ADR that result in revision of patient information
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| New antibody persistence data of Mencevax ACWY Vaccine |
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GlaxoSmithKline Limited (GSK), a licensed drug wholesaler, informed the Department of Health (DH) about clinical data relevant to the antibody persistence of Mencevax ACWY Vaccine.
During the clinical development of another meningococcal vaccine manufactured by GSK, Mencevax ACWY was used as a comparator vaccine. New antibody persistence data for Mencevax ACWY are now available.
Previously, there was only limited antibody persistence data available showing persistence of two years post vaccination with Mencevax ACWY, and vaccine effectiveness data up to three years post vaccination for a related meningococcal vaccine containing serogroup A and C.
These new data indicate that among individuals 11-55 years of age who were vaccinated two years earlier with Mencevax ACWY, immunity to serogroups W-135 and Y persists in 24.0% and 44.0%, respectively, where antibody persistence is defined as the presence of serum bactericidal antibodies using rabbit complement (rSBA) titres ≥1:8. In addition, limited data showed a waning of serum bactericidal antibody titres against serogroup A one year post-vaccination when using human complement in the assay (hSBA). The clinical relevance of the waning of hSBA-MenA antibody titres is unknown and data now suggest that earlier revaccination may be appropriate for individuals who remain at high risk of exposure to meningococcal disease.
The current Prescriber Information for Mencevax ACWY states an antibody persistence of at least 3 years in the ‘Pharmacodynamics’ section. In the ‘Posology and Administration’ section also includes the statement that: “Adults who continue to be exposed to cerebrospinal meningitis caused by meningococci of serogroups A, C, W-135 and Y should be revaccinated by injection of a single dose of vaccine at an interval of 3 years at most”.
General guidance on earlier revaccination across a broader age group is now considered appropriate and the company intends to update the product information for Mencevax ACWY, including these new antibody persistence data.
Healthcare professionals are recommended by GSK that:
- Mencevax ACWY is generally well tolerated and immunogenic. These new data provide updated information regarding the persistence of immunity.
- Individuals remaining at high risk of exposure to serogroups A, W-135 and Y should be considered for revaccination.
- Alternatively conjugate vaccines can be used for the immunization against invasive meningococcal diseases caused by Neisseria meningitides group A, C, W-135 and Y.
In Hong Kong, Mencevax ACWY Vacicne (HK-48475) is registered by GSK and is a prescription-only medicine. Informed by GSK, a Dear Healthcare Provider Letter is to be issued today about the new antibody persistence data of Mencevax ACWY. Besides, application to change the package insert of the product by including the relevant safety information will be submitted. DH will keep vigilant on any safety updates of the drug.
Ends/ Monday, November 11, 2013
Issued at HKT 17:00
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