Immunization Update MAFP, Spring 2013

Transcription

1 Immunization Update MAFP, Spring 2013 Susan M. Lett, M.D., M.P.H. Medical Director, Immunization Program Division of Epidemiology and Immunization MDPH MDPH

2 Pertussis Outline Epidemiology Vaccination Recommendations Immunization Schedules Childhood, Adolescent Schedules Adult Schedule Contraindications and Precautions MDPH Updates Recommendations PCV13 for High Risk Children & Adults Flu MDPH

3 Pertussis Epidemiology Vaccine Recommendations MDPH

4 Changing Pertussis Epidemiology, U.S. Pertussis incidence has increased since the 1980s Immunity wanes after both disease and vaccination Resurgence of childhood disease, despite high DTaP coverage Excellent initial vaccine effectiveness Moderate and early waning of immunity Re-emergence of adolescent disease, despite Tdap Tdap boosts in DTaP recipients may more quickly Tdap VE study results to be available soon MDPH

5 Changing Pertussis Epidemiology, U.S., cont. Switch to ap vaccines is changing pertussis epidemiology despite vaccination Problem of susceptibility despite vaccination Waning immunity is driving disease incidence Providers are more aware and there are better diagnostics Incidence increasing in: Infants 7-10 years olds year olds adults MDPH

6 Annual Incidence by State, 2012* 2012 incidence = 13.4 Incidence In US: 18 infant deaths In MA: 1 st infant death in 10 years *2012 data are provisional. Source : CDC National Notifiable Disease Surveillance System, Census data used for population estimates; Incidence is per 100,000 population MDPH

7 Reported Pertussis Incidence by Age Group: * *2012 data are provisional. SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System MDPH

8 Pertussis Cases by Age United States, 2012 Centers for Disease C, et al. Pertussis epidemic - Washington, MMWR Morb Mortal Wkly Rep. 2012;61: MDPH

9 Overall VE & Duration of Protection Estimates Model * Case (n) Control (n) VE, % 95% CI Overall VE, All Ages 0 dose Ref -- 5 doses 629 1, Time since 5 th dose 0 doses Ref -- < 12 months months months months months months Misegades, et al., JAMA, November 28,20I2-Vol 308, No. 20 * Accounting for clustering by county and provider MDPH

10 Pertussis Disease among Unvaccinated compared to Vaccinated Children Pertussis Vaccination Status Case Control OR (95% CI) * Unvaccinated ( ) 5 DTaP doses 629 1,997 * Accounting for clustering by county and provider Misegades, et al., JAMA, November 28,20I2-Vol 308, No. 20 MDPH

11 Tdap Now Recommended with Every Pregnancy MDPH

12 Shifting the Timing of Mother s Tdap Dose* Pregnancy Postpartum Provides earlier protection to mother and therefore indirect protection to infant High levels of transplacental maternal antibodies transferred to infants may provide direct protection * Off-label. MMWR 2013;62(7):131. MDPH

13 Tdap Given at Every Pregnancy Rationale Maternal antibodies from women immunized before pregnancy waned quickly (Healy 2013 CID) Maternal antibodies short lived Vaccination in one pregnancy unlikely high enough to provide passive protection to infants in subsequent pregnancies. Tdap vaccination rates very low in some groups 78% - Adolescents (2011) 12.2% - Adults (2011) 2.6% - Women vaccinated during pregnancy (April 2012) Record setting increase in cases in 2012 New mathematical models show vaccination during pregnancy far superior in prevention vs vaccination post partum Best way to protect infants too young to be vaccinated MMWR 2013 ; 62(7);131. MDPH

14 Tdap Vaccination Recommended with Every Pregnancy 2012* Providers of prenatal care should implement systematic Tdap vaccination programs A dose of Tdap should be given during each pregnancy, regardless of the patient s prior history of receiving Tdap. Optimal timing for Tdap is between 27 and 36 weeks gestation Maximizes maternal antibody response and passive antibody transfer to infant, But, Tdap may be given at any time during pregnancy If Tdap not given during pregnancy, administer immediately postpartum. * Off Label. MMWR 2013 ; 62(7);131. MDPH

15 Tdap Vaccination Every Pregnancy Safety Data No problems identified in reviewing VAERS safety data Review of birth data shows most women only have 2 pregnancies and only 2.5% will have 4 pregnancies New studies of non-pregnant subjects who received 2 doses of Tdap, including shorter intervals (21 days or < 2 years), appears to be well tolerated TT and Td used for decades in pregnant women and no evidence of harm CDC will continue to monitor safety data MMWR 2013 ; 62(7);131. MDPH

16 DTaP and Tdap Other Recommendations Make sure infants and children < 7 years are up to date with DTaP. Children 7-10 years who are under-immunized with DTaP should get a Tdap.* All non-pregnant adolescents and adults need a single dose of Tdap. Persons who will have contact with infants are priorities: Healthcare Workers Family Members Care Givers *Off label recommendation. MMWR 2011: 60 (no.1):13- MDPH

17 Pertussis Reminders Clinical diagnosis not enough for public health response. Lab testing required for implementing control measures and reducing spread. Providers should have a high index of suspicion for pertussis, including in vaccinated patients. MDPH

18 CDC - Parent and Public Resources Disease overview Audio and video of the cough Vaccine recommendations Diagnosis and treatment guidelines Multimedia Podcasts Videos ecards Print materials Matte articles Photo novela Photos Can also use MDPH

19 CDC - Pertussis Professional Resources Videos Demonstrations PCR best practices Diagnostic timeline Vaccine recommendations Summaries Q&As Webcast Collaborating with AAP, Medscape, and others MDPH

20 MDPH Updates MDPH

21 MDPH Vaccine Supply Update DTaP-IPV-Hib (Pentacel ) Shortage will continue into June 2013 Continue to fill orders on a replacement basis Enough to provide 1 dose in the DTaP series Anticipate increased supply by summer with hopes of regular supply by fall 2013 Hib-Men CY-TT (MENHIBRIX ) Anticipated to be available for high risk sometime this spring. Flu for Season Pediatric providers should anticipate receiving at least the same amount of state-supplied vaccine as was used this past season. A portion of these doses will be quadrivalent vaccine Sites who privately purchase vaccine are encouraged to pre-book now through their usual vendors MDPH

22 Access immunization histories Search for new patients Current MIIS Functionality Look up immunization forecasts Print Immunization Certificates for school, camp and/or employment requirements Run Reminder/Recall Reports Uni-directional data exchange, i.e. EHR MIIS MDPH

23 MIIS Progress as of March 18, 2013 Total Sites: 235 Total Patients: 1,088,111 Total Shots: 4,167,116 MDPH

24 MIIS Vaccine Management Module New module within the MIIS, coming late spring Works independently of the registry module Integrated for automatic inventory decrementing when shot reported to registry (EHR or Manual Entry) Transitioning to online: Annual Enrollment Vaccine Ordering Inventory tracking and management Vaccine Usage Reporting MDPH

25 MIIS Vaccine Management Module (VM) Timeline April 1, Vaccine Unit Go Live with VM Module Late Spring - Training Opportunities for providers Summer - Provider Go Live with MIIS VM Module In preparation for transition: Register NOW on the ContactMIIS Resource Center (click on Enrollment tab) Look out for more communication on trainings and sign up early! MDPH

26 MDPH MIIS & Vaccine Unit Contact Information MIIS Help Desk Phone: Fax: Websites: MDPH Vaccine Unit Phone: Fax: Website: (click on Vaccine Management) MDPH

27 2013 US Immunization Schedules Available at : MDPH

28 MDPH

29 No separate child and adolescent schedules Dose # in series New Revised age ranges and catch-up bars For HibMenCY New green bar for recommended catch-up No recommendation MDPH

30 MDPH

31 Summary Changes in Footnotes Immunization Schedule 0-18 years Single set of footnotes: for Regular and Catch-Up Schedules Footnotes standardized and consist of sections: Routine Special conditions, High Risk Catch-up Tdap: recommended during each pregnancy, preferred during wks gestation Pneumococcal: Revised into 3 sections. PCV13 PPSV23 PPSV23 & PCV13 Hep A: More guidance on timing and catch-up. TIV: Changed to IIV for inactivated influenza vaccine since QIV anticipated in MCV: Vaccination of those with high risk conditions revised to reflect the licensure of HibMenCY which is approved for use down to 6 weeks of age for certain high risk infants MDPH

32 Influenza: Added information about a persons with only hives after exposure to eggs: They should receive IIV with additional safety precautions. Varicella, Zoster: Clarifies use of antivirals when vaccine varicella or zoster vaccine given: give > 24 hours before or > 14 days after vaccination. MDPH

33 Hep B: Removed pregnancy as a precaution for so now parallel with hepatitis A and other inactivated vaccines MDPH

34 Tdap extended for all ages New MMR used to say 1 dose MDPH

35 New New MDPH

36 Summary Changes in Footnotes Immunization Schedule > 19 years TIV: Changed to IIV for inactivated influenza vaccine since QIV anticipated in Tdap: Recommended during each pregnancy, preferred during weeks of gestation and for those > 65 years. MMR: Not routinely recommended for those born before Provider-diagnosed disease not acceptable evidence of immunity for measles, mumps or rubella. HPV: Not recommended during pregnancy. If found to be pregnant, no intervention and restart later PPV23: Clarifies who needs 1 vs 2 vs 3 doses of PPSV23. Everyone needs a dose at > 65. Give to those with an unknown or uncertain history. PCV13: New vaccine added & information about indications and timing of PCV13 relative to PPSV23. Hep A: Clarifies that illicit injection and non-injection drug use are both indications for hepatitis A vaccine. MDPH

37 IOM Report: The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies There is no evidence that the current routine immunization schedule is not safe or is associated with chronic illnesses The federal surveillance infrastructure for detecting adverse events is robust and provides confidence about safety of current schedule particularly Vaccine Safety DataLink Stakeholders, including parents with concerns about safety, should be engaged Identifying effective communication about safety is essential Stay tuned for more tools for communicating these findings! MDPH

38 Immunization Recommendations MDPH

39 PCV13 Recommendations for High Risk Children and Adults MDPH

40 ACIP Revised Recommendations PCV13 for Certain High Risk Children 6 through 18 Years* Certain high risk children 6 through 18 years, who have not yet received PCV13, are recommended to receive a single dose, whether or not they have received PCV7 or PPSV23 used to say consider High risk groups include: Functional or anatomic asplenia Immunocompromising conditions: Congenital or acquired immunodeficiencies HIV infection Chronic renal failure or nephrotic syndrome Leukemias, lymphomas, Hodgkin disease Generalized malignancy Diseases requiring treatment with immunosuppressive drugs, including longterm systemic corticosteroids or radiation therapy Solid organ transplantation Multiple myeloma CSF leaks and cochlear implants Children who have not already received their 1 st dose of PPSV23 should receive it > 8 weeks later, with 2 nd dose in > 5 years *CDC. Note to Providers: PCV13 (March1, MDPH

41 Indications for PCV13 in Adults > 19 Years* Functional or anatomic asplenia Immunocompromising conditions: Congenital or acquired immunodeficiencies HIV infection Chronic renal failure or nephrotic syndrome Leukemias, lymphomas, Hodgkin disease Generalized malignancy Diseases requiring treatment with immunosuppressive drugs, including long-term systemic corticosteroids or radiation therapy Solid organ transplantation Multiple myeloma CSF leaks and cochlear implants * Off-label. MMWR 2012;61(40):816 MDPH

42 Recommendations for PCV13 and PPSV23 in Adults* Vaccine naïve adults: PCV13 dose is recommended to be given before PPSV23, whenever possible PPSV23 should be given > 8 weeks after a dose of PCV13 Recommendations for 2 nd dose of PPSV for those with immunocompromising conditions and asplenia (including sickle cell) given at > 5 years Everyone should receive1 dose at age 65 years or older PPSV23-immunized adults A dose of PCV13 is recommended for adults with immunocompromising conditions who received 1 or more doses of PPSV23 > 1 year after the last PPSV23 dose Total number and interval between PPSV23 doses unchanged from current recommendations. Everyone should receive 1 dose at age 65 years or older * Off-label. MMWR 2012;61(40):816 MDPH

43 Indications for PCV13 and PPSV23 in Adults Risk Group Underlying Medical Condition PCV13 PPV23 Immunocompetent persons Persons with functional or anatomic asplenia Immunocompromised persons Chronic heart disease Chronic lung disease Diabetes mellitus Recommended CSF leaks Cochlear implants Alcoholism Chronic liver disease Cigarette smoking Sickle cell disease/other hemaglobinopathies Revacc. at 5 years Congenital or acquired asplenia Congenital or acquired immunodeficencies HIV infection Chronic renal failure Nephrotic syndrome Leukemia Lymphoma Hodgkin disease Generalized malignancy Iatrogenic immunosuppression Solid organ transplant Multiple myeloma MDPH

44 IAC Resources for Pneumococcal Vaccines Pneumococcal Vaccination Recommendations for Children and Adults by Age and/or Risk Factor Pneumococcal Vaccines CDC Answers Your Questions Updated Q&A including PC13 in Adults (for providers) MDPH

45 Hib-MenCY-TT (MenHibRix) MDPH

46 Hib-MenCY-TT(MenHibrix ) Combination Hib- Meningococcal Vaccine Licensed June 14, 2012 Contains meningococcal serogroups C and Y and Hib Vaccine Requires reconstitution with accompanying saline diluent Approved for use in certain infants 6 wks through 18 months of age 4-dose series at 2,4,6 and months Recommended high risk Infants: Persistent complement deficiencies Anatomic asplenia Functional asplenia (sickle cell) Can also be used for infants living in communities with outbreaks of serogroups C and Y Package insert: MenHibrix MMWR 2013;62(7):52. MDPH

47 Hib-MenCY-TT (MenHibrix ) cont.* Catch-up Schedule: Same as for Hib vaccine, except If 1 st dose given at > 12 mos, then 2 doses administered > 8 weeks apart Can be administered with other routine infant vaccines, including PCV13 A 4-dose series of HibMenCY-TT (MenHibrix) fulfills primary and booster doses for Hib Not adequate for children traveling to meningitis endemic areas Hajj Sub - Saharan Africa (Meningitis belt) They should receive the appropriate licensed quadrivalent vaccines: MenACWY-D (Menactra) or MenACWY-CRM (Menveo) Stay tuned for more guidance about HibMenCY-TT (MenHibrix)! *MMWR 2013;62(7):52 MDPH

48 IAC Resources for Meningococcal Vaccines Meningococcal Vaccination Recommendations by Age and/or Risk Factor Meningococcal Q&A About Disease and Vaccine for Public MDPH

49 Influenza Vaccines MDPH

50 Composition of the Influenza Vaccine A/California/7/2009 (H1N1)-like A(H3N2) antigenically like the cellpropagated or cell-grown A/Victoria/361/2011 (A/Texas/50/2012) Similar to last year s strain B/Massachusetts/2/2012 (B/Yamagata lineage) For quadrivalent, add B/Brisbane/60/2008- like (B/Victoria lineage) MDPH

51 New Influenza Vaccine Abbreviations for Season TIV (Trivalent Influenza Vaccine) replaced with IIV (Inactivated Influenza Vaccine): IIV refers to inactivated influenza vaccines as a class Includes trivalent (IIV3), both egg-based and cell-culture-based, and quadrivalent (IIV4) inactivated vaccines; Cell-culture-based IIV is referred to as cciiv/cciiv3; RIV/RIV3 refer to trivalent recombinant HA influenza vaccine; LAIV refers to Live-Attenuated Influenza Vaccine, all of which will be quadrivalent MDPH

52 Recently-approved Influenza Vaccines* Quadrivalent Live-attenuated Influenza Vaccine (LAIV) Flumist Quadrivalent (MedImmune) Healthy, non-pregnant persons aged 2-49 years All supply will be Quadrivalent Quadrivalent Inactivated Influenza Vaccine (IIV4) Fluarix Quadrivalent (GSK) Ages 3 and older Both IIV3 and IIV4 Fluarix available in ; most of supply expected to be IIV3 * Provisional information MDPH

53 Recently-approved Influenza Vaccines*, cont. Cell-culture based inactivated influenza vaccine (cciiv3) Flucelvax (Novartis) Ages 18 and older cciiv vs. other IIVs and mild egg allergy (persons who have experienced only hives in response to egg) Mammalian cells (VERO) Vaccine viruses for cciiv are not propagated in eggs; But, initial reference strains provided by WHO have been passaged in eggs Cannot be considered egg-free, though expected to contain considerably less egg protein than other IIVs Recombinant hemagglutinin vaccine (RIV3) FluBlok (Protein Sciences) Ages 18 through 49 years Recombinant HA protein, insect cell culture (Baculovirus vector) RIV is egg-free Sanofi quadrivalent vaccine not approved yet. Stay tuned for final guidance about all these new products * Provisional information MDPH

54 Avian Influenza A (H7N9) Virus Bird influenza that has caused serious respiratory illness and death in humans in four provinces China Shanghai, Anhui, Jiangsu, Zhejiang As of April 11, 38 cases with 9 deaths, 19 severe and 9 mild cases (WHO) Many cases had direct contact with live poultry; most were hospitalized No human-to-human transmission reported to date Virus has not been found in people or birds in US If you suspect avian influenza in a patient with respiratory illness and appropriate travel and/or exposure history, please notify your local board of health and MDPH immediately at An immunization epidemiologist is available at for assistance with specimen collection and infection control. Resources: Mass.gov/flu MDPH

55 For More Information Massachusetts Immunization Program Website Ordering MDPH materials al_materials_catalog.pdf CDC/NIP (1-800-CDC-INFO) for both English and Spanish TTY (M-F 10 AM 10 PM) Website MDPH

56 EXTRA MDPH

57 MMRV Vaccine (ProQuad ) Available for Ordering Since November Products/UCM pdf MDPH

58 MMRV Vaccine ACIP Recommendations* 1 st Dose in those months: Unless the parent expresses a preference for MMRV vaccines, ACIP recommends MMR and varicella be given as separate injections for this age group 2 nd Dose in those15 months 12 years or 1 st dose in those 48 months or older: MMRV is generally recommended over separate injections in this age group. Providers should use clinical judgment. Considerations include: provider assessment, parental preference and the potential for adverse events VIS is a helpful tool to discuss the risks and benefits of vaccination options with parents. Off label. MMWR 2010;59(RR-3). MDPH

59 MMRV Vaccine ACIP Recommendations, cont. Precautions: Personal or family (ie., parent or sibling) history of seizures of any etiology is now a precaution. These children should generally receive separate injections of MMR and varicella vaccines. Recent studies have not shown that antipyretics (e.g., acetaminophen or ibuprofen) prevent febrile seizures Other Contraindications and Precautions: Remain unchanged MMWR 2010;59(RR-3). MDPH

60 13-valent Pneumococcal Conjugate Vaccine (PCV13) for Adults* Licensed for use among adults > 50 years old on 12/30/11 But, ACIP reviewed the data and decided to make risk-based (not age-based) recommendations Extremely high burden of disease among immunocompromised adults Indirect effects of PCV13 use in children unlikely to eliminate PCV13 serotypes from immunocompromised adults PCV13 alone may not provide adequate coverage of serotypes causing disease Combined regimen of PCV13 and PPSV23 likely better than either vaccine alone * Off-label. MMWR 2012;61(40):816 MDPH

61 61 MDPH

62 Influenza Activity Summary, Influenza activity in the US during the season began approximately 4 weeks earlier than usual, and occurred at moderately high levels Activity increased in late November and peaked in late December Activity continues in much of the country, but is decreased in most areas Influenza A (H3N2) viruses responsible for most of the isolates, but influenza B responsible for most activity isolates now This influenza season has been moderately severe with high rates of influenza hospitalization in the elderly and a large proportion of deaths attributed to pneumonia and influenza Over 90% of the viruses antigenically characterized to date are well matched to vaccine CDC continues to monitor vaccine effectiveness MDPH

63 CDC s Three-pronged Approach to Influenza 1. Annual Vaccination 2. Appropriate Use of Influenza Antiviral Drugs Including early presumptive treatment and prophylaxis 3. Everyday Prevention Staying home when sick Covering coughs and sneezes Proper hand washing MDPH