VaccinesCombination 6-in-1 vaccines — convenience for parents or a burden on infants?
Sources: 11 · Article: 15 475 characters
The STOP NOP Association says that giving multiple antigens at the same time can bring benefits, but may also increase the risk of adverse reactions.
- According to the association, Infanrix Hexa combines several antigens, including hepatitis B virus antigen, and multi-antigen vaccinations are repeated three times from the age of two months, every 6–8 weeks.
- The association describes an infant’s immune system as immature and notes that the mechanism of the response to antigens in multicomponent vaccines is not fully understood.
- It also reports a recommendation to consider single vaccines in some cases if the patient may already be immune to some of the antigens.
What the authors write
Stowarzyszenie STOP NOP
Giving multiple antigens at the same time in a combination vaccine is said to bring benefits, but may increase the risk of adverse reactions.
„This approach brings many benefits on the one hand, but on the other it carries an increased risk of adverse reactions, whose immunopathogenesis is not fully understood in many cases (Ward 2000). An adverse event following immunization (AEFI) is any health problem that is temporally and causally related to vaccination (Bernatowska 2004).”Ten kierunek, dający z jednej strony wiele korzyści, z drugiej niesie zwiększone ryzyko działań niepożądanych, których immunopatogeneza w wielu wypadkach nie jest do końca wyjaśniona (Ward 2000). Niepożądany odczyn poszczepienny (NOP) to każde zaburzenie zdrowia czasowo i przyczynowo związane ze szczepieniem (Bernatowska 2004).
Stowarzyszenie STOP NOP
Infanrix Hexa combines several antigens, including an additional hepatitis B virus antigen.
„Most often, children are immunized simultaneously with diphtheria and tetanus toxoids, acellular pertussis antigen, polio, and H. influenzae (Infanrix-IPV+Hib, PENTAXIM), or with an additional hepatitis B virus antigen (Infanrix Hexa). These vaccinations are repeated three times from the age of two months, every 6–8 weeks.”Najczęściej dzieci immunizowane są jednocześnie toksoidem błoniczym, tężcowym, antygenem krztuścowym-bezkomórkowym, polio oraz H. influenzae (szczepionka Infanrix-IPV+Hib, PENTAXIM) lub z dodatkowym antygenem wirusa WZW t. B (Infanrix hexa). Szczepienia te powtarzane są od drugiego miesiąca życia trzykrotnie co 6?8 tygodni.
Stowarzyszenie STOP NOP
The STOP NOP Association says that multi-antigen vaccinations are repeated three times from the age of two months, every 6–8 weeks.
„These vaccinations are repeated three times from the age of two months, every 6–8 weeks. Infants up to 6 months of age are also offered recommended vaccinations against rotavirus and pneumococcal disease (2–3 doses). Together with the tuberculosis and hepatitis B vaccination given in the first 24 hours of life, an infant receives 24–26 doses of foreign antigens.”Szczepienia te powtarzane są od drugiego miesiąca życia trzykrotnie co 6?8 tygodni. Dziecku do 6 miesiąca życia proponowane są także zalecane szczepienia przeciwko rotawirusom i pneumokokom (2?3 dawki). Łącznie z przeprowadzanym w pierwszej dobie życia szczepieniem przeciw gruźlicy i WZW B niemowlę otrzymuje 24?26 dawek antygenu obcogatunkowego.
Stowarzyszenie STOP NOP
The STOP NOP Association also lists other vaccinations offered to infants up to six months of age and estimates the total number of antigen doses they receive.
„Infants up to 6 months of age are also offered recommended vaccinations against rotavirus and pneumococcal disease (2–3 doses). Together with the tuberculosis and hepatitis B vaccination given in the first 24 hours of life, an infant receives 24–26 doses of foreign antigens.”Dziecku do 6 miesiąca życia proponowane są także zalecane szczepienia przeciwko rotawirusom i pneumokokom (2?3 dawki). Łącznie z przeprowadzanym w pierwszej dobie życia szczepieniem przeciw gruźlicy i WZW B niemowlę otrzymuje 24?26 dawek antygenu obcogatunkowego.
Stowarzyszenie STOP NOP
The STOP NOP Association notes that the mechanism of the response to antigens in multicomponent vaccines is not fully understood.
„The mechanism of the immune response to different types of vaccine antigens is not fully understood or studied, especially when it comes to antigens in multicomponent vaccines. The Th2 pathway stimulated by vaccination, which is responsible for antibody production and predominates in newborns and infants, may lead to allergic reactions if it is not sufficiently balanced by a Th1 response (Willak-Janc 2003).”Mechanizm odpowiedzi immunologicznej na poszczególne rodzaje antygenów szczepionkowych nie jest do końca poznany i zbadany, tym bardziej jeśli chodzi o antygeny w szczepionkach wieloskładnikowych. Stymulowany szczepieniem szlak Th2 odpowiedzialny za produkcję przeciwciał, który przeważa u noworodków i niemowląt, przy braku wystarczającego zrównoważenia odpowiedzią Th1 może prowadzić do rozwoju reakcji alergicznych (Willak-Janc 2003).
Stowarzyszenie STOP NOP
The STOP NOP Association describes an infant’s immune system as immature and says that the immune system reaches full maturity at around three years of age.
„On the other hand, as the author writes, because maternal antibodies are present, vaccinations against some microorganisms given just after birth do not lead to lasting immunity. It should be emphasized that the immune system reaches full immunoregulatory and defensive maturity at around 3 years of age (Deggeller 1992).”Z drugiej strony, jak pisze autor, ze względu na istniejące przeciwciała pochodzenia matczynego, szczepienia przeciw niektórym mikroorganizmom, wykonane tuż po urodzeniu, nie prowadzą do trwałej odporności. Należy podkreślić, że pełną dojrzałość immunoregulacyjną i obronną osiąga układ immunologiczny około 3 roku życia (Deggeller 1992).
Stowarzyszenie STOP NOP
The STOP NOP Association asks how a child’s developing immune system responds to intense stimulation from a multi-antigen vaccine.
„However, questions arise: How will the not fully mature, developing immune system of a healthy child and the child’s developing central nervous system respond to such intense stimulation? Can they respond properly, with the same protective effect, to so many different stimuli?”Nasuwają się jednak pytania: W jaki sposób na tak intensywną stymulację odpowie nie w pełni dojrzały, rozwijający się układ immunologiczny zdrowego dziecka i jego kształtujący się ośrodkowy układ nerwowy? Czy jest w stanie prawidłowo odpowiedzieć, z jednakowym efektem ochronnym, na tyle zróżnicowanych bodźców?
Stowarzyszenie STOP NOP
The STOP NOP Association reports a recommendation to use single vaccines instead of combination vaccines in some cases if the patient may already be immune to some of the antigens.
„The commission strongly rejects this view, saying: “To prevent serious side effects of vaccination, only single vaccines should be given instead of multiple vaccines, because military personnel, as adults, may already have been immunized against only some of the antigens contained in combination vaccines.” “Therefore, it is recommended that the medical history before vaccination be reviewed for all patients.””Komisja ostro zaprzecza temu poglądowi, mówiąc: ?w celu zapobiegania poważnym skutkom ubocznym szczepień, tylko pojedyncze szczepionki powinny być podawane zamiast wielu, ponieważ wojskowi jako dorośli, mogli już być immunizowani tylko na niektóre antygeny zawarte w szczepionkach skojarzonych.? ?Dlatego zaleca się zwracać uwagę na historię medyczną okresu przed szczepieniami u wszystkich pacjentów.?
Stowarzyszenie STOP NOP
The STOP NOP Association describes multi-antigen vaccines as being given repeatedly.
„At the same time, as mentioned above, multi-antigen vaccines are recommended and given repeatedly. Doctors and scientists point to a decline in the health of the child population since the 1960s, which coincided with the increasingly widespread use of vaccinations.”Jednocześnie, jak wspomniano wyżej, zalecane są szczepionki wieloantygenowe, wielokrotnie podawane. Lekarze i naukowcy zwracają uwagę na pogorszenie stanu zdrowia populacji dziecięcej od lat 60. ubiegłego wieku, co zbiegło się w czasie z wprowadzanymi coraz szerzej szczepieniami.
Stowarzyszenie STOP NOP
The STOP NOP Association describes a final court ruling awarding compensation for autism that developed in a child after receiving Infanrix Hexa.
„In 2014, a court in Milan issued a ruling awarding compensation and a pension supplement from the state for autism that developed in a child after the Infanrix Hexa vaccine. The ruling is final.
The parents sued the ministry, “showing that their son’s autistic syndrome was caused by vaccinations that contained, in a dangerous way, certain heavy metals and contaminants — such as aluminum — whose toxicity would increase in the presence of other ingredients, such as polysorbate 80 — as well as mercury.”
The lawsuit was filed in 2011.”W 2014 roku Sąd w Mediolanie wydał wyrok zasądzający odszkodowanie i dodatek do renty od państwa za autyzm, który wystąpił u dziecka po szczepionce Infanrix Hexa. Wyrok jest prawomocny.
Rodzice pozwali ministerstwo „wykazując, że został wywołany u ich syna syndrom autystyczny na skutek szczepień, które zawierały, w niebezpieczny sposób, niektóre metale ciężkie i zanieczyszczenia – takie jak aluminium – którego toksyczność wzrosłaby w obecności innych składników, takich jak polisorbat 80 – oraz rtęć.”
Pozew został złożony w 2011 r.
Research from PubMed · Europe PMC
We selected 5 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: 5 938.
A review found that the 6-in-1 vaccine has a favorable safety profile and produces a good immune response, while reducing the number of injections.
Aim of the study: Hexaxim® is a fully liquid, hexavalent combination vaccine that provides immunization against diphtheria, tetanus, pertussis (whooping cough), polio, hepatitis B, and invasive diseases caused by Haemophilus influenzae type b. Combination vaccines such as Hexaxim reduce the number of injections needed, improving both vaccination compliance and operational efficiency.
Money for the studycompany or manufacturer · Sanofi
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?YES
Type of studydiscussion of other studies
“Not stated” does not mean nobody paid — the database does not always record it.
The review found that the 6-in-1 vaccine, when given with other routine vaccines, was well tolerated and did not significantly interfere with immune responses.
Aim of the study: The benefits of vaccine co-administration include improved vaccine acceptance and uptake resulting in increased coverage and protection against multiple childhood diseases, with minimal medical visits. The diphtheria-tetanus-acellular pertussis-hepatitis B-poliomyelitis-Haemophilus influenzae type b vaccine (DTaP-HBV-IPV/Hib) has been available for more than 19 years and is recommended for co-administration with several other infant vaccines.
Money for the studycompany or manufacturer · GlaxoSmithKline
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?YES
Type of studydiscussion of other studies
“Not stated” does not mean nobody paid — the database does not always record it.
The review indicates that the 6-in-1 vaccine produces an antibody response similar to that of vaccines given separately and shows no significant safety signals.
Aim of the study: Combination vaccines reduce the 'shot burden' and simplify the childhood immunization schedule. Only 5-valent DTaP-based vaccines are licensed in the U.S.
Results: Administration is associated with higher rates of mild fever, but without significant safety signals. Expert commentary: Incorporation of this hexavalent vaccine into the U.S. schedule could improve coverage rates and timeliness, and addition to the E.U. market would add depth to the available repertoire of combination vaccines.
Money for the studycompany or manufacturer · Sanofi Pasteur MSD, Sanofi Pasteur, Inc., Merck
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?YES
Type of studydiscussion of other studies
“Not stated” does not mean nobody paid — the database does not always record it.
The review rated the 6-in-1 vaccine as highly immunogenic, with an acceptable safety profile and a ready-to-use liquid formulation.
Aim of the study: Hexaxim is a hexavalent vaccine approved as primary and booster vaccination in infants 6 weeks and older, protecting against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenzae type b.
Money for the studynot stated · not funding
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 indicates that 6-in-1 vaccines can reduce the number of injections and simplify vaccination schedules.
Aim of the study: Hexavalent vaccines containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, poliomyelitis, and hepatitis B virus antigens have the potential to be used for the primary series in India (at 6, 10, and 14 weeks of age) and the toddler booster dose. Three hexavalent vaccines are available in India: DTwP-Hib/HepB-IPV (wP-hexa), DTaP-IPV-HB-PRP~T(2aP-hexa), and DTaP-HBV-IPV/Hib (3aP-hexa).
Results: Three hexavalent vaccines are available in India: DTwP-Hib/HepB-IPV (wP-hexa), DTaP-IPV-HB-PRP~T(2aP-hexa), and DTaP-HBV-IPV/Hib (3aP-hexa). In the three published phase-3 Indian studies, pertussis 'vaccine response' rates 1 month after a 6-10-14-week primary series were 68.4-75.7% for wP-hexa, 93.8-99.3% for 2aP-hexa, and 97.0-100% for 3aP-hexa; seroprotection rates for the other five antigens were 88.2-100%, 49.6-100%, and 98.6-100%, respectively. Studies outside India show: good immunogenicity/safety after booster dosing; immune persistence to age 4.5 years (2aP-hexa), 7-9 years (3aP-hexa) (all antigens), and 9-10 and 14-15 years, respectively (hepatitis B); and successful co-administration with other vaccines. Hexavalent vaccines could reduce the number of injections, simplify vaccination schedules, and improve compliance.
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
„Multiple analyses by Goldman and Miller affirm a positive correlation between the number of vaccine doses and infant mortality rates. There is credible evidence and biological plausibility for an association between pediatric vaccines and infant deaths. Of the 2605 infant deaths reported to the Vaccine Adverse Event Reporting System (VAERS) from 1990 through 2019, 58% clustered within three days post-vaccination, and 78% occurred within seven days post-vaccination, confirming that infant deaths tend to occur in temporal proximity to vaccine administration [6].”Multiple analyses by Goldman and Miller affirm a positive correlation between number of vaccine doses and infant mortality rates There is credible evidence and biological plausibility for an association between pediatric vaccines and infant deaths. Of the 2605 infant deaths reported to the Vaccine Adverse Event Reporting System (VAERS) from 1990 through 2019, 58% clustered within three days post-vaccination, and 78% occurred within seven days post-vaccination, confirming that infant deaths tend to occur in temporal proximity to vaccine administration [6].
Orthomolecular Medicine News Service Opinion material
„I've written articles about nutritional treatments for colic (sodium ascorbate, probiotics/yogurt), [1] coughs from colds or flu (pediatric multivitamin and additional vitamin C and vitamin D) [2, 3], sore throat (adequate doses of multivitamin, vitamin D and mega-doses of vitamin C) [4], and superfluous and potentially toxic contents of vaccinations (multivitamins and additional vitamin C), [5, 6]. Mother's milk has many benefits, including antibodies pre-made by the mother's immune system. Milk contains very little iron, and nearly all the iron it contains is bound to a special protein called lactoferrin.”I've written articles about nutritional treatments for colic (sodium ascorbate, probiotics/yogurt), [1] coughs from colds or flu (pediatric multivitamin and additional vitamin C and vitamin D) [2, 3], sore throat (adequate doses of multivitamin, vitamin D and mega-doses of vitamin C) [4], superfluous and potentially toxic contents of vaccinations (multivitamins and additional vitamin C), [5, 6]. Mother's milk has many benefits, including antibodies pre-made by the mother's immune system. Milk contains very little iron, and nearly all the iron it contains is bound to a special protein called lactoferrin.
Orthomolecular Medicine News Service Opinion material
„This makes a nonsense of Big Pharma's advice to vaccinate all members of a new infant's family to protect the infant from infection. This "cocooning" strategy increases the risk of infant infection. Herd immunity cannot apply to vaccines that afford protection against bacterial endotoxins, so herd immunity cannot possibly occur with tetanus and diphtheria vaccines. The spread of diphtheria has been controlled by isolating sufferers and treating them with antibiotics. Herd immunity is impossible to achieve with influenza vaccine because the flu virus is constantly evolving and changes every year.”This makes a nonsense of Big Pharma's advice to vaccinate all members of a new infant's family to protect the infant from infection This "cocooning" strategy increases the risk of infant infection. Herd immunity cannot apply to vaccines which afford protection against bacterial endotoxins and so herd immunity cannot possibly occur with tetanus and diphtheria vaccines. The spread of diphtheria has been controlled by isolating sufferers and treating them with antibiotics. Herd immunity is impossible to achieve with influenza vaccine because the flu virus is constantly evolving and changes every year.
Pisaczek does not judge who is right. It shows what was written and where to read it. Every sentence above has its source.