2005 Influenza Vaccination Programme Confirmed

Media Release
15 March 2005

2005 Influenza vaccination programme confirmed

The Ministry of Health confirmed today that there will be an influenza vaccination programme this year, scheduled to start in April.

``We will very soon have a vaccine for our most vulnerable New Zealanders and we are continuing to work with the vaccine we already have to come up with the best options for other New Zealanders,'' Deputy Director-General of Public Health Dr Don Matheson said.

The Ministry of Health and PHARMAC have secured an extra supply of vaccine from international pharmaceutical group Solvay Pharmaceuticals. The Solvay vaccine will give New Zealanders protection against all three strains of influenza identified by the World Health Organization as likely to circulate this winter.

Dr Matheson said an expert group of clinicians this week advised the Ministry to target the approximately 50,000 Solvay doses at the country's most vulnerable groups.

``We will continue to work with the sector to identify how best to use the vaccine for the population groups most at risk, and how we can best deliver the supplies we have around the country. We'll have further advice on this in a week's time,'' he said.

``It's important to note that this supply from Solvay is in addition to the vaccine Sanofi Pasteur is contracted to deliver to New Zealand. We've had urgent meetings with representatives of Sanofi Pasteur and we are continuing to seek more information from the company.

``But we are satisfied that the Sanofi vaccine is safe. It's effective for two of the three Southern Hemisphere influenza strains and partially effective for the third. The issue that has arisen is the third strain is too dilute to be fully effective for all population groups, even though our expert advice is that there will a considerable number of New Zealanders who may well be protected.''

Dr Matheson said that after advice from the expert sector group, the Ministry planned to consider a number of options around making the Sanofi Pasteur vaccine available. This includes giving people two doses at the same time, giving a second dose at a later stage and single dose options for different groups.

``We need more information about these options, their safety and effectiveness, and we are urgently working to get answers to these. We expect to be in a position to announce further details in a week, but at the moment we have secured 1.38 million doses of Sanofi Pasteur vaccine to cover all of our vaccination programme demands. This is almost double the amount of vaccine we would normally get, but to cover our options, we need to ensure we have an appropriate buffer. The first of these doses should be in the country within two weeks.

``We expect the influenza vaccine programme to be underway a short time after the first of the vaccine arrives in the country, and we hope to be vaccinating in April.''

Last year the Ministry's influenza vaccination programme began on March 21. It usually begins as soon as the vaccine becomes available.

Dr Matheson said as soon as the Ministry has progress on vaccine availability and distribution, health professionals will be informed so they can plan their vaccination programme. He urged vaccinators to delay patient recall notices until a vaccine arrival date has been confirmed.

The Ministry is actively working with the health sector to ensure the influenza vaccination programme runs smoothly.

This year the Southern Hemisphere vaccine contains three influenza strains: A/Wellington/2004 (H3N2), A/New Caledonia/1999 (H1N1) and B/Shanghai/2002.

ENDS

QUESTIONS & ANSWERS

Why is there a delay in the supply of influenza vaccine this year?

The Ministry of Health's medicine regulatory arm Medsafe was notified of a problem with the manufacture of a vaccine supplied by Sanofi Pasteur (Vaxigrip-®) on 28 February 2005. The vaccine was not deemed unsafe. The problem is that one of the three influenza strains was not the full strength which potentially means it is not as effective against that strain of flu. This problem was first detected by the Australian Therapeutic Goods Administration's pre-release testing programme. There are no safety issues associated with this manufacturing programme. It is still effective for the other two strains and will provide protection against the third strain to some degree.

The company produced 28 million vaccine doses with this problem, estimated to be 70% of the Southern Hemisphere market. Officials in South Africa and most South American countries are still considering the best options for protection against influenza available to them.

What is happening to New Zealand's 2005 influenza vaccination programme?

The 2005 influenza vaccination programme is going ahead, but it will start slightly later than in previous years. It is important that people still make a flu shot part of their winter health programme.

Why do people need to vaccinate?

Influenza immunisation is the best protection against influenza. Influenza infection in people with ongoing medical conditions, even if well controlled, may lead to more serious illness. Influenza can cause pneumonia and can act as a trigger that makes existing medical conditions worse. In older people and those with ongoing medical conditions such as heart disease, other respiratory problems and diabetes this can lead to hospitalisation.

How will existing supplies be targeted?

The free flu vaccinations are available to everyone over the age of 65, plus people with one or more chronic medical conditions (see background). High risk children and people over the age of 65 with chronic medical conditions are likely to receive the first vaccinations.

Who manufactures the vaccine?

The subsidised vaccine is manufactured by Sanofi Pasteur (France) and distributed by Merck Sharpe and Dohme. PHARMAC has the contract for supply with the manufacturer. Sanofi Pasteur is a major European manufacturer of vaccines and has 70 percent of the Southern Hemisphere market.

Why was PHARMAC given the responsibility of sourcing the supply of flu vaccine?

PHARMAC took over the responsibility for sourcing the influenza vaccine this year. It is a specialist agency set up to purchase medicines.

When does the influenza vaccination campaign start?

It usually starts at the weekend when daylight saving ends, last year that was 21 March, this year it was intended to begin on Sunday 20 March. As in Australia this year, New Zealand's vaccination campaign will be delayed for what is expected to be a few weeks. This is not expected to have a major impact on the outcome of the immunisation programme.

What happened in the 2004 flu season?

During the 2004 influenza season, 3 277 consultations for influenza-like illness were reported from a national sentinel network of 86 general practices. It is estimated that Influenza Like Illness affected over 35 186 New Zealanders during the season, compared with an estimated 46 116 in 2003 Overall, 91.4% of influenza isolates in 2004 were influenza A and 8.6% were influenza B. Among the types and subtypes, influenza A/Fujian/411/2002 predominated with 47.4% and A/Wellington/1/2004 with 43.4%

The full 2004 report on is available at: http://www.surv.esr.cri.nz/virology/influenza_annual_report.php

What is happening in Australia?

Australia recognised the problem with this vaccine before 28 February. Australia has contracts with more than one supplier, including CSL Limited, which is an Australian based vaccine manufacturer. As a result, Australia's Therapeutic Goods Administration asked CSL to increase its manufacturing capacity to meet Australian demand. Australia has now successfully sourced extra supplies for its winter flu vaccination programme. Despite having secured a supply, the Australian vaccination programme is running two to three weeks behind schedule.

Why couldn't New Zealand get extra supplies with Australia?

New Zealand has a contract for supply with one manufacturer. While Medsafe have approved two other vaccines for use in New Zealand, the manufacturers of these vaccines are unable to supply enough vaccine either singly or together to meet the needs of the vaccination programme. In addition, all of the capacity at the Australian manufacturing site is dedicated to meeting the Australian demand.

Why does New Zealand only have one supplier?

New Zealand is a small market, and as such has had a sole supplier for the annual vaccination programme since 1997, when free flu vaccine for over 65s was introduced. Since then the free vaccine programme has been extended to include people with chronic medical conditions (see background). Using a sole supplier allows New Zealand to negotiate a better price for the vaccine and therefore purchase more vaccine for the resources available, meaning a greater number of people overall can be vaccinated.

Why are annual recommendations for influenza vaccine composition necessary? Circulating influenza viruses in humans are subject to antigenic changes which require the vaccine formulation to be updated each flu season. This is to ensure the closest possible match between the influenza vaccine strains and the circulating influenza strains.

How is it decided which strains should be included in the vaccine each year?

The World Health Organization makes recommendations about which strains should be included in flu vaccines each flu season. There are two seasons each year, the Northern Hemisphere season and the Southern Hemisphere season.

Information on circulating strains and epidemiological trends is gathered by the WHO Global Influenza Surveillance Network administered by WHO since 1948, the year of WHO's inception. The Global Influenza Surveillance Network currently consists of 112 national influenza centres in 83 countries and four WHO Collaborating Centres for Reference and Research on Influenza located in Atlanta, United States; London, United Kingdom; Melbourne, Australia; and Tokyo, Japan.

The National Influenza Centres sample patients with influenza-like illness and submit representative isolates to WHO Collaborating Centres for immediate strain identification. In addition to genetic and antigenic analyses of influenza viruses, the WHO CCs jointly with key national laboratories involved in registration and quality control of influenza vaccines (Australia, United Kingdom, United States) collaborate annually on serological studies to obtain evidence as to whether the current vaccines induce satisfactory antibody levels to new epidemic strains.

Twice a year, WHO organises a consultation with the Directors of the WHO Collaborating Centres and representatives of key national laboratories to review the results of these laboratory and clinical studies and make recommendations on the composition of the influenza vaccine (February: northern hemisphere; September: southern hemisphere). Immediately after this consultation WHO informs representatives of pharmaceutical companies on its decisions which are published in the press and the WHO Weekly Epidemiological Record. WHO collaborates with key national licensing agencies on the provision of viruses for vaccine production as well as vaccine potency testing reagents. More than 250 million vaccine doses are produced annually based on the WHO recommendations. Since 1972 WHO has recommended 39 changes in the influenza vaccine formulation.

What is the difference between Northern Hemisphere and Southern Hemisphere vaccine?

The most recent Northern Hemisphere season vaccine did not contain the A/Wellington strain which is the one that has not met efficacy specifications, and the manufacture for the next Northern Hemisphere season has only just begun.

Do flu vaccinations actually work?

Yes. For those at high risk, influenza vaccination reduces hospitalisation by 50 percent and mortality by 70 percent. In general the vaccine is 70-90 percent effective in preventing influenza in healthy adults.

Will I get influenza if I have a vaccination?

Influenza vaccine cannot give you the flu as it does not contain live vaccine, however you could still get a strain of influenza that is not in the vaccine you have been given.

What is influenza?

Influenza is a highly infectious illness caused by a virus.

What are the symptoms?

Influenza has a sudden onset and is accompanied by some or all of the following symptoms:

 Fever and chills

 Cough

 Body aches and pains

 Fatigue

 Headache

How can I tell the difference between a cold and influenza?

Influenza makes people feel miserable and is much more serious that an common cold. Influenza will leave you ill for up to 10 days. Most people suffer from a high fever and may require bed rest. Those affected can also suffer from shivering attacks, muscular pains, headaches a dry cough, possible vomiting and there can be complications like pneumonia. A vaccine is available to protect against influenza.

A cold however has much less severe symptoms and they generally last only 2-4 days. High fever is less common and shivering attacks and severe headaches are rare. Muscular pains and vomiting are infrequent and the cough will be less severe. There is no vaccine available.

Background

Those people with chronic health conditions are more at risk of complications from influenza and that is why the vaccination is provided free to these groups. This includes those 65 years and over, and those adults and children with certain chronic conditions including:

 heart disease

 stroke

 ongoing respiratory (chest) diseases like chronic bronchitis or asthma (but only those requiring regular preventative medication)

 diabetes

 ongoing renal (kidney) disease

 most cancers

 other conditions affecting the immune system such as HIV/AIDS, rheumatoid arthritis and organ transplants.

Overseas research studies have shown that influenza vaccination cuts hospitalisations and deaths in the over 65 age group during the influenza season.

Vaccination is the best protection against influenza. For those in the 'at risk' groups, early vaccination is recommended even if they are fit and healthy.

Annual vaccination is also recommended as the virus is always changing so the vaccines need to be updated annually to provide optimal protection against illness. Therefore people must get vaccinated each year regardless of whether they've been vaccinated the year before.

A short timeline of recent events:

28 February 2005: New Zealand advised of a problem with the vaccine

28 February 2005: Medsafe advised Public Health Directorate and PHARMAC of problem

01 March 2005: Medsafe approves GSK vaccine for use in New Zealand

01 March 2005: Pharmac begins seeking alternative supplies

03 March 2005: Merck, Sharp and Dohme advises sector of delay in vaccine availability. Information sent to:

-· GP practices

-· All GP & Specialist Combined practices

-· Wholesalers

-· Hospital Pharmacies

-· Endocrinologist Specialists

-· Infectious Disease Specialists

-· Microbiologist Specialists

-· Laboratories

-· Paediatrician Specialists

04 March 2005: Australian authorities announce a problem with the vaccine supply

07 March 2005: Australia announces it has successfully sourced alternate supply of vaccine

10 March 2005: Medsafe approves Solvay flu vaccine for use in New Zealand

11 March 2005: Ministry announces problem with vaccine supply

15 March 2005: New Zealand confirms flu vaccine programme for 2005 will go ahead and outlines options under consideration

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