MeNZB Vaccine Safety

• Safety Results Published in Scientific Journal

• Adverse Events Following MeNZB™  - Safety Surveillance to June 2006

• ACC payments for adverse events following MeNZB™

• Issues and Concerns around safety of MeNZB™

Safety Results Published

Adverse Events Following MeNZB™

From 19 July 2004 to 30 June 2006, over 3 million doses of MeNZB™ vaccine were administered, with almost 1.06 million individuals having received at least one dose of vaccine. For the same period 2,212 spontaneous reports of events following MeNZB™ vaccination were received by CARM. The most frequently reported event terms (irrespective of possible causal association with immunisation) and the proportion of the total reports that these events account for are included in table below.

Most frequent event terms (irrespective of possible causal association) reported to CARM following MeNZB™ vaccination for the period 19 July 2004 to 30 June 2006. *Each report may include more than one event, therefore the proportion of all reports will total to > 100%.

Overall, the main pattern of events observed was that of local reactions (injection site pain/limb pain, injection site inflammation, injection site erythema, injection site mass); somatic immune responses (fever, headache, gastrointestinal and musculoskeletal symptoms) and hypersensitivity (skin reactions – most commonly rashes, less frequently urticaria and much less frequently erythema multiforme; peri-orbital oedema and facial swelling and bronchospasm, with occasional anaphylactic-type events). Sleepiness and irritability were also reported accounting for around 4 and 5% of reports respectively.

Hypersensitivity-type events of a more significant nature

• Urticaria (n=195); Peri-orbital oedema (n=35); Facial oedema (n=21); Bronchospasm/chest tightness (n=24); Angioedema (n=13);
  Peripheral (limb) oedema (n=9)
  Anaphylactic-type events (n=9)
• Six anaphylactic-type events were mild reactions.
• Three anaphylactic-type events were for more significant reactions: one occurred approximately five hours post immunisation and resulted in overnight admission to hospital for observation; two occurred shortly following immunisation, with one also presenting with urticaria. Both were hospitalised for observation. It is difficult to establish whether these events were classic anaphylactic reactions. 
  

Haematological disorders

• Thrombocytopenia/Idiopathic thrombocytopenic purpura (n=6)
  In two reports the duration to onset was two and five days and the others ranged from 12-36 days.  One occurred following MeNZB™ given concurrently with MMR vaccine. (Note: the hospital-based monitoring found no increased incidence of thrombocytopenia following MeNZB™ vaccination when compared with other routine childhood vaccinations).
• Henoch Schönlein Purpura (HSP) (n=2)
  In one report of HSP the duration to onset was one day and the other 10 days. The latter report documented a coryzal-like illness at about the same time as immunisation. (Note: the Hospital-based monitoring found no increased risk of HSP within 30 days after MeNZB™ vaccination)
  Notable reports received but not considered to be associated with MeNZB™.
• Kawasaki Disease (n=2)
  One child with duration to onset of 34 days went on to receive a second MeNZB™ without exacerbation of symptoms. Onset for the other case was six days after a second MeNZB™ a dose but no further information was provided. (Note: the hospital-based monitoring found no increased incidence of Kawasaki Disease following the start of the MeNZB™ vaccination programme).
• Wegeners Granulomatosis (n=1)
  Symptoms began two weeks after a first MeNZB™ dose, and were considered Wegeners Granulomatosis following a positive biopsy.  However, some uncertainty around the exact diagnosis exists.
  

ACC Payments for adverse events following adminsitration or MeNZB™ vaccine

• During the period July 2004 to March 2006 about three million doses of the MeNZB™ vaccine were administered to over one million people.
• ACC has accepted 33 claims arising from people receiving the MeNZB vaccine.  
• Of these 33 some are not related to the vaccine itself but to receiving an injection.  The injuries were as listed below.
  • MeNZB accepted Treatment Injuries from 1 July 2005 to current (Source: ACC)
  • 10cm localised tissue reaction left thigh to 3rd Menz B vaccine (1)
  • allergic reaction (7)
  • Anaphylactic reaction (2)
  • Axillary nerve injury left arm (1)
  • Bicipital tenosynovitis (1)
  • Cellulitis (1)
  • Contusion injection site (2)
  • Frozen shoulder (1)
  • Haematoma at vaccination site (6)
  • Infection (1)
  • Nerve damage (1)
  • Periositis and muscle inflammation (1)
  • Relex sympathetic dystrophy (1)
  • Rotator cuff impingement (3)
  • Skin puncture (1)
  • Tendonitis (1)
  • The development of immune thrombocytopenia (1)
  • Fractured upper teeth (1)
    
  • Total: 33
    
• Once a claim has been accepted the person concerned could receive the following types of entitlements:
  • medical treatment for any resulting injury
  • compensation for lost wages if they were working
  • home help if they required it while recovering and other entitlements as laid out in the Act under which ACC operates.
  • It should be noted that none of these claims qualified for any form of lump sum payment.
• The 33 claims have cost ACC a total of $7493.61 (median $79.74)
• Once cover has been established ACC can consider a wide range of entitlements for the person.  These might include funding medical or rehabilitation costs, compensation of lost weekly income, provision of home help or other assistance, home or vehicle modification or a range of other options.  
• In the MeNZB cases, with a median cost of $79,  the entitlements would appear to have been mainly GP visits, perhaps with some prescriptions as well. 
  

Issues and Concerns around MeNZB™ Safety

• Did New Zealand begin using the MeNZB vaccine while there were compensation payouts being made to Norwegians for vaccine damage?

This is misleading. This originates form an individual who developed chronic fatigue syndrome following vaccination in the 1980's. This was not believed to have been caused by the vaccine however in 2003 the individual received a payout from the Norwegian compensation system. This person went on TV in 2006 with their story and since then (unsurprisingly) more people have claimed they too developed chronic fatigue after vaccination. These claims are under investigation.  The NZ authorities were aware of the case of chronic fatigue and this as a possible but rare adverse event. This was clearly stated on the data sheet provided to health professionals and also available to the public when the vaccine was rolled out.  Click here for more on chronic fatigue and vaccination.

Key Message: These claims are misleading.

• Was the information brochure given to teenagers prior to the Norwegian trials inadequate?

Whatever informed consent process the Norwegians used for their trials in the 1980's is irrelevant to New Zealand. New Zealand had its own, robust, informed consent process which conformed to our current ethics guidelines.

Key message: Irrelevent

• Were there serious adverse events that occurred during the Norwegian trials?

Yes, this is true, there were 14 serious events that occurred after receipt of the vaccine. What is often not mentioned is that in those who had not received the vaccine there were 43 serious events. Click here for more information on adverse events following immunisation. 

 

Diagnosis	After Vaccn #	Before vaccn or not vacc’d
Encephalitis, myelitis and encephalomyelitis	7	15
Other diseases of the spinal cord	1	1
Multiple Sclerosis	0	3
Other demyelinating diseases of CNS	1	0
Hemiplegia	0	1
Other paralytic syndromes	3	2
Encephalopathy, unspecified	1	8
Guillain Barre Syndrome	1	13
TOTAL   N= 375,000 teens, 149,000 were vaccinated over 3.5 years	14	43

Later, the placebo group were offered the vaccine. 53,000 were vaccinated and there was one case of Guillain-Barre syndrome. This case was preceded by varicella infection

Key Message:   Serious conditions - no more in the vaccinated than non vaccinated group

• New Zealand did not test the vaccine properly and did not run Phase 3 trials, shouldnt these have occured?

New Zealand rolled out the MeNZB™ vaccine in line with international standards. It is not necessary to undertake phase 3 trials when sufficient data are already available, in New Zealand’s case it would also have been unethical (refer here for more information on the ethics).  We have previously discussed this extensively. Click here for information on why phase 3 trials were not run.

Key Message: The issue of phase 3 trials in New Zealand has been extensively discussed. They were both unecessary and unethical.