News Video | Policy | GPs | Hospitals | Medical | Mental Health | Welfare | Search


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.''


© Scoop Media

Culture Headlines | Health Headlines | Education Headlines


Howard Davis: Charlotte Yates' Mansfield Project

Katherine Mansfield's vapid verses are of even less interest than her over-rated short stories, but Yates has risen to the challenge of producing a fascinating compilation album by a variety of musicians to accompany her poetry. More>>

Howard Davis: Dazed & Confused by Beats

Beats is both a coming-of-age tale and a romantic movie about endings, set to a nostalgic backdrop of the disappearing tail of the UK's illegal rave scene. More>>

Howard Davis: And The Oscar Goes To … Parasite

For its deliciously dark wit and genre-bending ingenuity, Bong Joon-ho's latest movie has just won four out of a potential six Academy Awards, including Best Screenplay and Director. Only ten foreign-language films have previously been nominated for Best Picture and none have won before. More>>

Howard Davis: 1917's 1,000 Yard Stare

Sam Mendes has created a terrible and barbarous trek, one that we appreciate all the more for being catapulted right into the midst of this ear-splitting melee from the film's opening sequence. More>>




  • Wellington
  • Christchurch
  • Auckland