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Immunization Potpourri 2010 Peter N. Wenger, MD Departments of Preventive Medicine and Community Health/Pediatrics UMDNJ-New Jersey Medical School Newark, NJ Pandemic Influenza A Virus H1N1 2009 aka Swine Flu, Novel Influenza A H1N1, Swine-Origin Influenza A Virus H1N1, The Pandemic, End of Life as we Know It Flu CDC Estimates of 2009 H1N1 Cases from April 2009 – March 13, 2010, By Age Group 2009 H1N1 Cases Mid-Level Range Estimated Range 0-17 years ~19 million ~14 million to ~28 million 18-64 years ~35 million ~25 million to ~51 million 65 years and older ~6 million ~4 million to ~9 million Cases Total ~60 million ~43 million to ~88 million http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm #Table%20Cumulative CDC Estimates of 2009 H1N1 Related Hospitalizations from April 2009 – March 13, 2010, By Age Group Hospitalizations Mid-Level Range Estimated Range 0-17 years ~86,000 ~61K to ~127K 18-64 years ~158,000 ~112K to ~232K 65 years and older ~26,000 ~19K to ~39K Hospitalizations Total ~270,000 ~192K to ~398K http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm #Table%20Cumulative CDC Estimates of 2009 H1N1 Related Mortality from April 2009 – March 13, 2010, By Age Group Deaths Mid-Level Range Estimated Range 0-17 years ~1,270 ~900 to ~1,870 18-64 years ~9,420 ~6,700 to ~13,860 65 years and older ~1,580 ~1,120 to ~2,320 Deaths Total ~12,270 ~8,720 to ~18,050 http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm #Table%20Cumulative Percentage of Visits for Influenza-like Illness (ILI) Reported by the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet) National Summary 2008-2009 and Previous Two Seasons Through the week Ending May 22, 2010 http://www.cdc.gov/h1n1flu/updates/us/ National H1N1 Flu Survey* Week of December 6-12, 2009 ~46 million people (15.3%) vaccinated vs 2009 pandemic influenza A virus H1N1 • 28 million adults (13.0%) • 18 million children (24.0%) Amount of vaccine distributed to providers • ~21% of US population 3 of 4 shipped doses administered • 74% of vaccine went to people in initial target groups 42% of all vaccine given to children • 23% of vaccine doses given were nasal spray *http://www.cdc.gov/h1n1flu/in_the_news/influenza_vaccination.htm Pandemic Influenza A (H1N1) 2009 Monovalent Vaccination Coverage, New Jersey, October 2009 – January 2010* Children aged 6 months to 17 years • 32.7% (95% CI, + 4.6) Persons aged ≥18 years • 13.1% (95% CI, + 2.0) Persons in initial target groups • 29.0% (95% CI, + 4.5) Persons aged 25-64 years at high risk • 17% (95% CI, + 5.8) Persons aged 25-64 years not included in the initial target groups • 9.5% (95% CI, + 2.4) Persons aged ≥ 65 years • 12.2% (95% CI, + 3.7) *CDC. MMWR April 2, 2010. 59;12:363-68 Influenza Vaccine Development http://www.ifpma.org/Influenza/index.aspx?000_The_Influenza_Virus/001a_Influenza_Virus.html Influenza Strategy to Escape Immune Detection Drift • Minor change in HA glycoprotein Gradual accumulation of amino acid changes Mutations in viral RNA • Occurs continuously Shift • Major change in HA glycoprotein Reassortment (Reassortant) • Exchange of gene segments Direct transmission from a different species to humans without reassortment • 1918? • 1997 – 2005 Hong Kong; Netherlands; Canada; South Asia; New York • Occurs infrequently ~ 33 years Cox NJ, Subbarao K. Lancet. 1999;354:1277–82. Genetic Reassortment To Generate Vaccine Strains Master strain high-growth potential in eggs or cell culture PB1 PB2 PA HA NA NP M NS Circulating wild-type strain Co-infect cells From Master strain PB1 PB2 PA HA NA NP M NS PB1 PB2 PA HA NA NP M NS From wild-type strain New high-growth reassortant vaccine strain Currently Available Influenza Vaccines Trivalent Inactivated Vaccine (TIV) Live Attenuated Influenza Vaccine (LAIV) FDA-approved Since 1960s Since 2003 Route of administration Intramuscular Intranasal Primarily humoral Mucosal and humoral Split-virus or subunit inactivated virus (HA) Cold-adapted, temperature-sensitive, live attenuated virus Chick embryos Chick embryos Persons 6 months Healthy persons 2–49 years Immunity Virus Growth Medium Indication Ruben FL. Clin Infect Dis. 2004;38:689-91. cdc.gov/nip/publications/pink/flu.pdf. Considerations Include strain that closely match community circulating strains • May differ in different regions Dose considerations • Induces protective immune response in individuals Age-dependent • <6 months: inadequate response • Older individuals: less robust response • Hemagglutinin antigen (HA) 15 µg in those ≥3 years of age 7.5 µg in those 6 - 35 months of age • Vaccine-naïve children, 6 months through 8 years of age require a priming dose Priming dose for pandemic (novel) strains? • Maximizing population coverage • Minimizing adverse reactions Timeline for Vaccine Development Reflect the need to produce and administer vaccine before and during each influenza season • Global surveillance Year round in both hemispheres • Trends in viral antigenic changes Collection, analysis, and assessment of circulating strains for selection of appropriate vaccine strains • Timing is everything! Too early – significant antigenic changes may be missed Too late – vaccine output may be affected World Health Organization (WHO) Global Influenza Surveillance System ● Established in 1948 • 130 national influenza centers in 101 countries • Analyzed by 4 WHO Collaborating Centers for Reference and Research on Influenza CDC; Atlanta, GA, US National Institute on Medical Research; London, UK Victoria Infectious Diseases Reference Laboratory; Melbourne, Australia National Institute for Infectious Diseases; Tokyo, Japan • US Food and Drug Administration (FDA) determines viral components of US-licensed vaccines Timeline for Vaccine Development From selection to consumer release of trivalent influenza virus vaccine • Six to eight months Preparation of each reassortant viral component • Development of high-growth reassortants Capable of high growth in eggs/cell cultures • Purification Solvents Unnecessary viral antigens Bacteria Standardization and testing of HA components • Development of appropriate reagents Safety and efficacy testing Production of trivalent vaccine • Purification • Mass production Regulatory Issues • Monovalent pandemic vaccine Four to six months Production of Influenza Vaccines for Pandemics or Pandemic Alerts 1957 - 1998 Wood, JM. Developing vaccines against pandemic influenza. Phil. Trans. R. Soc. Lond. 2001;356:1953-60. To Prime or Not To Prime Minimum Immunogenic Dose of H1N1, H2N2, and H5N3 Vaccines Data from many clinical trials from 1976 to 1999 Wood, JM. Developing vaccines against pandemic influenza. Phil. Trans. R. Soc. Lond. 2001;356:1953-60. 2010 – 2011 Influenza Vaccine And the winners are…….. A/California/7/2009(H1N1)-like virus A/Perth/16/2009 (H3N2)-like virus B/Brisbane/60/2008-like virus New Recommendation February 24, 2010 • Advisory Committee on Immunization Practices (ACIP) Universal immunization for all persons ≥6 months of age • Published in the MMWR August 6, 2010 Volume 59; RR-08 New Recommendation June 24, 2010 • All children aged 6 months through 8 years of age who did not receive at least 1 dose of the monovalent 2009 Influenza A H1N1 vaccine: Receive 2 doses of the 2010-11 seasonal influenza vaccine regardless of their previous vaccination history High-Dose Inactivated Influenza Vaccine for Persons Aged ≥65 Years* 12/23/2009 • FDA licensed an injectable inactivated trivalent influenza vaccine containing an increased amount of viral hemagglutinin antigen compared with other TIVs • Single dose for persons aged ≥65 years Rationale • Greater risk of hospitalization and mortality from influenza • Less immunogenic response 04/30/2010 • Advisory Committee on Immunization Practices (ACIP) No preference for new vaccine over other TIVs *CDC. MMWR. Licensure of a high-dose inactivated influenza vaccine for persons aged ≥65 years and guidance for use-US 2010. 04/30/2010;59(16);485-86. New Jersey Attendance at pre-Kindergarten and daycare centers • Mandatory annual influenza immunization For those 6 months through 8 years of age • Naïve 2 doses Administered at least 4 weeks apart Estimates of Death Associated with Seasonal Influenza, United States, 1976-2007* Annual estimates of influenzaassociated deaths • Death certificate data Respiratory and circulatory causes (includes pneumonia and influenza causes) • Estimated annual average: 23, 607 (range,3,349 [1986-87] to 48,614 [2003-04]) • Average: 9.0 per 100,000 persons (range,1.4 to 16.7) *CDC. Estimates of deaths associated with seasonal influenza, US. 1976-2007. MMWR August 27, 2010;59(33):1057-62. Estimates of Death Associated with Seasonal Influenza, United States, 1976-2007* Age-specfic estimates • <19 years of age Estimated annual average: 124 (range, 57 [1981-82] to 197 [1977-78]) Rate: 0.2 deaths per 100,000 (range, 0.1-0.3) • 19-64 years of age Estimated annual average: 2,385 (range, 504 [198182] to 4,752 [2003-04]) Rate: 1.5 per 100,000 persons (range, 0.4-3.1) • ≥65 years of age Estimated annual average: 21,098 (range, 2,344 [1986-87] to 43,727 [2004-04] Rate: 66.1 per 100,000 persons (range, 8.0 – 121.1) 89.4% of influenza-associated mortality *CDC. Estimates of deaths associated with seasonal influenza, US. 1976-2007. MMWR August 27, 2010;59(33):1057-62. Estimates of Death Associated with Seasonal Influenza, United States, 1976-2007* Wide variation in the estimated mortality from season to season associated with predominant influenza type and subtypes • ≥20% of all isolates tested during season • Influenza A(H3N2) 2.7 times higher 22 seasons *CDC. Estimates of deaths associated with seasonal influenza, US. 1976-2007. MMWR August 27, 2010;59(33):1057-62. Estimates of Death Associated with Seasonal Influenza, United States, 1976-2007* Substantial variability in influenzaassociated mortality estimates • Year (season to season) • Age group • Influenza type/subtype A single estimate cannot be used to summarize influenza-associated mortality • A range of estimates should be used Age groups Circulating types/subtypes *CDC. Estimates of deaths associated with seasonal influenza, US. 1976-2007. MMWR August 27, 2010;59(33):1057-62. Intradermal Influenza Vaccine Sanofi Aventis submitted FDA application for approval • Becton Dickinson Short, thin needle • 1/10th size of regularly used needle 1.5 mm vs 25 to 40 mm • 1/5th antigen dose Stimulates the dendritic cells • • • • Extends vaccine supply Less discomfort Less expensive? Approval in early 2011? 13-valent Pneumococcal Conjugate Vaccine (PCV13) Transition from PCV7 to PCV 13 Since introduction of PCV7 in 2000 • Dramatic overall decrease in invasive pneumococcal disease (IPD) IPD due to serotypes not included in PCV7 have increased February 24, 2010 • FDA approved a new 13-valent pneumococcal conjugate vaccine (PCV13) • ACIP recommended transition from PCV7 to PCV 13 Pneumococcal Serotypes in PCV7 and PCV 13 Invasive Pneumococcal Disease (IPD) in Newark Residents* December 1, 2007 – November 30, 2008 2/72 (2.8%) were serotypes included in the PCV7 • Reflected success of PCV7 in decreasing IPD due to vaccine serotypes 32/72 (44.4%) were covered by PCV13 • Serotypes 3 (6), 6A (3), and 19A (19) Serotype 19A was dominant • 19/72 (26.4%) • Serotype 19A was most closely associated with penicillin-resistance • Consistent with trends reported in US • A significantly higher proportion was found in children compared with adults and the elderly *Tasslimi A, et al. Clinical and Vaccine Immunology. August 2009. 16;8:1256 Pneumococcal Immunization with PCV13 Advisory Committee on Immunization Practices (ACIP) Recommendations Infants and children under 2 years of age • 4-dose regimen • 2, 4, 6, and 12-15 months Older children and adolescents • Healthy between 2nd and 5th birthdays Not completed PCV7 or PCV13 series before age 2 • 1 dose • Children at high risk between 2nd and 6th birthday Received 3 doses of PCV7/PCV13 before 2 years • 1 dose Received ≤2 doses of PCV7/PCV13 before 2 years • 2 doses • Children and adolescents at high risk 6 through 18 years 1 dose Even if previous recipient of PCV7 or PPSV23 • Children who have completed the 4-dose series with PCV7 and are healthy and <5 years or at high risk and <6 years 1 dose Risk Factors for Invasive Pneumococcal Disease Sickle cell disease Functional or anatomical asplenia Cochlear implants CSF leaks Diabetes Chronic heart and lung disease Immunocompromised conditions • HIV infection and congenital immunodeficiencies • Chronic renal failure and nephrotic syndrome • Diseases associated with treatment with immunosuppressive medications or radiation therapy Solid organ transplantation Lymphomas, leukemias, malignant neoplasms Asthma if treated with prolonged, high-dose oral corticosteroids Mumps Outbreak New York and New Jersey 2009-2010 Mumps RNA virus Systemic disease • Swelling of ≥1 salivary glands Parotids • ~1/3 of patients do not demonstrate salivary gland swelling Respiratory tract symptoms • >50% of patients have CSF pleocytosis • <10% have CNS symptomology Mumps Mumps Systemic Disease (continued) • Orchitis Post-pubertal complication • Sterility is rare • Rare complications Arthritis, thyroiditis, mastitis, glomerularnephritis, myocarditis, endocardial fibroelastosis, pancreatitis, oophoritis, hearing impairment • Infections in adults more likely to be severe Death, though rare, occurs most often in adults • Infection in first trimester associated with increased risk of spontaneous abortion Mumps Epidemiology • Transmission via infected respiratory tract secretions • Incubation period 12–25 days (usually 16-18 days) • Period of maximum communicability 1 to 2 days prior to parotid swelling 5 days after onset of swelling • Virus has been isolated in salivia from 7 days prior to swelling onset to 9 days after onset of swelling • Reported incidence in US in 1967 186,000 Mumps Vaccine • Licensed in US in 1967 • Recommended for routine childhood immunization in 1977 One-dose schedule Disease incidence fell to very low levels • Outbreaks occurred between 1986-1991 • Two-dose schedule recommended in 1989 2000-2005: <300 reported cases/year 2006: Mumps outbreak: 6584 cases • 18-24 years of age • Many received 2 doses MMR • Mumps least effective component of MMR 73%-91% after 1 dose 79%-95% after 2 doses Mumps Immunization Advisory Committee on Immunization Practices (ACIP) Recommendations Two doses of mumps-containing vaccine (in US – MMR) • All school-aged children (K-12) 1st dose: 12-15 months 2nd dose: 4-6 years • Adults at high-risk for infection i.e., person who work in healthcare facilities, international travelers, students at post-high school educational institutions, etc.) • For healthcare workers born before 1957 without laboratory evidence of immunity Consider receiving 1 dose During outbreaks • Children aged 1-4 years Offer 2nd dose • Confirm 2-doses in others Mumps Outbreak New York and New Jersey 2009-2010* June 17, 2009: 11-year old boy returns from United Kingdom • ~7,400 reports of laboratory confirmed mumps in 2009 Symptomatic by June 28 • At camp for tradition-observant Jewish boys Subsequent transmission to other camp attendees and staff member 25 cases reported from June 28th–September 8th Transmission occurred in multiple locations when campers returned home • As of January 29, 2010: 1,521 cases reported *CDC. MMWR. Update: mumps outbreak-New York and New Jersey, June 2009-January 2010. February 12, 2010;59(5):125-29. Mumps Outbreak New York and New Jersey 2009-2010* Confined primarily to the traditionobservant Jewish community • New York City {Brooklyn} (44%); Orange County, NY (24%); Rockland County, NY (20%); Four counties in New Jersey (10%) • Camp-associated cases in Sullivan County, NY (2%) • <3% of cases occurring outside the community Reported regular contact with members of the affected community *CDC. MMWR. Update: mumps outbreak-New York and New Jersey, June 2009-January 2010. February 12, 2010;59(5):125-29. Mumps Outbreak New York and New Jersey 2009-2010* 61% of cases occurred in persons aged 718 years of age • 4.9% in children aged 1-4 years • Range, 3 months-90 years • 76% were male Among patients in which vaccination status was known (n=1,115) • 88% received at least 1 dose of mumpscontaining vaccine (MCV) • 75% received 2 doses of MCV *CDC. MMWR. Update: mumps outbreak-New York and New Jersey, June 2009-January 2010. February 12, 2010;59(5):125-29. Mumps Outbreak New York and New Jersey 2009-2010* Complications • 65 reports Orchitis: 55 cases (85%) Pancreatitis: 5 cases (8%) Aseptic meningitis: 2 cases (3%) Transient deafness: 1 case (1.5%) Bell’s palsy: 1 case (1.5%) Oophoritis: 1 case (1.5%) • 19 reported hospitalizations No deaths *CDC. MMWR. Update: mumps outbreak-New York and New Jersey, June 2009-January 2010. February 12, 2010;59(5):125-29. Mumps Outbreak New York and New Jersey 2009-2010* Mumps outbreak in a highly vaccinated population • Most cases occur in vaccinated people Why????? • Specific close-knit, closed community No sustained transmission outside the specific community • Congregate setting Prolonged close contact • Large household size Mean household size in the affected community was 5.7 versus mean US household size of 2.6 • Effectiveness of mumps component of MMR *CDC. MMWR. Update: mumps outbreak-New York and New Jersey, June 2009-January 2010. February 12, 2010;59(5):125-29. Mumps Outbreak New York and New Jersey 2009-2010* Public Health Response • Health-care providers notified Verify children are completely vaccinated • Offer 2nd dose in children aged 1-4 years Offer vaccine to adults • Unknown immunity or vaccine status • State and local health departments Affected schools • Enhance vaccination policies Exclude unvaccinated children from school during outbreak Home isolation for 5 days after onset of parotitis Orange County, New York beginning 01/19/2010 • 3rd dose of MMR in 3 schools Continued transmission of infection despite high level of 2-dose coverage Institutional Review Board-approval protocol that includes evaluation of intervention *CDC. MMWR. Update: mumps outbreak-New York and New Jersey, June 2009-January 2010. February 12, 2010;59(5):125-29. Rotavirus Vaccine Contamination Contamination of Rotavirus Vaccine March 22, 2010 • FDA recommends temporary suspension of use of Rotarix® (GlaxoSmithKline Biologicals) Porcine circovirus 1 (PCV1) DNA, particles, infectious virus are present in vaccine May 6, 2010 • Preliminary studies by Merck identified PCV1 and PCV2 DNA at low levels in Rotateq® (Merck & Co, Inc.) Porcine Circovirus (PCV) Types 1 and 2 Small viruses • Single strand of circular DNA • Commonly found in pigs PCV2 may cause disease in pigs • Neither PCV1 or PCV2 are known to infect or cause disease in humans FDA Recommendations May 14, 2010 It is appropriate for clinicians and healthcare professionals to resume the use of Rotarix® (GSK Biologicals) and to continue to use Rotateq® (Merck & Co, Inc.) Considerations • Strong safety records Clinical trials • Tens of thousands of participants Post-licensure clinical experience • Millions of recipients No evidence the PCV1 or PCV2 poses a safety risk to humans • Benefits of vaccination outweigh the risks which are theoretical Next Steps FDA and manufacturers are updating labeling for both vaccines to include information concerning presence of PCV1 and PCV2 Planning appropriate follow-up studies Continuing investigation into the findings of PCV in rotavirus vaccines • GSK plans to rederive its vaccine in consultation with the FDA • Merck is in early stages of its investigation and has not determined as yet its next steps in this regard Guillain-Barré Syndrome (GBS) and Conjugated Meningococcal Vaccine (MCV4) June 24, 2010 • Studies have not demonstrated an increased risk of GBS associated with the meningococcal vaccine • Removed precautionary warning from the sanofi pasteur MCV4 label Religious Exemptions* New Jersey • Eightfold increase since 2005-06 school year 3,865 student exemptions this school year New York • Double the amount seen in 1999 3,615 student exemptions in 2008 Connecticut • 455 student exemptions in 2009 versus 248 in 1999 *The Wall Street Journal. More parents seek vaccine exemption. July 6. 2010 Thank You For All you Do!!!