Pediatric Immunization Update St. Anne s Hospital Fall River, MA November 9th, 2012

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1 Pediatric Immunization Update St. Anne s Hospital Fall River, MA November 9th, 2012 Peter Rappo, MD, FAAP Clinical Professor of Pediatrics Harvard University School of Medicine

2 Disclosure Information Speakers Bureau Merck Vaccines Novartis Sanofi Pasteur Questionable choice of eyewear and hairstyle

5 Objectives 1. Review changes to current immunization schedule 2. Discuss barriers to parental/patient reception of immunization 3. Clarify current data regarding vaccine safety

8 New Vaccine Codes and Are codes every practice should embrace if you have patients under the age of 18 Ask me about the Medicarization of Medicaid Coming to a billing system near you on January 1, 2013

2012 Recommended Immunization Schedules http://www.

11 2012 Recommended Immunization Schedules

12 Changes to 2012 Childhood Schedules General notes on the 2012 immunization schedules: As in previous years, three schedules provide advice on administration of immunizations for children 0 through 6 years of age, 7 through 18 years of age and a catch-up schedule. Because of increased complexity of the schedules and a limited amount of space, repetition among footnotes has been eliminated. Providers are recommended to use all three schedules and their respective footnotes together (not as standalones).

13 Changes to 2012 Childhood Schedules Hepatitis B Administration of Hepatitis B vaccine and Hepatitis B immune globulin to infants weighing less than 2,000 grams or weighing more than 2,000 grams who are born to HBsAg positive mothers.

14 Changes to 2012 Childhood Schedules Influenza Updated influenza vaccine footnotes vaccine dosing for children 6 months through 8 years of age. For season, administer two doses separated by at least four weeks to those who did not receive at least one dose during season. Those who received at least one dose during season require one dose for season. Guidance on contraindications to use live attenuated influenza vaccine NOT CHANGED.

15 Changes to 2012 Childhood Schedules Hib Vaccine Guidance for use of Hib vaccine in people 5 years of age and older updated in the catch-up schedule.

16 Changes to 2012 Childhood Schedules MMR Vaccine Infants 6 through 11 months of age who are traveling internationally should receive one dose of MMR vaccine. A dose should be repeated at 12 through 15 months of age and at least four weeks after the first dose. A third dose should be administered at 4 to 6 years of age. AND, the return of MMRV

17 Changes to 2012 Childhood Schedules Hepatitis A Vaccine Footnotes have been updated to emphasize administration of the second dose 6 to 18 months after the first dose. Hepatitis A vaccine is recommended for all children from 12 through 23 months of age and for unvaccinated children 24 months or older in target areas for older children who are increased risk for infection or for whom immunity against hepatitis A is desired. A new yellow and purple bar has been added to the Recommended Immunization Schedule for Persons Aged 0 through 6 years to reflect hepatitis A vaccine for children 2 years and older.

18 Changes to 2012 Childhood Schedules Meningococcal Conjugate Vaccine Guidance for routine administration of a booster dose of MCV4 is provided. Guidance is provided of children at increased risk of meningococcal disease, including children infected with HIV, with persistent complement component deficiency, with anatomic or functional asplenia, residents of or travelers to countries with hyperendemic or epidemic disease, and children present during outbreaks caused by a vaccine serogroup. The MCV4 purple bar has been extended in the Recommended Immunization Schedule for Persons 0 through 6 years to reflect licensure of MCVV4-D (Menactra) use in children as young at 9 months.

19 Changes to 2012 Childhood Schedules HPV Vaccine HPV vaccine footnotes have been updated to include a routine recommendation for vaccination of males with HPV4 (Gardasil).

20 Changes to 2012 Childhood Schedules Poliovirus Vaccine IPV footnotes have been updated to note that the vaccine is not routinely recommended for U.S. residents ages 18 years or older.

21 Changes to 2012 Childhood Schedules Tdap Vaccines Clarification of Tdap vaccines is provided for children ages 7 through 10 years who are not fully immunized with the childhood Dtap series.

23 Administration Record keeping Precautions Contraindications Side effects VAERS Timing Minimum spacing Handling biologics Storage Interchangeability Timing after IG/IVIG Special situations Altered Immunity CME/CEU credits! SUPERB REFERENCE!

24 Barriers to parental/patient reception of immunization A great deal of vaccine information is available to parents. Parents should have access to the most information for making decisions about their child; however, information is sometimes published that is inaccurate or taken out of context. Anti-vaccine sentiment is not something new.

25 June 12, 1802

27 April 20, 2011 Decreased vaccination rates More cases of measles 36 0f 53 EU countries 26,000 cases thru 10/ hospitalizations 11 deaths MMWR 12/2/11

28 Shifting Targets of Vaccine Concerns Bad lots of vaccine MMR causes autism M and M and R given separately Thimerosal causes autism Aluminum is toxic Vaccines will wear out the immune system Too many shots at the same time

30 Parents Level of Trust for Vaccine Safety Information A lot Some Not at all Child s doctor 76% 22% 2% Other HCP s 26% 70% 4% Govt / vaccine experts 23% 61% 16% Family & friends 15% 67% 18% Parents who claim harm from vaccine 8% 65% 27% Celebrities 2% 24% 74% Pediatrics 2011; 127:S107

31 Health-care Providers - not celebrities have the strongest impact on parents decisions to vaccinate their child! Speak Up! State your practice philosophy up front.

33 Overcoming Barriers Physicians represent the best opportunity to influence the vaccine-hesitant by: Demonstrating a willingness to listen respectfully, encouraging questions, and acknowledging parental concerns. Providing accurate information about both risks and benefits is crucial to maintaining trust. Diagnosing the reasons for hesitancy will permit a more effective discussion and approach. Providing accurate information from reputable sources: CDC, AAP, AAFP Diekema, Douglas, MD, MPH; Improving Childhood Vaccination Rates. N Engl J Med 336;

34 Overcoming Barriers It is counterproductive to ask parents who refuse to vaccinate their children to seek care elsewhere. (Note: The American Academy of Pediatrics does not recommend firing patients.) Healthcare professionals need to set the example by being vaccinated. BUT, our policy as a practice is : Diekema, Douglas, MD, MPH; Improving Childhood Vaccination Rates. N Engl J Med 336;

35 Responding to Concerns Recommend good web sites Provider Resources for Vaccine Safety (CDC) (American Academy of Pediatrics) (Immunization Action Coalition) Stories of unvaccinated children who became ill Chance vs. cause and effect Biologic plausibility Be willing to address concerns without compromising science, standard of care

36 Google: Colbert and Offit

37 Benjamin Franklin In 1736 I lost one of my sons, a fine boy of four years old, by the small-pox, taken in the common way. I long regretted bitterly, and still regret that I had not given it to him by inoculation.

38 Take Home Messages Vaccines are safe. Benefits outweigh risks of acquiring a VPD. A mechanism is in place to report adverse reactions (VAERS). All reported reactions are investigated and action is take as necessary (Rotavirus). The vaccine schedule was developed to protect children when they are most vulnerable to disease.

39 Remember A choice not to get a vaccine is not a risk-free choice, it is a choice to take different risks; risks of VPD s are real Parents must choose which risks they want to take for their children Choosing NOT to get a vaccine increases the risk your children and those around you will get disease Unimmunized children in our waiting rooms are at risk

40 Does Cocooning Work? Immunize mom & dad post partum Immunize grandparents & care providers Successful examples: TX, NV A champion Donated provider time Free Tdap Not successful at national na level

41 The Challenges We Face Infants are vulnerable to certain vaccine-preventable diseases in the first few months of life, before they have completed their primary immunization series Infants are at high risk for life-threatening complications, hospitalization, and death due to pertussis and influenza Infants who develop pertussis or influenza are most likely to acquire it from a family member Adults and adolescents have low rates of immunization against pertussis and influenza

42 Pertussis: Preventable but Persistent There is a relative lack of awareness among health-care providers that pertussis immunity from natural infection or childhood vaccination wanes 5-8 years after the last booster dose. This leaves adolescents and adults vulnerable to pertussis infection, and those infected can transmit risk of life-threatening disease to young infants. 1 Reference: 1. Healy CM, et al. Vaccine. 2009;27(41):

Reported Cases of Pertussis Are Highest in Adolescents and Adults ~10,000-25,000 cases of pertussis are reported in the US every year 1 ~60% of reported cases occur among adolescents and adults 2

Despite increasing awareness and recognition of pertussis as a disease that affects adolescents and adults, pertussis is overlooked in the differential diagnosis of cough illness in this population.

43 Reported Cases of Pertussis Are Highest in Adolescents and Adults ~10,000-25,000 cases of pertussis are reported in the US every year 1 ~60% of reported cases occur among adolescents and adults 2 Reported cases are the tip of the iceberg Estimated actual cases among adolescents and adults: 800, million per year 3 Courtesy of the Centers for Disease Control and Prevention (CDC). Despite increasing awareness and recognition of pertussis as a disease that affects adolescents and adults, pertussis is overlooked in the differential diagnosis of cough illness in this population. 4 References: 1. CDC. (Published July 9, 2009 for 2007). MMWR. 2007;56(53): CDC. Data on file (Pertussis Surveillance Reports), MKT ( ); MKT18596 (2007); MKT (2008). 3. Cherry JD. Pediatrics. 2005;115(5): CDC. MMWR. 2005;55(RR-14):1-16.

44 The Very Young are Very Vulnerable to Complications of Pertussis Pertussis complications, hospitalizations, and deaths 1 Age No. with pertussis a Hospitalization Pneumonia Seizures Encephalopathy Death <6 months months years a Individuals with pertussis may have had 1 or more of the listed complications. Data are for Unvaccinated or incompletely vaccinated infants aged <12 months have the highest risk for severe and life-threatening complications and death. 2 References: 1. CDC. MMWR. 2002;51(4): CDC. MMWR. 2005;54(RR-14):1-16.

45 Multicenter study in France, Germany, Canada, US Study population: 95 infants 6 months of age with labconfirmed pertussis Household members were responsible for 76%-83% of transmission to infants in 44 cases where a source could be identified Transmitting Pertussis to Infants Is a Family Matter 1 Friend/Cousin 10% Implementation of the ACIP recommendation for adult and adolescent [Tdap] vaccination could substantially reduce the burden of infant pertussis, if high coverage rates among those in contact with young infants can be achieved. Part-time caretaker Grandparent 2% 6% Aunt/Uncle 10% Sibling 16% Father 18% Mother 37% Reference: 1. Wendelboe AM, et al. Pediatr Infect Dis J. 2007;26(4):

46 ACIP a Recommendations for Use of Tdap b in Adults and Adolescents All adults years of age who have not already received Tdap: 1 Single dose to those who received their last tetanus and diphtheria toxoid (Td) vaccine 10 years ago Interval as short as 2 years since last Td may be used, especially in settings of higher risk (outbreaks, contact with infants) All adolescents years of age 2 Single dose of Tdap instead of Td Preferred timing is years of age a ACIP = Advisory Committee on Immunization Practices. b Tdap = Tetanus, diphtheria, and acellular pertussis vaccine. Reference: 1. CDC. MMWR. 2006;55(RR-17): CDC. MMWR. 2006;55(RR-3):1-43.

The ACIP Recommends: Build a Cocoon of Protection Around Infants 1 Tdap is recommended for all adults who have or anticipate having close contact with infants <12 months of age Parents, grandparents

47 The ACIP Recommends: Build a Cocoon of Protection Around Infants 1 Tdap is recommended for all adults who have or anticipate having close contact with infants <12 months of age Parents, grandparents (<65 years of age), child-care providers, health-care personnel All should receive Tdap at least 2 weeks before beginning contact with the infant An interval as short as 2 years from the last dose of Td is suggested; shorter intervals may be used Reference: 1. CDC. MMWR. 2006;55(RR-17):1-37.

48 Support for ACIP Recommendations on Tdap More than 20 medical societies endorse ACIP s Tdap recommendations for adolescents and adults, including: American Academy of Pediatrics American Academy of Family Physicians American Congress of Obstetricians and Gynecologists American College of Physicians Infectious Diseases Society of America Society for Adolescent Health and Medicine Reference: 1. American Academy of Pediatrics (AAP) Committee on Infectious Diseases. Pertussis (whooping cough). In: Red Book. AAP, Elk Grove Village, IL, 2009: The AAP and ACIP recommend that immunization status of household contacts of newborn infants should be evaluated, and those who are eligible for DTaP or Tdap should be immunized as soon as feasible. Protection against pertussis may develop 7 to 10 days after immunization. 1

49 ACIP Recommendations: Tdap for Mothers Women are encouraged to receive a single dose of Tdap before conception if they have not already received Tdap 1 Maternal antibody affords only limited (<2 months) protection for the infant 2,3 For mothers who have not already received Tdap, Tdap is recommended as soon as feasible in the immediate postpartum period 1 Vaccination should occur before discharge from the hospital or birthing center References: 1. CDC. MMWR. 2008;57(RR-4): Healy CM, et al. J Infect Dis. 2004;190(2): Shakib JH, et al. J Perinatol. 2010;30(2):93-97.

50 Influenza: More Than Just a Bad Cold Protection of young infants, who have hospitalization rates [for influenza] similar to those observed among the elderly, depends on vaccination of the infants close contacts All household contacts, health-care and day care providers, and other close contacts of young infants should be vaccinated. 1 Reference: 1. CDC. MMWR. 2009;58(RR-8):

Influenza: An Annual Epidemic 5%-20%: Percentage of US population that becomes ill with influenza each year 1 15 million to 60 million cases 10%-40%: Annual attack rate among the pediatric population

51 Influenza: An Annual Epidemic 5%-20%: Percentage of US population that becomes ill with influenza each year 1 15 million to 60 million cases 10%-40%: Annual attack rate among the pediatric population 2 24%: Reported secondary attack rate in households 3 36,000: Average influenza-related deaths per year 4 90% occur in persons 65 years of age 226,000: Average hospitalizations per year 4 Hospitalization rates highest among infants and the elderly Courtesy of the CDC. References: 1. CDC. Key facts about seasonal influenza (flu). Accessed January 3, AAP Committee on Infectious Diseases. Pediatrics. 2008;121(4):e1016-e Viboud C, et al. Br J Gen Pract. 2004;54(506): CDC. MMWR. 2009;58(RR-8):1-52.

52 Annual average excess no. of hospitalizations per 100,000 children Pediatric Hospitalizations for Influenza: Young Infants are Most Vulnerable Influenza-related hospitalization rates for infants and young children (per 100,000 population) are comparable to rates in the elderly <6 mos 6- <12 mos 1- <3 yrs 3-<5 yrs 5-<15 yrs Age References: 1. Neuzil KM, et al. N Engl J Med. 2000;342(4): CDC. MMWR. 2009;58(RR-8):

53 ACIP Recommendations for Influenza Vaccine CDC now recommends annual influenza vaccination for all children, adolescents, and adults 6 months of age and older 1 Effective with season Priority groups for immunization include household and other close contacts of children <5 years of age with particular emphasis on immunizing contacts of infants <6 months of age 2 References: 1. CDC. ACIP provision recommendations for the use of influenza vaccines. Accessed March 18, CDC. MMWR. 58(RR-8):1-52.

56 Measles and Airline Travel

58 Measles and Airline Travel 2011 Measles is easy to transmit Expensive to trace: 9 cases UT $300,000 Indiana: 14 cases; 13 unvax; Indonesia All cases linked to imported disease WHO: 26,000 cases in Europe: 11 deaths France: 14,000 cases Congo: 123,000 cases; 1500 deaths US: 212 cases

60 Diagnosis Measles testing for suspected cases is extremely important. MDPH offers free testing at the Hinton State Laboratory Viral culture of throat or NP swab and urine Serum for measles-specific IgM antibody Commercial laboratory results are not acceptable for public health purposes. Contact MDPH (available 24/7) at for technical guidance

61 Post-Exposure Control Measures Identify all exposed patients and staff Assess all exposed individuals for acceptable evidence of immunity Vaccinate all susceptibles. Measles vaccine given within 72 hours of exposure may prevent disease. Exclude all susceptible contacts from work from day 5 through day 21 after exposure. (If the case is confirmed, even those staff vaccinated within 72 hours should be excluded.) Surveillance for early identification of secondary cases should be continued for two incubation periods.

62 Please report all cases or suspect cases of measles to your local board of health and to the MDPH Division of Epidemiology and Immunization at

63 MA DPH Immunization Audit Are your patients shots up to date? Have you documented reasons for any delay? Are vaccines given at proper intervals? Are you giving current VIS forms? Are you storing vaccines properly? Do you have a vaccine disaster plan?

64 MDPH Vaccine Restitution Policy Effective January 1, incidents in 2011 as of 10/11 - $170 - $27,793 Policy in accordance with federal guidelines re: fraud and abuse Criteria: 1 st incident and total loss is over $10,000 2 nd incident (or greater), regardless of total value Failure to immediately open vaccine shipment, regardless of total value Providers will privately purchase doses lost Will have option of purchasing new vaccine storage and monitoring equipment in lieu or in addition to replacement vaccine Purchases must be pre-approved by MDPH Must provide copy of invoices to vaccine unit Can appeal decision MDPH 2-12

67 Vaccine Accountability - NEW Restitution for federal / state vaccine lost due to improper storage (examples): Failure to open shipments on arrival Failure to rotate vaccine stocks Freezing what should be refrigerated Refrigerating what should be frozen Refrigerator unplugged Vaccines lost to power outages for which there is no backup plan vaccine management

3 rd dose. 3 rd or 4 th dose, see footnote 5. see footnote 13. for certain high-risk groups

3 rd dose. 3 rd or 4 th dose, see footnote 5. see footnote 13. for certain high-risk groups Figure 1. Recommended immunization schedule for persons aged 0 through 18 years 2013. (FOR THOSE WHO FALL BEHIND OR START LATE, SEE THE CATCH-UP SCHEDULE [FIGURE 2]). These recommendations must be read