"The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Bexsero is the second vaccine approved"...
Neomycin, streptomycin, polymyxin B, 2-phenoxyethanol, and formaldehyde are used in the production of this vaccine. Although purification procedures eliminate measurable amounts of these substances, traces may be present (see DESCRIPTION section), and allergic reactions may occur in persons sensitive to these substances (see CONTRAINDICATIONS).
Systemic adverse reactions reported in infants receiving IPV concomitantly at separate sites or combined with DTP have been similar to those associated with administration of DTP alone.11 Local reactions are usually mild and transient in nature.
Although no causal relationship between IPOL vaccine and Guillain-Barre Syndrome (GBS) has been established,28 GBS has been temporally related to administration of another inactivated poliovirus vaccine. Deaths have been reported in temporal association with the administration of IPV (see ADVERSE REACTIONS section).
Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible sensitivity to the vaccine or similar vaccines.
Healthcare providers should question the patient, parent or guardian about reactions to a previous dose of this product, or similar product.
Epinephrine injection (1:1000) and other appropriate agents should be available to control immediate allergic reactions.
Healthcare providers should obtain the previous immunization history of the vaccinee, and inquire about the current health status of the vaccinee.
Administration of IPOL vaccine is not contraindicated in individuals infected with HIV.33,34,35
Special care should be taken to ensure that the injection does not enter a blood vessel.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.
Animal reproduction studies have not been conducted with IPOL vaccine. It is also not known whether IPOL vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. IPOL vaccine should be given to a pregnant woman only if clearly needed.
It is not known whether IPOL vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when IPOL vaccine is administered to a nursing woman.
SAFETY AND EFFECTIVENESS OF IPOL VACCINE IN INFANTS BELOW SIX WEEKS OF AGE HAVE NOT BEEN ESTABLISHED.12,20 (See DOSAGE AND ADMINISTRATION section.)
In the US, infants receiving two doses of IPV at 2 and 4 months of age, the seroprevalence to all three types of poliovirus was demonstrated in 95% to 100% of these infants after two doses of vaccine.12,13
11. Unpublished data available from Sanofi Pasteur SA.
16. Plotkin SA, et al. Inactivated polio vaccine for the United States: a missed vaccination opportunity. Pediatr Infect Dis J 14: 835-839, 1995.
20. Wehrle PF, et al. Transmission of poliovirus; III. Prevalence of polioviruses in pharyngeal secretions of infected household contacts of patients with clinical disease. Pediatrics 27: 762-764, 1961.
28. ACIP. Poliomyelitis prevention in the United States: introduction of a sequential vaccination schedule of Inactivated Poliovirus Vaccine followed by Oral Poliovirus Vaccine. MMWR 46: No. RR-3, 1997.
33. ACIP. General recommendations on immunization. MMWR 43: No. RR-1, 1994.
34. Barbi M, et al. Antibody response to inactivated polio vaccine (eIPV) in children born to HIV positive mothers. Eur J Epidemiol 8: 211-216, 1992.
35. Varon D, et al. Response to hemophilic patients to poliovirus vaccination: Correlation with HIV serology and with immunological parameters. J Med Virol 40: 91-95, 1993.
36. Vidor E, et al. Fifteen-years experience with vero-produced enhanced potency inactivated poliovirus vaccine (eIPV). Ped Infect Dis J, 312-322, 1997.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/30/2015
Additional Ipol Information
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