HiB or H.influenza is the next vaccine given along with DTaP at two, four and six months. HiB is not a vaccine against Meningitis in general; its only target is one subtype of one of the many bacteria, not to mention the many viruses that cause Meningitis. Haemophilus Influenza, the bacterium targeted by this vaccine, is commonly present in the mucosa of the throat without doing any harm at all. Granoff et al completed one key study in 1986 in which it was found that vaccinated children that contracted HiB Meningitis actually had lower serum antibody levels against this disease than non-vaccinated children from the same age groups. The study went further and looked at fifty-five children who had contracted invasive HiB at least three weeks after they had been vaccinated. Thirty-nine of these children developed Meningitis, of whom three died. A Finnish study of 114,000 children, found that those who received four doses of the vaccine had a higher incidence of Type 1 Diabetes than those who received only one dose. In a more disturbing study Hib may be changing and becoming more virulent do to vaccination. Viruses want to stay alive just like anything else in nature and to do this they must adapt. Take a look at this study and see what you think.

Emerging Diseases

http://www.infectiousdiseasenews.com/200111/frameset.asp?article=Influenzae= .asp

New Haemophilus influenzae pathogen may be emerging

Non-b serotypes of Haemophilus influenzae may be replacing Hib as a serious pathogen.
November 2001

SALT LAKE CITY While Haemophilus influenzae type b (Hib) has been nearly eliminated as a major cause of serious disease in children, other serotypes, especially H. influenzae type a, may have acquired virulence traits and may be emerging as disease-causing pathogens.

A recent report in Pediatrics described 5 cases of H. influenzae type a, 2 of which were strikingly reminiscent of disease caused by Hib, said the report. In 2 other cases, infections were similar to Hib infections, but different enough to suggest that 2 distinct clones of H. influenzae type a may be circulating concurrently.

Case reports In December 1998, a previously healthy 6-month-old girl presented to her doctor with lethargy, irritability and poor oral intake for 1 day, following episodes of altered consciousness and peripheral cyanosis. Upon admission to the hospital, her blood pressure was 40/20 mm Hg, pulse was 210 beats/min and her tympanic temperature was 39.4° C; there was purpura present on the nose, ear and legs, and petechiae on her face and trunk. Medical history revealed that she had received 3 doses of Hib conjugate vaccine.

The infant required intubation and mechanical ventilation with fluid support and was given intravenous cefotaxime (Claforan, Aventis), vancomycin and gentamicin. Laboratory testing revealed a white blood count (WBC) of 4,900/mm3, hematocrit 27.5% and a platelet count of 35,000/mm3. Cultures of the cerebrospinal fluid (CSF) and blood grew H. influenzae type a.

Treatment was further complicated by renal failure, purpura fulminans and subdural empyema; soft-tissue necrosis ultimately required the amputation of 2 toes, said the report. The second patient, a 1-year-old girl, was admitted to the hospital in June 1999 with a 3-day history of vomiting, fever, irritability, diarrhea and seizures. The infant also had received 3 doses of Hib conjugate vaccine.

An initial exam of the 1-year-old showed that she was toxic appearing and minimally responsive. CSF was cloudy; the WBC was 1,660/mm3, red blood count 70/mm3, glucose 34 mg/dl and protein levels were 300 mg/ml. Cultures of the CSF and blood grew H. influenzae serotype a. The second patient's hospitalization was complicated by aseptic necrosis of the right femoral head and prolonged fever. Following 4 weeks of treatment with cefotaxime, she was discharged with evidence of reduced hearing and regression of fine and gross motor skills.

Epidemiology and infectivity

There had been no reported cases of invasive disease caused by H. influenzae type a in Utah between 1991 and 1998. However, between November 1998 and October 1999, there were 4 reported cases in children ranging from 6-13 months of age. All cases displayed bacteremia and meningitis, and 3 had prolonged fever, subdural empyema and aseptic necrosis of the hip common markers for Hib. A review of laboratory records for the same period revealed a fifth patient who grew H. influenzae type a on pure culture.

Previously reported cases of H. influenzae type a occurred exclusively in patients older than 5 years. Serotype a strains isolated from 3 of the patients demonstrated the IS1016-bexA deletion that has been described in invasive type a and type b strains. DNA sequencing, assisted by primers specific to IS1016 and bexA, amplified a 362 base-pair sequence that confirmed the finding.

Three H. influenzae type a strains with the IS1016-bexA deletion may have recombined with a circulating Hib strain because Haemophilus strains are transformable. Most virulent Hib strains contain a 1,198 base-pair sequence that removes a portion of IS1016 and bexA, promoting gene amplification, resulting in an increase in the production of capsules and increasing the virulence of Hib. The areas where IS1016 and bexA are usually found are surrounded by transposable elements, further suggesting the possibility of a recombinant H. influenzae type a strain.

The 2 other patients lacked the IS1016-bexA deletion, but nevertheless suffered invasive disease due to H. influenzae type a, the report stated.

For more information:
Adderson E, Byington C, Spencer L, et al. Invasive serotype a Haemophilus influenzae infections with a virulence genotype resembling Haemophilus influenzae type b: emerging pathogen in the vaccine era Pediatrics. 2001;108(1):e18.

HiB infection is only a threat to a compromised immune system. If your baby is born healthy you might want to forgo this one. However if you decide to vaccinate against this do so with only one dose. Here is the Package insert for you to read. If you baby is premature, this is a good article to read

Also, the incidence of invasive Haemophilus b disease peaks between 6 months and 1 year of age, and approximately 55% of disease occurs between 6 and 18 months of age. Interpersonal transmission of Haemophilus b occurs and risk of invasive disease is increased in children younger than 4 years of age who are exposed in the household to a primary case of disease. Clusters of cases in children in day care have been reported and recent studies suggest that the rate of secondary cases may also be increased among children exposed to a primary case in the daycare setting.

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) - ActHIB^® is identical to Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) - OmniHIB^® (distributed by SmithKline Beecham Pharmaceuticals); and is manufactured by Pasteur Mérieux Sérums Vaccins S.A.ActHIB®, Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), produced by Aventis Pasteur SA, is a sterile, lyophilized powder which is reconstituted at the time of use with either saline diluent (0.4% Sodium Chloride) or Aventis Pasteur Inc. (AvP) Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole-cell pertussis vaccine D.P. or Tripedia®, AvP Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) (when reconstituted known as TriHIBitTM) for intramuscular use only. The vaccine consists of the Haemophilus b capsular polysaccharide (polyribosyl- ribitol- phosphate, PRP), a high molecular weight polymer prepared from the Haemophilus influenzae type b strain 1482 grown in a semi-synthetic medium, covalently bound to tetanus toxoid.1 The lyophilized ActHIB® powder and saline diluent contain no preservative. The tetanus toxoid is prepared by extraction, ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium.2 The toxoid is filter sterilized prior to the conjugation process. Potency of ActHIB® is specified on each lot by limits on the content of PRP polysaccharide and protein in each dose and the proportion of polysaccharide and protein in the vaccine which is characterized as high molecular weight conjugate.

When ActHIB® is reconstituted with saline diluent, each single dose of 0.5 mL is formulated to contain 10 µg of purified capsular polysaccharide conjugated to 24 µg of inactivated tetanus toxoid, and 8.5% of sucrose.

When ActHIB® is combined with AvP DTP vaccine by reconstitution, each single dose (0.5 mL) is formulated to contain 10 µg of purified capsular polysaccharide conjugated to 24 µg of inactivated tetanus toxoid 8.5% of sucrose 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, and an estimate of 4 protective units of pertussis vaccine. Thimerosal (mercury derivative) 1:10,000 is added as a preservative to AvP DTP vaccine. (Refer to product insert for AvP whole-cell DTP.)

When ActHIB® is combined with Tripedia® (TriHIBitTM) by reconstitution for booster dose, each single dose (0.5 mL) is formulated to contain 10 µg of purified capsular polysaccharide conjugated to 24 µg of inactivated tetanus toxoid, 8.5% of sucrose, 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid and 46.8 µg of pertussis antigens. Thimerosal (mercury derivative) 1:10,000 is added as a preservative to Tripedia®. (Refer to product insert for Tripedia®.)

The reconstituted vaccine, using saline diluent, appears clear and colorless. The reconstituted vaccine, using AvP DTP vaccine, appears whitish in color. TriHIBitTM, the reconstituted vaccine, using Tripedia® is a homogenous white suspension.

Manufacturer: Wyeth-Ayerst

And then there is the plant contamination issue...

Common Children's Vaccine Recalled

By MIKE STOBBE and LINDA A. JOHNSON – 2 hours ago

ATLANTA (AP) — More than a million doses of a common vaccine given to babies as young as 2 months were being recalled Wednesday because of contamination risks, but the top U.S. health official said it was not a health threat. The recall is for 1.2 million doses of the vaccine for Hib, which protects against meningitis, pneumonia and other serious infections, and a combination vaccine for Hib and hepatitis B. The vaccine is recommended for all children under 5 and is usually given in a three-shot series, starting at 2 months old.

Drug maker Merck & Co., which announced the recall after testing this week showed a sterility problem in a Pennsylvania factory, said concerned parents should contact their child's doctor. "The potential for contamination of any individual vaccine is low," said Merck spokeswoman Kelley Dougherty. Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, echoed that in a news conference. "This is not a health threat in the short run, but it is an inconvenience," she said. Merck produces about half of the nation's annual supply of 14 million doses of Hib vaccine.

Barbara Kuter, executive director of pediatric medical affairs for Merck, told The Associated Press that because of the contamination, the company's production line has been shut down for at least nine months.

"Manufacture of vaccines is pretty complicated, and we have to basically make some changes in the process," then get approval from the Food and Drug Administration before resuming production and shipments, Kuter said. Merck hopes to restart production in the fourth quarter of 2008, she said. "It's likely that there's going to be a shortage of this product," Kuter said, adding that the impact on the public is unclear because the other company making the vaccine in the U.S., Sanofi Pasteur, may be able to produce more. Health officials said they already are talking about prioritizing shots for American Indian and Alaska Native children, who are considered at higher risk for Hib-caused illnesses, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.

Health officials said they did not know how many of the 1.2 million doses were administered to children.

The recalled doses are considered potent, so children who got vaccine from the recalled lots will not have to be revaccinated, Schuchat said.

Parents will probably be concerned, CDC officials acknowledged. Should the vaccine later prove contaminated, health officials believe most children will experience, at worst, a skin irritation around the vaccination site. Problems could be worse for children with compromised immune systems.

Such problems would have appeared within one week of the vaccination, Schuchat said, adding that there have been no reports suggesting vaccine contamination so far.

The contamination involved unspecified equipment used in making the vaccine, which involves taking concentrated Hib virus, diluting it and combining it with other agents. Kuter said that during a routine evaluation of Merck's West Point, Pa., vaccine plant, a sterility test determined that the equipment was contaminated with a bacteria called Bacillus cereus, or B. cereus.

It is a spore-making microorganism commonly associated with food poisoning and has caused diarrhea and vomiting in people who eat contaminated foods. It's one of the most common organisms" around, Kuter said. The recall is likely to heighten a debate over childhood vaccines and their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown such a connection. This week, New Jersey took a controversial step toward becoming the first state to require flu shots for preschoolers after a health advisory board backed new vaccine requirements over opposition from parents.

Merck, based in Whitehouse Station, N.J., is one of the few drug makers that produces a significant number of vaccines.

While the company took a black eye with its September 2004 withdrawal of the painkiller Vioxx due to increased risk of heart attacks and strokes, the company has been performing well recently. On Tuesday, it gave an upbeat assessment in its annual briefing for analysts.

Five weeks ago, Merck reached a deal to settle up to 50,000 Vioxx lawsuits for $4.85 billion, an amount expected to save the company millions in trial costs.

Its stock price has more than recovered from its post-Vioxx slump, a two-year-old restructuring plan is going well and profits are up. For example, Merck posted a 62 percent increase in its third-quarter profit as revenues jumped by double digits.

The company also has had an impressive seven new products approved for U.S. sale in the last two years, including three vaccines: RotaTeq, to prevent an intestinal virus that is the top cause of early childhood diarrhea; Zostavax to prevent shingles, and Gardasil, to block the virus that causes cervical cancer.

Merck shares fell 68 cents Wednesday to close at $59.72 before the recall announcement. The shares fell 12 cents in after-hours trading.

AP Medical Writer Mike Stobbe reported from Atlanta and AP Business Writer Linda A. Johnson reported from Trenton, N.J.