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MeNZB™ - Use science not opinion!

MeNZB™ - Use science not opinion!
9 June 2005.

Today’s comments by Green MP Sue Kedgley suggested that because Phase 3 trials were not carried out in New Zealand, parents haven’t been given enough information about the safety and efficacy of the MeNZB™ vaccine.

Immunisation Advisory Centre director Dr Nikki Turner says there’s a wealth of scientific information available, but parents don’t always know where to look for it.

Dr Turner says “a Phase three trial was run on the parent vaccine in Norway and based on that trial, international experts considered it unnecessary to repeat it in the New Zealand environment. This is similar to influenza vaccines where the strain changes yearly but the recipe of the vaccine stays the same.”

“Extensive information is available on how the vaccine works and the immune response to it- hence the confidence that this vaccine will be effective in New Zealand.”

“Withholding MeNZB™ immunisation while a phase 3 trial takes place would extend the epidemic by years. It would be unethical to delay.” says Dr Turner.

MeNZB™ has a vast body of international scientific evidence behind the development and roll out of this programme.

This is poorly presented in many ‘sound bites’ and personal opinions currently expressed nationally.

The high profile anti-immunisation lobbyists Ron Law and Barbara Sumner-Burstyn do not have strong or credible academic background. ‘Sound bites’ and strongly stated opinion become misleading when they are simply supported by conveniently selected & isolated snippets of information.

The concept of ‘efficacy’ is poorly understood and is being misrepresented in most discussions – please refer to the attachment. There is already very good news of effectiveness of the vaccine in South Auckland where disease rates have dropped, much more than other areas that have yet to roll out the vaccine.

The key issue for parents is how much, or what sort of information do they need to make a decision they feel secure and comfortable with. This varies enormously from parent to parent. Our experience shows many parents prefer complex information – this needs to be easily accessible for those who would like it.

We would like to suggest some resources that are currently available:

To discuss General issues related to MeNZB™ vaccine phone
0800 20 30 90 or visit www.immunise.moh.govt.nz

General issues on in depth information around the science of immunisation, including MeNZB™ in New Zealand phone to discuss
0800 IMMUNE 466 863 or visit www.immune.org.nz

Response to first press release Meningococcal Gold Rush by Barbara Sumner-Burstyn and Ron Law (Dec 2004). Available from www.immune.org.nz


ENDS

Background:

Some examples of the academic background to the decision-making processes:


Meningococcal Disease – description, diagnosis, treatment and cause
Rosenstein NE, Perkins BA, Stephens DS, Popovic T, Hughes JM. Meningococcal Disease. New England 2001;344(18):6.
Thomas M. Prevention of group B meningococcal disease by vaccination: a difficult task. The New Zealand Medical Journal 2004;117(1200):http://www.nzma.org.nz/journal/117-1200/1016/.

Incidence of Meningococcal Disease in New Zealand – Epidemiology
Lopez L, Martin D. Meningococcal Disease report January to December 2004. Wellington: Ministry of Health; 2005.


What puts us more at risk for meningococcal disease?
Baker M, McNicholas A, Garrett N, Jones N, Stewart J, Koberstein V, et al. Household crowding a major risk factor for epidemic meningococcal disease in Auckland children. Pediatric Infectious Disease Journal 2000;19(10):983-90.

Natural Protection against meningococcal disease
Pollard AJ, Frasch C. Development of natural immunity to Neisseria meningitidis. Vaccine 2001;19:1327-46.
Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med 1969;129(6):1307-26, 1969 Jun 1.
Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. II. Development of natural immunity. J Exp Med 1969;129(6):1327-48, 1969 Jun 1.


MeNZB™ – Manufacture and ingredients
Jodar L, Feavers I, Salisbury D, Granoff D. Development of vaccines against meningococcal disease. The Lancet 2002;359:1499-1508.
Frasch CE, Alphen Lv, Holst J, Poolman JT, Rosenqvist E. Outer Membrane Protein Vesicle Vaccines for Meningococcal Disease. In: Pollard AJ, Maiden MCJ, editors. Methods in Molecular Medicine, Meningococcal Vaccines: Methods and Protocols. Totowa NJ: Humana Press. p. 81-107.
The Development of the NZ Meningococcal B Vaccine. Immunisation Advisory Centre, University of Auckland; 2004.
Hem SL. Elimination of aluminum adjuvants. Vaccine 2002;20(Supplement 3):S40-S43.

Studies show group B vaccines work
Borrow R, Balmer P, Miller E. Meningococcal surrogates of protection--serum bactericidal antibody activity. Vaccine 2005;23(17-18):2222-2227.
Wedege E, Hoiby EA, Rosenqvist E, Bjune G. Immune responses against major outer membrane antigens of Neisseria meningitidis in vaccinees and controls who contracted meningococcal disease during the Norwegian serogroup B protection trial. Infection and Immunity 1998;66(7):3223-31,.
Boslego J, Garcia J, Cruz C, Zollinger W, Brandt B, Ruiz S, et al. Efficacy, safety, and immunogenicity of a meningococcal group B (15:P1.3) outer membrane protein vaccine in Iquique, Chile. Chilean National Committee for Meningococcal Disease. Vaccine. 1995;13(9):821-9.
Tappero JW, Lagos R, Ballesteros AM, Plikaytis B, Williams D, Dykes J, et al. Immunogenicity of 2 serogroup B outer-membrane protein meningococcal vaccines: a randomized controlled trial in Chile.[see comment]. Jama. 1999;281(16):1520-7.

The MeNZB trials
Oster P, Lennon D, O'Hallahan J, Mulholland K, Reid S, Martin D. MeNZB[trademark]: a safe and highly immunogenic tailor-made vaccine against the New Zealand Neisseria meningitidis serogroup B disease epidemic strain. Vaccine 2005;23(17-18):2191-2196.


Safety first
Report of the Independent Safety Monitoring Board. 7 April 2005. Safety Monitoring Following MeNZB™ Immunisation 19 July 2004 – 27 February 2005
Further Evidence Based information is available from:

The Meningococcal B Epidemic
Annual reports and epidemic summary: National Reference lab, ESR (Environmental Science & Research Ltd) www.esr.cri.nz
Weekly updates on Ministry of Health web site www.moh.govt.nz
Regional epidemic information – contact local Public Health Units
Published literature including The Lancet and Vaccine Journals

The Development and Manufacture of MeNZB™
The vaccine data sheet is available from Medsafe www.medsafe.govt.nz
Overview: Meningococcal information web site www.immunise.moh.govt.nz
Making of MeNZB™ article www.immune.org.nz
Published literature on the Norwegian vaccine, The Cuban vaccine, Group b meningococcal vaccines and MeNZB™ available from Pubmed, including The Lancet and Vaccine Journals
The manufacturer of MeNZB™ is Chiron Corporation: www.chiron.com
Safety of MeNZB™ & Outer membrane Protein (OMV) vaccines
CARM Centre for Adverse Reaction Monitoring, University of Otago http://carm.otago.ac.nz/index.asp?link=carm
Meningococcal information web site www.immunise.moh.govt.nz for detail on design of the safety monitoring programme
Independent Safety Monitoring Board – for progress reports on the safety monitoring outcomes to date available from www.immunise.moh.govt.nz
Clinical Trial results summarised on www.immunise.moh.govt.nz details available online from Pubmed, including The Lancet and Vaccine Journals, or researchers at University of Auckland & Norwegian Institute of Public Health
Efficacy of Meningococcal B and MeNZB ™ vaccines
Summary of study designs to establish efficacy and effectiveness data : Plotkin Orenstein, Vaccines fourth Edition, Saunders, Pennsylvania 2004.
Clinical trial results : summarised on www.immunise.moh.govt.nz details available from Pubmed, including The Lancet and Vaccine Journals, or researchers at University of Auckland & Norwegian Institute of Public Health
Licensing of MeNZB™
Overview of standard medication licensing processes available from Medsafe www.medsafe.govt.nz
New Zealand Gazette Thursday, July 08, 2004 www.medsafe.govt.nz
New Zealand Gazette Thursday, February 03, 2005 www.medsafe.govt.nz

Public Health Policy Decisions
Office of the Minister of Health

Background Information: 9 June 2005

Summary
Withholding MeNZB™ immunisation while a phase 3 trial takes place would extend the epidemic by years. It is unnecessary as there is good academic evidence that this vaccine will work. It would be unethical to delay.


What is a Phase 3 Vaccine trial?

Phase 3 trials are to evaluate efficacy. Efficacy measures are obtained under trial conditions by measuring the percentage of people that the vaccine protects from catching the disease.

Phase 3 trials involve comparing a group of people who have been given the vaccine with a group of people who have not been given the vaccine and following how many in each group gets the disease. The size of the trial groups depends on how rare the disease is, as there needs to be enough people in the trial to compare the two groups and find a statistically significant difference.

Effectiveness is the measure of how a vaccine works when it is delivered to a large population. NZ will have effectiveness data as the vaccine is rolled out. Clearly there is no data until the vaccine is delivered. We already have strong early data showing a drop off in disease rates in South Auckland.


Are there Phase 3 Trials on the Meningococcal B Vaccines (comparing disease rates in vaccinated and unvaccinated people)?

There are Phase 3 trials on the group of vaccines called OMP vaccines (Outer Membrane Vaccines) which provide good evidence supporting the expected effectiveness of MeNZB™. There is no phase 3 trial on the NZ version of the vaccine.


Phase 3 Trials on the ‘Parent’ Vaccine

The ‘parent’ vaccine is the Norwegian vaccine. There was a large Phase 3 trial on this vaccine showing efficacy of 87% at 10 months post vaccination in a trial of 172,000 teenagers using a two dose regime.

The Norwegians did not go ahead and use this vaccine in their community because of two reasons:
By the time they had completed this large trial the epidemic was clearly on the wane 19 years into it.
A two dose regime does not give very long protection i.e. the protection waned for many by 3 years. Hence the NZ decision to add the third dose to give longer protection.


What is the Difference between the ‘Parent’ Vaccine and the NZ Vaccine

The strain of Meningococcal B disease in NZ is different to the Norwegian epidemic. The Norwegian vaccine recipe has been used to make the NZ vaccine, with the piece of protein that is recognized by the body as foreign (the antigen), changed to the NZ strain.

Why is there no Phase 3 Study on the NZ MeNZB™ Vaccine?

There is a Phase 3 study on the ‘parent’ vaccine. The difference between these vaccines is a different antigen (the piece of protein that the immune system responds to) used with the same recipe. This is similar to the process done every year with the influenza vaccine, where the same recipe is used to make the vaccine, but the particular antigen best suited to the most prevailing strain of influenza is used. This has been done safely and effectively for many years with influenza and the Phase 3 trial is not repeated every time the same recipe is used but a different antigen is inserted.

NZ obtained international expert advice on undertaking a Phase 3 trial before introducing the vaccine. After extensive consultation with the World Health Organisation, The UK regulatory authorities and other international academic experts, it was decided that it is acceptable to use the Norwegian Phase 3 study, bridging NZ studies on all the key age groups covering safety and immune response.

If NZ had undertaken a large Phase 3 study if could have taken up to 15 years. This would be unethical considering there is a vaccine available that is known to have a good safety profile and a large body of science showing it is very likely to be effective.

NZ has put in place an extensive, broad safety monitoring surveillance system to closely monitor the roll out of this vaccine. This is a world class surveillance system and has passive and active monitoring components, and the ability to follow up any possible short tem and long term consequences. There are no major safety concerns.

Immunisation Advisory Centre
University of Auckland
June 2005

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