Lot-release criteria, postlicensure quality control, and the Haemophilus influenzae type b conjugate vaccines

Article Abstract:

Postmarketing surveillance of vaccines may be needed to insure that they retain their effectiveness. The case of Merck's conjugated Haemophilus influenza type b (Hib) vaccine, known as PedvaxHib, is discussed. Conjugated vaccines are complex vaccines. In the case of the Hib vaccine a bacterial polysaccharide is linked to a protein carrier. Researchers studying the effectiveness of various dosing schedules for Hib vaccines in infants found that one lot of Merck's vaccine produced lower immune system responses in infants than were expected. This occurred despite the fact that each lot of Merck's vaccine was subject to tests by the Center for Biologics Evaluation and Research of the Food and Drug Administration before being released for sale. Merck then reviewed the vaccine-manufacturing process and four additional tests were added to the prerelease requirements. Other Hib vaccines have also been reported to produce lower than expected immune system responses in infants. In addition to postmarketing surveillance, further research is needed to develop accurate tests of effectiveness for other conjugate vaccines under development.

Editorial, Standards, Quality management, United States. Food and Drug Administration

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FDA approval for infants of a Haemophilus influenzae type b conjugate and hepatitis B (recombinant) combined vaccine

Article Abstract:

The FDA has approved a vaccine that immunizes against both Haemophilus influenzae type b (Hib) infections and hepatitis B. The COMVAX vaccine has been tested in 2,612 infants and was found to cause no serious adverse effects. Shots should be given at 2,4 and 12 to 15 months. Over 90% of children have antibodies against Hib and hepatitis B virus after the third shot. The vaccine can be given at the same time as other vaccines such as the DTP vaccine, the polio vaccine and the chicken pox vaccine.

Laws, regulations and rules, Hepatitis B vaccine, Hepatitis B vaccines

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Effectiveness of Haemophilus influenzae type b conjugate vaccine introduction into routine childhood immunization in Kenya

Article Abstract:

Clinical, microbiological and epidemiologic surveillance mechanisms are used to define invasive Haemophilus influenzae type b (Hib) disease incidence and to evaluate Hib conjugate vaccine program effectiveness in Kenya. It is found that introduction of Hib vaccine into the routine childhood immunization program reduces Hib disease incidence among children younger than 5 years to 12% of its baseline level, the impact not being observed until the third year after vaccine introduction.

Kenya, Patient outcomes, Drug therapy, Dosage and administration, Hemophilus meningitis

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