HiB Vaccine

One of the long-term effects of the Hib vaccine that has shown up in follow-up studies is Diabetes:

Clustering of Cases of Insulin Dependent Diabetes (IDDM) Occurring Three Years after Hemophilus Influenza B (Hib) Immunization Support Causal Relationship between Immunization and IDDM            http://www.vaccines.net/1TOPEDJ.pdf

Hemophilus Vaccine Study in Finland Proves a Causal Relationship Between Vaccines and Diabetes

PedvaxHIB - Merck

PedvaxHIB – Merck – Product Insert

PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] is a highly purified capsular polysaccharide of Haemophilus influenzae type B that is covalently bound to an outer membrane protein complex of the B11 strain of Neisseria meningitis serogroup B. (Page 1)

Safety studies compared liquid PedvaxHIB to lyophilized PedvaxHIB and followed for 3 days.  DTP and OPV were given at the same time.  Reactions included fever, Erythema and swelling. (Page 6 & 7)

The use of Haemophilus b Polysaccharide Vaccines and another Haemophilus b Conjugate Vaccine has been associated with early onset Hib disease and Guillain-Barre syndrome. (Page 7)

Post-Marketing Adverse Reactions included lymphadenopathy, angioedema, and febrile seizures. (Page 8)

PedvaxHIB ingredients: amorphous aluminum hydroxyphosphate sulfate, sodium chloride, complex fermentation medium 

PedvaxHIB is given in a 3-dose series at 2, 4, and 12-15 months.

ActHIB - Sanofi Pasteur

ActHIB – Sanofi Pasteur – Product Insert  https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM109841.pdf

ActHIB is a Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), where the Haemophilus influenzae type b is covalently bound to tetanus toxoid.

Adverse Reactions: See pages 5-9.  Post-Marketing Experience included anaphylaxis, urticaria, angioedema, convulsions, extensive limb swelling, peripheral edema, pruritus, and rash.

ActHIB is given in a 4-dose series at 2, 4, 6 and 12-15 months.

ActHIB ingredients: sodium chloride, modified Mueller and Miller medium (the other culture medium contains milk-derived raw materials [casein derivatives], formaldehyde, sucrose.

Pentavalent Vaccine (DTAP, Polio, Hib)

 Pentacel (Pentavalent vaccine) – DTaP-IPOL/Hib – Sanofi Pasteur

Package Insert  https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm109810.pdf

Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including Pentacel vaccine. (p.6)
(In other words, if a DTaP containing shot caused brain damage, don’t give the child another one).

The most frequent (>50% of participants) systemic reactions following any dose were fussiness/irritability and inconsolable crying. The most frequent (>30% of participants) injection site reactions following any dose were tenderness and increased circumference of the injected arm. (Adverse Reactions – p.8)

Safety Studies used vaccine control groups and/or concomitantly administered vaccines. (Table 1 – p.10)

Pentacel ingredients: aluminum phosphate, polysorbate 80, formaldehyde, glutaraldehyde, bovine serum albumin, 2-phenoxethanol, neomycin, polymyxin B sulfate, Mueller’s Growth Medium, Mueller-Miller casamino acid medium (without beef heart infusion), Stainer-Scholte medium (modified by the addition of casamino acids and dimethyl-beta-cyclodextrin), MRC-5 (human diploid) cells, CMRL 1969 medium (supplemented with calf serum), ammonium sulfate, and medium 199                                                                                                      http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

Pentavalent Vaccine – DTaP-IPOL-Hib

Bhutan – Introduced July 2009, withdrawn in 2 months following 8 deaths.

Pakistan – Introduced Nov. 2008 – 3 deaths (1 within ½ hour, 2 within 12-14 hrs.)


Sri Lanka – Introduced Jan. 2008, withdrawn April 2008 after 5 deaths.

Kerala - 2012 - 3 deaths

Haryana - 2012 -1 death

Vietnam - November 2012 - 3 deaths - PV vaccine use terminated


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