Dear Healthcare Professional Letter on eventual need for earlier re-vaccination with conjugated vaccines in individuals vaccinated with Mencevax ACWY Vaccine, who are highly at risk of exposure to serogroups A, W-135 and Y

25.04.2014

GlaxoSmithKline d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals on the available persistence data of Mencevax ACWY Vaccine.

Summary

Clinical trial results demonstrate a decrease in antibody titre one to two years after vaccination with Mencevax ACWY.
In individuals who continue to be exposed to the bacteria Neisseria meningitides, an earlier re-vaccination from the initially recommended, should be considered.
In individuals who continue to be exposed to serogroups A, W-135 and Y, a revaccination should be considered, two years after vaccination with Mencevax ACWY, according to local recommendations. This includes:
- individuals who live in endemic areas with exposition to Neisseria meningitides longer than two years and who have previously been vaccinated with Mencevax
- travellers planning shorter trips and who are vaccinated with Mencevax more than two years ago.
When re-vaccination within two years with previous vaccination with Mencevax ACWY is considered, the use of conjugated vaccines is recommended.

More information

In clinical trials of other meningococcal vaccine manufactured by GSK, Mencevax was used as a control vaccine. Now data on antibody persistence to Mencevax are available from these trials. Only limited data existed previously indicating on persistence in two years duration after vaccination with Mencevax MCWYand data on efficacy for serogroups A and C meningococcal vaccine up to three years after vaccination.

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. Therefore, according to local recommendations, an earlier re-vaccination may be appropriate for individuals who remain at high risk of exposure to meningococcal disease.

Here you may view the Dear Healthcare Professional Letter.

Mencevax ACWX is indicated for active immunisation of children above two years, adolescents and adults against meningococcal disease caused by serogroup A, C, W-135 and Y-containing meningococci. This vaccine is not registered in the Republic of Croatia, but rather imported under the legal exemption scheme from EU. This vaccine is available in the EU Member States under several brand names: Mencevax, Mencevax ACWY, Mencevax ACWY Novum and ACWY Vax.

So far, HALMED has not received any suspected adverse reaction report to this vaccine that would indicate its decreased efficacy. HALMED will continue closely monitoring the safe use of this vaccine and inform the public promptly about any new finding.

We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.