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1 An Update on Immunisation and Infectious diseases in Australia: 2013 Prof Robert Booy National Centre for Immunisation Research (NCIRS) Many thanks: Dr Rashmi Dixit, Dr Greg Rowles, Profs Peter McIntyre & Kristine MaCartney

2 Nigeria polio vaccinators shot dead in Kano 8 February 2013 Nine female polio vaccinators have been killed in two shootings at health centres in northern Nigeria Nigeria is one of only three countries where polio is still endemic Some Nigerian Muslim leaders have previously opposed polio vaccinations, claiming they could cause infertility One cleric told people that new cases of polio were caused by contaminated medicine

3 Outline of talk  Some qanda at beginning and end  Pertussis: a real curly one..  Influenza: always something new under the sun  Rotavirus vaccine: yet again, the haves have more  HPV: the wizardry of Oz Ian Frazer  Measles: what, that old chestnut?  Varicella and Shingles.. On the downhill run  Pneumococcal disease  Polio  Meningitis, encephalitis: no time except #qanda

4 Kids Research Institute Annual Report 2011 - 2012 The cause of encephalitis, or swelling of the brain, is still unknown in more than half of cases. It can kill in hours and leaves many others with brain damage and other major complications Five year-old Behnam went from a sniffle and a headache at a birthday party on Saturday to intensive care by Monday morning…..

5 Baby Button and Mother

6 The Herald Sun Deadly whooping cough warning March 14th, 2012. “3 week old infant caught pertussis from 2 year old fully vaccinated sister” …… Learning points: suspect pertussis in neonates & test; prolonged cough in older child, even if vaccinated

7 Weekend Gold Coast Bulletin - Saturday, 02 April 2011

8 Bordetella pertussis: whooping cough  Vaccination began 1950s but pertussis still prevalent  1990-2008 data consistent with outbreaks every 3-5 years Prior to vaccine: every 2-3 years present epidemic c.f. epidemics in 1997 & 2002: -Longer & many more infections were reported 2009-12 -fewer deaths BUT same number of hospitalisations Australia had record 38,000 cases diagnosed in 2011 Seven infant deaths in Australia 2008-11 Notifications falling in 2012/3  Bordetella parapertussis: A related GNB Clinically milder Pertussis vaccine not effective Europe: up to 1/3 of “whooping cough cases”; less in Aus


10 Pertussis symptoms Typical symptoms in children 1,3 Atypical symptoms frequently in adolescents/adults 2 Paroxysmal coughSneezing Post-tussive vomitingCoryza Inspiratory whoopLow grade fever Prolonged cough duration (Mean duration 36–48 days) 3 Non-specific cough 1.Cherry et al. Pediatr Infect Dis J 2005; 24(5 Suppl): S25–34; 2.2. Brooks, Clover. J Am Board Fam Med 2006; 19: 603–11; 3. Wirsing von König et al. Lancet Infect Dis 2002; 2:744–50 Neonatal apnoea +/- cough/whoop If older child/adult 1 may resemble URTI, bronchitis, sinusitis, asthma Consider if prolonged coughing: B. pertussis 3

11 Reasons for recent outbreak  Vaccine refusal Refusal clusters promote spread However: -in Australia 94% of 2y-olds UTD with vaccines -Cases not confined to these communities -most pertussis cases >one dose dTPa, many UTD!  More / better testing Increased clinical recognition Use of PCR testing much increased last 5 years McIntyre and Wood: Pertussis Prevention in early infancy. Current Opinion in Infectious Diseases. 2009; 22; 215-223

12 Reasons for recent outbreak  Shorter period of protection / Waning immunity Neither natural nor vaccine immunity is lifelong Adults (?teens) & sibs are source of infection to infants Recent outbreak: pre-schoolers and primary schoolers  ? Vaccine less effective: mutations in pertussis toxins No evidence of this (but looking: NCIRS study 2012) 2 doses required before significant protection Currently: significant immunity from 18/52 age (2/52 post dose 2) One dose probably ↓ death / ventilation Most deaths < 12/52 age McIntyre and Wood: Pertussis Prevention in early infancy. Current Opinion in Infectious Diseases. 2009; 22; 215-223

13 J Infect Dis.J Infect Dis. 2012; 205:1220-4 (Lan: senior author) Newly Emerging Clones of Bordetella pertussis Carrying prn2 and ptxP3 Alleles Implicated in Australian Pertussis Epidemic 2008-2010 Octavia et al  A total of 194 Bordetella pertussis isolates collected 2008-10 were typed by single-nucleotide polymorphism (SNP) analysis  Strains with 2 closely related SNP profiles carrying prn2 and ptxP3 from the recently emerged SNP cluster I predominated  The data suggest but don’t prove increasing selection among the B. pertussis population in Australia in favour of strains carrying prn2 and ptxP3 under the pressure of acellular vaccine- induced immunity

14 But  "The vaccine is still the best way to reduce transmission of the disease and reduce cases, but it appears to be less effective against the new strain and immunity wanes more rapidly….” said Dr Lan

15 Pertussis vaccination: benefits and risks  Opponents (“Anti-vaccinists”) argue pertussis vaccine ‘ineffective’ +/or ‘risky’  The DTPa vaccine: overwhelmingly safe and effective Pre-vaccine 1940s: hundreds died, now death rate v low Encephalopathy (‘brain damage’) -Dravet’s syndrome: genetic condition = explanation for most cases of encephalopathy post whole-cell pertussis vaccine Berkovic SF. et al. De-novo mutations of the sodium channel gene SCN1A in alleged vaccine encephalopathy: a retrospective study. Lancet Neurology. 5(6):488-92, 2006 Jun Tro-Baumann B. et al.A retrospective study of the relation between vaccination and occurrence of seizures in Dravet syndrome. Epilepsia. 52(1):175-8, 2011 Jan. McIntosh AM. Et al. Berkovic SF. Effects of vaccination on onset and outcome of Dravet syndrome: a retrospective study. Lancet Neurology. 9(6):592-8, 2010 Jun. 

16 Effects of vaccination  For vaccinated person: Reduction in susceptibility to infection Reduction in disease severity -? Effect on transmissibility Reduction in infectiousness  For unvaccinated person: Reduced proportion of contacts infected Herd immunity

17 Evidence of vaccine on transmission. Halloran ME, Préziosi MP, Chu H. Estimating vaccine efficacy from secondary attack rates. Journal of the American Statistical Association. 2003;98:38–46. Senegal household study Index case: vaccinated vs unvaccinated 0 0.05 0.1 0.15 0.2 0.25 VaccinatedUnvaccinated Status of index case Secondary attack rate The unvaccinated who acquire pertussis are more infectious, with a higher secondary attack rate, than the vaccinated.

18 US Data  Pertussis deaths US 2000 – 2005: (N = 140 deaths)  Majority (n = 131) of fatalities were in infants Too young (<4 m) to be vaccine protected (n = 126)  Of deaths: 97% unvaccinated 1% had one dose of vaccine against pertussis 2% had 2 or more doses against pertussis  Conclusion: Vaccine protects against death. Tiwari T. Reported pertussis-related deaths to the National Notifiable Diseases Surveillance system and the CDC in the United States, 2000-2005. #82. Presented at: the 42nd National Immunization Conference; March 17-20, 2008; Atlanta.

19 Pertussis hospitalisations < 1 yr old: 1994 - 2008 Well over 60% cases by 16 weeks of age

20 Strategies for Infant Pertussis: Indirect protection  4 year old booster: ?4 yrs  3.5 yrs: as many pre-schoolers in recent outbreak* Not categorically shown to reduce infant pertussis  Universal adolescent / adult vaccine -Recent data USA / Australia: adolescents do not transmit to infants, unless teen parents -mathematical models in American / European context demonstrate pertussis spreads child-to-child, not often child-to-adult Immunity wanes after 5 yrs with DTPa/ dTpa: may need 10 yr boosters Kandola K, Lea A, White W, Santos M. A comparison of pertussis rates in the Northwest Territories: pre and post acellular pertussis vaccine introduction in children and adolescents. Can J Infect Dis Med Microbiol 2005; 16:271–274 Rohani P et al., Contact Network Structure Explains the Changing Epidemiology of Pertussis. Science magazine. 330 (6006): 982-985 Quinn H and McIntyre P. The Impact of adolescent pertussis immunisation 2004-2009: lessons from Australia. Bull World health Organ. 2011; 89: 666-674 Skoff TH et al. early Impact of the US Tdap Vaccination Program on Pertussis Trends. Archives Paediatr Adolesc Med Online January 2 2012

21 Strategies to address Pertussis: Indirect protection  Cocoon: mother (father +/- grandparents +/- childcare workers) Parents (mother) commonest source, but source often hard to identify APERT trial: reduced pertussis in adults -Expected  lower transmission; no field data Modelling: cocooning + regular / single booster  ↓ infant pertussis Poor uptake despite parental support -Funding / implementation support required -Maternity hosp for mums; GPs for fathers /family [before delivery] HCW vaccination ↓ intensive care nursery outbreaks / cost effective  Current NCIRS study on effect of cocooning McIntyre and Wood: Pertussis Prevention in early infancy. Current Opinion in Infectious Diseases. 2009; 22; 215-223 Ward JI et al. Bordetella Pertussis Infections in Vaccinated and Unvaccinated Adolescents and Adults, as Assessed in a National Prospective Randomized Acellular Pertussis Vaccine Trial (APERT). Clin Infect Dis. (2006) 43; 151-157.

22 USA experience with cocooning: Key Points  “Cocooning can be Successful” in short-term.. Demonstration projects -Houston, TX – Ben Taub General Hospital -Nevada - 18 birthing hospitals Important success factors -“Champion” for the cause -Donated healthcare provider time -Free dTPa Clark, Thomas. Centers for Disease Control and Prevention; NCIRS Pertussis Meeting; August 26, 2011  Clark, T. CDC. NCIRS Pertussis Meeting, August 2012

23 Five years later, is cocooning working in the USA?  Not at a national level  Limited success vaccinating fathers / family  Poor uptake of dTpa at birthing hospitals  No demonstration of program sustainability or scale-up  No program of support at Federal level  Cf States in Aus cutting back…. SLIDE BORROWED FROM Clark, Thomas. Centers for Disease Control and Prevention; NCIRS Pertussis Meeting; August 26, 2011 4

24 25 June 2012  New mothers are the latest target for pertussis vaccination as cocooning programs are discontinued  “In NSW, a 3 year pertussis vaccination campaign that provided free vaccine to carers of new babies was halted from end of June 2012, but new mothers are still eligible for vaccine; most states stopping entirely  BUT parents/g’parents can still PAY for vaccination

25 Potential source of pertussis transmission to infants – who? StudyNo. of Identified pertussis contacts Coughing contacts (identified in ~50% of cases) 1–5 MotherFatherGrandparentSiblingOther* USA 1 26432%15%8%20%26% Australia 2 7240%11%4%22%4% Australia 3 3126% --- Australia 4 8615%9%21%*36%19% Multi- centre 5 4441%21%6%16%22% NCIRS review 6 12–50%10–26%4–8%16–45%- 1. Bisgard et al. Pediatr Infect Dis J 2004; 23: 985–98; 2. Elliot et al. Pediatr Infect Dis J, 2004; 23: 246–52; 3. Chuk et al. Commun Dis Intell 2008; 32: 449–56; 4. Jardine et al. Commun Dis Intell 2010; 34: 116–21; 5. Wendelboe et al. Pediatr Infect Dis J 2007; 26: 293–9; 6. Wiley. Presentation at NCIRS Pertussis workshop 25 August 2011, Sydney, Australia Parents and siblings were common sources of infection (Mother > Sibling, Father) *Groups includes aunts and uncles NCIRS, National Centre for Immunisation Research and Surveillance

26 The Cocoon Effectiveness Study: Australia  Matched case-control study (1:3 ratio)  Telephone Survey (CATI): Size of ‘cocoon’ Frequency of care (if non-household carer) Pertussis vaccination status Childcare attendance, demographics, illness- associated costs  Statistical analysis (Odds Ratio & Vaccine Effectiveness) estimates effect of cocoon on risk of infant pertussis disease NCIRS + NSW Health Peter McIntyre, Helen Quinn, Clayton Chiu, Andrew Habig, Paula Spokes

27 Infant Pertussis: Direct Protection  Passive (transplacental) or active (immunisation)  Accelerate the first dose to 6/52: USA study: reduced infant deaths / hospitalisations 9% Plus: improve on-time administration of 3 doses* Aus estimate: accel’n to 6 weeks reduces notific’ns & hosp’ns by 8-9% ( Foxwell et al PIDJ 2011)  Pertussis vaccination from 20 weeks of pregnancy Protect until 1 0 series complete in infant McIntyre and Wood: Pertussis Prevention in early infancy. Current Opinion in Infectious Diseases. 2009; 22; 215-223

28 Pertussis vaccination pregnancy: Pros  Mother protected from 20 weeks of pregnancy  Covers infants before start of 1 0 series: highest incidence disease first weeks of life  Vaccine highly immunogenic in adults 2-5x higher levels after first dose than in infants  Well tolerated in pregnancy  Recommended!

29 Pertussis vaccine in pregnancy: Cons  ?uptake / liability  Protection not perfect from passive maternal ab transfer Data from pre-vaccine era: transfer of natural abs Maternal abs wane after 6-8/52 of age Not detectable after 2-6/12 age Interfere with response to active immunisation, DTPa -Abs neutralise antigens in vaccine -Demonstrated with wP vaccine trials  Mum’s Abs wane after about 5 years, ?boost next pregnancy

30 USA: ACIP Conclusions 2012  Recommend vaccinating all contacts of infants  Nonetheless, cocoon insufficient national strategy to prevent infant pertussis  Recommendation for pregnancy immunisation ACIP Published 2012 Bridges CB, ACIP Recommended Adult Immunization Schedule: United States, 2012*Ann Intern Med. 2012;156:211-217. SLIDE BORROWED FROM Clark, Thomas. Centers for Disease Control and Prevention; NCIRS Pertussis Meeting; August 26, 2011

31 NCIRS RCT Study: aP vaccine to infants  Pa vaccine, measured ab levels up to 8/12 Earlier ab response in birth-dose group (As per studies from Italy and Germany)  Non significant difference at 7-8 months As per study from Germany Contrary Italy and USA: reduced abs in birth dose group -‘immune tolerance’  Reactogenicity: Sydney Birth dose -Nil fever >38C -Nil injection site reactions >10mm after birth Pa dose PIDJ 2010. Acellular Pertussis vaccine and 0 and 1 months induces antibody responses by 2 months” NCIRS study Wood et al

32 Australian dTpa booster recommendations The Australian Immunisation Handbook 9th edition recommends: Australian immunisation handbook, 9 th edition: (accessed June 2011) GroupRecommendation Pre-school (4 years)Booster dose of DTPa Adolescent (12–17 years) Second booster using the adolescent/adult formulation dTpa Adults (cocooning)A single booster dose provided that no documented dTpa booster dose has been previously received: Adults planning a pregnancy, or for both parents as soon as possible after delivery of an infant Adults working with young children (especially recommended for childcare workers) All healthcare workers Any adult expressing an interest in receiving a booster dose of dT vaccine should be encouraged to do so with dTpa vaccine

33 Pertussis: national public campaign  Public campaign: brochure Nov 2011:  Identify, protect, prevent??  Infant: keep people with a cough away from baby emphasise timeliness of 2, 4 and 6 months -Dose 1 can be given at 6 weeks Vaccine can fail to protect esp. before dose 2 -Clinicians / parents need to consider pertussis in respiratory infections  Older children / adolescents vaccine @ 3.5 yrs & high school: direct & indirect benefits Vaccinated kids can still get infection

34 Influenza  3 strains: pH1N1 Influenza A 2009 California: swine flu (now ‘seasonal’ flu) H3N2 Flu A : Victoria strain Flu B Wisconsin (likely 2 B strains in future)  2012 season increased numbers esp’ly H3N2 in Oz; also 2013 H3N2 surge in USA etc  More rain and colder so people remain more indoors  First line of defence: Hand-washing, masks, isolation, cough/sneeze etiquette, smile: don’t shake hands is my motto

35 Figure 3.5.2: Influenza notification rates, Australia, 2006 to 2007, and hospitalisation rates, 2005/2006 to 2006/2007,* by age group * * Notifications – diagnosis between January 2006 and December 2007 Hospitalisations – separation between July 2005 and June 2007

36 Who is at increased risk of complications from influenza infection? Older aged and Aboriginal and Torres Strait Islanders Individuals aged ≥ 65 years Aboriginal and Torres Strait Islanders ≥ 15 years of age Ref: NHMRC. Influenza. The Australian Immunisation Handbook 9 th Edition. 2008

37 Influenza: High-risk groups  Funded vaccines also available for: Chronically ill: comorbidities -Respiratory / cardiac / renal / diabetes (metabolic) / neurological/ hepatic/ immune deficiency -Asthma?? Pregnant women -(particularly badly affected by swine flu pandemic)

38 Influenza Vaccine  Fever & seizures in children CSL Fluvax® 2010 processing error during manufacture? Excess RNA/short gene fragments; insufficient splitting.. Excessive immune response  Fluvax® no longer recommended for < 5 yr olds Safe for older children and adults  Other flu vaccines safe: data - Australia/ NZ/ OS

39 Horvath Review 10/ 2010 (former CMO) Of Public Health response to the adverse events to Fluvax Australian system similar to passive AE surveillance systems in comparable countries Able to detect safety signal with 2010 vaccine take appropriate action Reporting of adverse events could be more timely$File/adverse- event-march-2011.pdf

40 Monovalent H1N1 vaccine delay  A/California/09/2009 Detected in Apr 09  The monovalent pandemic H1N1 vaccine s  Now known as A(H1N1)pdm09 vaccines Available from late Sept 09 in small numbers 40

41 Impacts on influenza A(H1N1)pdm09 infection from cross-protection of seasonal trivalent influenza vaccines and A(H1N1)pdm09 vaccines: Systematic review and meta-analyses Yin JKYin JK, Chow MY, Khandaker G, King C, Richmond P, Heron L, Booy RChow MYKhandaker GKing C Richmond PHeron LBooy R Vaccine May 2012

42 Risk of H1N1 infection after : increased, decreased, no different Mexico (2) U.S. (1) Argentina (1) Australia (2) U.S. (5) UK (1) Argentina (1) Spain (1) New Zealand (1) Australia (3) 7 Europe countries (1) Hong Kong (1) Canada (2) seasonal influenza vaccination

43 Endpoints: 14 days after the vaccination 43 Laboratory-confirmed A(H1N1)pdm09 2009 illness Sickness absenteeism

44 Results  Confirmed illness 1 RCT (7,334 subjects): 38% (19 to 53%) protection 13 case-control studies 44 Cross-protection (CP) of TIV

45 TIV, case-controls studies: confirmed illness 45 Excluding studies with moderate or high risk of bias Cross-protection=34% (95% CI=9 to 52%), I 2 =91%

46 Bird Flu (H5N1 Influenza A) in 2013  Kills up to 60% of victims  Indonesia: our nearest neighbour.. Canoe ride away 200 + cases reached Overall >150 deaths in Indonesia (global total >350)  Currently no licensed vaccine… but progress underway and mock-ups are licensed

47 Indonesian bird markets on cusp of avian flu (H5N1) outbreak Saturday, 06 October 2012 06:00 NEW research has revealed an urgent need to improve biosecurity in live bird markets in Bali and Lombok to prevent future outbreaks of the Highly Pathogenic Avian Influenza (HPAI or H5N1) “The level of biosecurity practiced at markets is extremely low. In our field observations, we saw little segmentation of bird species and frequent mixing of birds in cages, including ducks, which may have no symptoms of HPAI, and chickens,” said Ms Kurscheid of Murdoch Uni

48 “In one market in Lombok we saw birds being slaughtered in the open, which is not good practice in terms of infectious disease control, as the main way humans have contracted HPAI is through slaughter of infected birds and handling of dead birds “Basically, all traders engaged in a number of practices that could sustain virus circulation in live bird markets.” Rotterdam Experiment a big worry

49 Science 2012; 336:1534-41 Airborne transmission of influenza A/H5N1 virus between ferrets Fouchier RA; 336:1534-41  Department of Virology, Rotterdam, The Netherlands  To address the concern that the virus could acquire transmission ability under natural conditions, we genetically modified A/H5N1 virus by site-directed mutagenesis and subsequent serial passage in ferrets. The virus acquired mutations ultimately becoming airborne transmissible in ferrets..  Risk for human pandemic influenza

50 Not as bad as we thought…  None of the recipient ferrets died after airborne infection with the mutant A/H5N1 viruses  Four amino acid substitutions in the host receptor-binding protein hemagglutinin, and one in the polymerase complex protein basic polymerase 2, were consistently present in airborne-transmitted viruses  The transmissible viruses were sensitive to the antiviral drug oseltamivir and reacted well with antisera raised against H5 influenza vaccine strains

51 Rotavirus: Impact of Immunisation  500K death annually esp. Dev. World  Causes gastroenteritis (GE)  First vaccine: Rotashield : Used in USA late 90s Caused 10-20 cases intussusception / 100,000 doses Withdrawn: safety paramount.. A good lesson  Rotateq: pentavalent: Bovine-Human strains  Rotarix: monovalent: human strain only IDSA conference 2010

52 Rotarix and Rotateq  Rix RV1 and Tec RV5: no intussusception in 60-70k children: pre-registration safety studies 85-98% effective against severe disease cross-protection to many strains  Rix RV1 reduced: all cause gastro 78% (richer countries) hospitalisation 84%-86% for certain common genotypes  Ecological data from Mexico: reduces all cause mortality but confounders e.g. better IV rehydration IDSA conference 2010 Ruiz-Palacios G, Pérez-Schael I, Velázquez F, H HA, Breuer T et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. New England Journal of Medicine 2006;354(1):11-22. Vesikari T, Matson D, Dennehy P, Damme PV et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. New England Journal of Medicine 2006;354(1):23- 33.

53 Australian burden and efficacy  Prior to vaccine, almost every child infected by age 5 yrs -10,000 children < 5 hospitalised annually -One childhood death each year  Rotavirus vaccine introduced into NIP 2007 ->70% decrease in rotavirus p.a. hospitalisations <5 years -34%↓ in “non-rotavirus” hospitalisations in <5 year olds Reduction too in the 5 -19 year age group: herd immunity effect$File/intussusception-provider.pdf Macartney KK, Porwal M, Dalton D, Cripps T et al Decline in rotavirus hospitalisations following introduction of Australia’s national rotavirus immunisation programme. J Paediatr Child Health 2011 Lambert SB, Faux CE, Hall L, Birrell FA et al. Early evidence for direct and indirect effects of the infant rotavirus vaccine program in Queensland. Med J Aust 2009; 191: 157-160. Dey, A. WSPID conference presentation 2011

54 © 2011 Lippincott Williams & Wilkins, Inc.2 SUMMARY DATA Reduction in rotavirus-associated acute gastroenteritis following introduction of rotavirus vaccine into australia's national childhood vaccine schedule Buttery JP; Lambert SB; Grimwood K; Nissen MD; Field EJ; MacArtney KK; Akikusa JD; Kelly JJ; Kirkwood CD Pediatric Infectious Disease Journal. 30 (SUPPL. 1) (pp S25-S29), 2011. Date of Publication: January 2011. FIGURE 1. Rotavirus positive fecal samples 2001-2009. A, Westmead Children's Hospital, New South Wales. B, Royal Children's Hospital, Victoria. C, Queensland Health, Queensland. Pre-vaccine 2001-6 Post-vaccine 2007-9

55 Rotavirus vaccine & intussusception  Intussusception: telescoping of bowel segment into itself  gut obstruction, 1/3 require surgery, v few die Annual incidence < 12m in Australia 80/100,000  Pre-registration safety studies cannot detect rare events  In Australia two post-marketing studies Paediatric Enhanced Disease Surveillance (PAEDS) hospital- based network Australian Paediatric Surveillance Unit (APSU) IDSA conference 2010

56 Intussusception following rotavirus vaccine administration: post-marketing surveillance in the National Immunization Program in Australia Buttery JP, et al Vaccine. 2011;29:3061-6 Post-marketing surveillance for intussusception following vaccination commenced with funding of RotaTeq(®) and Rotarix(®) vaccines under the National Immunization Program (NIP) in July 2007 Two active surveillance mechanisms (hospital-based case ascertainment and monthly reports from paediatricians) Linkage to vaccination records identified cases occurring within 1-7 and 1-21 days of rotavirus vaccination. Expected cases within the post-vaccination windows were calculated by applying rates of intussusception from national hospitalisation data over 6 years (mid-2000 to mid-2006), by age and state, to numbers vaccinated (by dose) according to the Australian Childhood Immunization Register

57 No evidence of an increased risk of intussusception overall following vaccination for either vaccine H owever, in infants 1 to <3 months of age, there was some evidence of excess intussusception cases 1-7 days following dose 1 (1-7 days) RotaTeq(®) RR=5.3, 95% CI 1.1,15.4 Rotarix(®) RR=3.5, 95% CI 0.7,10.1  Although we found no overall increase in intussusception following receipt of rotavirus vaccine, there was some evidence of an elevated risk following the 1st dose of both vaccines and also to a lesser extent after the 2 nd dose  Larger population-based studies using linked databases are soon to be published to provide more definitive evidence

58 Rotavirus Vaccine: safe and effective  WHO, USA ACIP and ATAGI: benefits greatly outweigh risks found to date  Avoid giving to baby with Hx of intussusception  Parents to be alerted to symptoms of intussusception  ATAGI: No preference for which vaccine Further surveillance ongoing  Ongoing surveillance to check if a strain not covered by vaccine emerges -cnt

59 Age limits for dosing of oral rotavirus vaccines Doses Age of routine oral administ ration Age limits for dosing Minimum interval between doses 1st dose 2nd dose 3rd dose Rotarix2 oral doses (1.5 mL) 2 and 4 months 6–14 weeks 10–24 weeks None4 weeks RotaTeq3 oral doses (2 mL) 2, 4 and 6 months 6–12 weeks 10–32 weeks 14–32 weeks 4 weeks

60 HPV Types More than 100 types of HPV identified in humans 1 More than 40 types infect the ano-genital mucosa 1  –High risk HPV types (eg 16, 18)  –Responsible for majority of high grade pre- cancerous lesions and virtually all cervical cancers 2,3  –Sufficient evidence for causality of HPV 16 in following cancers: Vulva & vagina Anus Penile Oropharynx 4 , HPV 85% anal cancers, 50% penile, 70% vaginal, 40% vulvar 1. Schiffman et aI, 2003. 2. Wallboomers et al, 1999. 3. Clifford et al, 2003. 4. International Agency for Research on Cancer, 2007.

61 HPV vaccines  HPV: DNA virus Cumulative lifetime risk of infection 80% Genital skin to skin contact = mode of transmission 10% do not clear infection -oncogenes integrate into host epithelial cells DNA -Epithelial carcinomas thus arise  Gardasil: 4 valent HPV vaccine Serotypes 6,11: anogenital warts Serotypes 16,18: mucosal cancer  Cervarix: bivalent HPV vaccine 16 & 18 Both have some cross protection against other serotypes

62 Anal cancers in Australia by sex, 1982-2005 J Fin et al 2011 Ladies in Red

63 Oropharyngeal cancers in Australia,by sex and HPV association, 1982-2005 Hocking J, et al. Br J Cancer 2011 A HPV related B smoking related

64 HPV Vaccine Programme  Australia 1 st country national programme: 2007 School programme 12-13 year old females; males 2013 (Time-limited catch up: schools & GPs) Licensed to age 26 in MALES age 45 years in females  2007-2012 Over 1,000,000 doses 79% eligible cohort: one dose 68% eligible cohort fully vaccinated  Barriers: Anti-vaccination: philosophical beliefs Social disadvantage; English as second language Vicky Sheppard, Director of Western Sydney Public Health: Bug Breakfast presentation

65 HPV vaccine safety  AE reports same level as infant combination vaccines 0.06% of doses Most common: injection site reaction Occasional mass hysteria / anxiety symptoms -Avoided after measures taken to avert in subsequent doses –E.g. one child/teenager in room at a time

66 MJA 2011 ( Skinner U Syd)  Fear was promoted by witnessing: the fear reactions of peers; perceived judgement by peers; lack of information or misinformation; and being vaccinated later in the day.  Fear was moderated by procedural factors, the support of peers, appropriate knowledge, and nurses’ distraction techniques or approach. Fear also affected acceptance of HPV vaccination.  Conclusions: Fear of HPV vaccination was a near universal experience among adolescents in the school setting and was often associated with significant distress that had an adverse impact on the vaccination process

67 GARDASIL Safety  Pregnancy & Lactation 1  Category B2 - Not recommended for use in pregnancy  In clinical trials, 3,620 women reported at least one pregnancy  Proportion of pregnancies with adverse outcomes were analysed  No evidence to suggest that GARDASIL adversely affects pregnancy outcomes  May be administered to lactating women  Adverse Events 1 In clinical trials, adverse events included:  Mostly mild to moderate injection site reactions including pain, swelling, erythema Fever.

68 Study based on 112,083 new patients – 9867 (9%) had genital warts (2004 to 2009) Study in 8 Australian Sexual Health Centres pre / post HPV vaccine programme

69  Findings comparing pre and post 2007: ↓ genital warts up to 73% in young women Herd effect: 35% decline in heterosexual men -Esp men < 26 years (partners of vacc’d women) No effect in MSM Donovan et al Lancet Inf Dis 2011 ; 2012

70 Govt Announcement July 2012 GARDASIL Males NIP Listing The Australian Government has announced the extension of GARDASIL on the National Immunisation Program (NIP) to include males The proposed NIP listing includes an ongoing program for males 12-13 years of age (similar to current female program) and a catch – up program over 2 years for Year 9 males

71 Are males funded on any other programs in any other markets? The United States’ Advisory Committee on Immunisation Practice (ACIP) has approved a routine recommendation for vaccination of males 12-21. This recommendation includes funding for males, however, there is not an organised program Similarly in Canada, its National Advisory Committee on Immunization has issued a recommendation for all males 9-26. However, no province in Canada has started

72 Measles

73 measles virus circulated in Sydney last year  Clinical presentation: Prodrome lasts 2-4 days, characterised by fever and malaise followed by conjunctivitis, cough, cough, occasionally Koplik’s spots Maculopapular non-itchy rash appears 2-7 days after prodrome onset; begins on face Infectious from beginning of prodromal period and up to 4 days after the rash appears

74 Measles- – 30% of reported measles cases have one or more complications, diarrhoea (8%), otitis media (7%), pneumonia (6%), seizures (0.7%), encephalitis (0.1%), subacute sclerosing panencephalitis (now rare) – Infection in pregnancy can be severe for the woman and can result in increased risk of premature labour or spontaneous abortion

75 Prevent transmission in General Practice  General practitioners are often the first point of contact for cases and therefore must take precautions to prevent further spread Possible cases (patients presenting with fever rash, cough, coryza or conjunctivitis) should be shown immediately to a separate room and not left to wait in the general waiting room to prevent transmission of measles to other patients. Provide patient with a mask

76 , Last updated on: 31July 2012. Measles notifications in NSW residents, by month of disease onset. January 2008 to July 2012 Last updated on: 31 July 2012. Measles notifications in NSW residents, by five year age group and sex. 01Aug2011 - 31Jul2012 Sex0-4 yrs5-9 yrs10-14 y15-19 yrs20-24 yrs25-29 yrs30-34 yrs35-39 yrs40-44 yrs45-49 yrs Males8018554110 Females11259005310 Persons192617559420

77 Measles Outbreak Alert Were you born after 1965? Have you received two doses of MMR? (Measles/Mumps/Rubella) You could get measles! Yes Don’t Know/Maybe/No Ask your GP today if you need another MMR Make sure your kids are up to date with their immunisations too

78 Measles The second dose of MMR can be given as early as 4 weeks (28 days) after the first dose and be counted as a valid dose if both doses were given after the child's first birthday The second dose is not a booster, but intended to produce immunity in the small number of people who fail to respond to the first dose

79 Measles  Where no documentation is available, give your patient 2 doses of MMR at least 4 weeks apart There is no harm in giving MMR to a person who may already be immune to one or more of the vaccine viruses



82 Measles complications  Pre-vaccine: major epidemics every 2 years Morbidity: 1/15 people have complications Mortality: 1/1,000 die  1966–75: 146 deaths in Australia 1 in 22 admissions: encephalitis  1962–71: Fairfield Hospital Melbourne: 3660 hospital admissions 85 cases encephalitis 1972-85: 16 cases encephalitis 1985 onwards: 0 cases encephalitis$FILE/cdi3302k. pdf Tobin S, Kelly H. Measles encephalitis in Victoria, 1962-96: down but not out. Aust N Z J Public Health 1999; 23: 443-

83 Measles Vaccine Licenced 1968  1975 in NIP 1976-1985 slow uptake but mortality halved  1993-1994: large epidemic > 10 000 cases Second dose introduced adolescents 1993 Moved to age 4 years 1998; now 18 months NHMRC recommend all adults have 2 doses$FILE/cdi3302k.pdf

84 Measles 2002 sero-survey  93.9% of Australians immune Lower: -Those < 4 years: not completed second dose -Born 1978-82 missed out on catch-up program  Need > 90% people to be immune to avert epidemics

85 Australia: incidence ↓ since 1994 Since 2002: 0.5 – 6.0 cases per million population Reached WHO target for elimination <1 / 10 6 2005/07 Other years: cases imported / linked to imported cases Genotyping: no endemic strains in Australia  Young adult travellers major source of imported infection MMR vaccine recommended for international travel for those born after 1965 without 2 doses of measles vaccine


87 MMR-V  New combination vaccine MMRV for children aged 18 months to be added to NIP Schedule 1 July 2013 replaces “individual” doses -MMR vaccine (currently for 4 year olds) -chickenpox vaccine (currently for 18 month olds)  Total number of injections reduced by one  Improved MMR protection 2-3 years earlier

88 WHO report European measles outbreak  26,000 cases in 36 European countries 2011  England & Wales almost 1,000 c.f. 374 in 2010 HPA UK: ‘associated with recent travel abroad or small clusters in unvaccinated children / young adults aged 10-24yrs’  11 deaths first half of 2010 France 6 Germany, Kyrgyzstan, Romania, Macedonia, UK 1 each  Rebecca Martin, of WHO: "There's been a build-up of children who have not been immunized over the years. It's almost like a threshold. When you have enough people who have not been immunized, then outbreaks can occur.“

89 Court Rules Autism Not Caused by Childhood Vaccines Washington Post, 2009 Thousands of parents who claimed that childhood vaccines had caused their children to develop autism are wrong and not entitled to federal compensation, a special court ruled today in three decisions with far-reaching implications for a bitterly fought medical controversy. The vast majority of the scientific establishment, backed by federal health agencies, has strenuously argued there is no link between vaccines and autism, and warned that scaring parents away from vaccinating their youngsters places children at risk for a host of serious childhood diseases.

90 Varicella  Varicella zoster vaccination @ 18 mths age from Nov ‘05  VZV vaccine prevents 85% of varicella 97% protection against moderate / severe disease 69%↓ hospitalisation rates in children aged 1.5 to 4yrs  Significant ↓ in congenital & neonatal varicella: due to herd immunity  1997-1999 data compared to 2006-09 CVS: 0.8 /100 000 live births p.a.  0.19/100 000: 2006-07 -0 cases: 2008-2009 Neonatal varicella: 5.8 / 100 000 live births p.a.  0.7/100 000 Khandaker G et al. Congenital and neonatal varicella: impact of the national varicella vaccination programme in Australia. Arch Dis Child 2011;96:453-456 Heywood, AE, et al. How can we better understand trends in varicella zoster virus related disease epidemiology? MJA Volume 194 Number 5 7 March 2011

91 SEVERE AND COMPLICATED CHILDHOOD VARICELLA: PAEDIATRIC ACTIVE ENHANCED DISEASE SURVEILLANCE (PAEDS) OF CHILDREN HOSPITALISED WITH VARICELLA IN AUSTRALIA Marshall H 1,2, Richmond P 3, Buttery J 4, 5, Royle J 4, Gold M 1,2, McIntyre P 6,7,8 Wood N 6,7,8, Elliott EJ, 6,8,9 Zurynski Y 8,9, Toi C 9 and Booy R 6,7 Data were collected prospectively over 3 years (01Aug2007 – 31July2010) children aged 1 month-15 years hospitalised at 4 tertiary paediatric hospitals Diagnosis, clinical features, complications and immunisation history were documented on a specific standardised questionnaire Varicella vesicles were swabbed for varicella genetic sub-typing

92 115 children hospitalised with varicella (n= 97) or zoster (n=18) enrolled, aged 1 month-15 years  Of the 46 (40%) children who were immunocompromised, only 6 were immunised (13%)  Of the immunocompetent children, just 6 of 32 (19%) eligible for varicella immunisation were immunised  Complicated varicella occurred in 43% of children hospitalised with 67 individual complications reported, most commonly secondary skin infections (n=25) and seizures (n= 8)  Three immunocompetent children were admitted to a Paediatric Intensive Care Unit and developed severe multiple complications.  All strains genotyped were wild type varicella, with Clade 1 (European origin) predominating

93 Shingles  Lifetime risk of zoster 20-90%  13 -26% develop complications Post Herpetic Neuralgia Keratitis / chorioretinitis Bacterial infection Rare: liver / lung / CNS

94 Shingles Vaccination  Clinical trials: zoster vaccination reduced: zoster by 51.3% PHN by 66.5% Burden of illness by 61.1% More effective in 60-70 years c.f. 70+ yrs  Safe & well-tolerated among adults ≥50 years of age Local reactions including local vesicles

95 Shingles Vaccination Immunisation Guidelines  One dose live attenuated zoster vaccine: from 60 yrs Higher potency than childhood vaccine  Catch-up dose for all aged 61 to < 80 yrs  Not yet on NIP  Vaccine supply issue - manufacturer

96 Pneumococcal Vaccination  Bacterium Streptococcus pneumoniae  Colonises upper respiratory tract of healthy: esp’ly kids  Spread: infected droplets in air and by touch  Diseases: middle ear and sinus infections pneumonia Invasive Pneumococcal Disease (IPD) -meningitis -septicaemia/bacteraemia -peritonitis -bone / joint

97 Pneumococcal Vaccine  7-valent pneumococcal vaccine (7vPCV, Prevenar®): NIP Indigenous children: 2001 (Good old Oz!)  All Australian children: Jan 2005  2002-2007: incidence IPD ↓ 74% in those < 2 years old 7vPCV serotypes ↓ Partially offset by non-7vPCV serotype ↑ 2007, 19A predominant serotype in IPD (37.7%) in children < 2 years age 19A notifications further increased 2008-09 Williams SR Changing epidemiology of invasive pneumococcal disease in Australian children after introduction of a 7- valent pneumococcal conjugate vaccine. MJA Volume 194 Number 3 7 February 2011

98 Serotypes: Blue = before Red = after 7v Vaccine serotypes 23v (not 7v) serotypes Non-vaccine serotypes

99 Pneumococcal Vaccination: Adults  Pneumovax 23®: 23-valent pneumococcal vaccine  2011: 7 severe local reactions: safety review  Revised recommendations by ATAGI: One dose of Pneumovax 23® @ 65 yrs age For non-Aboriginal ≥65 yrs, second dose ≥5 yrs after dose 1 ONLY if high-risk condition For Indigenous > 50yrs give 2 nd dose -Second dose aged 15 to 49 only if at high risk

100 High Risk Conditions  Asplenia  Impaired immunity, e.g. HIV / acute nephrotic syndrome/ blood and lymph cancers /BMT  Chronic heart / lung / kidney disease  Diabetes, alcohol-related problems  CSF leak

101 Pneumococcal vaccination: children  From 1 July 2011, Prevenar 13® (13 valent) replaced Prevenar® (7 valent) vaccine Every jurisdiction except NT 1 October 2011 NT replaced Synflorix® (10-valent) with Prevenar 13®  Prevenar 13®: additional 6 serotypes, which cause IPD Includes increasingly predominant serotype 19A

102 Pneumococcal vaccination: children  What to do with Children who’ve had 1 or 2 doses of Prevenar® (7v) or Synflorix® (10v)?  merely complete 3-dose course with Prevenar 13® 1 Oct 2011 - 30 Sep 2012: children 12 -35m who completed primary course Prevenar® eligible for free supplementary dose of Prevenar 13®  Prevenar 13® at 2, 4, 6 months of age 4th dose to high-risk risk children at 12m High-risk children should also receive dose of Pneumovax 23® between 4 - 5 yrs

103 What’s even newer in pneumococcal disease prevention?  June 20, 2012  An advisory committee to the US Centers for Disease Control and Prevention (CDC) recommended adding  13-valent pneumococcal conjugate vaccine (PCV13) to 23-valent pneumococcal polysaccharide vaccine (PPSV23) for adults with immunocompromising conditions

104 Poliomyelitis  Polioviruses are enteroviruses Enter body through GIT, tropic for CNS 3 types cause poliomyelitis  In Australia, incidence peaked 1938: 39.1/100 000 Last 2 notified cases imported from Turkey 1977 2 oral vaccine-associated cases 1986 & 1995 inactivated poliomyelitis vaccine (IPV) since 2007 -Can not cause vaccine-associated paralytic poliomyelitis (VAPP): -1 in 2.4 million doses OPV /

105 WHO Global Polio Initiative  1988 resolution: worldwide eradication of polio  High immunization coverage: 4 doses OPV by 12 mths  Supplementary doses of OPV to all <5yrs of age  Surveillance for wild poliovirus test all acute flaccid paralysis (AFP) cases < 15yrs  Targeted “mop-up” campaigns in specific focal areas  Hurrah! India eliminates in 2012

106 Decline in Polio  1988: 350 000 cases; endemic in 125 countries  2010: 1349 cases  In 2011: Afghanistan, India, Nigeria, Pakistan “polio-endemic” Jan 13 2011 last case of polio recorded in India -Status: ‘Polio free’: Require min. 3 years no wild-type polio cases  All countries are at risk of polio importation 2009-2010, 23 previously polio-free countries re-infected due to polio imports

107 Immunisations and Family Tax Benefits  Meningococcal C, pneumococcal, varicella vaccines currently on NIP schedule will be added to the list required for children to be assessed as ‘fully immunised’ for payments to families / immunisation providers from July 2012  Vaccines encouraged but not required for family payments: the rotavirus vaccine vaccines free to ATSI / those at high risk: -influenza -hepatitis A -booster doses (e.g. pneumococcal)

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