevention.org/latest-research
MMWR: New Dosing Interval and Schedule for the Bexsero MenB-4C Vaccine: Updated Recommendations of the Advisory Committee on Immunization Practices United States, October 2024 […] Meningitis B has been responsible for all US college outbreaks of meningococcal disease since 2011 […] Achieving high MenB vaccination coverage is necessary to help protect persons during outbreaks of meningococcal disease caused by serogroup B […] Meningitis B accounts for 70% of meningococcal disease cases among 16-23 year olds […] More than 80% of parents have not heard of the MenB vaccine […] The MenB vaccine not being required or mandated by a patients school/college is the main reason patients (and/or their parents) decline the MenB vaccine […] Why providers who care for pediatric populations should be knowledgeable about the MenB vaccine and recommend it […] Many doctors are not talking to their patients about the MenB vaccine […] The American Academy of Pediatrics encourages pediatricians to discuss the availability of the MenB vaccines with families and to document the discussion.
- #1 Invasive Meningococcal Disease in the Post-COVID World: Patterns of Disease Reboundhttps://www.mdpi.com/2076-393X/13/2/165
Invasive meningococcal disease (IMD) is a global health threat with an unpredictable epidemiology that varies regionally and over time. […] Here, we report the epidemiology of IMD from the United States, England, France, Australia, and Chile during and after the COVID-19 pandemic. […] The data indicate that surveillance of IMD cases, associated serogroups, and vaccination uptake is essential for monitoring the effectiveness of disease prevention strategies and guiding future public health policy. […] Understanding trends in the epidemiology of communicable diseases such as IMD is critical for informing public health policy. […] The COVID containment measures may have resulted in a decline in asymptomatic carriage of N. meningitidis or closely related species, such as Neisseria lactamica, which have been shown to confer protection against meningococcal disease, potentially contributing to a decline in herd protection in the general population.
- #1 Meningococcal Disease and the Men B Vaccine | AAFPhttps://www.aafp.org/family-physician/patient-care/prevention-wellness/immunizations-vaccines/disease-pop-immunization/meningococcal-disease-vaccine.html
In 2014 and 2015, two vaccines offering protection against the B serotype of meningococcus were licensed. MenB-FHbp (Trumenba) and MenB-4C (Bexsero) are composed of novel protein or lipoprotein antigens. […] A serogroup B meningococcal (Men B) vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for Men B vaccination is 16 through 18 years of age. […] The ACIP recommends routinely administering Men B vaccines among certain individuals 10 years or older who are at increased risk for serogroup B meningococcal disease. […] The incidence of all meningococcal B serotype infections in the United States is estimated to be about 200 cases per year among persons of all ages.
- #1 MenB Information | Student Affairs and Campus Diversity | SDSUhttps://sacd.sdsu.edu/health-promotion/healthier-you/menb
San Diego State University is continuing its efforts to support the health and safety of the university community. […] SDSU is asking all students 23 years of age and younger to check their immunization records and to get vaccinated for MenB a potentially fatal disease spread through close contact with those who are ill. […] The effective vaccines for MenB are Trumenba and Bexsero, which were approved by the FDA in 2014-15. […] MenB is life-threatening. Prompt diagnosis and treatment is critical because the disease progresses rapidly and can be fatal in as few as 12 hours after symptoms that often resemble influenza. […] All San Diego State University undergraduate students ages 23 and younger who have not been fully immunized with the meningococcal B (MenB) vaccine are urged to get vaccinated as soon as possible.
- #1https://www.meningitis.org/meningitis/vaccine-information/meningococcal-group-b-vaccine
Meningococcal vaccines protect against disease caused by meningococcal bacteria. There are several groups (called serogroups) of meningococcal bacteria that can cause disease. The most common disease-causing groups around the world are A, B, C, W, X and Y. The vaccines that protect against meningococcal group B (MenB) are protein vaccines. These vaccines contain proteins found on the surface of the bacteria. Like the other meningococcal vaccines, they trigger our immune system to produce antibodies that attack and fight off infection. The MenB vaccine provides protection against meningococcal disease, but doesn’t stop you from carrying the bacteria. […] Vaccination against meningococcal meningitis is also recommended if you’re travelling to areas at risk. Large outbreaks of meningococcal disease have been linked to the Hajj and Umrah pilgrimages. So it’s very important for pilgrims participating in Hajj or Umrah to get vaccinated with the MenACWY vaccine before travel.
- #1https://journals.lww.com/pidj/fulltext/2022/04000/a_real_world_claims_data_analysis_of_meningococcal.27.aspx
In the United States, meningococcal serogroup B (MenB) vaccination is recommended for 16-23-year-olds based on shared clinical decision-making. We estimated series completion among individuals initiating MenB vaccination for the 2 available vaccines: MenB 4-component (MenB-4C, doses at 0 and 1 month) and MenB factor H binding protein (MenB-FHbp, doses at 0 and 6 months). […] Series completion rates were suboptimal but were higher among those who initiated MenB-4C. To maximize the benefits of MenB vaccination, interventions to improve completion and reduce missed opportunities should be implemented. […] In this retrospective database study, MenB series completion rates were suboptimal in the Commercial (56.7%) and Medicaid (44.7%) populations who initiated MenB vaccination. […] In the current study, individuals who received the first dose of MenB-4C were significantly more likely to complete the series than those who received the first dose of MenB-FHbp (Commercial: 61.1% versus 49.8%; Medicaid: 47.8% versus 33.9%), and this relationship persisted after adjustment in Poisson regression models.
- #1 Meningococcal Bhttps://www.hse.ie/eng/health/immunisation/pubinfo/pcischedule/vpds/menb/
Meningococcal B disease is prevented by vaccination. […] All children are offered MenB vaccine at 2 and 4 months of age with a booster dose of MenB vaccine given at 12 months. […] The MenB vaccine was introduced in Ireland for all children born on or after 1 October 2016 because children under one year are at the highest risk of meningococcal B disease. […] The National Immunisation Advisory Committee recommends a catch up programme for children up until when they reach the age of two years. […] Only meningococcal B infection is prevented by the MenB vaccine. Other types of meningococcal infection are not covered by this vaccine. […] MenB vaccine has been shown to very effective and safe, providing 88% protection against MenB bacteria types.
- #1 Meningococcal Bhttps://www.hse.ie/eng/health/immunisation/hcpinfo/othervaccines/meningococcalb/
Meningococcal B disease is prevented by vaccination. […] All children born on or after 1 October 2016 will now be given MenB vaccine at 2 and 4 months of age with a booster dose of MenB vaccine given at 12 months. […] Studies have now shown that MenB vaccine can be given at the same time as any of the other PCI vaccines. […] Studies from the UK have demonstrated that appropriate protection was provided prior to the peak incidence of invasive meningococcal disease (peak at 5 months of age) using a 2 dose primary schedule. […] MenB vaccine is given as an intramuscular injection into the anterolateral thigh. […] MenB vaccine is indicated for individuals from 2 months and older. […] MenB vaccine should be given to cases and all previously unimmunised close contacts of a case of any age and to control outbreaks of meningococcal disease as agreed by the Department of Public Health and the Health Protection Surveillance Centre.
- #1 Meningococcal disease | The Australian Immunisation Handbookhttps://immunisationhandbook.health.gov.au/contents/vaccine-preventable-diseases/meningococcal-disease
Meningococcal vaccines are recommended for infants, children, adolescents and young adults. […] Several vaccines are available in Australia to reduce the risk of meningococcal disease. […] 1 vaccine protects against meningococcal serogroup B â MenB vaccines. […] The incidence of meningococcal W disease has fallen with widespread use of the MenACWY vaccine in these age groups. […] MenACWY and MenB vaccines are funded through the NIP for people with certain medical conditions that increase their risk of invasive meningococcal disease. […] Aboriginal and Torres Strait Islander people aged 2 months to 19 years are recommended to receive a course of MenB vaccine. […] The number of doses needed depends on the vaccine brand used and the personâs age when they start the vaccine course. […] The incidence of meningococcal B disease made up the majority (83%) of all meningococcal disease notifications. […] State-funded MenB vaccination programs have been introduced in South Australia, from 2018, and in Queensland, from 2024.
- #1 Meningococcal vaccines: Canadian Immunization Guide – Canada.cahttps://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-13-meningococcal-vaccine.html
The majority of invasive meningococcal disease (IMD) is associated with Neisseria meningitidis serogroups A, B, C, Y and W. […] IMD is endemic in Canada but occurs at low rates. […] The highest incidence rates are observed in infants younger than one year of age, followed by those in children 1 to 4 years of age. […] Higher than average incidence rates are also observed in the 15 to 24 year and 60 years of age and older age group. […] Serogroups B, W, Y and C are most commonly reported types in the country. […] However, with the introduction of childhood immunization programs against serogroup C IMD in 2002, the incidence of IMD due to serogroup C has decreased by 93% from the pre-vaccine era to 2015. […] The incidence of serogroup B remains predominant, followed by disease caused by serogroup W and Y.
- #1 Patient Counseling | BEXSERO (Meningococcal Group B Vaccine)https://www.bexserohcp.com/patient-counseling/
CDC recommends a MenB vaccination series for adolescents not at increased risk, aged 16-23 years (preferred age 16-18 years), based on shared clinical decision-making. […] Follow the latest CDC MenB vaccination recommendation. […] BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals aged 10 through 25 years. […] BEXSERO may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains. […] Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B even if they develop antibodies following vaccination with BEXSERO.
- #1 MenB vaccine – NHShttps://www.nhs.uk/vaccinations/menb-vaccine/
The MenB vaccine helps protect against meningococcal group B bacteria that can cause serious illnesses, including meningitis and sepsis. […] The MenB vaccine helps protect children against bacterial infections caused by meningococcal group B bacteria (MenB). […] Children are offered 3 doses of the MenB vaccine as part of the NHS vaccination schedule. […] It’s best to have the MenB vaccines on time so children are protected when they’re most at risk of getting MenB illnesses. […] Most children can have the MenB vaccine. […] There is 1 type of MenB vaccine routinely given to children in the UK. […] Your GP surgery will usually contact you about your child’s MenB vaccinations. […] Like all medicines, the MenB vaccine can cause side effects, but not all children get them. […] The MenB vaccine works very well at protecting children against most types of meningococcal group B bacteria in the UK. […] Research has shown that the vaccine is very effective at preventing illnesses caused by these bacteria. […] Since the vaccine has been used in the UK, there has been a big drop in the number of young children getting MenB illnesses.
- #1 Recent advances in the prevention of meningococcal B disease: Real evidence from 4CMenB vaccination | Vacunas (English Edition)https://www.elsevier.es/en-revista-vacunas-english-edition–259-articulo-recent-advances-in-prevention-meningococcal-S2445146021000443
Vacunas publishes research articles related to the field of vaccine-preventable diseases in humans and those with zoonotic potential in animals. It places special emphasis on aspects associated with planning and evaluation, including the epidemiology of vaccine-preventable diseases, the development of vaccination programs, and the evaluation of the efficacy, effectiveness, and efficiency of vaccinations. […] The 4CMenB vaccine confers protection against serogroup B invasive meningococcal disease (MenB IMD). Licensed worldwide based on immunogenicity and safety data, we now have data on its effectiveness and impact. […] Data from 7 countries provide evidence of effectiveness and impact in different settings and age groups, including national/regional immunisation programmes, observational studies, and outbreak control.
- #1 Meningitis B vaccine disappoints in campus outbreak | CIDRAPhttps://www.cidrap.umn.edu/meningitis/meningitis-b-vaccine-disappoints-campus-outbreak
A study in the New England Journal of Medicine yesterday showed the meningitis B (MenB) vaccine, Bexsero, when administered during an outbreak at Princeton University in 2013, produced an immune response in most recipients, but 34% had no immune response to the outbreak strain. […] Researchers began administering the vaccine, made by GlaxoSmithKline, at Princeton in December 2013, when a MenB outbreak began on campus. […] By the end of the 2-year outbreak, there were 9 cases of MenB reported on campus and 1 death. […] „All students who were tested had an immune response to at least one strain contained in the vaccine, but a third didn’t have any response to the outbreak strain.” […] Two months after receiving the second dose of the vaccine, only 66% of subjects showed bactericidal activity against the MenB strain that was infecting students.
- #1 Gaps in Coverage | PENBRAYA (Meningococcal A,B,C,W,Y vaccine) Safety Infohttps://penbraya.pfizerpro.com/about-penbraya/gaps-in-vaccination-coverage
Substantial gaps in meningococcal vaccination leave the majority of older adolescents at risk. It is important to protect older adolescents at age 16, especially as meningococcal disease risk rises. Meningococcal vaccination rates decline to suboptimal levels as adolescents age. 84.8% of HCPs agree that there is a significant gap in meningococcal vaccination coverage among teens. Disparities in meningococcal vaccination among adolescents persist, contributing to gaps in coverage. Among 16-to 23-year-olds, the completion rate for the MenB vaccine series differs for individuals in the Medicaid database (44.7%) and individuals with commercial healthcare plans (56.7%), showing greater inequity in vaccination for patients covered by Medicaid. […] Based on data in the CDC enhanced meningococcal surveillance reports from 2017 to 2022 for 16- to 23-year-olds. The number of cases for each serogroup were as follows: MenA=0; MenB=120; MenC=20; MenW=5; MenY=9; other/unknown=31; and non-groupable=49. Risk rises and peaks in adolescents between ages 15 and 22. Based on the 2022 National Immunization Survey of 13- to 17-year-olds in the United States, coverage rates among 17-year-olds for MenACWY was 90.7% for Dose 1 and 60.8% for Dose 2. For MenB coverage, 29.4% received Dose 1 and 11.9% received Dose 2.
- #1 Selection of diverse strains to assess broad coverage of the bivalent FHbp meningococcal B vaccine | npj Vaccineshttps://www.nature.com/articles/s41541-019-0154-0
MenB-FHbp is a recombinant meningococcal serogroup B (MenB) vaccine composed of 2 factor H binding proteins (FHbps). […] This work represents an innovative approach to license a non-toxin protein vaccine with 2 antigens representing a single virulence factor by an immune correlate, and uniquely demonstrates that such a vaccine provides coverage across bacterial strains by inducing broadly protective antibodies. […] MenB-FHbp has been approved for the prevention of IMD in several countries and regions, including the United States, Canada, Europe, and Australia. […] The serum bactericidal assay using human complement (hSBA) measures complement-dependent, antibody-mediated lysis of meningococcal bacteria. […] Accurately predicting strain coverage of protein-based vaccines is more complex using hSBA than for vaccines targeting capsular polysaccharides, given that protein sequence diversity and variability in expression levels differ among the different meningococcal disease strains.
- #1 One STD is Decreasing As Off-Label Vaccine Use Increases â Vax-Before-Travelhttps://www.vax-before-travel.com/one-std-decreasing-label-vaccine-use-increases-2024-11-16
The U.S. CDC recently published a Sexually Transmitted Infections Surveillance Report for 2023, which provides the latest data on trends for nationally notifiable sexually transmitted infections (STIs), including gonorrhea. […] In the U.S., GSK’s Bexsero (MenB-4C) vaccine is FDA-approved for intramuscular injection to prevent meningococcal group B disease caused by Neisseria meningitidis bacteria. […] Furthermore, real-world evidence revealed that Bexsero provides cross-protection against gonorrhea. […] On July 8, 2024, the Journal of Infection published results from a systematic review and meta-analysis. Adjusted vaccine effectiveness (VE) for OMV vaccines against gonorrhea ranged from 22% to 46%. The pooled VE estimates of OMV vaccines against any gonorrhea infection following the entire vaccine series were 33-34%.
- #1 Meningococcal vaccines shown to be moderately effective against gonorrhea | CIDRAPhttps://www.cidrap.umn.edu/meningitis/meningococcal-vaccines-shown-be-moderately-effective-against-gonorrhea
Of the 12 studies included in the review, conducted by a team of researchers from Australia, nine evaluated the evidence of vaccine effectiveness (VE) of meningococcal B (MenB) outer membrane vesicle (OMV) vaccines against gonorrhea, and one evaluated VE of a non-OMV-based vaccine (MenB-FHbp) […] The adjusted VE for OMV-based vaccines against gonorrhea ranged from 22% to 46%. The pooled VE estimates of OMV vaccines against any gonorrhea infection following the full vaccine series were 33% to 34%. The observed vaccine impact (VI) ranged from a 30% reduction in gonorrhea incidence in South Australia to a 59% reduction in Quebec, Canada. […] The study authors say that while the variation in VE and VI could be attributed to differences in vaccination programs, target age-groups, and the regional epidemiology of gonococcal infections, the findings „provide reassurance regarding the cross-protection provided by MenB vaccines.” […] These findings emphasise the potential value of incorporating meningococcal vaccination into strategies aimed at controlling gonococcal infections.
- #1 Vaccine Update: Reducing the Ouch During Vaccination | Children’s Mercy Kansas Cityhttps://www.childrensmercy.org/health-care-providers/refer-or-manage-a-patient/connect-with-childrens-mercy/newsletter-the-link/link-newsletter-september-2023222/vaccine-update/
On Oct. 25, 2023, after significant review and discussion, the Advisory Committee on Immunization Practices (ACIP) voted to approve the use of Penbraya, the first pentavalent meningococcal vaccine that targets serogroups A, B, C, W and Y, the top serogroups that lead to most cases of invasive meningococcal disease. […] The most recently available data, from 2021, shows 210 reported cases of meningococcal disease in the United States. […] In the United States, the vaccination rate for 1 dose of MenACWY is 89%, while the vaccination rate for 1 dose of MenB is 31%. […] Current recommendations for meningococcal vaccines in most individuals are that MenACWY be administered at 11-12 years of age with a booster at 16 years of age. A two-dose series of Men B is recommended based on shared clinical decision-making between 16 and 23 years of age. […] The ACIP meningococcal work group acknowledged that this new product and its current recommendations require further discussion and may require changes in the future for best implementation.
- #1 Health and Economic Outcomes of Introducing the New MenB Vaccine (Bexsero) into the Italian Routine Infant Immunisation Programme | PLOS Onehttps://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123383
Health and Economic Outcomes of Introducing the New MenB Vaccine (Bexsero) into the Italian Routine Infant Immunisation Programme […] In January 2013 a novel type of multicomponent protein-based vaccine against group B meningococcal disease was licensed by the European Medicines Agency. The aim of this study is to investigate the health and the economic outcomes of MenB vaccine introduction into the Italian routine mass vaccination programme. […] MenB serotype is responsible for 59% of the 341 cases of Invasive Meningococcal Disease in Lombardia and Piemonte. Incidence rate for MenB infection is estimated to be 0.21/100,000/y resulting at the highest level in children 4 years of age. Although the new MenB vaccine can potentially prevent about one third of the disease cases in the Italian population, model results show this strategy is unlikely to be cost-effective (ICER value over 350,000/QALY) with a vaccine that prevents disease only.
- #1 NACI update on invasive meningococcal disease epidemiology, CCDR 49 – Canada.cahttps://www.canada.ca/en/public-health/services/reports-publications/canada-communicable-disease-report-ccdr/monthly-issue/2023-49/issue-9-september-2023/naci-update-invasive-meningococcal-disease-epidemiology-prevention.html
Following recent outbreaks of invasive meningococcal disease (IMD) in Canada and updates to provincial vaccination guidelines, the National Advisory Committee on Immunization (NACI) conducted a targeted review of evidence with a focus on immunization of adolescents and young adults. […] NACI reviewed national and international immunization recommendations for populations at high-risk of IMD, national IMD epidemiology and program-relevant considerations. […] Given the varied IMD epidemiology, NACI determined that recommending a pan-Canadian targeted program is currently challenging and that regional programs may be better suited to prevent IMD in population groups considered to be at high-risk of exposure. […] Further data is needed to ascertain contemporary risk factors for IMD (including activities and settings associated with bacterial acquisition, carriage and transmission) and estimate the true cost of meningococcal vaccine-preventable infections in Canada.
- #1https://link.springer.com/article/10.1007/s40121-024-01063-5
Invasive meningococcal disease (IMD) is associated with high morbidity and mortality and predominantly caused by five Neisseria meningitidis serogroups (A/B/C/W/Y). […] Successful vaccination programs must be tailored to local epidemiology, which varies geographically, temporally, and by age and serogroup. […] Recent IMD epidemiology underscores the importance of vaccinating at-risk age groups against regionally prevalent serogroups; for example, the anti-serogroup X component of the recently prequalified MenACWXY vaccine is likely to provide limited protection outside the African meningitis belt. In other regions, comprehensive vaccination against MenB and MenACWY, which could be streamlined by the recently approved MenABCWY vaccine, seems more appropriate. […] Meningococcal epidemiology has propelled vaccine development, with previously and currently available meningococcal vaccines designed to provide protection against some individual or various combinations of serogroups (i.e., A, B, C, W, X, and Y).
- #2https://link.springer.com/article/10.1007/s40121-024-01063-5
Invasive meningococcal disease (IMD) is associated with high morbidity and mortality and predominantly caused by five Neisseria meningitidis serogroups (A/B/C/W/Y). […] Successful vaccination programs must be tailored to local epidemiology, which varies geographically, temporally, and by age and serogroup. […] Recent IMD epidemiology underscores the importance of vaccinating at-risk age groups against regionally prevalent serogroups; for example, the anti-serogroup X component of the recently prequalified MenACWXY vaccine is likely to provide limited protection outside the African meningitis belt. In other regions, comprehensive vaccination against MenB and MenACWY, which could be streamlined by the recently approved MenABCWY vaccine, seems more appropriate. […] Meningococcal epidemiology has propelled vaccine development, with previously and currently available meningococcal vaccines designed to provide protection against some individual or various combinations of serogroups (i.e., A, B, C, W, X, and Y).
- #2 Global epidemiology of serogroup B meningococcal disease and opportunities for prevention with novel recombinant protein vaccineshttps://pmc.ncbi.nlm.nih.gov/articles/PMC5989912/
Despite the availability of safe and effective meningococcal conjugate vaccines against serogroups A, C, W and Y for several years, only recently two serogroup B recombinant protein meningococcal vaccines were licensed and recommended for prevention of serogroup B meningococcal disease (B-MD) across different age groups in several countries. […] Incidence rates (IR) of B-MD have declined during the past years, in the absence of any vaccine intervention. A recently published systematic review reports an average rate ranging from 0.01 to 4.26 per 100,000 population, with a decreasing overall trend, particularly in countries where data collection is more consistently collected. […] In Latin America, incidence rates of MD have varied widely during past years, from 0.1 cases per 100,000 in Mexico, Peru, Paraguay and Bolivia, to 2/100,000 in Brazil, with the highest incidence rates observed in infants.
- #2 Chapter 14: Meningococcal Disease | Pink Book | CDChttps://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-14-meningococcal-disease.html
Incidence of meningococcal disease in the United States has declined annually following a peak in the late 1990s. In 2018, 329 total cases were reported in the United States, representing an incidence of 0.10 per 100,000 population. Serogroups B and C are the major causes of meningococcal disease in the United States, each being responsible for approximately 25% to 40% of cases; serogroups W and Y, along with nongroupable meningococci, are each responsible for another 5% to 15%. […] In the United States, meningococcal outbreaks account for about 5% of reported cases (i.e., 95% of cases are sporadic). An outbreak is defined as 23 outbreak-associated cases (e.g., cases of the same serogroup unless found to be genetically unrelated by molecular typing methods) in an organization (e.g., school, college, correctional facility) during a three-month period, or multiple outbreak-associated cases with an incidence of meningococcal disease that is above the expected incidence in a community during a three-month period.
- #2 Ask The Experts About Vaccines: Meningococcal B | Immunize.orghttps://www.immunize.org/ask-experts/topic/menb/
The incidence of meningococcal disease has declined steadily in the U.S. since a peak of reported disease in the late 1990s. Even before routine use of a meningococcal conjugate vaccine against serogroups A, C, W, and Y (MenACWY) was recommended for adolescents in 2005, the overall annual incidence of meningococcal disease had decreased 64%, from 1.1 cases per 100,000 population in 1996 to 0.4 cases per 100,000 population in 2005. In 2021, the rate of meningococcal disease in the United States reached a historic low of 0.06 cases per 100,000 population. […] In 2021, the most recent CDC surveillance final report stated that, of U.S. cases with known serogroup, 46 cases were serogroup B (incidence rate of 0.01 cases per 100,000, or 1 case per 10 million population) and 108 cases were serogroups C, Y, or W.
- #2 Meningococcal Disease and the Men B Vaccine | AAFPhttps://www.aafp.org/family-physician/patient-care/prevention-wellness/immunizations-vaccines/disease-pop-immunization/meningococcal-disease-vaccine.html
Since 2009, seven outbreaks of serogroup B meningococcal disease have occurred on college campuses. […] The development of these vaccines required sequencing of the bacterial genome to find proteins unique to the Neisseria bacterial wall that could be used as antigens to stimulate immunity in humans. […] Clinical trials of vaccine effectiveness are not practical or possible because the incidence of disease is low. […] So far, limited studies have not shown a decrease of asymptomatic carriage in immunized populations. […] Both vaccines have a tendency to cause minor, self-limiting reactions, such as pain at the injection site, fever, headache, fatigue, myalgia, and arthralgia. […] FDA approval for the Men B vaccines was granted via an accelerated process, based on 3,000 to 4,000 subjects. […] The ACIP estimates the cost per quality-adjusted life year to be in excess of four million dollars. […] As a result of experience with the vaccines in the U.S. and other countries, more information will emerge in the next few years.
- #2 Recent advances in the prevention of meningococcal B disease: Real evidence from 4CMenB vaccination | Vacunas (English Edition)https://www.elsevier.es/en-revista-vacunas-english-edition–259-articulo-recent-advances-in-prevention-meningococcal-S2445146021000443
The administration of at least 2 doses of 4CMenB reduced IMD by 50-100% in individuals from 2 months to 20 years of age. […] MenB IMD is a rare but potentially fatal disease, with unpredictable epidemiology. […] The results underline the importance of directly protecting the groups most at risk: infants/young children and adolescents. […] The first estimate of vaccine effectiveness in infants was published in 2016 and described the effectiveness and impact of 2 doses of 4CMenB administered in the UK infant immunization program. […] The overall effectiveness of 2 doses of 4CMenB against MenB IMD was 82.9% (95% confidence interval [CI] 24.1, 95.2). […] In this review we describe the most recently available effectiveness and impact data for 4CMenB. […] The results of 3 of these emergency vaccination campaigns have been published and reported that no further cases occurred in vaccinated individuals after the implementation of the vaccination campaign.
- #2 Invasive Meningococcal Disease in the Post-COVID World: Patterns of Disease Reboundhttps://www.mdpi.com/2076-393X/13/2/165
In the current evaluation, with the exception of the United States, serogroup B was the most prominent serogroup of re-emergence, and in Australia, case numbers of MenB in 2022 were similar to pre-pandemic (i.e., 2019) case numbers. […] The findings suggest the importance of MenACWY vaccination programs to reduce disease burden caused by these serogroups. […] Our findings suggest the occurrence of a post-pandemic rebound in meningococcal disease globally, particularly in countries without active meningococcal vaccination programs. […] Understanding the epidemiology of vaccination uptake will be essential for monitoring the effectiveness of disease prevention strategies and guiding future public health policy.
- #2 Overview of meningococcal epidemiology and national immunization programs in children and adolescents in 8Â Western European countrieshttps://pmc.ncbi.nlm.nih.gov/articles/PMC9727280/
IMD is highly unpredictable, although most cases occur in the winter months in Europe. It manifests as isolated cases or outbreaks. Outbreaks or clusters occur in certain settings, such as universities, due to lifestyle and living conditions. […] There is no universal vaccine preventing all serogroups causing meningococcal disease but, to date, several vaccines have been developed for the prevention of the main IMD-causing serogroups. […] In Europe, MenC vaccination was first introduced in the routine childhood NIP in the UK, in 1999, with a conjugate vaccine. Since then, recombinant protein meningococcal B (MenB) vaccines and quadrivalent (MenACWY) meningococcal conjugate vaccines have been authorized. […] As of July 2, 2022, 12 of the 30 ECDC countries did not include any meningococcal vaccination in the program for the general population, 8 included MenB and 17 MenC.
- #2https://www.gov.uk/government/publications/meningococcal-disease-laboratory-confirmed-cases-in-england-in-2022-to-2023/invasive-meningococcal-disease-in-england-annual-laboratory-confirmed-reports-for-epidemiological-year-2022-to-2023
Infants in the UK were offered routine MenB immunisation with 4CMenB from 1 September 2015. […] In England, the latest annual vaccine coverage estimates (1 April 2021 to 31 March 2022) for infants eligible for 4CMenB were 91.5% for 2 doses by 12 months of age and 88.0% for the one-year booster dose by 24 months of age. […] The schedule has been shown to be highly effective in preventing MenB disease in infants and toddlers. […] The MenACWY teenage vaccine has led to large reductions in IMD caused by these capsular groups across all age groups as a result of both direct and indirect (herd) protection. […] All teenage cohorts remain eligible for opportunistic MenACWY vaccination until their 25th birthday and it is important that these cohorts continue to be encouraged to be immunised.
- #2 Meningococcal vaccines: Canadian Immunization Guide – Canada.cahttps://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-13-meningococcal-vaccine.html
Meningococcal vaccines are recommended for individuals at high risk of IMD including those with underlying medical conditions and those who are at increased risk of exposure. […] Meningococcal vaccine is also recommended for most close contacts of a case of IMD and for outbreak control, if the disease is caused by a serogroup contained in the vaccine. […] Consultation with public health officials, experts in communicable disease, or both is important in the assessment and control of meningococcal disease outbreaks. […] Outbreaks may be controlled by the use of meningococcal vaccines.
- #2 Meningococcal Bhttps://www.hse.ie/eng/health/immunisation/hcpinfo/othervaccines/meningococcalb/
MenB vaccine has been shown to be very effective at producing an immune response to the particular strains of meningococcal B causing invasive meningococcal disease in Ireland. […] Research has suggested that up to 88% of meningococcal B strains should be protected by MenB vaccine. […] There are many countries with recommendations for MenB vaccine including UK, USA, Italy, Austria and Spain. […] However the UK and Italy (12 regions) are the only countries offering a national funded immunisation programme for MenB vaccine, as is being provided now in Ireland.
- #2https://journals.lww.com/pidj/fulltext/2022/04000/a_real_world_claims_data_analysis_of_meningococcal.27.aspx
Many individuals who initiated MenB vaccination did not complete the series. In the current study, 40.2% of the Commercial population and 34.7% of the Medicaid population who did not receive a completion MenB vaccine dose within the applied time limits attended a vaccine administration or preventive care/well-child office visit during these times. Had they received their completion dose at such a visit, completion rates could have been considerably higher.
- #2 Selection of diverse strains to assess broad coverage of the bivalent FHbp meningococcal B vaccine | npj Vaccineshttps://www.nature.com/articles/s41541-019-0154-0
Immune sera elicited by MenB-FHbp in preclinical and early clinical studies demonstrated broad bactericidal antibodies that could kill diverse MenB strains containing FHbp subfamily A and B variants heterologous to the vaccine FHbp variants A05 and B01. […] To select strains with broad antigenic and epidemiologic diversity for clinical testing, over 1200 invasive MenB disease isolates were collected from laboratories and health agencies in the United States and Europe to represent the prevalence of MenB isolates that were contemporary at the time of collection; all strains contained the FHbp gene. […] Collectively, the 14 MenB test strains represent the majority of the prevalent meningococcal FHbp, with FHbp variants corresponding to ~80% of circulating invasive disease-causing isolates in the United States and Europe.
- #2 Genomic surveillance of invasive meningococcal disease in the Czech Republic, 2015-2017 | PLOS Onehttps://journals.plos.org/plosone/article?id=10.1371/journal.pone.0219477
The Prague NRL used WGS in 2017 to study a set of 31 Czech isolates of N. meningitidis W from 1984-2017, and the results have already been published. […] WGS data on the Czech serogroup W meningococcal isolates confirm the presence of MenB vaccine antigen genes and thus do not disprove the hypothesis that this vaccine has potential for protection against N. meningitidis W. […] In our study, WGS data showed the presence of MenB vaccine antigen genes in all study B and non-B isolates of N. meningitidis, which suggests that the vaccine has potential for protection also against non-B meningococci in the Czech Republic. […] Continuing the monitoring of MenB vaccine antigen genes in Czech N. meningitidis isolates is needed for a qualified prediction of the efficiency of MenB vaccines in the Czech Republic.
- #2 Fluctuations in serogroup B meningococcal vaccine antigens prior to routine MenB vaccination in France | Communications Medicinehttps://www.nature.com/articles/s43856-025-00800-2
Consequently, MenDeVAR predicted a coverage of 973 isolates (57.5%) for the 4CMenB vaccine and of 1268 isolates (75.0%) for the Bivalent rLP2086 vaccine of the 1961 total isolates of the study. […] This coverage fluctuated but not significantly over the four periods between 46.8% and 60.6% for the 4CMenB. […] The coverage rate by the bivalent rLP2086 showed higher coverage since 2010. […] Our results argue that surveillance of NmB strain coverage by 4CMenB and bivalent rLP2086 vaccines can change overtime substantially even before introduction of routine vaccine programs.
- #2 Health and Economic Outcomes of Introducing the New MenB Vaccine (Bexsero) into the Italian Routine Infant Immunisation Programme | PLOS Onehttps://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123383
The introduction of the novel vaccine into the routine immunisation schedule needs to be carefully evaluated. The new MenB vaccine has the potential to reduce the disease burden at the population level. However, from the Italian Health Service perspective, the immunisation programme is unlikely to be cost-effective at the current incidence levels and vaccine price. […] The purpose of this study is to investigate the health and the economic outcomes of a potential introduction of the new 4CMenB vaccine (Bexsero) in Italy in order to help inform policy decisions. In details, the current work aims to: 1) assess the epidemiological burden of MenB disease using official hospitalisation and notification data from two of the most populated Italian regions (Piemonte and Lombardia); 2) evaluate the effectiveness and cost-effectiveness of the programme calculating Quality-Adjusted Life Years (QALYs) gained, Net Costs and Incremental Cost-Effectiveness Ratio (ICER) under base case parameters assumptions.
- #3https://www.who.int/publications/m/item/vaccine-preventable-diseases-surveillance-standards-meningococcus
Neisseria meningitidis (Nm) is a gram-negative bacterium that usually resides harmlessly in the human pharynx. […] The majority of invasive infections are caused by meningococci of serogroups A, B, C, X, W or Y capsular polysaccharides. […] The recent epidemiology of meningococcal disease in Africa is changing, particularly in the wake of the introduction of the conjugate serogroup A vaccine over the last decade; in addition, outbreaks caused by serogroups C, W and X have occurred more frequently in recent years. […] In Europe, North America and Latin America, serogroups B, C and W currently cause the majority of disease, while in Asia, though surveillance data are limited, serogroups A and C appear to cause most disease.
- #3 Ask The Experts About Vaccines: Meningococcal B | Immunize.orghttps://www.immunize.org/ask-experts/topic/menb/
Rates of meningococcal disease in the United States increased in 2023. Much of this increase was due to a sharp increase in serogroup Y disease. In 2023, 415 confirmed and probable meningococcal disease cases were reported in the United States (preliminary data), which is similar to the rate in 2014. […] The vaccines for meningococcal serogroups A, C, W, and Y (MenACWY-TT, MenQuadfi [Sanofi]; MenACWY-CRM, Menveo [GSK]) contain meningococcal conjugate in which the surface polysaccharide is chemically bonded (conjugated) to a protein to produce a robust immune response to the polysaccharide. […] Since late 2014, vaccines have become available that offer protection from meningococcal serogroup B disease (MenB; Bexsero by GSK; Trumenba by Pfizer). […] MenACWY vaccines provide no protection against serogroup B disease, and MenB vaccines provide no protection against serogroup A, C, W, or Y disease.
- #3 Global epidemiology of serogroup B meningococcal disease and opportunities for prevention with novel recombinant protein vaccineshttps://pmc.ncbi.nlm.nih.gov/articles/PMC5989912/
A small fraction of reported MD cases occur within the context of meningococcal outbreaks. They are unpredictable and associated with severe outcomes, which can be emotionally devastating within affected communities or institutions. […] Massive vaccination campaigns can be implemented for outbreak control. Importantly, vaccination does not replace recommended chemoprophylaxis. […] The two-serogroup B vaccines are a significant addition to our armamentarium against highly significant pathogens for humans. The vaccines should certainly be considered for persons at increased risk for MD and when dealing with serogroup B outbreaks occurring in institutions or specific regions, as they will most likely save lives and prevent severe sequelae. Incorporation into national programs will require thorough analysis such as has been done in the UK; the world is once again watching closely the vaccine experience of this country (a post licensure field experiment) which will be of significant help to other countries with relatively high prevalence rates, who may be considering the incorporation of a serogroup B vaccine for the benefit of their populations.
- #3 Overview of meningococcal epidemiology and national immunization programs in children and adolescents in 8Â Western European countrieshttps://pmc.ncbi.nlm.nih.gov/articles/PMC9727280/
Meningococcal C vaccines were introduced in the late 1990s early 2000s, first in the UK then in Belgium, Spain, and the Netherlands. […] MenB recombinant protein vaccines were first introduced in the UK in 2015 and then in Italy in 2017. […] As a result of increased MenW incidence worldwide, including Europe, several countries used quadrivalent MenACWY vaccines. […] The present study confirmed the diversity of NIPs, even in neighboring countries with similar factors like economic resources and epidemiological risk, highlighting other factors driving NIPs.
- #4 Health and Economic Outcomes of Introducing the New MenB Vaccine (Bexsero) into the Italian Routine Infant Immunisation Programme | PLOS Onehttps://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123383
The experience related to the post-market evaluation of the vaccine against meningococcus C has proved the importance of having a good post-vaccination surveillance in order to monitor the real clinical effectiveness of the drug. Good active population-based sentinel surveillance would allow to gather important information also about the 4CMenB capacity to disrupt carriage and reach the herd immunity.
- #5 Ask The Experts About Vaccines: Meningococcal B | Immunize.orghttps://www.immunize.org/ask-experts/topic/menb/
ACIP recommendations for MenB include a booster dose schedule for MenB vaccination of people at high risk for meningococcal serogroup B disease. The first booster dose is recommended one year after completion of the primary series, with a subsequent booster dose administered every 23 years thereafter, as long as risk remains.