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Making Sense of New Vaccine Recommendations

Making Sense of New Vaccine Recommendations. William Atkinson, MD, MPH National Center for Immunization and Respiratory Diseases. Vermont Immunization Conference Stowe, Vermont October 28, 2011.

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Making Sense of New Vaccine Recommendations

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  1. Making Sense of New Vaccine Recommendations William Atkinson, MD, MPH National Center for Immunization and Respiratory Diseases Vermont Immunization Conference Stowe, Vermont October 28, 2011

  2. William Atkinson is a federal government employee with no financial interest or conflict with the manufacturer of any product named in this presentation The speaker will discuss the off-label use of meningococcal conjugate vaccine The speaker will not discuss a vaccine not currently licensed by the FDA Disclosures

  3. Disclosures • The recommendations to be discussed are primarily those of the Advisory Committee on Immunization Practices (ACIP) • composed of 15 experts in clinical medicine and public health who are not government employees • provides guidance on the use of vaccines and other biologic products to the Department of Health and Human Resources, CDC, and the U.S. Public Health Service www.cdc.gov/vaccines/recs/acip/

  4. What’s New in Immunization • ACIP update • Measles redux • New influenza vaccine and recommendations • Tdap vaccine for pregnant women • Expansion of meningococcal conjugate vaccine recommendations

  5. October 26, 2011

  6. Routine HPV Vaccination of Males • In December 2010 FDA added prevention of anal cancer in males and females to the HPV4 indications • On October 25 ACIP voted to: • recommend routine vaccination of males at 11 or 12 years of age • recommend routine “catch-up” vaccination for males 13 through 21 years of age • “permissive” vaccination of males 22-26 years of age

  7. Hepatitis B Vaccination of Persons With Diabetes • Persons with diabetes who use glucose monitors are at increased risk of HBV infection • On October 25 ACIP voted to: • recommend hepatitis B vaccination of unvaccinated adults with diabetes younger than 60 years • “permissive” recommendation for adult with diabetes 60 years or older

  8. Measles – United States, 2011 • 220 cases reported to CDC from 30 states as of October 21 (VT = 1) • 194 (88%) cases are import-associated (73 imports, 67 import-linked, 32 imported virus, 22 linked to imported virus • 71% of imports were U.S. residents • 191 (87%) unvaccinated or undocumented vaccination status (67 PBE, 20 too young) CDC unpublished data, 2011

  9. MMR Vaccine • First dose at 12-15 month, second dose routinely at 4-6 years of age • Minimum interval between doses is 4 weeks • Infants as young as 6 months should receive MMR before international travel • Adults with unknown or undocumented MMR vaccination history should receive 1 or 2 doses MMWR 2011;60(No. 20):666-8

  10. Keep Your Guard Up • Any patient with fever and rash should be assumed to have measles until proven otherwise • immediate isolation • Be highly suspect of patients with fever and coryza and/or conjunctivitis, particularly if unvaccinated or international travel • Be certain of your measles immunity status

  11. Evidence of Measles, Mumps, and Rubella Immunity for Healthcare Personnel (HCP) • Appropriate vaccination against measles, mumps, and rubella • 2 doses of measles and mumps vaccine • at least 1 dose of rubella vaccine, or • Laboratory evidence of immunity, or • Laboratory confirmation of disease • Physician-diagnosed disease no longer recommended as evidence of measles or mumps immunity

  12. Influenza Vaccination Recommendation • Annual influenza vaccination is recommended for every person in the United States 6 months of age and older • Start vaccinating as soon as you receive your vaccine MMWR 2010;59(RR-8)

  13. Same 3 influenza strains as the 2010-2011 seasonal vaccine A/California/7/2009 (H1N1)-like A/Perth/16/2009 (H3N2)-like B/Brisbane/60/2008-like A dose of 2011-2012 vaccine is recommended regardless of whether the person received 2010-2011 vaccine Both inactivated and live attenuated vaccines will be available Influenza Vaccine Components 2011-2012 MMWR 2011;60(33):1128-32

  14. Pregnant Women, Newborns, and Influenza Vaccination • Pregnant women are at increased risk of complications of influenza • women who are or will be pregnant during influenza season should receive influenza vaccine (TIV only) • Infants younger than 6 months of age are at very high risk of complications and hospitalization from influenza • no vaccine is available for infants younger than 6 months MMWR 2010;59(RR-8)

  15. Effectiveness of Influenza Vaccination of Pregnant Women in Reducing Hospitalization of Infants Cases were children younger than 6 months of age hospitalized with culture-confirmed influenza. Clin Infect Dis2010;51:1355-61

  16. Influenza Vaccine Presentations 2011-2012 SDS=single dose syringe; SDV=single dose vial; MDV=multidose vial

  17. Influenza Vaccine Presentations 2011-2012 SDS=single dose syringe; SDV=single dose vial; MDV=multidose vial

  18. Fluzone TIV Formulations Formulation (age) HA per dose • Adult (>36 mos) 45 mcg/0.5 mL • Pediatric (6-35 mos) 22.5 mcg/0.25 mL • High dose (>65 yrs) 180 mcg/0.5 mL • Intradermal (18-64 yrs) 27 mcg/0.1 mL (135 mcg/0.5 mL) MMWR 2011;60(33):1128-32

  19. Fluzone High-Dose Contains 4 X amount of influenza antigen than regular Fluzone Approved only for persons 65 years and older Produced higher antibody levels; slightly higher local reactions Studies underway to assess clinical effectiveness No preference stated by ACIP for HD or regular influenza vaccination MMWR 2010;59(No. 16):485-6

  20. Fluzone Intradermal • Licensed by FDA in May 2011 • Approved only for persons 18 through 64 years of age • Dose is 0.1 mL administered in the deltoid area by a specially designed microneedle and injector system • Formulated to contain more HA (27 mcg) than a 0.1 mL dose of regular Fluzone formulation (9 mcg) MMWR 2011;60(33):1128-32

  21. Fluzone Intradermal Injection Device

  22. Fluzone Intradermal Injection Technique

  23. Fluzone ID site Traditional ID site

  24. MMWR 2011;60(33):1128-32 (August 26)

  25. MMWR 2011;60(33):1128-32

  26. Influenza Vaccination of Children 6 Months Through 8 Years of Age • Recommendations for the number of doses of influenza vaccine for children 6 months through 8 years of age are different than in previous years • The only factor to consider is whether or not the child received influenza vaccine during the 2010-2011 season • no 2010-2011 vaccine 2 doses • 1 or more doses during the 2010-2011 season 1 dose this year MMWR 2011;60(33):1128-32

  27. Influenza Vaccination of Persons with Egg Allergy • All types and formulations of influenza vaccine contain residual egg protein (ovalbumin) • The amount of ovalbumin per dose varies by manufacturer, vaccine type, and lot • Many persons with “egg allergy” can tolerate receipt of TIV without serious reaction MMWR 2011;60(33):1128-32

  28. Influenza Vaccination of Persons with Egg Allergy • If the person can eat cooked eggs without a reaction vaccinate (TIV) without special precautions • If after eating egg or egg-containing food the person has hives only vaccinate (TIV) and observe for at least 30 minutes • If the person has hives and other symptoms (e.g. wheezing, nausea) then refer the person to a physician with expertise in management of allergy • LAIV should not be administered to persons with egg allergy MMWR 2011;60(33):1128-32

  29. MMWR 2011;60(33):1128-32

  30. www.cdc.gov/vaccines/pubs/vis/

  31. www.cdc.gov/vaccines/pubs/vis/

  32. Influenza Vaccine, PCV13, and Febrile Seizures • Both influenza vaccine and PCV13 can cause fever • Some children with fever may have a febrile seizure • most common in children 12-23 months of age • VSD data (2011) indicate about 1 febrile seizure for every 2,225 children who receive both vaccines • ACIP recommends both vaccines be given at the same visit if indicated

  33. www.cdc.gov/vaccinesafety/Concerns/FebrileSeizures.html

  34. Pertussis—United States, 1980-2010

  35. Reported Pertussis Incidence by Age Group - 1990-2010* SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System. *2010 data are provisional

  36. Tdap and Pregnancy • Infants are most likely to be hospitalized or die from pertussis • If a woman receives Tdap before or during pregnancy, her passive immunity might help protect the newborn from pertussis • There are few safety data for pregnant women given Tdap • There are concerns by some experts that the passive pertussis antibody could interfere with the infant’s response to DTaP

  37. Tdap Recommendations for Pregnant Women • Any woman who might become pregnant is encouraged to receive a single dose of Tdap • Tdap should be administered to pregnant women who have not received a dose • Vaccinate during third trimester or late in second trimester (after 20 weeks gestation) • Alternatively, administer Tdap immediately postpartum MMWR 2011;60(41):1424-6 (October 21)

  38. Meningococcal Conjugate Vaccines • Menactra • approved in January 2005 for a single dose among persons 9 months* through 55 years of age • Menveo • Approved in February 2010 for a single dose among persons 2 through 55 years of age *as of April 22, 2011

  39. Meningococcal Vaccination of Children 9-23 Months of Age • In April 2011 FDA approved Menactra for children as young as 9 months • ACIP recommends Menactra for high-risk children 9 through 23 months of age • 2-dose series • 3-month interval between doses • administer at 9 and 12 months of age (minimum interval 2 months) MMWR 2011;60(40):1391-2 (October 14)

  40. Meningococcal Vaccination of Children 9-23 Months of Age • ACIP defines high-risk children age 9 through 23 months as: • those with persistent complement component deficiency • those in a community or institution where a meningococcal disease outbreak is occurring, or • those traveling to an area of the world where meningococcal disease is epidemic MMWR 2011;60(40):1391-2 (October 14)

  41. Meningococcal Vaccination of Children with Asplenia • Data suggest a reduction in response to PCV13 if given at the same visit as Menactra brand MCV4 • Asplenic persons are at very high risk of invasive pneumococcal disease • The minimum age for meningococcal vaccination of children with asplenia (including those with sickle cell disease) remains 2 years MMWR 2011;60(40):1391-2 (October 14)

  42. The Future • Additional combination vaccines • Meningococcal vaccination of infants • More than 1 dose of Tdap? • ACIP recommendation for HPV vaccination of males (currently a “permissive” recommendation) • PCV13 vaccination of adults?

  43. CDC Vaccines and ImmunizationContact Information Telephone 800.CDC.INFO (for patients and parents) Email nipinfo@cdc.gov (for providers) Website www.cdc.gov/vaccines/ Vaccine Safety www.cdc.gov/vaccinesafety/

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