New Zealand’s meningococcal B immunisation programme

The initiative

In 2004, the New Zealand Ministry of Health developed its Meningococcal Vaccine Strategy to plan and implement the country's Meningococcal B Immunisation Programme. One aim was “to reduce inequalities for Māori, Pacific peoples, and those living in more deprived areas, and achieve 90 percent coverage in those aged 0-19 years”. [3] The overall target was “a 70 percent reduction of cases of the New Zealand epidemic strain in children and young people aged 0-19”. [4] The immunisation programme ran from 2004 to 2011.

MeNZB™ (“MeNZB”), a vaccine that specifically targets the Meningococcal B strain, was developed and its licensing fast-tracked. “Trials proceeded on school children as soon as the NZ strain vaccine was known to be immunogenic and not to be associated with serious adverse events in adults.” [5]

It was developed as part of a “a public-private partnership [that] was forged between Chiron Vaccines (now Novartis) and the NZ Ministry of Health, with technology transfer from the Norwegian Institute of Public Health (NIPH).” [6] Novartis was to develop a vaccine specifically for the control of the NZ epidemic, based on one that had proved successful in a similar circumstances in Norway.

The vaccination campaign was rolled out in phases, with the highest-risk areas offered immunisation first and, once the vaccine was shown to be safe and effective in these areas, lower risk areas were vaccinated. This was done alongside a public information campaign. “Between 2004 and 2006 New Zealand offered free MeNZB vaccination to anyone under the age of 20. Routine immunisation for babies and preschoolers continued until June 2008. The last phase of this programme, immunisation for people with a high medical risk, ended in March 2011.” [7]

The challenge

In 1991, there was an epidemic of meningococcal disease in New Zealand. It is “a serious bacterial infection caused by the bacterium Neisseria meningitides, known as a meningococcus”. [1]  From the start of the epidemic until 2006, there were more than 5,900 cases and 239 deaths from the disease. An estimated 20 percent of sufferers are left with “some degree of disability including hearing loss, brain damage, and amputation or scarring”. [2] The particular strain of the disease, Meningococcal B, affected Māori and Pacific children disproportionately.

The public impact

More than a million young New Zealanders received the MeNZB vaccine during the Meningococcal B Immunisation Programme. This had significant impact on the epidemic:

• “The number of people developing meningococcal disease due to the epidemic strain of meningococcal B has significantly decreased- from over 300 cases in 2001 to less than 30 cases in 2010.” [8]
• “Between July 2004 and December 2008 an estimated 210 epidemic strain cases (95% CI 100-380), six deaths and 15-30 cases of severe sequelae were avoided in New Zealand due to the introduction of the MeNZB vaccine.” [9]
• “Between 2007 and 2014, there have been between 43 and 132 cases of, and between 3 and 13 deaths from, meningococcal disease each year in New Zealand.” [10]

Stakeholder engagement

The Ministry of Health demonstrated its engagement through funding and continuing to manage and review the programme.

Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, facilitated an accelerated approval process for MeNZB. [11] (“Medsafe is ... a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand.”)

District Health Boards (DHBs) facilitated the roll-out of the vaccination programme, while the country's promoted the programme by allowing public health nurses to conduct mass immunisations on school grounds during school hours.

Political commitment

“The Government invested NZD200 million in the Meningococcal Vaccine Strategy, which has “paid for the development of a strain-specific vaccine, clinical trials and implementation of our biggest mass immunisation campaign for all New Zealanders under 20 years old, and has announced a further NZD22 million over the next three years [2006-2009] to extend the programme”. [12] This indicates the strong commitment from the incumbent Labour coalition government.

Initially, the opposing National Party was not entirely in favour of MeNZB, and was accused of scaremongering. However, the vaccine programme continued after National Party was elected to government in 2008, suggesting that by that stage they were committed to the programme.

Public confidence

New Zealanders were aware of the dangers of meningococcal disease, both because many New Zealanders knew someone who had been diagnosed and because of a number of high profile cases in the media (such as Charlotte Cleverley-Bisman, a toddler who became a quadruple amputee as a consequence of meningococcal disease in 2004). This meant they were favourably disposed to the national immunisation programme. “The introduction of MeNZB had a high level of public acceptance and there was no widespread public concern regarding the safety of the vaccine.” [13]

Both the Labour coalition (which was in power at the start of the initiative) and the National Party (in power from 2008) enjoyed good public confidence during their time in the Beehive (the New Zealand Parliament building).

Clarity of objectives

Clear, measurable objectives were defined at the outset, maintained throughout, and were clearly measurable:

• The overall target was a 70 percent reduction of cases of the New Zealand epidemic strain in children and young people aged 0-19.
• An important subsidiary aim was to achieve 90 percent coverage in those aged 0-19 years for Māori, Pacific peoples, and those living in more deprived areas.

Strength of evidence

There was clear evidence that an existing vaccine, which had been deployed for a comparable Norwegian immunisation programme. “The New Zealand meningococcal B vaccine, MeNZB™, is being manufactured using the same processes as, but with a different strain to, the meningococcal B vaccine developed by the Norwegian Institute of Public Health.” [14] MeNZB was subject to the usual clinical trials, so there was good evidence that the vaccine itself would be effective prior to the roll-out.

The MeNZB vaccine was rolled out in Auckland and Counties Manukau first, with this region acting as a pilot. If safety monitoring of these first 150,000 immunisations had indicated problems with the vaccine, the nationwide scheme would not have been rolled out.

The planning of the programme has also been informed by the experience of recent meningococcal disease mass immunisation programmes in England and Canada.

Feasibility

The funding for the programme was provided by the national government.

The Ministry of Health and the DHBs had skilled nurses and doctors available to implement the vaccine programme. “Primary health care providers will vaccinate children under five years and children outside the school system. Public health nurses will vaccinate school students in a school-based programme. A variety of health providers will vaccinate young people who no longer attend school.” [15]

The scale of the vaccination initiative was predicted to disrupt normal DHB activities, but this was considered a manageable concern. “This programme will be New Zealand's largest-ever immunisation programme. The course of three doses given at six-week intervals and the number of people eligible to receive the vaccine will have a considerable impact on DHBs' ability to deliver on this and any other contracted obligations.” [16]

There were also concerns that “interruptions in programme delivery may occur as a result of factors such as variations in vaccine supply, workforce shortages, safety requirements, delivery complications or other health issues.” [17] The Ministry of Health had plans in place to work with DHBs to resolve these issues if they arose.

There are few legal issues involved in an immunisation programme. However, the programme was developed with reference to the three key principles of the Treaty of Waitangi (as evidenced by its focus on reducing health inequities by improving outcomes for Māori), as is standard for health policy in New Zealand.

Management

The Ministry of Health was ultimately responsible for all aspects of the programme, including its review. “The Ministry [of Health] leads the strategy, working in partnership with Auckland University (undertaking vaccine trials), Chiron Corporation (the vaccine developer and supplier) and the Institute of Environmental Science and Research Limited (surveillance and laboratory services).” [18]

DHBs were “responsible for coordinating primary health providers to ensure there is easy access to vaccine for families and caregivers”. [19] Public health nurses and nurses working at GP surgeries administered the vaccine, and were governed by their usual management structures.

The focus on the communities most at risk meant that there was a significant role for Māori and Pacific island managers. “Māori and Pacific representatives [were involved] in the development of local strategies and action plans. This should include Māori and Pacific DHB managers, Māori co-funding organisations (MAPOs), Māori development organisations (MDOs), regional iwi health service providers and the community in planning, and leadership in delivering and communicating the programme.”

Measurement

An Independent Safety Monitoring Board was established to review the clinical data collected and to report on the safety of the vaccine and any complications relating to the vaccine

A new computerised National Immunisation Register was developed to “record all immunisations given as part of the meningococcal B immunisation programme, from both primary health care and school-based programmes. This will enable safety and coverage monitoring of the new vaccine”. [20]

The Ministry of Health developed a comprehensive evaluation programme at the outset, which included “modelling, to provide an estimate of the vaccine programme effectiveness in reducing disease, a case control study, to obtain an estimate of vaccine effectiveness (an approximation of post-licensure vaccine efficacy), screening studies, which will compare disease rates among those vaccinated and those unvaccinated”. [21]

Alignment

The meningococcal B epidemic was a well-known health crisis in New Zealand at the time, and all of the groups involved in this initiative (DHBs, schools, GPs, etc.) were aligned in their desire to halt the epidemic. Prior efforts at containing the epidemic had failed, so there was support for a mass vaccination campaign across the board.

Bibliography

The Meningococcal B Immunisation Programme: A Response to an Epidemic National Implementation Strategy, April 2004, Ministry of Health

Meningococcal disease (including meningitis), Ministry of Health

Meningococcal, Ministry of Health

Fast Tracking the Vaccine Licensure Process to Control an Epidemic of Serogroup B Meningococcal Disease in New Zealand, Diana Lennon, Catherine Jackson, Sharon Wong, Maraekura Horsfall,Joanna Stewart and Stewart Reid, December 2008, Clinical Infectious Diseases 2009; 49:597-605

Ryall panic merchant wrong on vaccine, Pete Hodgson, 26 OCTOBER 2006, Government of New Zealand