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Medsafe Removes Restrictions On Vaxigrip Vaccine

Media Release

5 May 2005

Medsafe Removes Restrictions On Vaxigrip Vaccine

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) today removed restrictions on influenza vaccine Vaxigrip.

This means the Sanofi Pasteur vaccine is now registered for all New Zealanders who want to protect themselves against influenza this winter, regardless of their age or medical conditions.

Vaxigrip is not subsidised, so GPs and vaccinators should continue to give the three full-strength, fully subsidised vaccines to high-risk New Zealanders eligible for the free immunisation programme.

Those eligible for the free immunisation programme are people aged 65 years and over, as well as adults and children with an on-going medical condition such as asthma, diabetes and heart disease.

Medsafe spokeswoman Clare Van Der Lem said today that Vaxigrip was originally approved as a single dose vaccine for people aged under 65 years at low-risk from either influenza infection or the complications of influenza infection.

This restriction was put in place after a manufacturing error at Sanofi Pasteur resulted in a vaccine that did not meet its approved specifications -- it contained only 10 micrograms of A-H3N2 Wellington antigen rather than the 15 micrograms listed in the specifications and identified on the product label.

Ms Van Der Lem said that last Friday Sanofi Pasteur supplied Medsafe with additional data from a Vaxigrip clinical study exploring the likely efficacy of the vaccine.

``The study demonstrated that Vaxigrip influenza vaccine with a reduced level of the A Wellington strain met all three of the European Medicines Evaluation Agency (EMEA) requirements for efficacy for each of the three strains of influenza contained in the vaccine,'' she said.

``The evidence of efficacy is sufficient to justify removing the current restriction on use. Vaxigrip has now demonstrated acceptable levels of safety, quality and efficacy.''


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