HIB Vaccines

Package Inserts

ActHib and OmniHib are conjugated with tetanus toxoid.

Hib Titer is conjugated with mutant diphtheria protein.

PedvaxHib and Comvax are conjugated with meningococcal group B outer membrane protein.

 

 Efficacy? The information varies based on the brand of vaccine. Table 2 at the end of this page http://www.cdc.gov/mmwr/preview/mmwr…m#00001680.htm tells how effective each dose number is.

Efficacy:

Results of efficacy trials among infants are available for the three conjugate vaccines. The first efficacy trial of an Hib conjugate vaccine among infants was completed in Finland using the PRP-D vaccine. In a systematic, unblinded trial involving 60,000 infants (30,000 of whom received the vaccine at 3, 4, and 6 months of age), the point estimate of efficacy was 87% (95% CI = 50%-96%) (10). In a randomized, double-blind, placebo-controlled study of 2,102 Alaskan Natives, however, the point estimate of efficacy was 35% (95% CI = (-57%)-73%) (11). Immunogenicity of the vaccine was limited in both trials. In the Finnish trial, less than 40% of infants had attained an antibody level of greater than 1 ug/mL 1 month after receiving the third of three doses (geometric mean titer (GMT) = 0.42 ug/mL). In Alaska, infants with a similar vaccination schedule had lower mean titers (GMT = 0.2 ug/mL) 3 months after receiving the third dose. A subsequent immunogenicity study documented antibody responses that were similar to those in the Alaskan and Finnish efficacy trials.

ActHib (Sanofi): ActHib was tested for safety by giving one group ActHib w/ DTP and the control group was given Hepatitis B w/ DTP. Here is an excerpt from the product insert:

 In a randomized, double-blind US clinical trial, ActHIB® was given concomitantly with DTP to more than 5,000 infants and Hepatitis B vaccine was given with DTP to a similar number.
In this large study, deaths due to sudden infant death syndrome (SIDS) and other causes were observed but were not different in the two groups.
In the first 48 hours following immunization, two definite and three possible seizures were observed after ActHIB® and DTP in comparison with none after Hepatitis B vaccine and DTP. This rate of seizures following ActHIB® and DTP was not greater than previously reported in infants receiving DTP alone. (Refer to product insert for AvP DTP.) Other adverse reactions reported with administration of other Haemophilus b conjugate vaccines include urticaria, seizures, hives, renal failure and Guillain-Barré syndrome (GBS). A cause and effect relationship among any of these events and the vaccination has not been established.

Children are at more risk of getting Hib disease right after vaccination.  

Studies from Science News warn of increased susceptability to the disease during the first 7 days after vaccination. The AAP has warned doctors to look for signs of the disease following vaccination (AAP policy statement.) Several studies have found that that Hib vaccinated children are up to 6 times more likely than non Hib vaccinated children to contract Hib during the first week following vaccination. (Pediatric Infectious Disease Journal and JAMA). 
 
In one study of children who got Hib at least 3 weeks after their vaccination, 70% developed meningitis. Additional research shows that antibody levels DECLINE rather than increase immediately following Hib vaccination, even with the newer conjugated vaccines. (Journal of Pediatrics, Pediatrics, and Pediatric Infectious Disease Journal.) 
 

Who are the highest risks?

 Children from lower socioeconomic families are at highest risk for getting Hib disease. (Physicians Desk Reference, 53rd edition, 1999 pg 3072)

Thirty-two percent of children aged 6–59 months with confirmed type b disease had received three or more doses of HIB vaccine, including 22 who had received a booster dose 14 or more days before onset of their illness. The cause of Hib vaccine failure in these children is not known.

Vaccine Linked with Diabetes:

 The British Medical Journal warns about the dangers of childhood vaccines. Investigators pooled data on roughly 116,000 Finnish children who received Heamophisis Influenza type b vaccine at either 3 or 24 months of age. These children were compared with 128,5000 children who did not receive the vaccine.
Subjects were reevaluated at age 10. The study’s author found that “immunizations starting after the age of 2 months is associated with an increased risk of diabetes. Our analysis is further associated with a similar rise in diabetis after immunization with H influenzae type b vaccine in the US and UK. Furthermore, the increased risk of of diabetes in the vaccinated group exceeds the expected decreased risk of complication of H influenzae meningitis.

Research into immunisation has been based on the theory that the benefits of immunisation far outweigh the risks from delayed adverse events and so long term safety studies do not need to be performed. When looking at diabetes only one potential chronic adverse event we found that the rise in the prevalence of diabetes may more than offset the expected decline in long term complications of H influenzae meningitis. Thus diabetes induced by vaccine should not be considered a rare potential adverse event. The incidence of many other chronic immunological diseases, including asthma, allergies, and immune mediated cancers, has risen rapidly and may also be linked to immunisation. Classen JB, Claussen DC. Public should be told that vaccines may have long term adverse effects. (Brit Med Journal 1999 (Jan 16);   318 (7177):193 full text)

 

 

 

The Hib vaccine can cause adverse reactions such as convulsions, allergic reactions such as anaphylaxis, vomiting, and serum sickness-like reactions. The FDA did not recognize these reactions when licensure was granted. Incidence of Hib type meningitis peaks between 6-11 months.
Daum RS, Sood SK, Osterholm, MT et. al.   Decline in serum antibody to the capsule of Haemophilus influenzae type b in the immediate postimmunization period   J Pediatr. 1989 (May);   114 (5):   742-747
Milstien JB, Gross TP, Kuritsky JN  
Adverse reactions reported following receipt of Haemophilus influenzae type b vaccine: an analysis after 1 year of marketing   Pediatrics 1987 (Aug);   80 (2):   270-274.

The “Finnish” study, upon which license was granted, showed the vaccine was  ineffective for infants 3-17 months of age.
Peltola H, Kayhty H, Sivonen A, Makela H   Haemophilus influenzae type b capsular polysaccharide vaccine in children: a double-blind field study of 100,000 vaccinees 3 months to 5 years of age in Finland.   Pediatrics 1977 (Nov);   60 (5):   730-737.
Shinefield HR, Hiatt RA, Fireman BH   Efficacy of Haemophilus influenzae type b capsular polysaccharide vaccine.   Pediatr Infect Dis J. 1988 (Mar);   7 (3):   149-156
Shapiro ED, Murphy TV, Wald ER, Brady CA   The protective efficacy of Haemophilus b polysaccharide vaccine.   JAMA. 1988 (Sep 9);   260 (10):   1419-1422
Harrison LH, Broome CV, Hightower AW, Hoppe CC, Makintubee S, Sitze SLA day care-based study of the efficacy of Haemophilus b polysaccharide vaccine.   JAMA 1988 (Sep 9);   260 (10):   1413-1418

Other studies showed the vaccine has no efficacy at all:
Ward JI, Broome CV, Harrison LH, Shinefield H, Black S   Haemophilus influenzae type b vaccines: lessons for the future   Pediatrics 1988 (Jun);   81 (6):   886-893.
Osterholm MT, Rambeck JH, White KE, Jacobs JL, Pierson LM, Neaton JD, Hedberg   Lack of efficacy of Haemophilus b polysaccharide vaccine in Minnesota   JAMA 1988 (Sep 9);   260 (10):   1423-1428.
Ward J, Brenneman G, Letson GW, Heyward WL   Limited efficacy of a Haemophilus influenzae type b conjugate vaccine in Alaska Native infants. The Alaska H. influenzae Vaccine Study Group   N Engl J Med 1990 (Nov 15);   323 (20):   1393-1401

 

 

 

The C.D.C. stated “Efficacy of the conjugate vaccine (currently being used) has not been determined in field trials. MMWR 1988, Vol. 37, RR-37, pp. 13-16.

Your baby will actually become more susceptible to meningitis for up to 3 weeks following vaccination.  Daum RS, Sood SK, Osterholm, MT et. al.   Decline in serum antibody to the capsule of Haemophilus influenzae type b in the immediate postimmunization period.   J Pediatr. 1989 (May);   114 (5):   742-747.
Ward J, Brenneman G, Letson GW, Heyward WL   Limited efficacy of a Haemophilus influenzae type b conjugate vaccine in Alaska Native infants. The Alaska H. influenzae Vaccine Study Group.   N Engl J Med 1990 (Nov 15);   323 (20):   1393-1401
Sood SK, Schreiber JR, Siber GR, Daum RS.   Postvaccination susceptibility to invasive Haemophilus influenzae type b disease in infant rats.   J Pediatr 1988 (Nov);   113 (5):   814-819.
Hiner EE, Frasch CE   Spectrum of disease due to Haemophilus influenzae type b occurring in vaccinated children.   J Infect Dis 1988 (Aug);   158 (2):   343-348.
Granoff DM, Shackelford PG, Suarez BK, Nahm MH et. al. Hemophilus influenzae type B disease in children vaccinated with type B polysaccharide vaccine. N Engl J Med 1986 Dec 18;315(25):1584-1590. Ward J   Newer Haemophilus influenzae type b vaccines and passive prophylaxis.   Pediatr Infect Dis J. 1987 (Aug);   6 (8):   799-803.
 The risk of contracting meningitis one week after vaccination is 6.4-1.8 times greater than unvaccinated children.
Sood SK, Schreiber JR, Siber GR, Daum RS   Postvaccination susceptibility to invasive Haemophilus influenzae type b disease in infant rats   J Pediatr 1988 (Nov);   113 (5):   814-819.

41% of cases of Hib occurred in vaccinated individuals. The vaccine’s protective efficacy is about negative 58%.  You are more likely to get Hib if you are vaccinated.
Osterholm MT, Rambeck JH, White KE, Jacobs JL, Pierson LM, Neaton JD, Hedberg   Lack of efficacy of Haemophilus b polysaccharide vaccine in Minnesota.   JAMA 1988 (Sep 9);   260 (10): 1423-1428.

The widespread use of the Hemophilus influenza vaccine in 1986 was followed by a 62% rise (16 cases/100,000 children to 29.2 cases/100,000) in the incidence of diabetes in the 0-4 age group between the years 1980-1982 and 1990-1992.
Tuomilehto J, Virtala E, Karvonen M, Lounamaa R, Pikaniemi J et. al.   Increase in incidence of insulin-dependent diabetes mellitus among children in Finland   Int J Epidemiol 1995 (Oct);   24 (5):   984-992.

The incidence of IDDM also rose in the young children 2-3 year olds after the first dose of HiB was introduced.
Classen DC, Classen JB   The timing of pediatric immunization and the risk of insulin-dependent diabetes mellitus   Infectious Diseases in Clinical Practice 1997;   6:   449-454.
Drastic rises in the incidence of IDDM have been reported in the US and the UK after the introduction of the HiB vaccine.
 An epidemic of diabetes in the 0-4 age group occurred during the years 1985-1989 in Allegheny County at the time when the Hemophilus influenza vaccine was being incorporated into the immunization schedule. The annual incidence of IDDM in 0-4 year  olds living in Allegheny county rose 60% from the years 1980-1984 (10 cases/100,000) to 1985-1989 (16 cases/100,000). The incidence of diabetes in  0-4 year olds had been consistently below 10 cases/100,000 from 1965-1984.  The incidence of IDDM in this age group is expected to rise even higher since  the maximum effect of the HiB vaccine on IDDm is not seen until 4 years after  immunization.
 India appears to have a high rate of natural immunity:

 Studies from the early 1970’s might hold an explanation for this phenomenon. It is known that other bacteria have cross-reactive antigens to the Hib capsular polysaccharide. In an elegant experiment with burros, Bradshaw et al demonstrated the development of serologically specific precipitate antibodies to Hib after immunization of animals with Stephylococcus aureas and Bacillus subtillis. Strains of Staphylococci, Group D. Streptococci, Diphtheroids and Escherichia coli have been found with cross-reactive antigens to Hib. Robbins et al have demonstrated that infants show enhanced immune response to H influenzae capsular polysaccharide when they have concurrent cross reacting E. coli infection of the gut. Under these circumstances, a rapid and sustained rise in antibody to Hib was noted. E. Coli are ubiquitous in developing countries like India and their presence in the gut may have helped to stimulate antibody to Hib in the subjects reported….. There is thus a great potential for savings to be made in vaccination us in developing countries, if this finding is further substantiated. (Puliyel JM, Agarwal KS, Abass FA. Natural immunity to haemophilus b in infancy in Indian children. Vaccine 2001; 19: 4592-4594.)

 

 Hib and E Coli are not killers in undeveloped countries because the people can’t afford antibiotics. When you use antibiotics, the gut flora becomes unbalanced and causes E. Coli numbers to explode; making them very dangerous. Antibiotics kill E.Coli, and by doing so, can kill. The bacterial cell walls become endotoxin which cannot be processed by the liver and thus the person dies from antibiotic-induced endotoxic shock. Since 70% of the immune system resides in the gut, if you use antibiotics too much, not only do you create imbalances, you also create situations where you wouldn’t get good levels of diverse ‘good’ flora, so that they can make good levels of immunity to Hib.

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