Jak się bada bezpieczeństwo szczepionek?
Gdzie można znaleźć dowody i potwierdzenie na brak związku przyczynowego pomiędzy autyzmem a szczepieniami?
Zgodnie z wynikami badań naukowych bazujących na medycynie opartej na faktach (Evidence Base Medicine, EBM), publikowanych w recenzowanych czasopismach, nie ma związku między szczepieniami i autyzmem. Przytłaczające dowody wymieniono w reprezentatywnych recenzowanych artykułach, opublikowanych w prestiżowych czasopismach (z wysokim współczynnikiem IF).
Szczepionki nie wywołują autyzmu. Potwierdzają to dziesiątki niezależnych badań naukowych, których wyniki opublikowano w renomowanych czasopismach.
Poniższa lista obejmuje recenzowane artykuły naukowe opublikowane w renomowanych czasopismach, które nie potwierdzają korelacji (związku przyczynowego) rozwoju zaburzeń ze spektrum autyzmu (ASD) oraz szczepień.
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Czy można szczepić dzieci z zespołem Downa?
Zespół Downa jest jednym z najczęstszych zespołów wad wrodzonych. Dochodzi do niego na skutek aberracji chromosomowej, czyli nieprawidłowego podziału materiału genetycznego w momencie łączenia się komórki jajowej i plemnika. Charakteryzuje się obecnością dodatkowego chromosomu 21 albo jego części, co prowadzi do wielu wad rozwojowych.
Dzieci z zespołem Downa powinny być szczepione zgodnie z kalendarzem szczepień. Zespół Downa jako taki nie stanowi przeciwwskazania do szczepienia. Jednak podobnie jak w przypadku dzieci bez obciążeń genetycznych musimy wziąć pod uwagę czynniki oceniane w czasie kwalifikacji pacjenta do szczepienia. Stąd też, np. wystąpienie objawów neurologicznych (np. padaczki) może być czasowym przeciwwskazaniem do szczepień (szczególnie w przypadku szczepionki ze składnikiem krztuścowym czy tez szczepionki przeciw odrze, śwince i różyczce). Z drugiej strony ponieważ dzieci z zespołem Downa mogą mieć dodatkowe obciążenia oraz predyspozycje do rozwoju wad serca czy ciężkich zapaleń płuc i wielu innych schorzeń bardzo jest rozszerzenie obowiązkowego kalendarza szczepień i uwzględnienie szczepień przeciw pneumokokom, grypie, meningokokom, czy ospie wietrznej. W takim wypadku choroba przewlekła jest wskazaniem do rozszerzenia kalendarza sczepień i zastosowania dodatkowej profilaktyki.
Czy określono maksymalną liczbę antygenów, którą można podać w czasie wizyty szczepiennej?
- Szczepionki dostępne na rynku sa bezpieczne.
- Jak badamy bezpieczeństwo szczepionek?
- Jak sprawdzane są szczepionki zanim trafią do przychodni i apteka?
- Jak oceniamy bilans korzyści do ryzyka szczepionki?
- Jak ocenić ryzyko związane ze szczepieniem?
- Jakie działania uprzedzające możemy podjąć przed zagrożeniem?
- Szczepionki są bezpieczne i skuteczne
- Szczepionki są bezpieczne
- Szczepionki to produkty lecznicze
- Baylor N.W., Marshall V.B. 2013. Regulation and testing of vaccines. w: Vaccines, Plotkin S.A., Orenstein W.A., Offit P.A., 6th ed., 1425-46.
- Cessak G., Fordymacka A., Maciejczyk A. Dopuszczenie do obrotu i monitorowanie bezpieczeństwa szczepionek w Polsce i Unii Europejskiej. Medycyna Praktyczna Szczepienia. 2019/3 lipiec – wrzesień.
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- Gomez PL, Robinson JM. Vaccine manufacturing. w: Plotkin’s Vaccines, red. Plotkin S., Orenstein W., Offit P., Edwards M. wyd. 7, 2018, str. 51-61.
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- Global Advisory Committee on Vaccine Safety 10-11 June 2015. Weekly Epidemiological Record 2015, 90, 365-368.
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- Kwong J.C. i wsp. Risk of Guillain- Barré syndrome after seasonal influenza vaccination and influenza health-care encounters: a self-controlled study. Lancet 2013, 13, 769-776.
- Orenstein WA1, Paulson JA, Brady MT, Cooper LZ, Seib K. Global vaccination recomendations and thimerosal. Pediatrics 2013, 131, 149-51.
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- Taylor L.E. i wsp. Vaccines are not associated with autism: an evidence-based meta-analysis of case-control and cohort studies. Vaccine 2014, 32, 3623-3629.
- Więcej informacji na temat bezpieczeństwa szczepionek
- O badaniach bezpieczeństwa szczepień w zakresie niepożądanych odczynów poszczepiennych i ich rejestracji dr Iwona Paradowska-Stankiewicz mówiła podczas debaty o szczepieniach, która odbyła się 16 czerwca 2016 r. na 132. sesji Zgromadzenia Ogólnego Polskiej Akademii Nauk.
(ACADEMIA, Wydanie specjalne 1/2/2016, I. Paradowska- Stankiewicz Pod szczególnym nadzorem). - Augustynowicz E., Lutyńska A. Wykrywanie zanieczyszczeń czynnikami zewnątrzpochodnymi w ocenie bezpieczeństwa szczepionek. Przegl Epidemiol 2012; 66: 643-49.
- McClenahan S.D., Uhlenhaut C., Krause P.R. Evaluation of cells and biological reagents for adventitious agents using degenerate primer PCR and massively parallel sequencing. Vaccine; 32: 7115-21.
- Rozporządzenie Ministra Zdrowia z dnia 12 marca 2008 r. w sprawie określenia szczegółowych zasad trybu wstrzymania i wycofania z obrotu produktów leczniczych i wyrobów medycznych (Dz. U. Nr 57, poz. 347).
- Szczepienia dzieci z chorobami układu nerwowego. Stanowisko Polskiego Towarzystwa Wakcynologii. Medycyna Praktyczna/Szczepienia 3/2015, str. 21-31.
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- Gross L. A broken trust: lessons from the vaccine–autism wars. PLoS Biology. 2009;7(5):e1000114. doi:10.1371/journal.pbio.1000114. PMID 19478850.
- Sun Y., Christensen J. Hviid A. i wsp.: Risk of febrile seizures and epilepsy after vaccination with diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and Haemophilus influenzae type b. JAMA, 2012; 307: 823–831.
- Taylor LE, Swerdfeger AL, Eslick GD. Vaccines are not associated with autism: an evidence-based meta-analysis of case-control and cohort studies. Vaccine. 2014;32(29):3623–9. doi:10.1016/j.vaccine.2014.04.085. PMID 24814559.
- Thompson W.W., Price C., Goodson B. i wsp.: Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years. N. Engl. J. Med., 2007; 357: 1281–1292.
- Tozzi A.E., Bisiacchi P., Tarantino V. i wsp.: Neuropsychological performance 10 years after immunization in infancy with thimerosal-containing vaccines. Pediatrics, 2009; 123: 475 –482.
- Anjali Jain, MD1; Jaclyn Marshall, MS1; Ami Buikema, MPH2; Tim Bancroft, PhD2; Jonathan P. Kelly, MPP1; Craig J. Newschaffer, PhD3. Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism JAMA. 2015;313(15):1534-1540.