The first Hib vaccine was introduced in Canada in 1987 for two year old children. The initial polysaccharide Hib vaccine was not effective in infants. A 1988 study in Pediatrics stated, “it was known that the vaccine induced essentially no antibody response or protection in children less than 18 months old.” A study from Minnesota in 1988 shockingly concluded that there was a negative protection rate: “The vaccine’s protective efficacy for children who were most likely to be protected by vaccination was -55% (95% confidence interval = -238% to 29%). Our results indicate that vaccination with Haemophilus b polysaccharide vaccine had no effect in preventing H influenzae type b disease in Minnesota children.”
To get around the problem of the polysaccharide Hib vaccine failure and the lack of protection in infants, vaccine researchers developed Hib polysaccharide-conjugate vaccines. By attaching the Hib polysaccharide to different protein carriers it was thought this vaccine would “trick” the undeveloped infant immune system into recognizing the Hib antibody. Karl-Reinhard Kummer, M.D., warned in his 1994 paper, “Vaccine efficacy increased considerably when the polysaccharide antigens to Hemophilus influenzae were conjugated with the protein antigens to tetanus or diphtheria toxoid. With this, the vaccines were as effective in infants as in older children (review in Meyer and Gahr). This trick used in vaccine production must, however, be seen as a form of “poisoning.” It enables infants to develop the specific immunity which otherwise is reserved for a later time in life. It is not yet known if this premature development has disadvantages in other areas. Nor have potential consequences for the nonspecific immune system been established so far.”
It was clear that the initial polysaccharide Hib vaccine was rushed to market after reading a 1988 study in Pediatrics titled “Haemophilus influenza Type b Vaccines: Lessons for the Future.” In discussing the switch to the new conjugate vaccines, “Even if theoretical risks remain concerning use of the conjugate vaccines in older children, they are probably much less than the risk of permitting the current H influenza type b polysaccharide controversy to continue.” The study concluded “We believe many important lessons can be gained from the experience with the first-generation vaccine. Wisdom has been described as the ability to make the right decision without adequate evidence. In the case of the H influenza type b polysaccharide vaccine controversy, there has been almost too much evidence, so that the task has been to determine what is real, what is important, and what is artifact. Epidemiology is an inexact science that is unfamiliar to many clinicians; yet the results of epidemiologic studies are often the basis for establishing health policies and recommendations for vaccines. The issues we reviewed regarding the case-control studies of H influenza type b polysaccharide vaccine should be relevant to future studies with the H influenza type b conjugate vaccines and other vaccines as well. We hope that unrealistic expectations and misunderstanding can be avoided in the future recommendations for use of new vaccines.”
As many vaccine manufacturers raced to develop conjugate Hib vaccines, numerous types of vaccines with different protein carriers were introduced over the years 1988 to 1994 in Canada. These included HbOC (CRM197 mutant Corynebacterium diphtheria toxin protein), PRP-OMP (Neisseria meningitides outer membrane protein complex), PRP-D (Diphtheria toxoid) and PRP-T (Tetanus toxoid). This left some parents of children vaccinated with these various versions of Hib vaccine wondering if their children were being used as guinea pigs in the development of these vaccines.
The Journal of the American Medical Association published a study in 1992 indicating the newer conjugate vaccines were also worrisome and advised caution, concluding, “Concurrent administration of PRP-T vaccine with DTP vaccine, either in the same syringe or at different sites, interfered with antipertussis responses to a primary series of immunizations. Although the clinical significance of this antagonism is uncertain, these data underscore the caution required in decisions to add new vaccines to existing immunization regimens.”
Hib Vaccine Availability In Ontario
|1987||April. Immunization of 2 year old children against Haemophilus influenzae b with PRP (polysacchride) Hib vaccine.|
|1988||Conjugate Haemophilus b vaccine introduced for children aged 18 months to 5 years (PRP-D, ProHIBiT). PRP discontinued.|
|1991||August 31. Two Haemophilus influenzae type b vaccines licensed in Canada for use for children aged 2-59 months: HbOC (HibTITER Lederle Laboratories) and PRP-OMP (PedvaxHIB, Merck Frosst Canada). Commercially available in Ontario beginning October 1991 (Merck) and February 1992 (Lederle).|
|1992||March. A third infant Hib vaccine licensed for use in children aged 2-59 months: PRP-T (ActHIB), Connaught Laboratories Ltd). Commercially available in Ontario in June.
September 1. HbOC (HibTITER) introduced into the routine infant immunization schedule in Ontario at 2, 4, 6 and 18 months of age.
|1994||June 1. PENTA (DPT-eIPV/PRP-T) introduced for routine immunization at 2, 4, 6 and 18 months.
HibTITER discontinued. ActHIB (PRP-T) introduced, as a component of PENTA.
|1997||July. Acellular pertussis vaccine introduced, in the form of PENTACEL (Pasteur Merieux Connaught), at 2, 4, 6, and 18 months of age, and as QUADRACEL given at 4-6 years. Products containing whole cell pertussis vaccines (PENTA DPT-Polio, pertussis vaccine) were discontinued.|
Above – Source: VACCINE AVAILABILITY IN ONTARIO 1882 – 1997
|2000||“In 2000, Pediacel®, also manufactured by sanofi pasteur, was approved for use in Canada but has not been marketed. It differs from PentacelTM in that the Hib component comes pre-mixed in a liquid formulation with the other components in an ampoule. While the concentrations and types of the three poliovirus strains in PediacelTM are identical to those in PentacelTM, they are grown in Vero monkey kidney cell lines. The pertussis vaccine contains the five component antigens at the same concentrations as PentacelTM; the amounts of tetanus and diphtheria toxoids are also the same.” Ref: http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/07vol33/acs-01/index-eng.php|
|2007||Pediacel introduced in Alberta only
“The manufacturer of Pentacel® also produces a vaccine called Pediacel® (for the same diseases) which is not derived from human cell lines. Although it is administered in the UK and has been approved for use in Canada since 2000, it has not been marketed here. Dr. Leiva suspects manufactures have only produced Pentacel® for the Canadian market in previous years because it was less expensive. This prompted Physicians for Life, a national organization of pro-life doctors, to canvass the provinces and territories this past fall, asking them to procure Pediacel® when negotiating new contracts with vaccine suppliers. To date, Alberta is the lone jurisdiction to report that it will make Pediacel® available in the provincial immunization program after March 2007. Ontario is seeking to renew the bulk vaccine contract this spring, says Dr. Leiva, which makes this an ideal time for concerned parents to contact provincial health officials in that province.”
|2009||Infanrix-hexa introduction for routine infant schedule in BC in February 2009 [6 in 1 vaccine] “BC is the only Canadian jurisdiction introducing Infanrix-hexa at this time. Yukon Territory, Northwest Ter ritories, Newfoundland, New Brunswick, and Prince Edward Island also have infant hepatitis B programs, but at present these are on other three-dose schedules ranging from birth to 15months of age, whereas the 2-, 4-, and 6-month hepatitis B schedule in BC lends itself to ready Infanrix-hexa adoption.”|
|2009||Pediacel introduced Ontario (we will investigate other provinces as time permits)
“Why has Pentacel been replaced by Pediacel? Will Pentacel still be available? … Once Pentacel stock is exhausted, Pediacel will fully replace Pentacel.”
Source: Publicly Funded Immunization Schedules for Ontario – January 2009
This article from the Pediatric Infectious Disease Journal (2009) explains the progression of Hib vaccines in Canada:
Epidemiology of Pertussis and Haemophilus influenza type b Disease in Canada With Exclusive Use of a Diphtheria-Tetanus-Acellular Pertussis-Inactivated Poliovirus-Haemophilus influenza type b Pediatric Combination Vaccine and an Adolescent-Adult Tetanus-Diphtheria-Acellular Pertussis Vaccine – Implications for Disease Prevention in the United States
“The first Hib vaccine, unconjugated PRP, was licensed in Canada in 1986, but its ability to protect children was limited because it was not consistently immunogenic in those under 24 months of age. PRP was replaced in 1988 by PRP-diphtheria toxoid conjugate (PRP-D) vaccine administered at 18 months of age, which later was proven to have an efficacy of only 74% to 88%. More effective Hib conjugate vaccines were introduced in 1991 for use in toddlers and in 1992 for infants starting at 2 months of age. Hib conjugate vaccines contributed to a steep decline of cases during the late 1980s and early 1990s. PRP-tetanus toxoid conjugate (PRP-T) vaccine has been the Hib vaccine used in all Canadian provinces and territories since 1995, as a component of either whole-cell or acellular pertussis combination vaccines.”
As shown above, since 1995 the Hib vaccine has been given in a 5 in 1 (PENTA, Pentacel or Pediacel) or 6 in 1 (Infanrix-Hexa) combination vaccination to Canadian children.
This very important study released in April of 2015 reveals disturbing numbers of reactions to Hib vaccines reported to the US VAERS:
Adverse Events following Haemophilus influenzae Type b Vaccines in the Vaccine Adverse Event Reporting System, 1990-2013
“VAERS received 29 747 reports after Hib vaccines; 5179 (17%) were serious, including 896 reports of deaths. Median age was 6 months (range 0-1022 months). Sudden infant death syndrome was the stated cause of death in 384 (51%) of 749 death reports with autopsy/death certificate records. The most common nondeath serious AE categories were neurologic (80; 37%), other noninfectious (46; 22%) (comprising mainly constitutional signs and symptoms); and gastrointestinal (39; 18%) conditions. No new safety concerns were identified after clinical review of reports of AEs that exceeded the data mining statistical threshold.”
Another disturbing point in the history of the Hib vaccine is the PENTA vaccine saga. Parents whose children had adverse reactions to the first generation 5 in 1 vaccine PENTA (including Hib) launched investigations into this combination. After years of Access to Information requests, correspondences to all levels of government, physicians and health officials it was finally revealed through an e-mail from the Biologics and Genetic Therapies Directorate at Health Canada that the PENTA vaccine combination did not have a DIN # or Notice of Compliance rendering it illegal. This puts into question all subsequent 5 in 1 and 6 in 1 vaccine approvals for Pentacel, Pediacel and Infanrix-Hexa.
From Penta Project:
With the routine administration of PENTA an immediate flood of reports of adverse events (AEFI reports) poured into Health Canada: through the Canadian Freedom of Information Act we received from the Public Health Agency of Canada (PHAC) over 11,000 adverse event reports that included 15 deaths following vaccination with PENTA.
An average of 300 AEFI reports a month with a death every other month following immunization with PENTA were delivered to Health Canada.
Adverse events following immunization (AEFI) with the combination called PENTA included: inconsolable screaming (the ‘neuro-scream’), lethargy, allergic reactions, severe pain, ear infections, anorexia, ‘ice cold hands and feet while with fever’, hypokinesia, ‘myoclonic seizures with a recommendation to defer immunization’, involuntary muscle contractions, ‘oculogyric crisis’ (eyes rolling), ‘abnormal gat following vaccination’ where the ‘child hobbled with valgus deformity’, ‘periods of limpness’, swelling of the brain, neurological damage and death. Two of the 15 deaths described in the AEFI reports following immunization with PENTA: one child died from cerebral infarction and another following autopsy, the child was found to have suffered meningoencephalomyelitis, brain and spinal cord inflammation.
In 2004, a Canadian Department of Pediatrics information sheet stated, “Significant side effects were observed after PENTA vaccination, commonly blamed on the whole cell pertussis component. PENTA was also only about 60–80% effective against pertussis.”
Please visit Penta Project for further information.
In 2008, The Prime Minister of Canada, Stephen Harper, announced $5 Million in funding for the Medic Alert Foundation’s No Child Without program. This wasn’t for children needing food or shelter. This was for children who have life threatening conditions. How did we get to this point in history where 1 in 10 children have a life threatening condition without huge alarm bells ringing throughout the land? “Speaking to an audience of parents, teachers and children at Cleardale Public School in London, Prime Minister Harper noted that an estimated one in 10 Canadian children have severe allergies, asthma, diabetes, epilepsy and other conditions that can be life-threatening if emergencies are not treated properly and promptly. ‘This is a constant worry for parents of kids with medical conditions that are potentially dangerous,’ said the Prime Minister, himself a father of two young children.” There is no explanation or worry as to WHY these 1 in 10 children have life threatening conditions and until such time definitive causes are found for these conditions, vaccines must be in the list of suspects.
Karl-Reinhard Kummer, M.D.’s paper describes “Side effects of Hib immunization appear on the body boundaries: aggravation of eczema, local reactions, skin eruptions, neuritis, rheumatoid arthritis or epileptic reactions (Stickl 1991).”
Below is an excerpt from the article, “Anaphylactic Children – Canaries in the Public Health Mine Shaft?” including quotes from medical journal articles regarding the Hib vaccine:
“Although Hib vaccines have been credited as being a public health miracle, the road to the development and implementation of these vaccines seems to have been anything but smooth. The lack of knowledge about this vaccine’s interactions with the immune system is frightening. Here are just a few examples:
Nicol et al concluding in 2002, a decade after infants were given this vaccine, that 1/10th of the dose of Haemophilus influenzae type B conjugate vaccine (PRP-T) was as immunogenic and safe as the full dose. (22) Considering that the Hib vaccine results in “greatly enhanced antibody responses”, does this mean that children have been receiving 10 times the amount of Hib vaccine that would be necessary to provide that antibody response, thus creating a hypersensitivity to proteins encountered during and after vaccination in children, especially children with a tendency toward allergy?
Also shocking was Pichichero (2000) in his paper on new combination vaccines, describes….”the protective threshold for conjugated PRP [Hib] vaccines is not known….” (23)
Pabst and Spady (1990) studied infants immunized at 2, 4, and 6 months with conjugate Haemophilus influenzae type B vaccine. They found that “antibody levels were significantly higher in the breast-fed (57 infants) than in the formula-fed group (24 infants) at 7 months and at 12 months” and that breastfeeding “enhances the active immune response in the first year of life, and therefore the feeding method must be taken into account in the evaluation of vaccine studies in infants.” (24) Many anaphylactic children were breastfed as infants, which would have boosted this immune response even more! Breast fed and bottle fed babies receive the same doses of vaccines, even though sixteen years ago the above authors found that feeding methods should be evaluated in vaccine studies! This study was later challenged in Scheifele et al’s letter to The Lancet in 1992 in which they conclude that “It seems that the earlier conclusions were incorrect and that breastfeeding does not enhance responses to haemophilus b conjugate vaccines, at least when assessed on completion of the primary series.” (25). The Hib vaccine that Pabst and Spady studied was the CRM 197 mutant diphtheria toxin conjugate vaccine. Scheifele’s study used the PRP-T (tetanus conjugate) vaccine. If Dr. Scheifele was going to discount Pabst and Spady’s results why didn’t he use the same vaccine?
Numerous studies have sounded warnings regarding combination or concurrently administered vaccines including Hib. Here are just three examples:
Even as late as May 2000, Rennels et al concluded that “In this trial concurrent IPV [inactivated polio vaccine] appeared to interfere with the anti-PRP [Hib] response to DTaP/Hib vaccine suggesting that introduction of new vaccines may require evaluation of immune responses to all concurrently administered vaccines.” (26)
The 2004 American Academy of Pediatrics Annual Meeting report on New Combination Vaccines for Childhood Diseases raised red flags about combination vaccines, saying “However, the reactogenicity and potential side effects of the combined antigens have not yet been determined. Since there is the potential for physical and chemical interaction among the vaccine components and the buffers and preservatives, the immunogenicity of each component needs to be addressed to determine whether these are similar to and as effective as the components given individually.” (27)
Redhead K et al (1994) in a very frightening study, state: “However, combination with the Hib vaccine comprising polysaccharide conjugated to tetanus toxoid had dramatic effects on tetanus potency and immunogenicity when assayed in mice. This combination resulted in a five-fold potentiation of the tetanus potency and a similarly large increase in the antibody responses to tetanus toxin and toxoid. The level of the antibody response to the Hib polysaccharide in this vaccine was also elevated, more than 20-fold, as a result of the combination.” (28)
Medical Journal articles re: Hib injury:
Anaphylaxis Complicating Routine Childhood Immunization: Hemophilus Influenza b Conjugated Vaccine
“We report the case of a 4-month-old Caucasian male who developed an urticarial rash within 10 minutes of receiving his 4-month immunizations, diphtheria-tetanus-acellular pertussis (DTaP), inactivated polio (IPV), and the diphtheria mutant protein (CRM197) conjugated Hemophilus influenzae type b (HiB). The child was referred for an allergy-immunology consultation in order to determine the cause of the reaction and a future vaccine management strategy… Skin testing with CRM197 alone (the protein conjugate in HiB) was positive, confirming the source of the reaction. The patient tolerated subsequent Hib immunization with a CRM-free preparation without complications. Our case report suggests that the mutant diphtheria protein CRM197 may be an allergenic protein in some patients who develop anaphylaxis to the HiB vaccine. The new pneumococcal vaccine (Prevnar) contains CRM197.”
Clustering of cases of insulin dependent diabetes (IDDM) occurring three years after hemophilus influenza B (HiB) immunization support causal relationship between immunization and IDDM
“CONCLUSION: Exposure to HiB immunization is associated with an increased risk of IDDM. NOD mice can be used as an animal model of vaccine induced diabetes.”
Clustering of cases of type 1 diabetes mellitus occurring 2-4 years after vaccination is consistent with clustering after infections and progression to type 1 diabetes mellitus in autoantibody positive individuals
“CONCLUSION: The identification of clusters of cases of T1DM occurring in consistent temporal time periods allowed a link between the hemophilus vaccine and T1DM to be established. The current findings indicate the there are also clusters of cases of T1DM occurring 2-4 years post-immunization with the pertussis, MMR, and BCG vaccine. The data are consistent with the occurrence of clusters following mumps infection and the progression to T1DM in patients with antipancreatic autoantibodies.”
Association between type 1 diabetes and Hib vaccine – Causal relation is likely (letter)
“Editor—We initiated and funded a collaborative study with Tuomilehto on the effect of the Haemophilus influenzae type b vaccine on type 1 diabetes and found that the data support a causal relation (paper submitted for publication). Furthermore, the potential risk of the vaccine exceeds the potential benefit. We compared a group that received four doses of the vaccine, a group that received one dose, and a group that was not vaccinated. The cumulative incidence of diabetes per 100 000 in the three groups receiving four, one, and no doses of the vaccine was 261, 237, and 207 at age 7 and 398, 376, and 340 at age 10 respectively.”
Adverse reactions reported following receipt of Haemophilus influenzae type b vaccine: an analysis after 1 year of marketing
“During the period April 1985 to May 1986, adverse reaction reports on 152 patients, excluding those of vaccine failure and concurrent infection, were received. Several adverse reactions not previously recognized, including convulsions, allergic reactions such as anaphylactoid-like and serum sickness-like reactions, and vomiting were received.”
Medical Journal Hib vaccine animal studies showing injury
IgA nephropathy in mice following repeated administration of conjugated Haemophilus influenzae type B vaccine (PRP-T)
“We concluded that conjugated Haemophilus influenzae type b vaccine, given at two-week intervals to a total of six doses, caused secondary IgA nephropathy in mice.”
Bronchial hyperreactivity to histamine induced by Haemophilus influenzae vaccination
Comparison of vaccination of mice and rats with Haemophilus influenzae and Bordetella pertussis as models of atopy
“The Haemophilus influenzae vaccinated experimental animal provides a model that is possibly more related to human atopy than the Bordetella pertussis vaccinated animal.”
Overview of Haemophilus influenzae type b vaccine (Hib) – Vaccine Choice Canada
Zur Impfung gegen Haemophilus influenzae-B (HlB), from Merkurstab 1994; 47: 170-81. By: Karl-Reinhard Kummer, English by A. R Meuss, FlL, MTA.
Can Hib Vaccine Cause Asthma? by Heidi White, Hospital Pharmacist
The Perilous HIB by New Zealand researcher Hilary Butler
Is Alarming Rise in Autism Linked to 1988 Event? – Dr. Joseph Mercola
“New Hypothesis: the Hib Vaccine May Explain Rapid Rise in Autism – According to a recent study in the journal Medical Hypotheses”
Can Vaccines Cause Immune Dysfunction Resulting in Allergies, Asthma and Anaphylaxis?
“Rates of anaphylaxis have increased dramatically since the introduction of the Hib vaccine.”
Anaphylactic Children – Canaries in the Public Health Mine Shaft?
“Although Hib vaccines have been credited as being a public health miracle, the road to the development and implementation of these vaccines seems to have been anything but smooth. The lack of knowledge about this vaccine’s interactions with the immune system is frightening.”
Beware of HIB vaccine by Dr Robert Mendelsohn MD
Compiled by Vaccine Choice Canada Links accessed February 2016.