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Meningococcal B Vaccine—Significant Adverse Health Events

Wednesday 25 October 2006 Hansard source (external site)

Ryall3. Hon TONY RYALL (National—Bay of Plenty) Link to this
to the Minister of Health

Have there been any significant adverse health events associated with the meningococcal B vaccine; if so, how many?

HodgsonHon PETE HODGSON (Minister of Health) Link to this

There are a range of side effects associated with all vaccinations. However, significant adverse health events are very rare after vaccination with meningococcal B disease vaccine.

RyallHon Tony Ryall Link to this

Does the Minister stand by his answer last week to a written question that he is confident there are no significant adverse events associated with the meningococcal B vaccine, and is he aware that the Accident Compensation Corporation (ACC) has advised it has accepted 33 claims for adverse events related to the meningococcal B vaccine?

HodgsonHon PETE HODGSON Link to this

Yes and no. The member may be referring to some of the anaphylactic shock reactions that occur, or may occur, with any vaccine or, indeed, with any medication. They have occurred with the meningococcal B vaccine, but they have been extremely rare. There have been fewer than 10 of them, most of which have only a possible association with the vaccination procedure.

StreetMaryan Street Link to this

How many cases of the epidemic strain of meningococcal B disease did we have in New Zealand prior to the roll-out of the vaccine?

HodgsonHon PETE HODGSON Link to this

About 200 children and young people each year used to contract this disease, almost a quarter of whom were left with a lasting disability or died. Saving our young people from either of those outcomes is a prime motivation for our hard-working health sector and for this Government.

StewartBarbara Stewart Link to this

Is the Minister aware of concerns raised by New Zealand First at the time the vaccine was rolled out regarding its safety and effectiveness, and, in light of the latest evidence, is he willing to give the House an unequivocal assurance that the vaccine is safe, as his predecessor did in response to an oral question by the Rt Hon Winston Peters in 2004?

HodgsonHon PETE HODGSON Link to this

As I said in my answer to the primary question, significant adverse events are very rare after vaccination with the meningococcal B disease vaccine. Accordingly, I think it is appropriate to describe this vaccine as safe. It is certainly the most intensively monitored vaccine in New Zealand’s vaccination history.

KedgleySue Kedgley Link to this

Is he confident that the Ministry of Health made the right call to proceed with a massive vaccination of 1 million New Zealand children before it had carried out stage three clinical trials of the vaccine—trials that are normally considered essential before any new medicine is approved—and does that not mean that basically the roll-out has been a gigantic experiment?

HodgsonHon PETE HODGSON Link to this

No, I do not agree with that. The member will, I am sure, be aware that at the beginning of this process the first 100,000 children under 5 and the first 100,000 children over 5 were part of a hospital-based surveillance scheme, in which any child who had been vaccinated and was then found to be in hospital for any reason was then carefully and closely examined, to see whether there was a link with the vaccine. No links were found, except in a few cases where there had been an anaphylactic reaction.

KedgleySue Kedgley Link to this

I raise a point of order, Madam Speaker. I specifically asked why there had not been a stage three clinical trial. The Minister gave us some comments about monitoring, but he did not address the issue of why there had not been a stage three clinical trial.

HodgsonHon PETE HODGSON Link to this

In vaccination that is what a stage three trial looks like.

RyallHon Tony Ryall Link to this

When he was advised by his ministry that there was no evidence of any significant adverse health event associated with the meningococcal B vaccine, was he aware that the ACC has accepted 33 claims of adverse reactions to the meningococcal B vaccine and has declined 42 because the injury reported was an expected result of the vaccine—bruising, redness, minor pain for a short time—and the fact that it has accepted 33 claims means that those cases are more significant than those expected outcomes; as a result of that information, what action will the Minister take?

HodgsonHon PETE HODGSON Link to this

No I was not aware of that, as I said in my answer to the member’s prior question on that matter.

RyallHon Tony Ryall Link to this

Would it surprise the Minister to know that while his officials are saying that there is no evidence of a significant adverse reaction to the meningococcal B vaccine, the ACC has accepted 33 claims, including the claim of an 8-year-old girl whose specialist has said she developed a severe blood disorder as a result of the meningococcal B vaccine; surely that must be a significant adverse event?

HodgsonHon PETE HODGSON Link to this

I am not the member responsible for the ACC, but it is the case that the Ministry of Health—[ Interruption]

WilsonMadam SPEAKER Link to this

Let the Minister address the question.

HodgsonHon PETE HODGSON Link to this

—but it is the case that the Ministry of Health has looked hard for, for example, cases of meningococcal meningitis, cases of Guillain-Barre disease, cases of thrombocytopenia, and all of the things that might be associated with a vaccination, and has found no higher incidence of them after vaccination than before. That does not mean that a person who has been vaccinated might not develop one of those conditions, but it does mean that their prevalence has not increased at all.

RyallHon Tony Ryall Link to this

What action will the Minister take now that he has become aware for the first time that, while his officials have been telling the nation and the Government that there have been no reports of significant adverse events, the ACC has accepted that a meningococcal B vaccination caused a severe blood disorder, and surely the fact that 32 other claims have been accepted would warrant the Minister instructing his officials to start to investigate the serious cases that the ACC has accepted?

HodgsonHon PETE HODGSON Link to this

The member may not be aware that apart from 33 ACC claimants, this vaccine has been subject to three separate ongoing monitoring regimes—three of them. They have been of such a high standard that they are regarded by the independent scientific committee that oversees them as being of a gold standard and worthy of international attention, which, indeed, they received. This vaccine has been monitored harder than any vaccine in our history and most vaccines in anyone’s history.

RyallHon Tony Ryall Link to this

Does the Minister of Health actually appreciate how serious this information is, because the public have been assured by health officials that there have been no significant adverse events, and parents like myself have immunised our children on that basis, and what we are now discovering is that the ACC has accepted 33 claims? We are uncertain about the range of injuries that they are claims for, but we are aware that the ACC has accepted the claim that this vaccine caused a severe blood disorder in an 8-year-old girl. Surely the Minister realises that that puts in question the advice he is receiving?

PetersRt Hon Winston Peters Link to this

I raise a point of order, Madam Speaker. What is so special about the National Party that members like Mr Ryall can get up and go on and on in question time, when we are asked on numerous occasions by you to truncate our questions? There should not be a special rule for Mr Ryall, particularly since 2 years ago he did not have anything to say about this issue, at all.

WilsonMadam SPEAKER Link to this

Members should be reminded that in supplementary questions there is only one question, and that all questions and answers should be succinct. There is a tendency for members on both sides of the House to make speeches.

SmithDr the Hon Lockwood Smith Link to this

I raise a point of order, Madam Speaker. If you check the Hansard, Madam Speaker, I am sure you will find that the last supplementary question asked by the Rt Hon Winston Peters did not start with a question. You have ruled many times that questions must start as a question. I would appreciate your sorting that matter out for the future.

WilsonMadam SPEAKER Link to this

I do not need any help on that. Please be seated. Yes, if all members observed the Standing Orders all the time, it would certainly be very helpful.

PetersRt Hon Winston Peters Link to this

I raise a point of order, Madam Speaker. You do need help on this, Madam Speaker, and I will tell you why. If that point of order was to be valid, it had to be raised at the time that I asked the supplementary question.

WilsonMadam SPEAKER Link to this

Yes, that is quite right, but we are having a little general discussion here on how we are all going to observe the Standing Orders—and we are.

HodgsonHon PETE HODGSON Link to this

It may help the House if I offer the following advice. A range of serious blood conditions occur in children, and the question is whether they occur with greater frequency after the population of New Zealand children has been vaccinated. The view of the Ministry of Health is that they occur at no greater rate than previously. Although, of course, a child who has been vaccinated may nonetheless at some point develop a serious blood condition, the issue of causality is one that can be proven only epidemiologically, whether or not the ACC has accepted it.

KedgleySue Kedgley Link to this

I seek leave to table a transcript of a Norwegian documentary that recently screened in Norway, in which three Norwegian professors of medicine expressed grave concerns about the safety of the meningococcal B vaccine—the so-called parent vaccine used in New Zealand.

WilsonMadam SPEAKER Link to this

Leave is sought to table that document. Is there any objection? Yes, there is objection.

RyallHon Tony Ryall Link to this

I seek leave to table the answer to a written question from the ACC. It is not yet on the written questions website, so it will be of interest to members. I seek leave to table the document, which shows 33 adverse events—

Document, by leave, laid on the Table of the House.

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