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

2. 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. 3 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 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 Disclosures www.cdc.gov/vaccines/recs/acip /

4. 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 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. 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 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. 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 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

9. 9 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) 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

11. 11 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 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

12. 12 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 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

13. 13 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 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

15. 15 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 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)

16. 16 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

17. 17 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 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)

18. 18 Cases Controls Mother vaccinated 2 (2%) 2 (2%) 31 (20%) Mother unvaccinated 89 (98% 21 (80%) Vaccine Effectiveness 92% Cases were children younger than 6 months of age hospitalized with culture-confirmed influenza. Clin Infect Dis 2010;51:1355-61 Effectiveness of Influenza Vaccination of Pregnant Women in Reducing Hospitalization of Infants

19. 19 Vaccine Doseform Age Fluzone TIV (sanofi pasteur) SDS, SDV, MDV 6 months and older Fluarix TIV FluLaval TIV (GSK)SDSMDV 3 years and older 18 years and older Fluvirin TIV (Novartis) SDS, MDV 4 years and older Afluria TIV (CSL)SDS 9 years and older Flumist LAIV (MedImmune) Nasal spray 2-49 years (healthy, nonpregnant) SDS=single dose syringe; SDV=single dose vial; MDV=multidose vial Influenza Vaccine Presentations 2011-2012

20. 20 Vaccine Doseform Age Fluzone TIV (sanofi pasteur) SDS, SDV, MDV 6 months and older Fluarix TIV FluLaval TIV (GSK)SDSMDV 3 years and older 18 years and older Fluvirin TIV (Novartis) SDS, MDV 4 years and older Afluria TIV (CSL)SDS 9 years and older Flumist LAIV (MedImmune) Nasal spray 2-49 years (healthy, nonpregnant) SDS=single dose syringe; SDV=single dose vial; MDV=multidose vial Influenza Vaccine Presentations 2011-2012

21. 21 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) 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

22. 22 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

23. 23 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) 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

24. Fluzone Intradermal Injection Device

25. Fluzone Intradermal Injection Technique

26. Fluzone ID site Traditional ID site

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

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

30. 30 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 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

31. 31 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 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

32. 32 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 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

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

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

36. 36 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 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

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

39. 39 Pertussis—United States, 1980-2010

40. 40 Reported Pertussis Incidence by Age Group - 1990-2010* SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System. *2010 data are provisional

41. 41 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 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

42. 42 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 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)

43. 43 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 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

44. 44 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) 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)

45. 45 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 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)

46. 46 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 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)

47. 47 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? 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?

48. 48 CDC Vaccines and Immunization Contact 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/