Sanofi pasteur statement on influenza vaccine

Sanofi pasteur has provided data to the New Zealand Ministry of Health demonstrating that its influenza vaccine, VAXIGRIP, has enough antigen, the substance that stimulates the production of protective antibodies, to be effective against two of the three strains of influenza virus most likely to be in circulation in the country this year (A/New Caledonia/ 20/99 (H1N1) and B/Shanghai/361/2002).

Additionally, the influenza vaccine may also provide sufficient protection for most people against the third strain known as A/Wellington/2004 (H3N2). There is no issue about the safety of the vaccine.

"We are working with the Ministry of Health on the most appropriate course of action to ensure New Zealanders are well protected from influenza this year," said Dr Victor Carey, medical director of sanofi pasteur, Australia.

Sanofi pasteur provides approximately 28 million doses of VAXIGRIP to Southern Hemisphere countries each year – representing about 70-80 per cent of the public market for this region.

As the world's leading vaccine specialist with vaccines against 20 diseases, sanofi pasteur produces approximately 1.4 billion doses of vaccine yearly, of which 120 million are influenza vaccine. The company provides approximately 40 per cent of the influenza vaccine in both the Northern and Southern Hemispheres. It produces influenza vaccine at three of its four production sites in Europe and North America. Southern Hemisphere vaccine is manufactured at two locations in France.

Sanofi pasteur recently notified Medsafe, the Health Ministry's pharmaceutical regulator, when routine testing in Australia showed that the level of antigen, in the A/Wellington strain was less than required. The other two strains have the required levels of antigen.

The company discovered that during manufacture one of the reference antigen reagents (an assay used to measure the levels of antigen contained in the vaccine,) was miscalculated, resulting in the lower level of antigen.

A medical review of existing data indicates that reduced antigen content may provide satisfactory antibody levels. Additionally, the circulation of H3N2 viruses – of which A/Wellington is one – in the past few years is likely to have provided some level of immunity to large parts of the population in New Zealand.

Sanofi pasteur will continue to prepare the product for shipping so that it can be released as quickly as possible,

"Influenza can be a life-threatening illness, so in the cases of vaccine shortage or in the absence of a vaccine from another source, we believe that from a public health perspective this vaccine will provide New Zealand with the best option to protect the majority of people," said Dr Carey.