Szczepionka przeciw wirusowi rotawirusa
Zapobieganie i profilaktyka
Szczepionki przeciw wirusowi rotawirusa stanowią podstawę profilaktyki rotawirusowego zapalenia żołądka i jelit, głównej przyczyny ciężkiej biegunki u niemowląt i małych dzieci. Dostępne preparaty doustne, takie jak Rotarix (2 dawki w 2. i 4. miesiącu życia) oraz RotaTeq (3 dawki w 2., 4. i 6. miesiącu życia), wykazują wysoką skuteczność na poziomie 85-98% w zapobieganiu ciężkim postaciom choroby oraz 74-87% w ochronie przed biegunką o dowolnym nasileniu. Szczepionki te są bezpieczne, z niskim ryzykiem powikłań, takich jak wgłobienie jelita (ok. 1/100 000 zaszczepionych), a ich stosowanie jest rekomendowane przez WHO, CDC i inne międzynarodowe organizacje zdrowotne. Wprowadzenie szczepień doprowadziło do redukcji hospitalizacji z powodu rotawirusa o około 85% w krajach rozwiniętych oraz zapobiegło około 140 000 zgonów dzieci w latach 2006-2019 na świecie.
- Szczepionka przeciw wirusowi rotawirusa
- Skuteczność szczepionek przeciw rotawirusom
- Bezpieczeństwo szczepionek przeciw rotawirusom
- Zalecenia dotyczące szczepień przeciw rotawirusom
- Znaczenie szczepień przeciw rotawirusom w kontekscie globalnym
- Integracja szczepień z innymi działaniami profilaktycznymi
- Przyszłość szczepień przeciw rotawirusom
- Znaczenie profilaktyki rotawirusowej
Szczepionka przeciw wirusowi rotawirusa
Szczepionka przeciw wirusowi rotawirusa stanowi kluczowy element w zapobieganiu rotawirusowemu zapaleniu żołądka i jelit, które jest główną przyczyną ciężkiej biegunki u niemowląt i małych dzieci na całym świecie. Zakażenia rotawirusowe są wysoce zakaźne i stanowią poważne zagrożenie dla zdrowia dzieci, szczególnie w krajach rozwijających się, gdzie dostęp do opieki zdrowotnej może być ograniczony. Szczepionki przeciw rotawirusom są uważane za najbardziej skuteczną metodę profilaktyki, ponieważ poprawa warunków sanitarnych nie zmniejsza występowania choroby rotawirusowej1.
Dostępne szczepionki przeciw rotawirusom
Obecnie na rynku dostępne są różne szczepionki przeciw rotawirusom, zatwierdzone do stosowania w wielu krajach:
- Rotarix (GlaxoSmithKline) – monowalentna, atenuowana szczepionka zawierająca ludzki szczep rotawirusa, podawana w 2 dawkach doustnych w wieku 2 i 4 miesięcy12
- RotaTeq (Merck) – pentawalentna szczepionka będąca reasortantem ludzko-bydlęcym, podawana w 3 dawkach doustnych w wieku 2, 4 i 6 miesięcy12
- Rotavac (Bharat Biotech) – naturalnie występujący reasortant bydlęco-ludzki noworodkowy G9P, również nazywany 116E12
- RotaSiil (Serum Institute of India) – reasortant bydlęco-ludzki z ludzkimi G1, G2, G3 i G4 oraz bydlęcym UK G6P[5]12
Wszystkie te szczepionki są uznawane za wysoce skuteczne w zapobieganiu ciężkim chorobom układu pokarmowego wywołanym przez rotawirusy. Światowa Organizacja Zdrowia (WHO) prewalidowała cztery doustne, żywe, atenuowane szczepionki przeciw rotawirusom do stosowania międzynarodowego1.
Schemat podawania szczepionek
Schemat dawkowania zależy od rodzaju stosowanej szczepionki:
- Rotarix: 2 dawki doustne – pierwsza w wieku 6-14 tygodni, druga po co najmniej 4 tygodniach, przed ukończeniem 24 tygodni życia12
- RotaTeq: 3 dawki doustne – pierwsza w wieku 6-12 tygodni, kolejne w odstępach 4-10 tygodni, trzecia dawka nie później niż do 32 tygodnia życia12
Według zaleceń CDC, pierwsza dawka dowolnej szczepionki przeciw rotawirusom powinna być podana przed ukończeniem przez dziecko 15 tygodnia życia, a wszystkie dawki powinny zostać podane przed ukończeniem 8 miesiąca życia1. WHO zaleca podawanie pierwszej dawki szczepionki jak najwcześniej po ukończeniu 6 tygodnia życia, wraz ze szczepieniem DTP1.
Skuteczność szczepionek przeciw rotawirusom
Szczepionki przeciw rotawirusom wykazują wysoki poziom skuteczności w zapobieganiu zakażeniom i powikłaniom związanym z rotawirusem.
Skuteczność kliniczna
Badania kliniczne wykazały, że szczepionki przeciw rotawirusom zapewniają:
- 85-98% ochrony przed ciężkim przebiegiem choroby rotawirusowej i hospitalizacją w pierwszym roku po szczepieniu12
- 74-87% ochrony przed rotawirusowym zapaleniem żołądka i jelit o dowolnym nasileniu12
- Skuteczność szczepionki RotaTeq przeciw serotypom G1, G2, G3, G4 i G9, będącym najczęstszymi szczepami w Europie1
- Skuteczność szczepionki Rotarix przeciw serotypom G1 i non-G1 (G3, G4 i G9)1
Badania skuteczności w Afryce i Azji, prowadzone w krajach o wysokiej umieralności dzieci, wykazały skuteczność na poziomie 50-77%, co wskazuje na nieco niższą skuteczność w tych regionach w porównaniu z krajami rozwiniętymi1.
Wpływ na zdrowie publiczne
Wprowadzenie szczepionek przeciw rotawirusom do programów szczepień przyczyniło się do znacznego zmniejszenia obciążenia chorobami:
- Kraje, które wprowadziły rutynowe szczepienia przeciw rotawirusom, odnotowały zmniejszenie liczby hospitalizacji i wizyt na oddziałach ratunkowych z powodu choroby rotawirusowej o około 85%1
- W Stanach Zjednoczonych szczepienia przeciw rotawirusom zapobiegają rocznie około 40 000-50 000 hospitalizacji niemowląt i małych dzieci1
- Od czasu wprowadzenia szczepionki w 2006 roku liczba hospitalizacji z powodu rotawirusa w USA zmniejszyła się o około 80%1
- Według badań CDC, skuteczność pojedynczej dawki szczepionki przeciw rotawirusowi w zapobieganiu wizytom na oddziałach ratunkowych lub hospitalizacjom z powodu zapalenia przewodu pokarmowego wynosiła 78% u dzieci poniżej 5 lat i 53% u starszych dzieci w latach 2009-20221
W skali globalnej, szczepienia przeciw rotawirusom zapobiegły około 140 000 zgonów dzieci w latach 2006-2019, a liczba ta nadal rośnie1. Kraje, które wprowadziły szczepionkę, zaobserwowały średnio 59% redukcję hospitalizacji z powodu rotawirusa wśród dzieci poniżej piątego roku życia oraz 36% zmniejszenie liczby zgonów z powodu ciężkiej biegunki1.
Bezpieczeństwo szczepionek przeciw rotawirusom
Profil bezpieczeństwa szczepionek przeciw rotawirusom jest dobrze udokumentowany, a korzyści zdecydowanie przewyższają potencjalne ryzyko.
Profil bezpieczeństwa
Obecne szczepionki przeciw rotawirusom (RotaTeq i Rotarix) zostały szeroko przebadane pod kątem bezpieczeństwa:
- Są one uznawane za bezpieczne i dobrze tolerowane przez większość niemowląt1
- Rzadko występującym potencjalnym działaniem niepożądanym jest wgłobienie jelita (intussusception), które może wystąpić w ciągu tygodnia po podaniu pierwszej lub drugiej dawki szczepionki1
- Ryzyko wgłobienia jelita jest bardzo niskie i szacuje się je na około 1 na 100 000 zaszczepionych dzieci1
- Dane nie wykazują zwiększonego ryzyka wgłobienia jelita w przypadku obecnie stosowanych w USA szczepionek RotaTeq i Rotarix1
Globalny Komitet Doradczy ds. Bezpieczeństwa Szczepionek (GACVS) potwierdza, że profil bezpieczeństwa obecnych szczepionek przeciw rotawirusom jest akceptowalny, a korzyści z ich stosowania znacznie przewyższają potencjalne ryzyko1.
Przeciwwskazania i środki ostrożności
Istnieją pewne przeciwwskazania do stosowania szczepionek przeciw rotawirusom:
- Ciężki złożony niedobór odporności (SCID)1
- Wcześniejsze przypadki wgłobienia jelita12
- Ciężka nadwrażliwość na jakikolwiek składnik szczepionki lub reakcja alergiczna na wcześniejszą dawkę1
- Nie należy podawać szczepionki dzieciom z ostrym, umiarkowanym lub ciężkim zapaleniem żołądka i jelit do czasu poprawy ich stanu1
Należy zachować ostrożność przy podawaniu szczepionki dzieciom ze zmienionym stanem układu odpornościowego, rozważając korzyści i potencjalne ryzyko1. W przypadku wcześniaków, szczepionkę przeciw rotawirusom można podawać, jeśli ukończyły co najmniej 6 tygodni życia, są wypisywane z oddziału noworodkowego i są klinicznie stabilne12.
Zalecenia dotyczące szczepień przeciw rotawirusom
Międzynarodowe i krajowe organizacje zdrowia zalecają włączenie szczepień przeciw rotawirusom do rutynowych programów szczepień.
Zalecenia WHO i innych organizacji
WHO zaleca włączenie szczepionek przeciw rotawirusom do wszystkich krajowych programów szczepień i uznaje je za priorytet, szczególnie w krajach Azji Południowej i Południowo-Wschodniej oraz Afryki Subsaharyjskiej1. Według WHO, pierwsza dawka szczepionki przeciw rotawirusom powinna być podana jak najszybciej po ukończeniu 6 tygodnia życia, wraz ze szczepieniem DTP1.
W Stanach Zjednoczonych, Komitet Doradczy ds. Praktyk Szczepień (ACIP) zaleca rutynowe szczepienia przeciw rotawirusom wszystkich niemowląt1. Amerykańska Akademia Pediatrii (AAP) również popiera stosowanie szczepionek przeciw rotawirusom i nie wskazuje preferencji dla żadnej z dostępnych szczepionek – RotaTeq czy Rotarix1.
Narodowa Fundacja Chorób Zakaźnych w USA zaleca, aby dzieci otrzymały pierwszą dawkę szczepionki przed ukończeniem 15 tygodnia życia i ukończyły wszystkie dawki przed ukończeniem 8 miesiąca życia1.
Implementacja w różnych krajach
Ponad 120 krajów wprowadziło krajowe programy szczepień przeciw rotawirusom, a około 17 dodatkowych krajów planuje je wprowadzić12. Szczepionki przeciw rotawirusom są włączone do rutynowych programów szczepień w wielu krajach europejskich, co podsumowuje Harmonogram Szczepień ECDC1.
W niektórych krajach, jak na przykład w Wietnamie, ministerstwo zdrowia oficjalnie włączyło szczepionkę przeciw rotawirusom do Krajowego Rozszerzonego Programu Szczepień, oferując ją bezpłatnie w celu zapewnienia równego dostępu dla wszystkich dzieci1.
Znaczenie szczepień przeciw rotawirusom w kontekscie globalnym
Szczepienia przeciw rotawirusom mają kluczowe znaczenie dla globalnego zdrowia publicznego, szczególnie w krajach o ograniczonych zasobach.
Efektywność kosztowa
Szczepionki przeciw rotawirusom okazały się być interwencją opłacalną kosztowo, która nie tylko ratuje życie, ale także zmniejsza obciążenie rodzin i systemów opieki zdrowotnej1. Według badania przeprowadzonego w 116 krajach, szczepienia przeciw rotawirusom są opłacalne kosztowo, szczególnie w krajach o niskich i niższych średnich dochodach z wysoką umieralnością dzieci1.
Analizy opłacalności kosztowej nadal wykazują wyraźną korzyść dla decydentów w zakresie inwestowania w szczepionki przeciw rotawirusom1. Wprowadzenie szczepionek przeciw rotawirusom w okresie 2006-2008 doprowadziło do zmniejszenia liczby hospitalizacji z powodu rotawirusa o około 75% i hospitalizacji z powodu biegunki o 33% w USA1.
Globalne wyzwania i perspektywy
Pomimo znaczących postępów, nadal istnieją wyzwania związane z dostępem do szczepionek przeciw rotawirusom:
- Prawie połowa wszystkich niemowląt na świecie nadal nie ma dostępu do szczepionki przeciw rotawirusom, głównie w Azji1
- Wprowadzenie nowych szczepionek przeciw rotawirusom na globalny rynek jest kluczowe dla poprawy przystępności cenowej i zapewnienia zrównoważonej podaży1
- Potrzebne są międzynarodowe wysiłki, aby zapewnić, że szczepionki przeciw rotawirusom dotrą do populacji o największym obciążeniu chorobą rotawirusową1
Gdyby szczepionki przeciw rotawirusom zostały wprowadzone w rutynowych programach szczepień wszystkich krajów, potencjalnie można by zapobiec około 170 000 zgonów rocznie1. Największy wpływ na śmiertelność byłby widoczny w krajach o niskich i średnich dochodach, pomimo słabego zasięgu szczepień i niższej skuteczności12.
Integracja szczepień z innymi działaniami profilaktycznymi
WHO podkreśla, że stosowanie szczepionek przeciw rotawirusom powinno być częścią kompleksowej strategii kontroli chorób biegunkowych, wraz ze zwiększeniem skali zarówno profilaktyki, jak i leczenia1.
Kompleksowe podejście do profilaktyki
Szczepienia przeciw rotawirusom powinny być zintegrowane z innymi interwencjami:
- Promocja wczesnego i wyłącznego karmienia piersią1
- Mycie rąk mydłem1
- Poprawa jakości wody i warunków sanitarnych1
- Pakiety lecznicze, w tym roztwory do nawadniania doustnego o niskiej osmolarności i cynk1
Warto jednak podkreślić, że w przypadku rotawirusów, które są wysoce zakaźne, nawet poprawa warunków sanitarnych nie zmniejsza występowania choroby rotawirusowej, dlatego szczepienia są najskuteczniejszą metodą profilaktyki1.
Zalecenia dla rodziców i opiekunów
Rodzice i opiekunowie są zachęcani do:
- Zapewnienia dzieciom szczepień przeciw rotawirusom zgodnie z zaleceniami, rozpoczynając od 2 miesiąca życia i kończąc przed ukończeniem 6 miesiąca życia1
- Przestrzegania zasad higieny, w tym mycia rąk i utrzymywania czystości przedmiotów (w tym zabawek), które mogą być wspólnie używane1
- Wykluczenia osób z rotawirusem z żłobków, przedszkoli, szkół i pracy, dopóki nie minie co najmniej 24 godziny od ustąpienia wymiotów lub biegunki1
- Niepozwalania niemowlętom, dzieciom i dorosłym z zakażeniem rotawirusem na pływanie, dopóki nie minie 24 godziny od ustąpienia biegunki1
Proaktywna profilaktyka jest najlepszym sposobem ochrony dzieci od samego początku życia przed ryzykiem ostrej biegunki wywołanej przez rotawirusy oraz wspierania ich zdrowego i wszechstronnego rozwoju1.
Przyszłość szczepień przeciw rotawirusom
Badania nad nowymi rodzajami szczepionek przeciw rotawirusom są kontynuowane, a trwające prace mogą prowadzić do dalszej poprawy skuteczności i bezpieczeństwa szczepień.
Nowe szczepionki w fazie rozwoju
Opracowywane są nowe rodzaje szczepionek przeciw rotawirusom, które mają potencjał do przezwyciężenia niektórych ograniczeń obecnych szczepionek:
- Szczepionki inaktywowane przeciw rotawirusom (IRV) podawane pozajelitowo są w fazie badań klinicznych12
- Szczepionki nienamnażające się, podawane parenteralnie, mają potencjał do zmniejszenia różnic w skuteczności i obaw dotyczących bezpieczeństwa związanych z żywymi doustnymi szczepionkami przeciw rotawirusom1
- Szczepionka Rotavin-M1, żywa, atenuowana, mrożona szczepionka doustna pochodząca z ludzkiego szczepu rotawirusa (G1P[8]) wyizolowanego od dziecka hospitalizowanego z powodu biegunki w Nha Trang w Wietnamie, wykazała dobrą tolerancję i immunogenność (73% serokonwersji) w badaniu wietnamskich niemowląt1
W kwietniu 2009 roku Grupa Strategicznych Doradców Ekspertów WHO (SAGE) zaleciła włączenie szczepień przeciw rotawirusom do wszystkich krajowych programów szczepień niemowląt1. Częstość występowania choroby rotawirusowej znacznie spadła we wszystkich krajach, które wprowadziły szczepionkę1.
Monitorowanie i nadzór
Komitet silnie zaleca, aby wprowadzenie szczepionek przeciw rotawirusom było związane z uważnym rozważeniem nadzoru po wprowadzeniu do obrotu na poziomie krajowym i zabezpieczeniem jego finansowania jako istotnej części programów szczepień1.
Aby utrzymać zaufanie społeczeństwa do programu szczepień przeciw rotawirusom, kluczowe jest monitorowanie długoterminowej skuteczności szczepionek, szczególnie przeciwko ciężkim chorobom1.
Badania postmarketingowe w celu oceny bezpieczeństwa szczepionek w odniesieniu do wgłobienia jelita oraz skuteczności szczepionek są w toku, a rozszerzenie rutynowego stosowania obu szczepionek jest przewidywane wraz z ogólnokrajowym wprowadzeniem1.
| Nazwa szczepionki | Producent | Typ | Schemat dawkowania | Skuteczność przeciwko ciężkiej biegunce rotawirusowej | Skuteczność przeciwko biegunce rotawirusowej o dowolnym nasileniu | Serotypy |
|---|---|---|---|---|---|---|
| Rotarix | GlaxoSmithKline | Monowalentna, atenuowana ludzka | 2 dawki (2 i 4 miesiąc życia) | 85-98% | 74-87% | G1 i non-G1 (G3, G4, G9) |
| RotaTeq | Merck | Pentawalentna ludzko-bydlęca reasortowana | 3 dawki (2, 4 i 6 miesiąc życia) | 85-98% | 74-87% | G1, G2, G3, G4, G9 |
| Rotavac | Bharat Biotech | Naturalny reasortant bydlęco-ludzki | 3 dawki | Dane różnią się w zależności od regionu (50-77% w Afryce/Azji) | Dane różnią się w zależności od regionu | G9P |
| RotaSiil | Serum Institute of India | Bydlęco-ludzki reasortant | 3 dawki | Dane różnią się w zależności od regionu | Dane różnią się w zależności od regionu | Ludzkie G1, G2, G3, G4 z bydlęcym G6P[5] |
Znaczenie profilaktyki rotawirusowej
Zakażenie rotawirusowe jest uważane za chorobę, której można zapobiec poprzez szczepienia, na podstawie pomyślnych wyników u dzieci i spadku liczby hospitalizacji w krajach rozwiniętych1. Szczepienia przeciw rotawirusom znacząco zmniejszyły zachorowalność i śmiertelność z powodu biegunki na całym świecie1.
Szacuje się, że zwiększenie dostępu do tych szczepionek w krajach wspieranych przez GAVI może zapobiec ponad 2,4 milionom zgonów do 2030 roku1. Wraz z innymi interwencjami, takimi jak zapewnienie bezpiecznej żywności i wody, poprawa warunków sanitarnych, promocja karmienia piersią i zapobieganie niedożywieniu dzieci, szczepionki przeciw rotawirusom będą miały istotny wpływ na zmniejszenie zachorowalności i śmiertelności z powodu ciężkiej biegunki u dzieci na całym świecie1.
Wprowadzenie rutynowych szczepień przeciw rotawirusom doprowadziło do szybkiego i znacznego zmniejszenia obciążenia ciężką biegunką rotawirusową w krajach stosujących szczepionkę, a bezpieczeństwo szczepionki zostało wykazane poprzez dobrze zaprojektowane, szeroko zakrojone oceny po wprowadzeniu do obrotu1. Szczepionki przeciw rotawirusom stały się więc kluczowym narzędziem w globalnej walce z chorobami biegunkowymi u dzieci.
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Materiały źródłowe
- #1 Rotavirus – Wikipediahttps://en.wikipedia.org/wiki/Rotavirus
Rotaviruses are highly contagious and cannot be treated with antibiotics or other drugs. Because improved sanitation does not decrease the prevalence of rotaviral disease, and the rate of hospitalisations remains high despite the use of oral rehydrating medicines, the primary public health intervention is vaccination. […] In 2006, two new vaccines against rotavirus A infection were shown to be safe and effective in children, and in 2009, the WHO recommended that rotavirus vaccine be included in all national immunisation programmes. […] The incidence and severity of rotavirus infections has declined significantly in countries that have acted on this recommendation. […] A 2014 review of available clinical trial data from countries routinely using rotavirus vaccines in their national immunisation programs found that rotavirus vaccines have reduced rotavirus hospitalisations by 49-92% and all cause diarrhoea hospitalisations by 17-55%. […] In the United States, rotavirus vaccination since 2006 has led to drops in rotavirus-related hospitalisations by as much as 86 percent. […] Globally, vaccination has reduced hospital admissions and emergency department visits by a median of 67%.
- #1 Rotavirus Vaccine Recommendations | Rotavirus | CDChttps://www.cdc.gov/rotavirus/hcp/vaccine-considerations/index.html
There are two rotavirus vaccines approved for use in infants in the United States; both are safe and effective. […] Infants should get 2 or 3 doses of rotavirus vaccine, depending on the brand of vaccine used. […] Each year, the vaccine prevents an estimated 40,000 to 50,000 hospitalizations among U.S. infants and young children. […] During an infant’s first year, rotavirus vaccine provides: – 85% to 98% protection against severe rotavirus illness and hospitalization. – 74% to 87% protection against rotavirus illness of any severity. […] CDC recommends routine vaccination of infants with either of the two available vaccines: RotaTeq licensed in 2006 Given in 3 doses at ages 2 months, 4 months, and 6 months Rotarix licensed in 2008 Given in 2 doses at ages 2 months and 4 months. […] The first dose of either vaccine should be given before a child is 15 weeks of age. Children should receive all doses of rotavirus vaccine before they turn 8 months old. […] You may consider vaccinating babies with weakened immune systems due to: HIV/AIDS, or any other disease that affects the immune system.
- #1https://www.who.int/teams/immunization-vaccines-and-biologicals/diseases/rotavirus
Four oral, live, attenuated rotavirus vaccines, Rotarix (derived from a single common strain of human rotavirus); RotaTeq (a reassorted bovine-human rotavirus); Rotavac (naturally occurring bovine-human reassortant neonatal G9P, also called 116E); and RotaSiil (bovine-human reassortant with human G1, G2, G3 and G4 bovine UK G6P[5] backbone) are available internationally and WHO prequalified. All four vaccines are considered highly effective in preventing severe gastrointestinal disease. […] WHO recommends that rotavirus vaccines should be included in all national immunization programmes and considered a priority particularly in countries in South and Southeast Asia and sub-Saharan Africa. WHO continues to recommend that the first dose of rotavirus vaccine be administered as soon as possible after 6 weeks of age, along with DTP vaccination.
- #1 Rotarix, RotaTeq (rotavirus oral vaccine, live) dosing, indications, interactions, adverse effects, and morehttps://reference.medscape.com/drug/rotarix-rotateq-rotavirus-oral-vaccine-live-343148
Live, attenuated oral vaccine indicated for immunization to prevent rotavirus gastroenteritis in infants and children […] RotaTeq: 3 Dose Regimen […] Pentavalent vaccine; prevention of rotavirus gastroenteritis caused by the G1, G2, G3, and G4 serotypes, plus attachment protein serotype P7 […] Total of three 2 mL doses administered orally […] First dose given at 6-12 weeks of age […] Subsequent doses administered at 4-10 week intervals […] Third dose should not be given after 32 weeks of age […] Rotarix: 2-Dose Regimen […] Prevention of rotavirus gastroenteritis caused by G1 and non-G1 serotypes (G3, G4, and G9) […] Total of two 1 mL doses administered orally […] Administer first dose to infants beginning at 6 weeks of age […] Administer second dose after an interval of at least 4 weeks and prior to 24 weeks of age […] CDC researchers observed rotavirus-associated diarrhea decreased by 75% and hospitalizations for diarrhea by 33% during 2007-2008 following 2006 introduction of pentavalent rotavirus vaccine; diarrhea-related incidence also decreased among age-matched unvaccinated children.
- #1 Administration for RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)https://www.merckvaccines.com/rotateq/rotavirus-vaccine-administration/
RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age. […] The vaccination series consists of 3 ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age. […] RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children. […] RotaTeq may not protect all vaccine recipients against rotavirus.
- #1 Rotavirus Vaccination: For Providers | CDChttps://www.cdc.gov/vaccines/vpd/rotavirus/hcp/index.html
CDC recommends that infants get rotavirus vaccine to protect against rotavirus disease. […] The first dose of either vaccine should be given before a child is 15 weeks of age. Children should receive all doses of rotavirus vaccine before they turn 8 months old. […] Both vaccines are given by putting drops in the child’s mouth.
- #1https://link.springer.com/article/10.2165/11205030-000000000-00000
Moreover, RotaTeq has demonstrated efficacy against the five most prevalent serotypes of rotavirus in Europe (G1G4, G9), in terms of reductions in associated healthcare resource use. […] In conclusion, RotaTeq is a generally well tolerated vaccine that has efficacy against the five most prevalent serotypes of rotavirus in Europe and provides sustained efficacy over the main risk period for rotavirus gastroenteritis in infants and children, reducing hospitalizations and emergency department visits by decreasing the incidence and severity of illness.
- #1 Homepage | ROTARIX (Rotavirus Vaccine, Live, Oral) for HCPshttps://www.rotarixhcp.com/
ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age. […] ROTARIX demonstrated efficacy vs placebo in the prevention of rotavirus gastroenteritis (RGE). […] ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age. […] Vaccination with ROTARIX may not result in protection in all vaccine recipients.
- #1 Vaccines for the prevention of diarrhea due to cholera, shigella, ETEC and rotavirus | BMC Public Health | Full Texthttps://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-13-S3-S11
A total of 24 papers were selected and analyzed for all the four vaccines. Based on the evidence, we propose a 74% mortality reduction in rotavirus specific mortality, 52% reduction in cholera incidence due to their respective vaccines. […] Vaccines for rotavirus and cholera have the potential to reduce diarrhea morbidity and mortality burden. […] Prevalence of rotavirus related gastro-enteritis is similar in developed and developing countries, showing that it has little or no association with sanitation systems, as opposed to the former three organisms. This makes vaccination even more important and studies have shown that vaccination contributes significantly towards reduction in cases of rotavirus related illnesses in the developed world. […] Recent Phase III trials of the monovalent rotavirus vaccine in Malawi and South Africa have also shown a vaccine efficacy of 77% against severe rotavirus infection in South Africa and lower (50%) efficacy in Malawi.
- #1 Rotavirus vaccines: Canadian Immunization Guide – Canada.cahttps://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-19-rotavirus-vaccine.html
Rotavirus vaccine efficacy against diarrhea of any severity in developed world settings is 74% to 87%; efficacy against severe diarrhea is 85% to 98%. […] RV vaccine reduces physician and emergency room visits for diarrhea and hospital admissions for RV diarrhea. […] RV vaccines are recommended for infants starting at 6 weeks and before 15 weeks of age. The vaccination series should be completed before 8 months of age. […] To optimize protection, RV vaccine should be initiated as soon after 6 weeks of age as feasible. […] Countries with routine RV immunization programs have seen reductions in the number of infants and children needing hospitalization or emergency department care for RV disease by about 85%. […] The efficacy of RV vaccines is similar among infants who are breastfed and those who are not; therefore, breastfed infants can receive RV vaccine.
- #1 Rotavirus: The Disease & Vaccines | Children’s Hospital of Philadelphiahttps://www.chop.edu/vaccine-education-center/vaccine-details/rotavirus-vaccine
Without a rotavirus vaccine, approximately 55,000 to 70,000 children born in the United States would be hospitalized with rotavirus each year. Since the vaccine has been in use, this number has decreased by about 80 percent. There are no severe side effects from rotavirus vaccine. Therefore, the benefits of the rotavirus vaccine clearly outweigh the risks.
- #1 CDC: Rotavirus vaccine 78% effective against serious illness in preschoolers, 53% in older kids | CIDRAPhttps://www.cidrap.umn.edu/rotavirus/cdc-rotavirus-vaccine-78-effective-against-serious-illness-preschoolers-53-older-kids
The effectiveness of a single dose of the rotavirus vaccine against emergency department (ED) visits or hospitalizations for inflammation of the gastrointestinal tract was 78% in children younger than 5 years and 53% in older children from 2009 to 2022, estimates a US Centers for Disease Control and Prevention (CDC)-led study published yesterday in Pediatrics. […] „Rotavirus vaccines remain highly effective in preventing rotavirus-associated ED visits and hospitalizations across time, disease severity, and common genotypes in the US,” the researchers wrote. […] To maintain the public’s confidence in the rotavirus vaccination program, it is critical to monitor long-term effectiveness of rotavirus vaccines, especially against severe illness.
- #1 How rotavirus vaccines are changing the gameverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedhttps://www.gavi.org/vaccineswork/how-rotavirus-vaccines-are-changing-game
From 2006 to 2019, the vaccines saved an estimated 140,000 childrenâs lives, and that number has only grown since. […] More than 120 countries have introduced rotavirus vaccines into their routine immunization programs, with more planning to do so this year. […] Countries that introduced the vaccine observed a 59 percent average reduction in rotavirus hospitalizations among children less than five years old, and a 36 percent decrease in deaths from severe diarrhea. […] Over nearly two decades, rotavirus vaccines have proven to be a cost-effective intervention that not only saves lives, but also helps keep families from potentially crippling financial hardship.
- #1 What Is Rotavirus? Symptoms & Treatmenthttps://my.clevelandclinic.org/health/diseases/8275-rotavirus
Rotavirus vaccines have kept many kids healthy. […] The rotavirus vaccines Rotarix or RotaTeq can protect children from getting rotavirus or make their symptoms less severe if they do get it. […] The vaccines have significantly improved children’s health and hospitalization rates. […] The best way to prevent rotavirus and protect the health of your family is to make sure they get one of the rotavirus vaccines. […] About 70% of children who receive the vaccine don’t get rotavirus. For those who still get infected, the symptoms are much milder. […] Scientists have tested both rotavirus vaccines extensively in thousands of babies. They consider both vaccines safe and effective. […] The vaccine is your best defense against the disease. […] The rotavirus vaccine is the best way to protect your child’s health.
- #1 Rotavirus: The Disease & Vaccines | Children’s Hospital of Philadelphiahttps://www.chop.edu/vaccine-education-center/vaccine-details/rotavirus-vaccine
The Centers for Disease Control and Prevention (CDC) approved a rotavirus vaccine for use in all infants in the United States in 2006. The vaccine, called RotaTeq, is given as a series of three doses by mouth at 2 months, 4 months and 6 months of age and can be given with other vaccines typically administered at those times. A second vaccine, called Rotarix, was approved for use in June 2008 and is given as a series of two doses by mouth at 2 months and 4 months of age. […] The current rotavirus vaccines have also been found to be rare causes of intestinal blockage (intussusception) affecting about 1 in 100,000 children, usually occurring within a week after getting the first or second dose of vaccine. […] Because virtually every young child gets rotavirus, and about 1 of every 65 are hospitalized as a result, the benefit of getting the rotavirus vaccine clearly outweighs the risk. Therefore, the rotavirus vaccine has been added back to the U.S. infant immunization schedule and is recommended for all infants.
- #1 Rotavirus – Infectious Disease Advisorhttps://www.infectiousdiseaseadvisor.com/ddi/rotavirus/
Rotavirus is a highly contagious infection that causes diarrhea and vomiting. The first licensed modern rotavirus vaccine was introduced in 2006. Since then, rates of severe rotavirus infection have decreased, averting approximately 45,000 hospitalizations annually. […] Vaccination against rotavirus is currently the best protection against infection. Four vaccines have been developed for rotavirus: RV5 vaccine (RotaTeq [Merck]), RV1 vaccine (Rotarix [GSK]), ROTAVAC (Bharat Biotech), and Rotasiil (Serum Institute of India). In the US, only the RV5 and RV1 vaccines are available. The National Foundation for Infectious Diseases recommends that children receive their first vaccine before age 15 weeks and complete all doses before age 8 months. […] The rotavirus vaccines currently available in the US (RV5 and RV1) have been tested for intussusception. The data do not show an increased risk of intussusception with these vaccines.
- #1 Statement from the Global Advisory Committee on Vaccine Safetyhttps://www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/rotavirus-vaccines/related-links
Two rotavirus vaccines, Rotarix and RotaTeq, are in widespread use globally for the prevention of rotavirus gastroenteritis in young infants. WHO recommends the inclusion of rotavirus vaccine in all country immunization programs. Their use has resulted in reductions of infant diarrheal deaths, hospitalizations and incidence of rotavirus gastroenteritis. Thus even in countries where mortality rates for rotavirus gastroenteritis are low, there is a substantial health benefit associated with vaccination. […] However, the benefits of prevention of rotavirus gastroenteritis have continued to be judged to outweigh risks associated with vaccination, including the risk of intussusception. […] Based on its reviews over the past several years, including the risk of intussusception, GACVS continues to affirm that the safety profile of current rotavirus vaccines is acceptable, with the benefits of vaccination greatly exceeding risks. The benefits of rotavirus vaccination are particularly important in resource-poor countries where rotavirus disease remains an important cause of mortality among young children.
- #1 Public Health Resources for Rotavirus Infectionhttps://www.rotateq.com/caregiver-resources/patient-resources/
RotaTeq may not fully protect all children who get the vaccine. […] RotaTeq should not be given to infants who are allergic to any part of the vaccine. […] Your child should not get RotaTeq if he or she has Severe Combined Immunodeficiency Disease (SCID). […] Your child should not get RotaTeq if he or she has ever had intussusception, a form of blockage in the intestines.
- #1 ACIP Recommends Routine Rotavirus Vaccinations in Infants and Children | AAFPhttps://www.aafp.org/pubs/afp/issues/2007/0315/p924.html
It is acceptable for the rotavirus vaccine to be administered with the Hib, hepatitis B, pneumococcal conjugate, DTaP, and inactivated poliovirus vaccines. […] ACIP recommends against administering the rotavirus to infants who have severe hypersensitivity to any component in the vaccine or to infants who have had a serious allergic reaction to a previous dose of the rotavirus vaccine. […] Family physicians should consider the benefits and potential risks of administering the rotavirus vaccination to infants who are known or suspected to have altered immunocompetence. […] ACIP recommends against the administration of the rotavirus vaccine to infants who have acute, moderate-to-severe gastroenteritis until the condition improves. […] Premature infants may be at increased risk of hospitalization from viral gastroenteritis during their first year of life. ACIP recommends the vaccination of premature infants only if they are six weeks of age or older, are being discharged from the hospital nursery, and are clinically stable.
- #1 Rotavirus | The Australian Immunisation Handbookhttps://immunisationhandbook.health.gov.au/contents/vaccine-preventable-diseases/rotavirus
All infants <6 months of age are recommended to receive a course of oral rotavirus vaccine. [...] Infants can receive the 1st dose of rotavirus vaccine as early as 6 weeks of age. [...] Infants and children >6 months of age should not receive rotavirus vaccines. […] Rotavirus vaccine is funded through the NIP for all infants aged <6 months of age. [...] Infants who develop rotavirus gastroenteritis before receiving the full course of rotavirus vaccine should still complete the full 2- or 3-dose schedule. [...] Preterm infants are recommended to receive either rotavirus vaccine starting at the chronological age of at least 6 weeks, if the infant is clinically stable. [...] Vaccinating hospitalised infants, including hospitalised preterm infants, has a low risk of transmitting vaccine viruses if standard infection control precautions are maintained. [...] Infants living in households with pregnant women can receive rotavirus vaccines. [...] Rotavirus vaccination significantly reduces rotavirus-specific and all-cause hospital presentations for gastroenteritis.
- #1 Public Health Resources for Rotavirus Infectionhttps://www.rotateq.com/caregiver-resources/patient-resources/
The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) recommends routine rotavirus vaccination for all eligible babies. The CDC has included RotaTeq in its Vaccines for Children Program. […] RotaTeq is an oral vaccine used to help prevent rotavirus infection in children. […] RotaTeq may not fully protect all children that get the vaccine, and if your child already has the virus it will not help them. […] RotaTeq is not a shot; the vaccine is given by mouth. Your child will receive 3 doses of the vaccine. The first dose is given when your child is 6 to 12 weeks of age, the second dose is given 4 to 10 weeks later, and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks of age.
- #1 Does Your Child Really Need the Rotavirus Vaccine?https://www.verywellhealth.com/rotavirus-vaccine-8715245
The CDC recommends that infants receive their first dose of the rotavirus at 2 months old. […] The American Academy of Pediatrics (AAP) and the Advisory Committee on Immunization Practices (ACIP) support the use of rotavirus vaccinations and do not state a preference for either RotaTeq or Rotarix. […] The rotavirus vaccine is advised for all healthy infants, starting at 2 months of age. The vaccine is the best way to protect your child from the rotavirus and its severe complications. Your infant can receive comparable defense from either of two FDA-approved oral rotavirus vaccines. […] Side effects of the rotavirus vaccine are mild for most infants. The vaccine also carries a very small risk of intussusception. However, the benefits of being vaccinated outweigh the slight risk of getting this side effect.
- #1 Rotavirus vaccines for infants – UpToDatehttps://www.uptodate.com/contents/rotavirus-vaccines-for-infants
Rotavirus vaccines for infants […] Rotavirus vaccination of infants will be discussed below. […] More than 120 countries have introduced national rotavirus vaccination programs, and approximately 17 additional countries are planning to introduce them. […] Two live, attenuated oral rotavirus vaccines are licensed for use in the United States and many other countries. The vaccines have similar efficacy and safety, and no preference for one over the other vaccine exists.
- #1 Disease factsheet about rotavirushttps://www.ecdc.europa.eu/en/rotavirus-infection/facts
Rotavirus infections are vaccine-preventable following the approval of two oral, live attenuated rotavirus vaccines in 2006 for use in infants. […] Two live attenuated vaccines for oral use providing prevention against rotavirus disease were authorised in the European Union in 2006; The indication for these vaccines is active immunization of infants for prevention of gastroenteritis due to rotavirus infection. Some EU/EEA countries have introduced rotavirus vaccination in their national immunisation programme and this is summarised in the ECDC Vaccine Scheduler.
- #1 Rotavirus vaccine | UNICEF Viet Namhttps://www.unicef.org/vietnam/stories/rotavirus-vaccine
Since 2024, the Ministry of Health has officially included the rotavirus vaccine in the National Expanded Immunisation Program, offering it free of charge to ensure equal access for all children. […] Proactive prevention is the best way to protect children from the very beginning of life. Parents and caregivers are therefore strongly encouraged to take their children to local health facilities for rotavirus vaccination once the child turns two months old, and to ensure completion before six months of age, to shield them from the risks of rotavirus-induced acute diarrhoea and to support their healthy and comprehensive development.
- #1 How rotavirus vaccines are changing the gameverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedhttps://www.gavi.org/vaccineswork/how-rotavirus-vaccines-are-changing-game
Rotavirus vaccines have proven to be a cost-effective intervention that not only saves lives, but also reduces the burden on families and health systems. […] Rotavirus vaccines, first introduced in 2006, are a prime example of this achievementâand thanks to recent introductions in high-burden countries, their impact is poised to accelerate in the years ahead. […] Rotavirus presents a unique problem: it spreads quickly and cannot be prevented by improvements in water, sanitation, and hygiene (WASH), unlike the bacteria and parasites that cause other forms of diarrhea. […] That changed in 2006, when Nicaragua and the United States were among the first countries to introduce rotavirus vaccines. […] Rotavirus vaccine also helped facilitate greater momentum for integrated approaches to diarrheal diseases, an approach that was piloted in Nicaragua.
- #1 Rotavirus vaccine supporthttps://www.gavi.org/types-support/vaccine-support/rotavirus
Rotavirus vaccines protect against the deadliest form of diarrhoea in young children. One of Gavi’s main objectives is to ensure access to these vaccines in the countries that need them most. […] According to a study in 116 countries, rotavirus vaccination is cost-effective. This is particularly true in low- and lower-middle-income countries with high child mortality. […] Although it can be treated with proper healthcare, this is often lacking in low-income countries. As a result, vaccination is the best way to prevent rotavirus illness and death. […] WHO recommends that all countries introduce rotavirus vaccines in their national programmes. […] Recent studies show significant impact of rotavirus vaccines. Following introductions of the vaccine, diarrhoeal deaths in young children fell by 19â43% in Bolivia, 43â55% in Mexico and 57â64% in Venezuela.
- #1 Finding inspiration from rotavirus vaccines as we rally against COVID-19 – Defeat DDhttps://www.defeatdd.org/blog/finding-inspiration-rotavirus-vaccines-we-rally-against-covid-19/
A happy family awaits their childs receipt of rotavirus vaccine at Rwandas launch in 2012. […] As weve often said of diarrheal disease, vaccines offer the best form of protection against life-threatening infections where medical care may be difficult to access. […] Advocates can take inspiration from the rotavirus vaccine story. Rotavirus is the most lethal form of childhood diarrhea, and unlike many other diarrhea pathogens, even hygiene and sanitation are ineffective against it. […] In 2006, the rotavirus vaccine was introduced for the first time in both the US and Nicaragua. […] Since then, more than 100 countries have introduced the vaccine. […] Cost-effectiveness analyses continue to demonstrate the clear advantage for policymakers to invest in rotavirus vaccines. […] One of the most important actions we can take right now is to ensure children are protected against the greatest infectious threats with proven prevention tools like vaccines and WASH.
- #1 Finding inspiration from rotavirus vaccines as we rally against COVID-19 – Defeat DDhttps://www.defeatdd.org/blog/finding-inspiration-rotavirus-vaccines-we-rally-against-covid-19/
It is also an important recognition of the fact that were far from finished with rotavirus. Almost half of all infants still lack access to rotavirus vaccine, mostly in Asia. […] Rotavirus vaccines have proven to be a cost-effective intervention that not only saves lives, but also reduces the burden on families and health systems.
- #1 Deadly rotavirus and the vaccines that can stop it | PATHhttps://www.path.org/our-impact/articles/the-democratic-virus-and-its-major-weakness-vaccines/
The work to stop this leading child killer isn’t over yet. More than 40 percent of the world’s children still don’t have access to rotavirus vaccines. […] Bringing new rotavirus vaccines to the global market is critical to improving affordability and ensuring a sustainable supply. […] By helping make more rotavirus vaccines available for countries to choose from, we can increase access, improve supply, reduce costs, and ultimately save more lives from this preventable disease.
- #1 Prevention of rotavirus gastroenteritis in infants and children: rotavirus vaccine safety, efficacy, and potential impact of vaccineshttps://pmc.ncbi.nlm.nih.gov/articles/PMC2921258/
Rotavirus infection is the most common cause of severe gastroenteritis globally, with greater than 86% of deaths occurring in low-income and middle-income countries. There are two rotavirus vaccines currently licensed in the United States and prequalified by the World Health Organization. RV1 is a monovalent attenuated human rotavirus strain, given orally in two doses. RV5 is a pentavalent human-bovine reassortant rotavirus vaccine, given orally in three doses. A third rotavirus vaccine, LLV, is a lamb rotavirus strain given orally as a single dose, which is currently available only in China. RV1 and RV5 have been shown to be highly efficacious in developed countries, and initial results from trials in Africa and Asia are promising as well. […] Should rotavirus vaccines be introduced in the routine immunization programs of all countries, a potential of 170,000 deaths could be prevented annually. The largest impact on mortality would be seen in low-income and middle-income countries, despite poor immunization coverage and lower efficacy. Therefore, international efforts are needed to ensure that rotavirus vaccines reach the populations with highest burden of rotavirus disease.
- #1https://www.who.int/teams/immunization-vaccines-and-biologicals/diseases/rotavirus
The public health impact of rotavirus vaccination has been demonstrated in several countries. […] WHO reiterates that the use of rotavirus vaccines should be part of a comprehensive strategy to control diarrhoeal diseases with the scaling up of both prevention (promotion of early and exclusive breastfeeding, handwashing with soap, improved water and sanitation) and treatment packages (including low-osmolarity ORS and zinc).
- #1 Rotavirus infection – including symptoms, treatment and prevention | SA Healthhttps://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/conditions/infectious+diseases/rotavirus+infection/rotavirus+infection+-+including+symptoms+treatment+and+prevention
Rotavirus infection is a notifiable condition1 […] The rotavirus vaccine provides good protection against the most common types of rotavirus. Rotavirus vaccine is recommended for all infants. The first dose of rotavirus vaccine, in combination with other vaccines, is now recommended to be given at 6 weeks of age. […] Follow good hand washing and keeping areas clean procedures including objects (including toys) that may be shared. […] Exclude people with rotavirus from childcare, preschool, school and work until there has been no vomiting or diarrhoea for at least 24 hours. If working as a food handler in a food business, the exclusion period should be until there has been no diarrhoea or vomiting for 48 hours. […] Infants, children and adults with rotavirus infection should not swim until there has been no diarrhoea for 24 hours.
- #1https://link.springer.com/article/10.1007/s40272-018-0283-3
Rotavirus is the leading cause of diarrheal death among children 5 years old worldwide, estimated to have caused ~ 215,000 deaths in 2013. […] Two live, oral rotavirus vaccines have been implemented nationally in 100 countries since 2006 and their use has substantially reduced the burden of severe diarrheal illness in all settings. […] Vaccine efficacy and effectiveness estimates suggest there is a gradient in vaccine performance between low child-mortality countries ( 90%) and medium and high child-mortality countries (5775%). […] Two additional live, oral rotavirus vaccines were recently licensed and these have improved on some programmatic limitations of earlier vaccines, such as heat stability, cost, and cold-chain footprint. […] Non-replicating rotavirus vaccines that are parenterally administered are in clinical testing, and these have the potential to reduce the performance differential and safety concerns associated with live oral rotavirus vaccines.
- #1https://journals.lww.com/co-infectiousdiseases/fulltext/2019/10000/current_and_new_rotavirus_vaccines.10.aspx
Rotavirus-focused efforts led to the development of Rotavin-M1, a live, attenuated, frozen oral vaccine derived from a human rotavirus strain (G1P[8]) isolated from a child hospitalized for diarrhea in Nha Trang, Vietnam. […] This vaccine was shown to be well tolerated and immunogenic (73% seroconversion) in a trial of Vietnamese infants. […] Given the importance of this research question, the wide variability in intussusception epidemiology by geography, and the possibility that associations could vary by vaccine product, ongoing investigation is necessary.
- #1 Azthena logo with the word Azthenahttps://www.news-medical.net/health/Rotavirus-Prevention.aspx
Vaccination remains the primary public health intervention for tackling the rotaviral disease. The United States Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices recommends routine vaccination with an oral live vaccine at two, four, and six months of age. […] In April 2009, the WHO Strategic Advisory Group of Experts (SAGE) recommended that all national immunization programs should include rotavirus vaccination for infants. The incidence of rotavirus disease has dropped markedly in all the countries that introduced the vaccine. […] In conclusion, rotaviral gastroenteritis is considered to be a vaccine-preventable illness, based on successful outcomes in children and a drop in hospitalizations in developed countries.
- #1 Statement from the Global Advisory Committee on Vaccine Safetyhttps://www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/rotavirus-vaccines/related-links
The documented benefits of rotavirus vaccination against rotavirus-related disease are substantial. For example, in Mexico, nationwide use of Rotarix vaccine would prevent approximately 12 000 hospitalizations and 700 deaths from diarrhoea each year, a benefit that greatly outweighs the risk of vaccine-associated intussusception found in this preliminary analysis of possibly 20-40 cases. Furthermore, some studies have suggested that rotavirus vaccines may have an overall long-term protective effect against intussusception, an effect that might outweigh any short-term increased risk in the period shortly after the first dose of vaccine. […] The Committee strongly recommended that introduction of rotavirus vaccines should be associated with careful consideration of post-marketing surveillance at country level and securing its funding as an essential part of immunization programmes.
- #1https://journals.lww.com/co-infectiousdiseases/fulltext/2019/10000/current_and_new_rotavirus_vaccines.10.aspx
Rotavirus vaccines have demonstrated impact in reducing diarrheal morbidity and mortality worldwide. […] The prequalification of two products previously available only on a national level may help to alleviate global rotavirus vaccine supply constraints. […] The availability of more affordable rotavirus vaccines will be an important part of ensuring continued coverage into the future. […] Both Rotavac and ROTASIIL are being introduced on a phased basis in India. […] Postmarketing studies to evaluate the safety of the vaccines with respect to intussusception and the vaccine effectiveness are underway, and the expansion of routine use of both vaccines is anticipated with country-wide rollout projected by late 2019. […] Nationally licensed vaccines can play an important role in broadening the affordability and availability of rotavirus vaccination, particularly in countries with the desire and ability to pursue local manufacture.
- #1https://journals.lww.com/co-infectiousdiseases/fulltext/2019/10000/current_and_new_rotavirus_vaccines.10.aspx
As of 2019, four rotavirus vaccines have been prequalified by the WHO for use worldwide. This review highlights current knowledge regarding rotavirus vaccines available, and provides a brief summary of the rotavirus vaccine pipeline. […] The WHO recommends rotavirus vaccination as part of an integrated package of prevention-oriented and treatment-oriented interventions to reduce diarrheal morbidity and mortality. […] In 2006, two rotavirus vaccines Rotarix (GlaxoSmithKline Biologicals SA, Rixensart, Belgium) and RotaTeq (Merck Co., Inc., West Point, PA, USA) were licensed and almost immediately introduced into the national immunization programs of several countries. […] Currently, rotavirus vaccines are in wide use globally, and have made a demonstrable impact on the burden of disease.
- #1 Rotavirus vaccine supporthttps://www.gavi.org/types-support/vaccine-support/rotavirus
Increasing access to these vaccines in Gavi-supported countries can prevent more than 2.4 million deaths by 2030. […] Gavi offers support for low-income countries to introduce rotavirus vaccines. […] Gavi opened a funding window for rotavirus vaccines in Europe and Latin America in 2007. This was only a year after the USA and other high-income countries introduced the vaccine. […] WHO emphasises the need to integrate rotavirus vaccine with other interventions.
- #1 The control of diarrhea, the case of a rotavirus vaccinehttp://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0036-36342020000100001
The control of diarrhea, the case of a rotavirus vaccine […] Given its important etiologic role, efforts to reduce the burden of severe childhood diarrhea have targeted rotavirus. […] In 2006, the region of the Americas was the first to implement these new vaccines and in 2009 the World Health Organization issued a global recommendation for rotavirus vaccine use. […] Routine rotavirus vaccination has led to rapid and large declines in the burden of severe rotavirus diarrhea in countries using vaccine, and vaccine safety has been demonstrated through well-designed, large, post-licensure evaluations. […] Together with other interventions such as provision of safe food and water, improving environmental sanitation, promotion of breastfeeding, and prevention of childhood malnutrition, rotavirus vaccines will have a substantial impact in reducing the morbidity and mortality from severe childhood diarrhea worldwide.
- #2 Rotavirus: The Disease & Vaccines | Children’s Hospital of Philadelphiahttps://www.chop.edu/vaccine-education-center/vaccine-details/rotavirus-vaccine
The Centers for Disease Control and Prevention (CDC) approved a rotavirus vaccine for use in all infants in the United States in 2006. The vaccine, called RotaTeq, is given as a series of three doses by mouth at 2 months, 4 months and 6 months of age and can be given with other vaccines typically administered at those times. A second vaccine, called Rotarix, was approved for use in June 2008 and is given as a series of two doses by mouth at 2 months and 4 months of age. […] The current rotavirus vaccines have also been found to be rare causes of intestinal blockage (intussusception) affecting about 1 in 100,000 children, usually occurring within a week after getting the first or second dose of vaccine. […] Because virtually every young child gets rotavirus, and about 1 of every 65 are hospitalized as a result, the benefit of getting the rotavirus vaccine clearly outweighs the risk. Therefore, the rotavirus vaccine has been added back to the U.S. infant immunization schedule and is recommended for all infants.
- #2 Rotavirus – Infectious Disease Advisorhttps://www.infectiousdiseaseadvisor.com/ddi/rotavirus/
Rotavirus is a highly contagious infection that causes diarrhea and vomiting. The first licensed modern rotavirus vaccine was introduced in 2006. Since then, rates of severe rotavirus infection have decreased, averting approximately 45,000 hospitalizations annually. […] Vaccination against rotavirus is currently the best protection against infection. Four vaccines have been developed for rotavirus: RV5 vaccine (RotaTeq [Merck]), RV1 vaccine (Rotarix [GSK]), ROTAVAC (Bharat Biotech), and Rotasiil (Serum Institute of India). In the US, only the RV5 and RV1 vaccines are available. The National Foundation for Infectious Diseases recommends that children receive their first vaccine before age 15 weeks and complete all doses before age 8 months. […] The rotavirus vaccines currently available in the US (RV5 and RV1) have been tested for intussusception. The data do not show an increased risk of intussusception with these vaccines.
- #2https://www.healio.com/news/pediatrics/20120331/rotavirus-prevention-and-vaccination-strategies-to-address-burden-of-disease
The RV5 vaccine contains five reassortant viruses developed from human and bovine parent rotavirus strains and shares neutralizing identity with G1, G2, G3, G4, and P[8], the same P serotype as many of the G9 strains observed in the US. […] The RV1 vaccine is given as two oral doses; the first dose should be given between 6 and 14 weeks of age, and the second dose between 14 and 24 weeks of age. […] The tight administration window for rotavirus vaccination is based on clinical trial data that evaluated the incidence of intussusception before the age at which the risk of idiopathic intussusception rises sharply. […] The postlicensure safety monitoring of RV5 was also examined at this meeting. […] Importantly, Dr. Margaret Cortese presented data demonstrating the importance of improving background estimates of intussusception rates in order to properly monitor safety of the rotavirus vaccines. […] Overall, at the annual ICAAC/IDSA meeting, much of the rotavirus data focused on postlicensure surveillance and the impact of the two rotavirus vaccines, most notably RV5, as it has been available longer than RV1, which was approved for use in 2008.
- #2 Rotarix, RotaTeq (rotavirus oral vaccine, live) dosing, indications, interactions, adverse effects, and morehttps://reference.medscape.com/drug/rotarix-rotateq-rotavirus-oral-vaccine-live-343148
Live, attenuated oral vaccine indicated for immunization to prevent rotavirus gastroenteritis in infants and children […] RotaTeq: 3 Dose Regimen […] Pentavalent vaccine; prevention of rotavirus gastroenteritis caused by the G1, G2, G3, and G4 serotypes, plus attachment protein serotype P7 […] Total of three 2 mL doses administered orally […] First dose given at 6-12 weeks of age […] Subsequent doses administered at 4-10 week intervals […] Third dose should not be given after 32 weeks of age […] Rotarix: 2-Dose Regimen […] Prevention of rotavirus gastroenteritis caused by G1 and non-G1 serotypes (G3, G4, and G9) […] Total of two 1 mL doses administered orally […] Administer first dose to infants beginning at 6 weeks of age […] Administer second dose after an interval of at least 4 weeks and prior to 24 weeks of age […] CDC researchers observed rotavirus-associated diarrhea decreased by 75% and hospitalizations for diarrhea by 33% during 2007-2008 following 2006 introduction of pentavalent rotavirus vaccine; diarrhea-related incidence also decreased among age-matched unvaccinated children.
- #2 Rotavirus vaccines: Canadian Immunization Guide – Canada.cahttps://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-19-rotavirus-vaccine.html
Rotavirus vaccine efficacy against diarrhea of any severity in developed world settings is 74% to 87%; efficacy against severe diarrhea is 85% to 98%. […] RV vaccine reduces physician and emergency room visits for diarrhea and hospital admissions for RV diarrhea. […] RV vaccines are recommended for infants starting at 6 weeks and before 15 weeks of age. The vaccination series should be completed before 8 months of age. […] To optimize protection, RV vaccine should be initiated as soon after 6 weeks of age as feasible. […] Countries with routine RV immunization programs have seen reductions in the number of infants and children needing hospitalization or emergency department care for RV disease by about 85%. […] The efficacy of RV vaccines is similar among infants who are breastfed and those who are not; therefore, breastfed infants can receive RV vaccine.
- #2 Rotavirus | Better Health Channelhttps://www.betterhealth.vic.gov.au/health/conditionsandtreatments/rotavirus
Rotavirus immunisation is available free of charge to all Victorian babies. […] In Victoria, a free rotavirus vaccine is available for all babies. […] The vaccine contains a weakened form of rotavirus and works by prompting the body to make antibodies. In most cases, immunised children are protected against infection. […] It is estimated that the introduction of this vaccination has prevented more than 7,000 hospital admissions each year in children under 5. […] The rotavirus vaccine is delivered by mouth and is made up of 2 separate doses given at 2 and 4 months of age. […] To ensure effectiveness, it is important that the vaccine is given as close to these ages as possible. […] The oral rotavirus vaccine is given at the same time as other free vaccines in the National Immunisation Program. […] The oral rotavirus vaccine is generally effective and safe, although all medication can have unwanted side effects. […] A baby who has already had intussusception in the past should not be given the rotavirus vaccine.
- #2 ACIP Recommends Routine Rotavirus Vaccinations in Infants and Children | AAFPhttps://www.aafp.org/pubs/afp/issues/2007/0315/p924.html
It is acceptable for the rotavirus vaccine to be administered with the Hib, hepatitis B, pneumococcal conjugate, DTaP, and inactivated poliovirus vaccines. […] ACIP recommends against administering the rotavirus to infants who have severe hypersensitivity to any component in the vaccine or to infants who have had a serious allergic reaction to a previous dose of the rotavirus vaccine. […] Family physicians should consider the benefits and potential risks of administering the rotavirus vaccination to infants who are known or suspected to have altered immunocompetence. […] ACIP recommends against the administration of the rotavirus vaccine to infants who have acute, moderate-to-severe gastroenteritis until the condition improves. […] Premature infants may be at increased risk of hospitalization from viral gastroenteritis during their first year of life. ACIP recommends the vaccination of premature infants only if they are six weeks of age or older, are being discharged from the hospital nursery, and are clinically stable.
- #2 How rotavirus vaccines are changing the gameverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedhttps://www.gavi.org/vaccineswork/how-rotavirus-vaccines-are-changing-game
From 2006 to 2019, the vaccines saved an estimated 140,000 childrenâs lives, and that number has only grown since. […] More than 120 countries have introduced rotavirus vaccines into their routine immunization programs, with more planning to do so this year. […] Countries that introduced the vaccine observed a 59 percent average reduction in rotavirus hospitalizations among children less than five years old, and a 36 percent decrease in deaths from severe diarrhea. […] Over nearly two decades, rotavirus vaccines have proven to be a cost-effective intervention that not only saves lives, but also helps keep families from potentially crippling financial hardship.
- #2 Prevention of rotavirus gastroenteritis in infants and children: rotavirus vaccine safety, efficacy, and potential impact of vaccineshttps://pmc.ncbi.nlm.nih.gov/articles/PMC2921258/
Prevention in the form of vaccines is essential for the control of rotavirus disease. […] The potential impact of rotavirus vaccines is striking. If rotavirus vaccines were introduced at the current coverage of DTP-3, it would prevent approximately 166,000 deaths in children aged younger than 5 years each year globally. […] The largest impact on mortality would be seen in low-income and middle-income countries, despite poor immunization coverage and lower efficacy.
- #2 CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Phase 1 Clinical Trial in Healthy Adultshttps://ctv.veeva.com/study/cdc-9-inactivated-rotavirus-vaccine-irv-intramuscular-im-phase-1-clinical-trial-in-healthy-adult
This is a study of CDC-9 inactivated rotavirus vaccine (IRV) for intramuscular administration (IM) in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series. The purpose is to determine if it is safe and if the recipient’s immune system responds to the vaccine. […] A rotavirus vaccine with greater efficacy and stronger immunogenic response could further reduce infant mortality and morbidity, and a parenterally administered rotavirus vaccine could minimize interactions from co-administration with polio vaccination. Given the lower immunogenicity and vaccine efficacy of the oral rotavirus vaccines currently licensed by the US and in developing countries and approved for use by the World Health Organization (WHO), the IRV presents an opportunity to further prevent rotavirus-associated gastroenteritis in infants. […] Vaccination with IRV has shown to be safe and immunogenic in animal studies.