VaccinesThe BCG Vaccine for Tuberculosis — Why Does It Still Raise Questions?
Sources: 12 · Article: 18 443 characters
The STOP NOP Association states that vaccination does not reduce the number of cases, but does reduce severe forms of tuberculosis in children.
- The STOP NOP Association describes local and allergic reactions, as well as rare, severe infections following vaccination.
- Particular concerns relate to people with weakened immune systems, for whom vaccination may be contraindicated.
What the authors write
Stowarzyszenie STOP NOP
The rate of decline in cases is said to be the same in Poland and in countries where people are not vaccinated against tuberculosis.
„Despite the fact that they do not vaccinate in those countries, while they do vaccinate in Poland, the rate of decline is about 2.5% per year. However, we vaccinate children because it has also been scientifically proven that vaccinated children have a lower rate of severe clinical forms of tuberculosis.”Niezależnie od tego, że w tamtych krajach się nie szczepi, a w Polsce się szczepi, tempo spadku wynosi około 2,5% rocznie. Natomiast szczepimy dzieci, bo jest to również udowodnione naukowo, że u dzieci szczepionych występuje mniejszy odsetek ciężkich postaci klinicznych gruźlicy.
Stowarzyszenie STOP NOP
A description of a study from India says that no protective effect of the vaccine was demonstrated.
„“After nearly 8 years of observation, it was found that tuberculosis occurred more often in vaccinated than in unvaccinated people. No evidence of a protective effect of the vaccine was found.”
Director of the Institute of Tuberculosis and Lung Diseases in Warsaw, Kazimierz Roszkowski-Śliż, at a meeting of the Sejm Health Committee: “And there is also the issue of vaccinations, which of course have no protective effect whatsoever on incidence.””„Po blisko 8 latach obserwacji stwierdzono, że częstotliwość występowania gruźlicy jest większa u szczepionych niż u nie szczepionych. Nie znaleziono dowodu na ochronne działanie szczepionki”.
Dyrektor Instytutu Gruźlicy i Chorób Płuc w Warszawie, Kazimierz Roszkowski-Śliż na posiedzeniu sejmowej Komisji Zdrowia: „I jeszcze kwestia szczepień, które oczywiście nie mają żadnego znaczenia ochronnego dla zapadalności.
Stowarzyszenie STOP NOP
The higher incidence among adults is given as a reason for vaccinating children, to limit severe forms of the disease, such as tuberculous meningitis.
„Our incidence among adults is high enough that the probability of a child becoming infected is also high enough for that child to have a greater chance of becoming ill. And if the child has a greater chance of becoming ill, we prevent the severe form of tuberculosis, such as tuberculous meningitis.”Nasza zapadalność u dorosłych jest na tyle istotna, że prawdopodobieństwo zakażenia dziecka jest na tyle duże, że to dziecko ma mimo wszystko większą szansę zachorowania, a jeżeli ma większą szansę zachorowania, to eliminujemy zachorowanie na ciężką postać gruźlicy, jaką jest na przykład gruźlicze zapalenie opon mózgowo-rdzeniowych.
Stowarzyszenie STOP NOP
A proposed change to the vaccination programme provided for BCG only for children from regions with a high incidence of tuberculosis.
„discontinuing BCG vaccination of newborns (to be used only for children from regions where the rate of tuberculosis is above 40 per 100,000); ? in the remaining group of children, starting vaccination at 4 months of age; ? discontinuing the whole-cell pertussis vaccine; ?”zrezygnowanie ze szczepienia noworodków BCG (stosować tylko u dzieci z regionów, gdzie odsetek chorych na gruźlicę wynosi powyżej 40 na 100 tys.); ? w pozostałej grupie dzieci rozpoczęcie szczepień od 4 miesiąca życia; ? zrezygnowanie ze szczepionki krztuścowej pełnokomórkowej; ?
Stowarzyszenie STOP NOP
BCG was described as a vaccine that often causes reactions and should not be given to people with severe immune disorders.
„The BCG vaccine is among the most reactogenic vaccines. Therefore, it should not be used in cases of severe immune disorders, as it may cause acute, fatal BCG-itis resulting from an uncontrolled, multi-organ infection with attenuated bovine bacilli.”Szczepionka BCG należy do najbardziej reaktogennych szczepionek. Dlatego nie należy stosować jej w ciężkich zaburzeniach odporności, gdyż może powodować ostry, kończący się zgonem BCG-itis, będący wynikiem niekontrolowanego, wielonarządowego zakażenia atenuowanym prątkiem bydlęcym.
Stowarzyszenie STOP NOP
Ulceration or an abscess may occur at the injection site after vaccination, as well as enlarged or suppurating lymph nodes.
„Local reactions: 1. An accelerated post-vaccination reaction, often called the so-called abortive Koch phenomenon. 2. An ulcer and/or purulent lesion at the vaccination site measuring more than 10 mm in diameter in a newborn and 20 mm in an older child. 3. A subcutaneous abscess at the vaccination site.”Zmiany miejscowe: 1. Przyspieszony odczyn poszczepienny zwany często tzw. poronnym Fenomenem Kocha. 2. Owrzodzenie i/lub zmiana ropna w miejscu szczepienia o średnicy przekraczającej 10 mm u noworodka i 20 mm u dziecka starszego. 3. Ropień podskórny w miejscu szczepienia.
Stowarzyszenie STOP NOP
Live BCG bacilli may spread from the vaccination site to other organs, although they cause no symptoms in most vaccinated people.
„Attenuated but live BCG bacilli travel from the vaccination site to the nearest lymph nodes and then spread to distant organs and tissues through the lymphatic and circulatory systems. In the vast majority of vaccinated people, apart from the development of tuberculin hypersensitivity and partial immunity to the disease, this spread causes no other systemic or organ-specific symptoms.”Atenuowane, ale żywe prątki BCG z miejsca szczepienia wędrują do najbliższych węzłów chłonnych, a następnie rozprzestrzeniają się do odległych narządów i tkanek drogą układów limfatycznego i krwionośnego. U zdecydowanej większości szczepionych – poza powstaniem nadwrażliwości tuberkulinowej i częściowej odporności na zachorowanie – nie występują inne ogólnoustrojowe, czy też narządowe objawy tego rozsiewu.
Stowarzyszenie STOP NOP
In people with weakened immune systems, the spread of bacilli may, in rare cases, lead to illness.
„Only in rare cases—when the body’s immunity is weakened—can this spread lead to the development of disease (17, 25, 26, 33-50). Depending on the further course of such generalized spread, Lotte’s classification distinguishes cases of BCG sepsis, which end in death (fatal cases), from cases with a better prognosis (non-fatal cases) (17, 26).”Tylko wyjątkowo – przy obniżeniu odporności organizmu – następstwem tego rozsiewu może być rozwój choroby (17, 25, 26, 33-50). W zależności od dalszego rozwoju takiego uogólnionego rozsiewu Lotte w swojej klasyfikacji wyróżnia przypadki o przebiegu posocznicy BCG – kończące się śmiercią (fatal case) i przypadki o lepszym rokowaniu (non fatal case) (17,26).
Stowarzyszenie STOP NOP
Generalized BCG infection was described as potentially severe and often fatal; a link with immune disorders was reported.
„The prognosis is very often poor despite the use of anti-tuberculosis drugs. The disease usually ends in death, and BCG bacilli can be cultured from the blood, other bodily fluids (cerebrospinal fluid), and many organs. At autopsy, granulomatous lesions and foci of caseation are found in many lymph nodes and organs (liver, spleen, lungs, bones, joints, meninges).”Rokowanie mimo stosowania leków przeciwprątkowych jest bardzo często niepomyślne. Choroba zazwyczaj kończy się śmiercią, a z krwi, innych płynów ustrojowych (płyn mózgowordzeniowy) oraz wielu narządów można wyhodować prątki BCG. Podczas autopsji stwierdza się zmiany ziarniniakowate, ogniska serowacenia w wielu węzłach chłonnych, narządach (wątroba, śledziona, płuca, kości, stawy, opony mózgowe).
Stowarzyszenie STOP NOP
Generalized BCG dissemination was described as a very rare complication, with studies reporting rates ranging from 0.59 to 1.9 cases per million vaccinated people.
„In a second study, which included 5.5 million vaccinated people in six countries in 1979-1981 and continued follow-up until 1983, the frequency of this complication was 1.9 per million vaccinated people (26). Another researcher, analyzing cases of so-called idiopathic BCG dissemination, estimates its occurrence in France at 0.59 per million vaccinated people (36).”W drugim badaniu obejmującym 5,5 mln szczepionych w sześciu krajach w latach 1979-1981 i obserwowany do 1983 roku częstość występowania tego powikłania wynosiła 1,9 mln szczepionych (26). Inny badacz analizując przypadki tzw. idiopatycznych rozsiewów BCG, ocenia ich występowanie we Francji na 0,59/milion szczepionych (36).
Stowarzyszenie STOP NOP
Osteomyelitis following BCG vaccination occurred at very different rates in different countries.
„The frequency of this complication varies widely between countries: from the lowest rate, in Japan—1 case per 100 million vaccinated people (33)—to the highest, more than 300 cases per million vaccinated people in Finland (17, 25, 26).”Częstość występowania tego powikłania waha się w różnych krajach w dość szerokich granicach: od najniższej w Japonii – 1 przypadek na 100 milionów szczepionych (33) do najwyższej – ponad 300 przypadków na milion szczepionych w Finlandii (17, 25, 26).
Stowarzyszenie STOP NOP
An increase in the frequency of osteitis was reported in Czechoslovakia after the vaccine manufacturer changed.
„An increase in the frequency of this complication to 35 per 100,000 vaccinated people occurred in Czechoslovakia in 1982-1985 (25, 26, 53). In that country, this also coincided with a change from the locally produced BCG vaccine previously used (Prague substrain) to a stronger Russian vaccine (53, 54).”Wzrost częstości występowania tego powikłania do wartości 35/100 000 szczepionych wystąpił w latach 1982-1985 w Czechosłowacji (25, 26, 53). W tym kraju również zbiegł się on ze zmianą dotychczas stosowanej, własnej szczepionki BCG (z podszczepu Praga) na silniejszą – rosyjską (53, 54).
Stowarzyszenie STOP NOP
Rare allergic reactions following BCG were also described, including erythema nodosum, eye inflammation and, exceptionally, anaphylactic shock.
„In addition to skin lesions (erythema nodosum), which reflect an allergic-type reaction to the BCG vaccine, this group also includes inflammation of the iris and conjunctiva. Anaphylactic shock symptoms occur only exceptionally after BCG vaccination (26).”Poza zmianami skórnymi (rumień guzowaty), będącymi wyrazem typu reakcji alergicznej na szczepionkę BCG, do tej grupy należy zaliczyć także zapalenie tęczówki i spojówki. Tylko wyjątkowo po szczepieniu BCG może dojść do objawów wstrząsu anafilaktycznego (26).
Stowarzyszenie STOP NOP
Suppurative lymphadenitis, osteitis and disseminated infection were listed as possible complications, with different rates given for their occurrence.
„Disseminated BCG infection, occurring 1-12 months after vaccination, is a serious complication in people with weakened immune systems, for whom BCG vaccination is contraindicated. In people with normal immune systems, it is very rare (1 per 1,000,000 vaccinated people).
Source: “Wakcynologia” by Wiesław Magdzik, Danuta Naruszewicz-Lesiuk, Andrzej Zieliński”Rozsiane zakażenie BCG, 1-12 miesięcy, stanowi poważne powikłanie u osób z obniżoną odpornością, u których szczepienie BCG jest przeciwwskazane. U osób z prawidłową odpornością zdarza się bardzo rzadko 1/1 000 000 szczepionych).
Źródło: „Wakcynologia” Wiesław Magdzik, Danuta Naruszewicz-Lesiuk, Andrzej Zieliński
Stowarzyszenie STOP NOP
Severe congenital immunodeficiency was identified as an absolute contraindication, and prematurity as a relative contraindication.
„Congenital immunodeficiencies are an absolute contraindication to BCG vaccination. The minor was not tested to confirm that she did not have such disorders, and prematurity is also a relative contraindication.?
1. Do not sign the statement at the clinic2.”Bezwzględnym przeciwskazaniem do szczepienia BCG są wrodzone niedobory immunologiczne. U małoletniej nie wykonano badań, które mogłyby potwierdzić brak takich zaburzeń, a względnym przeciwskazaniem jest także wcześniactwo.?
1. Nie podpisuj oświadczenia w przychodni2.
Stowarzyszenie STOP NOP
The rules for reporting reactions following vaccination were described, but it was stated that many of them go unrecorded.
„As the survey results show, the vast majority of adverse events following vaccination are not recorded, and the few reports submitted by parents who know they should report them are challenged by doctors and sanitary-epidemiological stations.
According to the Regulation of the Minister of Health, adverse events following vaccination include, among other things: 1.”Jak pokazują wyniki ankiety, znaczna większość NOP nie zostaje zarejestrowana, a nieliczne zgłoszenia świadomych tej konieczności rodziców są kwestionowane przez lekarzy i stacje sanitarno-epidemiologiczne.
Według Rozporządzenia Ministra Zdrowia NOP- ami są m.in.: 1.
Stowarzyszenie STOP NOP
Suppurative lymph-node lesions and generalized BCG dissemination were considered complications relevant to assessing the safety and public acceptance of vaccination.
„Suppurative lymph-node lesions and generalized dissemination of BCG bacilli are considered significant post-vaccination complications that affect the assessment of vaccine safety and public acceptance.
GENERALIZED BCG DISSEMINATION
The possibility of generalized dissemination of BCG bacilli was demonstrated by one of the creators of BCG, Calmette, in an experiment on guinea pigs (17).”Zmiany ropne węzłów chłonnych i uogólniony rozsiew prątków BCG uważane są za istotne powikłania poszczepienne, wpływające na ocenę bezpieczeństwa szczepień i ich społeczną akceptację.
UOGÓLNIONY ROZSIEW BCG
Możliwość uogólnionego rozsiewu prątków BCG wykazał już jeden z twórców BCG – Calmette w doświadczeniu na świnkach morskich (17).
Research from PubMed · Europe PMC
We selected 4 studies with the best, positive results. This is a selection, not a full review of all research.
Total number of studies on this topic in PubMed: 7 165.
The review found that the first BCG dose provides good protection against disseminated tuberculosis and tuberculous meningitis, although findings for pulmonary tuberculosis are inconsistent.
Aim of the study: To review the protective efficacy of the first and second doses of BCG vaccine and to assess its major indications and contraindications.
Results: BCG vaccine has been used since 1921. However, the data concerning its use are variable and inconsistent. The protective efficacy of the first dose of BCG vaccine against miliary tuberculosis or tuberculous meningitis is remarkably important. Nevertheless, results regarding pulmonary tuberculosis have been inconsistent, either showing no efficacy or a protective efficacy rate around 80%. There is some evidence that a second dose of BCG vaccine does not increase its protective efficacy. Studies have shown that BCG vaccine protects against leprosy. The development of new vaccines to replace BCG in the future has been investigated. Despite the hope that a new vaccine against tuberculosis will be available in the future, BCG vaccine, in spite of its deficiencies, is today and will be for many years to come an important tool in controlling the harmful effects of tuberculosis, especially in countries where this disease has moderate to high levels of incidence.
Money for the studynot stated
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?unknown
Type of studycombined analysis of many studies (meta-analysis)
“Not stated” does not mean nobody paid — the database does not always record it.
The review found strong protection against miliary and meningeal tuberculosis, but varying results for the pulmonary form.
Aim of the study: The BCG vaccine has been in use since 1921, but still arouses controversy and uncertainties. The objective was to analyze the protective effect of the BCG vaccine in its first and second doses and the accompanying vaccination policies.
Results: The protective effect of the first dose of the BCG vaccine against tuberculosis in its miliary and meningeal forms is high. However, the results vary in relation to the pulmonary form of the disease, with some indicating zero effect and others levels of nearly 80%. Research is being carried out to develop new vaccines that could substitute the BCG or be used as a booster. There are evidences that the protective effect of the BCG vaccine does not increase with a second dose. In spite of its limitations and the expectation that a new tuberculosis vaccine will be developed in the future, the BCG vaccine remains an important tool in controlling the harmful effects of tuberculosis, particularly in countries with medium or high incidence levels of the disease.
Money for the studynot stated
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?unknown
Type of studyreview of many studies
“Not stated” does not mean nobody paid — the database does not always record it.
The review concluded that BCG protects children against tuberculosis, but not adults against its pulmonary form.
Aim of the study: Tuberculosis (TB) is the leading cause of death worldwide due to an infectious disease, causing around 1.6 million deaths each year. This situation has become more complicated by the emergence of drug-resistant Mycobacterium tuberculosis (M.tb) and HIV-TB co-infection, which has significantly worsened TB prognosis and treatment.
Results: Despite years of intensive research, Bacille Calmette-Guerin (BCG) remains the only licensed vaccine and has variable efficacy. It provides protection against childhood TB but is not effective in adult pulmonary TB. As a result of intense research in understanding TB vaccinology, there are many new vaccine candidates in clinical development and many more in pre-clinical trials which aim either to replace or boost BCG vaccine. This review discusses the history of BCG vaccine development and summarizes limitations of the current vaccine strategy and recent advances in improving BCG immunization along with other new vaccines in clinical trials which are promising candidates for the future tuberculosis vaccinology program.
Money for the studygovernment, public institutions · International Centre for Genetic Engineering and Biotechnology, Department of Science and Technology, Ministry of Science and Technology, India, Science and Engineering Research Board
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?unknown
Type of studydiscussion of other studies
“Not stated” does not mean nobody paid — the database does not always record it.
The review found that BCG provides protection that may wane over time, at least in some populations.
Aim of the study: Tuberculosis infects millions of people worldwide and remains a leading global killer despite widespread neonatal administration of the tuberculosis vaccine, bacillus Calmette-Guérin (BCG). BCG has clear and sustained efficacy, but after 10 years, its efficacy appears to wane, at least in some populations.
Results: Here we review the epidemiological need for tuberculosis vaccination, including evolving standards for administration to at risk individuals in developing countries. We also examine proven sources of immune protection from tuberculosis, which to date have exclusively involved natural or vaccine exposure to whole cell mycobacteria. After summarizing evidence for the use and efficacy of BCG, we detail the most promising new candidate vaccines against tuberculosis. The global need for a new tuberculosis vaccine is acute and huge, but clinical trials to be completed in the coming few years are likely either to identify a new tuberculosis vaccine or to substantially reframe how we understand immune protection from this historical scourge.
Money for the studynot stated
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?unknown
Type of studydiscussion of other studies
“Not stated” does not mean nobody paid — the database does not always record it.
Perspectives and opinion materials
The content below presents the authors’ opinions, interpretations and hypotheses. It is not treated as equal to scientific studies and systematic reviews.
Orthomolecular Medicine News Service Opinion material
„Similarly, BCG vaccination was first tried in people in the early 1920s but its widespread introduction was delayed until well after World War 2.”Similarly, BCG vaccination was first tried in people in the early 1920s but its widespread introduction was delayed until well after World War 2.
Orthomolecular Medicine News Service Opinion material
„(2013) Mycobacterium tuberculosis is extraordinarily sensitive to killing by a vitamin C-induced Fenton reaction. Nat Commun. 4:1881. doi: 10.1038/ncomms2898. Orthomolecular Medicine News Service.”(2013) Mycobacterium tuberculosis is extraordinarily sensitive to killing by a vitamin C-induced Fenton reaction. Nat Commun. 4:1881. doi: 10.1038/ncomms2898. Orthomolecular Medicine News Service.
Orthomolecular Medicine News Service Opinion material
„Levy TE (2013) Vitamin C, Shingles, and Vaccination. Orthomolecular Medicine News Service. Vilcheze, C., T. Hartman, B. Weinrick, and W. Jacobs, Jr. (2013) Mycobacterium tuberculosis is extraordinarily sensitive to killing by a vitamin C-induced Fenton reaction. Nature Communications 4:1881. Glorieux C, Calderon PB. (2017) Catalase, a remarkable enzyme: targeting the oldest antioxidant enzyme to find a new cancer treatment approach. Biol Chem. 398:1095-1108. Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J.”Levy TE (2013) Vitamin C, Shingles, and Vaccination. Orthomolecular Medicine News Service. Vilcheze, C., T. Hartman, B. Weinrick, and W. Jacobs, Jr. (2013) Mycobacterium tuberculosis is extraordinarily sensitive to killing by a vitamin C-induced Fenton reaction. Nature Communications 4:1881. Glorieux C, Calderon PB. (2017) Catalase, a remarkable enzyme: targeting the oldest antioxidant enzyme to find a new cancer treatment approach. Biol Chem. 398:1095-1108. Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J.
Pisaczek does not judge who is right. It shows what was written and where to read it. Every sentence above has its source.