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MoH response to Meningococcal Gold Rush Quickguide

MoH response to Meningococcal Gold Rush Quickguide

SCOOP EDITOR'S NOTE: The following is a point by point response to the "Gold Rush Quickguide" by Barbara Sumner Burstyn and Ron Law. The Quickguide was a short form version of the "The Meningococcal Gold Rush", an article published by Scoop on February 7th this year.

KEY:
Questions raised in the Quickguide in bold
Responses from Ministry of Health in plain text

The three questions all parents, health professionals and the media should be asking:

- Is it necessary?

Yes. The epidemic is likely to run for another 6-10 years if we take the 'do nothing' approach.

- Does it work?

The clinical trials showed that the vaccine generates antibodies in adults, children, toddlers and infants to provide protection against the epidemic strain of meningococcal disease.

- Is it safe?

Yes. More than 750,000 doses have been given in the Meningococcal B Immunisation Programme and the Independent Safety Monitoring Board said it had no concerns in relation to the safety of MeNZB vaccine. (The Independent Safety Monitoring Board was set up by the Health Research Council to independently monitor the roll out of the meningococcal B immunisation programme. The ISMB has five members from New Zealand and overseas with extensive expertise covering statistics, vaccine trials, public health epidemiology, clinical paediatrics and meningococcal disease.)

1.. The general public and the New Zealand government have been told that New Zealand is caught in the grip of a unique meningococcal B epidemic, caused by a single strain of bacteria [MenBe].

It is correct that New Zealand is in the grip of a meningococcal disease epidemic, however there are different strains of meningococcal disease. The strain doing the most damage, causing 76% of all lab-confirmed cases since 1997, is a B strain. We reached levels described as epidemic by the World Health Organization in 1991. This is 3 cases per 100,000 population, in 2004, the rate was 9.2 cases per 100,000 population.

2.. This strain of meningococcal B is found in a number of countries and has been confirmed in only 48 percent of meningococcal cases in New Zealand.

The strain causing 76% of all lab-confirmed cases since 1997, is a B strain that is rare in all countries except New Zealand where there is an epidemic.

3.. Only 43 percent of meningococcal deaths in 2003 and 2004 were caused by the strain of bacteria targeted by the MeNZB vaccine. This is a 76% decline from peak levels in 2001.

In 2004, 73 percent of the lab-confirmed cases of meningococcal disease were caused by the epidemic strain that the vaccine targets. The Programme is not just about preventing deaths, but also the effects of the disease on survivors. Reasons for fewer deaths include better awareness, diagnosis and treatment of the disease. For every 100 cases of meningococcal disease, approximately 4 will die and 20 will be permanently maimed or disfigured. 76 will be treated and make a full recovery.

While cases of meningococcal disease have declined since the year high of 2001, in 2004 we were still at more than three times the WHO levels for an epidemic. Cases have declined previously, and subsequently risen.

4.. The general public and the New Zealand government have been told that a one-off vaccine for our 'unique' or 'orphan' strain of meningococcal B bacteria was developed by Chiron Corp. Yet Chiron bought the rights to a vaccine developed in Norway by the Norwegian Institute of Public Health in 1999.

A different vaccine was first developed by the Norwegian Institute of Public Health (NIPH) in 1983. The MeNZB vaccine was produced in close collaboration between NIPH and Chiron for New Zealand. The difference is simply the antigen used in the vaccines. The vaccine developed for Norway was for a different B strain so they used a different antigen to promote the desired immune response.

5.. While Cabinet papers are partially censored, available data suggests that Chiron will receive about 140 million dollars.

This is entirely speculative, and it is incorrect. There is no public data on what Chiron is likely to receive as the deal is commercially sensitive, however we can say this figure is grossly excessive.

6.. The Norwegian Government did not use their meningococcal B vaccine nationally. Annette King said in parliament in Oct. 2004 that this was because the cost-benefit ratio did not stack up.

True. The epidemic had been running for 19 years in Norway by the time they got the vaccine to combat their epidemic and it was seen to be waning naturally. The cost of vaccinating the population outweighed the benefits by then. The epidemic had almost ended and vaccination at that late stage would have prevented very few cases. New Zealand has a vaccine much earlier in the epidemic cycle and vaccination at this stage of the epidemic can prevent many hundreds of cases of meningococcal disease.

7.. The Norwegians said the vaccine lacked efficacy. To date, the Norwegian vaccine has never been licensed.

The Norwegians said the vaccine was 87% effective in providing immunity to their epidemic strain of meningococcal disease when measured 10 months after a two-dose course in teenagers. The Norwegian vaccine was not licensed because they decided not to use it as their epidemic was perceived to be waning naturally.

8.. Cabinet, the public and some health officials involved in the roll-out have been told that the MeNZB vaccine confers herd immunity. The MenBe researchers acknowledge that it does not!

The Ministry has never said the vaccine will directly confer herd immunity. What was stated was that the delivery of a vaccine targetting Under 20's might confer herd immunity, but other options presented to Cabinet could not confer herd immunity. We have urged as many people as possible get immunised because we want as many people as possible protected.

9.. The "independent" cost-benefit analysis presented to cabinet was conducted by senior meningococcal vaccine researchers and their colleagues at Auckland University.

See 10

10.. These same researchers would be receiving several millions of dollars for conducting the NZ trials. The authors declared in the report to cabinet there were no conflicts of interest.

The main author of the independent cost-benefit analysis, Professor Richard Milne is not linked to vaccine research.

The decisions about whether or not to proceed with the programme rested with the Ministry of Health and Cabinet, not the vaccine researchers. Payment for conducting the trials went to Auckland University Services Limited, not the researchers themselves.

11.. A more objective cost-benefit analysis by Treasury in 2001 noted that the cost to benefit ratio was seven times that normally used by Pharmac to approve funding of prescription drugs.

This figure was before the natural decline in case-load [50 percent] and mortality [75 percent] had begun. Pharmac does not have a set funding benchmark - so seven times nothing is nothing. The Treasury analysis has not captured the heavier burden of this disease since 2000.

We don't know if there is a natural decline happening as rates have declined peviously then increased again, but we do know that based on similar epidemics overseas, New Zealand's epidemic has at least 6-10 years still to run before returning to pre-epidemic rates of 50-60 cases.

12.. Cabinet approved this vaccine after being told by the MOH that without intervention there would be 20 deaths a year for the next 10 years, and this vaccine would avert 13.6 of those.

Based on information at the time this projection is accurate. The 13.6 was arrived at based on 20 deaths and the multipliers of vaccine coverage, efficacy and the strain of meningococcal disease.

The majority of deaths from meningococcal disease are due to the epidemic strain. As well as the direct benefits of protection and awareness of the epidemic strain of the disease, there is the obvious benefit of increased awareness of meningococcal disease in general, which will help prevent deaths from other strains.

13.. The figure of 20 deaths includes deaths from seven strains of meningococcus bacteria.

See 12.

14.. Less than half of meningococcal deaths can be attributed to the epidemic MenBe strain. The average death rate in the last three years has declined naturally by about 70 to 80 percent.

During this epidemic, 76 percent of all laboratory-confirmed cases and 72 percent of the laboratory-confirmed deaths since 1997 have been from the epidemic strain. There are more cases that have been probably caused by the epidemic strain but where the specific strain of the disease cannot always be identified after a person has started antibiotic treatment, and aggressive treatment with antibiotics is standard treatment for suspected meningococcal disease.

Opponents of this programme say if it wasn't lab-confirmed then it wasn't the epidemic strain, however it is reasonable to assume 75% of those that cannot be confirmed would be epidemic strain. It cannot be said that if it was not lab confirmed then it was not epidemic strain.

15.. Based on 2003 and 2004 figures, if the vaccine proves effective then it could avert one or two deaths per year out of a total of 700 deaths for the 0 to 20 age group per annum.

The immunisation programme is not just about preventing deaths, and it is misleading to narrow the focus about what has been happening to in meningococcal disease to trends from any two years. At this time last year (May) there had been 2 deaths from meningococcal disease while this year there have been 5 so far. This sort of epidemic has peaks and troughs, which is why there needs to be a broad perspective not a selectively narrow focus on timeframes.

As well as the deaths, this programme is also about preventing brain damage, amputation, deafness, massive scarring, learning disabilities and other things caused by meningococcal disease.

As well as the direct benefits of protection and awareness of the epidemic strain of the disease, there is the obvious benefit of increased awareness of meningococcal disease in general, which will help prevent deaths from other strains.

16.. Based on that cost-benefit, the government would be spending 100 billion in preventing the rest of the 700 from dying.

This is extrapolation based on a false assumption. It has been estimated that the meningococcal epidemic has cost New Zealand a total of $1 billion so far, including $470 million in direct costs to the health sector to treat people with meningococcal disease. This does not include the cost of deaths.

17.. Deaths from MenBe are at their lowest levels since 1991 when the epidemic began.

The number of deaths will vary from year to year, but it is wrong to just focus on the deaths. We are also trying to stop non-fatal cases of the disease where patients suffer from brain damage, amputations, deafness and severe scarring.

For every 100 cases of meningococcal disease, approximately 4 will die and 20 will be permanently maimed or disfigured. 76 will be treated and make a full recovery.

18.. Chiron would only sign the contract with the New Zealand government if it were able to manage the trials as well as supply the vaccine for the roll out and trials, a large conflict of interest.

This is not true. A panel independent of the Ministry of Health chose the preferred provider of the vaccine from tenders submitted by four manufacturers. The principal investigator of the trials was not a Chiron employee.

19.. An unlicensed meningococcal C vaccine produced by Chiron called "Menjugate" was used as the control or "placebo" during some of the trials. Chiron recently withdrew its US license application, despite completing expensive phase 3 clinical trials.

This has nothing to do with the MeNZB programme in New Zealand. However, menjugate is licensed for use in 26 countries, including Australia, Canada, the UK and through Europe and Latin America. It also was approved for the MeNZB clinical trials in New Zealand.

Ethically, it was agreed that it was better to provide children in the control arm of the study with a vaccine that would protect against a disease that occurs in New Zealand.

20.. Phase 3 trials are the most definitive of all trials. They look at effectiveness and safety.

All phases of clinical trials look at safety and immunogemicity, which is the body's response to a medicine or vaccine. This includes the trials conducted with MeNZB vaccine.

In addition, as with all new medicines and vaccines, the rarest events will not be seen until the product is in the general population. This is why there is rigorous safety monitoring.

21.. The Minister says that phase 3 trials are unnecessary as data from Norway can be used. Approval of MeNZB based on the Norwegian phase 3 trials is like approving Vioxx because it is similar to Celebrex. The danger of Vioxx was revealed only after extensive phase 3 trials. Following completion of extensive phase 3 trials the Norwegian vaccine was not approved for mass use as the results didn't stack up.

At New Zealand's request, international experts, including including WHO and world leading public health researchers reviewed the body of research on meningiococcal B vaccines. They concluded it was not neccessary for New Zealand to conduct phase 3 trials for MeNZB as there was already sufficient applicable data the vaccine safety and efficacy in large populations. Following this, the Ministry of Health concluded that the size of the epidemic and the quality of data available meant it would be unethical to delay introduction of the vaccine further.

The New Zealand trials (phases 1 and 2) generated comprehensive data showing increased levels of antibodies against the epidemic strain of meningococcal disease in all age groups. There is also good data of similar vaccines to MeNZB administered in 65 million doses. MeNZB and MenBVac (the Norwegian vaccine) are essentially the same vaccine with a different target antigen and international experts accept they are comparable.

(Note - Vioxx was not withdrawn as a result of phase three trials. It was introduced to markets worldwide as a result of phase 3 trials.)

22.. The Minister's expert advisory committee expressed concern that there was no scientific evidence that the MeNZB vaccine would work.

This is a point presented out of context and before the clinical trials were complete. Once the trials were finished and all of the data was available, this expert advisory committee recommended the programme be rolled out. They did not have concerns about the science or the results of the clinical trials. The trials showed the vaccine to be safe and effective in generating a protective antibody response. This is reflected in the committee minutes when licensure was recomended.

23.. The MeNZBT adverse event monitoring system is conflicted. It is made up of handpicked pro-vaccine specialists. Two are colleagues of MenBe researchers.

The Independent Safety Monitoring Board (ISMB), which assesses the safety of the programme, was established by the Health Research Council to independently monitor the roll out of the Meningococcal B Immunisation Programme. The ISMB has five members from New Zealand and overseas with extensive expertise covering statistics, vaccine trials, epidemiology, clinical paediatrics and expertise in meningococcal disease. The Centre for Adverse Reactions Monitoring at the Otago School of Medicine in Dunedin, has been taking reports of adverse reactions from medical professionals for many years and maintains a database of adverse reactions reports going back to 1965. It is not made up of handpicked pro-vaccine specialists. Health professionals and members of the public can make an adverse reaction report to the centre.

24.. The adverse event monitoring system used for the MeNZB vaccine collects data only on a predetermined range of side-effects. This is not good pharmaco-vigilance and is not normal medical practice.

We are monitoring for ANY adverse event in relation to the Meningococcal B Immunisation Programme. Hospitals and GPs are part of the monitoring programme, with reports being made to New Zealand's pharma-covigilance centre at the Otago School of Medicine in Dunedin, called the Centre for Adverse Reactions Monitoring. On top of this medical community scrutiny, there is an Independent Safety Monitoring Board made up of international and local experts assessing the safety and efficacy of the programme.

25.. The MOH has been downloading school rolls in their entirety into their National Immunisation Register with all the children's ID information. Given that informed consent has not been sought or given this appears to constitute a form of unauthorized surveillance.

The school role data is not recorded directly on the NIR, but the School Based Vaccination System managed by DHBs. School role data is not kept on the NIR. Only immunisation event data is then transferred to the NIR. Legal opinions from both the Ministry of Education and the Ministry of Health supported the release of the school rolls to the Public Health services carrying out the vaccinations.

The Ministry of Education's Schools' Consultative Committee was briefed. This process was also discussed with both the Office of the Privacy Commissioner and the Office of the Ombudsman.

The Privacy Commissioner advised us that before school rolls can be provided to Public Health Nurses, schools will need to inform parents and children that the rolls will be used in this manner.

School newsletters would be an appropriate way to inform parents of this. A letter to all Principals in New Zealand included advice about the use of school roles and the need to inform parents through newsletter regarding the provision of school roles to PHNs (sent 20 February 2003 and 14 July 2004).

26.. The Minister's expert advisory committee expressed written concern that the vaccine used in the trials was not the vaccine manufactured by Chiron, and now being injected into 1.15 million New Zealand children.

The vaccine used in the trials was the vaccine manufactured by Chiron. The authors are referring to the wrong minutes.

27.. The Chiron manufactured MeNZB vaccine, made in their Italian plant, had only a handful of children involved in its trial, and the expert committee cited how the trial was incomplete and the evidence on efficacy was "far from compelling."

This is another example of a point being made out of context and before the trials had been completed. Once the trials were finished and all of the data was available, this expert advisory committee recommended the programme be rolled out, with support from Medsafe and the Independent Safety Monitoring Board.

28.. Is the MeNZB rollout in New Zealand a large uncontrolled experimental trial?

No. The clinical trials had already been completed in each age group before the roll out started in each of those age groups. There continues to be intensive safety monitoring from an independent group of international experts. They have no concerns about the safety of the vaccine after the administration of more than 750,000 doses of the MeNZB vaccine (May 2005).

29.. Medicines Assessment Advisory Committee (MAAC) the minister's statutory advisory experts were concerned at the fact that there was no evidence of efficacy for the vaccine.

This is another statement made out of context. We will have estimates of effectiveness when the programme is complete, and in the meantime we know from clinical trials that the MeNZB vaccine is effective in stimulating antibodies to fight the epidemic strain of the disease. The Medicines Assessment Advisory Committee supported the vaccine based on considerations including evidence that the vaccine increased antibody response to the epidemic strain of meningococcal disease.

30.. Trials for 6-10 week babies revealed a 55 percent antibody response. This has been communicated to GPs, but not to the public. The result has been described by the MenBe researchers privately as "disappointing" but to the public as exciting.

There are variations in how the antibody increase is measured. 55% of the 6-10 weekers generated more than a four-fold rise in antibodies against a baseline. If overseas measures are applied, these numbers would translate to 69% reaching the acceptable two-fold rise in antibodies. We know that many of the children who did not reach the fourfold rise in antibody activity are also likely to be protected as antibody response underestimates vaccine efficacy.

Quite simply, being able to offer children protection from the epidemic strain of meningococcal disease is exciting.

31.. Annette King, the Minister of Health has not denied that 2 deaths of children occurred during the trials.

See 34

32.. Since the Meningococcal Gold Rush report was written MOH documents reveal at least 10 previously healthy children have died following vaccination.

See 34

33.. None of these deaths have been assessed using published MedSafe guidelines for pharmaco-vigilance classification.

See 34

34.. Given that each of these deaths falls outside of the pre-determined range of side effects, each has been assessed as having died from non-vaccine related matters.

There have been no deaths attributed to the vaccine.

Since the programme started July last year, 34 children or young adults who have received MeNZB vaccine have died, but none of the deaths have been attributed to the 750,000 doses of vaccine delivered.

More than half of the deaths have been due to accidents and other injuries.

An intensive monitoring system has been running since the start of the vaccination programme, and an Independent Safety Monitoring Board (ISMB) has been set up to advise on the continuation of the programme based on risk.

The ISMB says it has no concerns about the safety of the vaccine.

We urge parents to get their children immunised to minimise one of the risks children face. All deaths in children and young adults are tragic, whatever the cause. The parents of all the children who had been vaccinated had taken every step possible to protect them from the Meningococcal B epidemic, but unfortunately their child has died from another event.

35.. In New Zealand only healthy children are eligible for vaccination. Therefore, using proper classification, 12 deaths (including the two during the trials) have occurred in previously healthy children.

There have been no deaths attributed to the vaccine. See 37.

36.. There have been documented cases of anaphylaxis and Guillain-Barre syndrome that should have been classified as "certain".

See 37.

37.. There have been at least 16 serious adverse reactions requiring hospitalization.

No serious adverse events have been attributed to the vaccine with over 750,000 doses delivered (as at 17 May 2005). There has been a single case of anaphylaxis which is likely to have been caused by the vaccine. The young person was treated appropriately and made a full recovery.

38.. There have been an estimated 9,706 adverse reactions severe enough to warrant going to a GP. This means that 1 in 16 children will have an adverse reaction severe enough to warrant being taken to a GP for medical assessment.

There have been a total of 645 reports of adverse events reported to the Centre for Adverse Reaction Monitoring (CARM) from the start of the programme in July 2004, through to 27 February 2005. About three-quarters of the events were skin reaction, injection site reaction and fever.

If an individual has more than one reaction, it is the reactions that are counted rather than the patients. That means one patient may have an injection site reaction, irritability, headache and fever and there will be four reactions entered.

Most frequent individual reactions spontaneously reported to CARM following MeNZB vaccination

Reactions |-| Number of reports received

Skin reactions (includes rash) |-| 165
Injection site reactions |-| 152
Fever |-| 155
Vomiting |-| 74
Irritability |-| 30
Headache |-| 27
Diarrhoea |-| 22
Musculoskeletal |-| 20

- From the ISMB monitoring report 7 April 2005.


39.. Despite the above, the MOH has stated that no safety issues have emerged during the MeNZBT campaign.

It is because of this information that the Independent Safety Monitoring Board says it has no concerns about the safety of the vaccine. These are all local and systemic reactions that are generally mild, and not serious.

40.. In January five year old Kaytlen Marie Destiny Nisbett, who had been fully vaccinated with MeNZBT died from meningococcal C. Her mother Donna Hutton was told there was no vaccine for meningococcal C. Meningococcal B immunisation programme director Jane O'Hallahan said in response to Kaytlen's death that scientists are years away from developing a vaccine against all strains of the disease.

Meningococcal C vaccine has been used in mass vaccination programmes in the UK, Canada and Australia where there have been a significant number of C cases. In New Zealand, a B strain dominates.

Meningococcal C vaccine has been used in New Zealand, most recently when outbreaks occurred in a pre-school and at a University. Last year, less than 8 percent of confirmed cases were caused by group C disease while 73 percent of cases were the New Zealand epidemic strain.

41.. There are two fully licensed meningococcal vaccines against meningococcal A, C, Y, and W-135 in New Zealand.

Scientists are years away from developing a single vaccine that will be effective against all strains, including B, of meningococcal disease.

42.. These strains cause about 50 percent of all meningococcal deaths in NZ. Whilst there are fewer cases percentage wise, these strains have much higher death rates than the MenBe strain.

Incorrect. More than 70 percent of deaths in the current epidemic have been caused by the strain of the disease that is targeted by the MeNZB vaccine.

However, it needs to be remembered that the vaccine is not only preventing deaths, it is also preventing people from suffering the non-fatal outcomes of the disease. For every 100 cases of meningococcal disease, 5 people will die and another 20 will suffer serious disability such as brain damage, amputation or deafness.

43.. Assuming the vaccines work - the Ministry of Health would appear to have deliberately prevented the public from choosing additional protection by not promoting the vaccines. Oddly it would appear that drug companies have not taken advantage of this opportunity to promote their products. Why?

Health professionals are in the best position to recommend treatment or disease prevention options for individual patients.

ENDS

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