CHAMPS 2012 Immunization Update

CHAMPS 2012 Immunization Update with Iyabode A. Beysolow, M.D., M.P.H. National Center for Immunization and Respiratory Diseases Teleconference (HRSA Region VIII) July 25, 2012 7/19/2012

Disclosures Dr. Beysolow has no financial conflict or interest with the manufacturer of any product named during this course. I will not discuss the use of vaccines in a manner that differs from the product insert with the exception of Tdap and PCV13 vaccines. I will not discuss vaccines not licensed by the FDA 7/19/2012

Objectives Increase provider knowledge regarding immunizations and the importance of promoting immunizations in the community. Explain one recent change to immunization recommendations coming from the Advisory Committee for Immunization Practices 7/19/2012

What do providers want to know about vaccines? What are CDC/ACIP Recommendations? What s new in the vaccine world? What should I tell my patients/parents? Where can I find resources quickly? 7/19/2012

Overview Introduction ACIP overview who is the ACIP? 2012 Immunization Schedules Feb 2012 and June 2012 ACIP Meeting Updates Updated ACIP recommendations PCV13 in Immunocompromised Adults Tdap adults and adolescence Influenza Updates HepB adults with diabetes HPV4 routine recommendation for males Health Care Worker Recommendations Vaccine Administration (S and H) Resources Q and A 7/19/2012

7/19/2012 Who is the ACIP?

Changes to the Schedules Concerns: Increasing complexity of the schedule Limited space for footnotes Solutions: In order to improve footnote readability: Redundancy between footnotes and figures eliminated Reference to respective MMWR documents for more details 7/19/2012

Changes to the Childhood Schedule Providers are asked to use all 3 schedules and their footnotes together and not separately 7/19/2012

CDC Vaccines Webpage http://www.cdc.gov/vaccines/recs/schedules/ch ild-schedule.htm#printable 7/19/2012

MMWR webpage http://www.cdc.gov/mmwr/ 7/19/2012

Changes to the Childhood Schedule 0-6 year schedule: MCV bar extended Hep A hashed bar clarification MMR use in 6 through 11 month olds 7-18 year schedule: - HPV4 routine use in males Catch-up Schedule: - HepA and HepB footnotes removed - MCV footnotes added 7/19/2012

Changes to Recommended Immunization Schedule for Persons Aged 0 Through 6 years 7/19/2012

Changes to Figure 2. Recommended Immunization Schedule for Persons Aged 7 Through 18 Years 7/19/2012

7/19/2012 Changes to the 2012 Catch-up Schedule

Changes to the Adult Schedule Table summarizing precautions and contraindications to vaccination was added. HepB Footnote updated to include recommendation to vaccinate adults younger than 60 years old who have diabetes, as soon as possible after diabetes is diagnosed. A new footnote to links for the full ACIP vaccine recommendations and where to find additional information on specific vaccine recommendations for travelers. 7/19/2012

February 2012 ACIP Meeting Highlights Tdap Vote: Use of Tdap in persons 65 years and older Discussion of PCV13 use in adults 50 yrs and older Discussion of meningococcal vaccine for infants No vote, no recommendation 7/19/2012

June 2012 ACIP Meeting Highlights PCV13 use in immunocompromised males vote taken new recommendation Influenza vaccine recommendations including dosing for 6 mos thru 8 years old Updates on HPV vaccine uptake, Adult immunizations Meeting slides and minutes: http://www.cdc.gov/vaccines/recs/acip/meetin gs.htm

PCV13 USE IN IMMUNOCOMPROMISED ADULTS

Pneumococcal Conjugate Vaccine (PCV13) for Adults On December 30, 2011, PCV13 (Pfizer) was licensed for use among adults 50 years of age and older FDA approved expanded age indications under the Accelerated Approval Pathway 7/19/2012

Pneumococcal Conjugate Vaccine (PCV13) for Adults PCV13 immunogenicity non-inferior to PPSV23 Indications Prevention of pneumococcal disease, including pneumonia and invasive disease Prevention of disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F 7/19/2012

Summary of Feb 2012 ACIP Deliberations: PCV13 for Adults Deferred universal recommendation pending the further collection of data -Efficacy of PCV13 against pneumonia (CAPITA trial, results in 2013) -Indirect (herd) effects of PCV13 use in children 7/19/2012

ACIP Recommendations June 2012 Pneumococcal Vaccine naïve adults Adults 19 years of age or older with immunocompromising conditions, functional or anatomic asplenia, CSF leaks or cochlear implants, and those who have not previously received PCV13 or PPSV23 should receive a single dose of PCV13 followed by a dose of PPSV23 at least 8 weeks later. DRAFT LANGUAGE 7/19/2012

Revaccination with PPSV 23 A second dose of PPSV23 is recommended 5 years after the first dose for persons aged 19 64 years with functional or anatomic asplenia and for persons with immunocompromising conditions. Those who received PPSV23 before age 65 years for any indication should receive another dose of the vaccine at age 65 years or later if at least 5 years have passed since their previous dose. Those who receive PPSV23 at or after age 65 years should receive only a single dose of PPSV23. DRAFT LANGUAGE 7/19/2012

ACIP June 2012- Adults previously vaccinated with PPSV 23(2) Adults 19 years of age or older with immunocompromising conditions, functional or anatomic asplenia, CSF leaks or cochlear implants, who have previously received one or more doses of PPSV23 receive a dose of PCV13 one or more years after the last PPSV23 dose was received. For those that require additional doses of PPSV23, the first such dose should be given no sooner than 8 weeks after PCV13 and at least 5 years since the most recent dose of PPSV23 DRAFT LANGUAGE 7/19/2012

Potential Scenarios for Adults previously vaccinated with PPSV23 Draft language 7/19/2012

Adults Previously Vaccinated with PPSV23 40-year-old male with asplenia who received PPSV23 three years ago administer PCV13 today (at least 1 year interval since PPSV23) administer 2 nd PPSV23 in 2 years (at least 5 year interval after last PPSV23 dose and at least 8 weeks after PCV13 dose) administer final dose of PPSV23 at 65 years of age 7/19/2012

PERTUSSIS VACCINES IN ADOLESCENTS AND ADULTS

PERTUSSIS IN THE U.S. 2012 As of 7/5/12: 17,000 cases reported 10 deaths reported so far (majority among infants < 3 months of age) Several outbreaks or increased activity in several states in 2012 so far 2010: 27,550 cases with 27 deaths (25 of these in children under a year old). Also increase in cases in 7-10 year olds. CDC Unpublished data, http://www.cdc.gov/pertussis/outbreaks.html

Why Adolescents and Adults Need Pertussis Vaccine Pertussis cases increased in the late 1990s and early 2000s 2004 25,827 pertussis cases: 67% of cases among adolescents or adults Severe illness among young infants with pertussis Pertussis immunity wanes in 5-10 years after vaccination 7/19/2012

Source of Infection for Infants With Pertussis Household contact 71% Parent 55% (mother 37%, father 18%) Sibling 16% Non-household contact 29% Aunt/uncle 10% Friend/cousin - 10% Grandparent 6% N=44 infants <6 months of age. Pediatr Infect Dis J 2007;26(4):293-9. 7/19/2012

Adolescent and Adult Pertussis Vaccination Primary objective protect the vaccinated adolescent or adult Secondary objective reduce reservoir of B. pertussis potentially reduce incidence of pertussis in other age groups and settings 7/19/2012

General Principles for Use of Tdap and Td Tdap preferred to Td to provide protection against pertussis Tdap approved only for a single booster dose in persons who have received a full series of pediatric DTaP or DTP Tdap is NEITHER approved NOR recommended for multiple administrations

Tdap Tdap reduces the risk of pertussis by 60% - 80% Tdap approved ages 10 years and older for Boostrix 11 through 64 years for Adacel Schedule: One time only dose (IM) Wei SC et al. Clin Infect Dis 2010;51:315-21 7/19/2012

Use of Tdap Among Children 7 Through 10 Years of Age Children 7 through 10 years of age who are not fully vaccinated against pertussis and who do not have a contraindication to pertussis vaccine should receive a single dose of Tdap* Either brand of Tdap may be used No revaccination at age 11-12 years old for those who received Tdap at ages 7 through 10 years Revaccination issue still being evaluated *off-label recommendation. MMWR 2011; 60 (No. 1):13-5 7/19/2012

Not Fully Vaccinated Against Pertussis Having received fewer than 4 doses of DTaP, or Having received 4 doses of DTaP but the last dose was prior to age 4 years 7/19/2012

Tdap Recommendations for Adolescents All adolescents should preferably receive Tdap at the 11 to 12 year-old preventive healthcare visit Persons 11 through 18 years of age who have not received Tdap should receive a dose followed by Td booster doses every 10 years Administer at the same visit as other indicated vaccines (e.g. MCV, HPV) MMWR 2011; 60 (No. 1):13-5

Tdap Vaccine in Adolescence Tdap/Td interval removed (NEW!!) Can be administered regardless of interval since the last tetanus- or diphtheria-toxoid containing vaccine No booster doses of Tdap recommended at this time MMWR: January 14, 2011 / 60(01);13-15

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6125a4.htm Updated recommendation for use of Tdap in Adults For adults aged 19 years and older who previously have not received a dose of Tdap, a single dose of Tdap should be given. Tdap should be administered regardless of interval since the last tetanus or diphtheria toxoid-containing vaccine. Adults should receive a Tdap dose if the dose is recommended and no record of previous administration exists.

Tdap in Adults Unchanged recommendations: After receipt of Tdap, persons should continue to receive Td for routine booster vaccination (every 10 years) Adolescents and adults (previously unvaccinated) planning close contact with an infant should receive Tdap (cocooning) 7/19/2012

Tdap in Adults over 65 years old Vote taken at ACIP meeting in Feb 2012, published 6/29/12 Providers should not miss an opportunity to vaccinate persons aged 65 years and older with Tdap, and may administer the vaccine that they have available. http://www.cdc.gov/mmwr/preview/mmwrhtml/m m6125a4.htm

Tdap in Adults over 65 years old(2) When feasible, for adults aged 65 years and older, Boostrix should be used; however, either vaccine product administered to a person aged 65 years and older provides protection and is considered valid. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6125a4.htm

Case studies An 8 year old patient arrives from Botswana without any immunization records. You decide to vaccinate against Diphtheria, Tetanus and Pertussis. Which vaccine would you give this child today and how many doses: DTaP or Tdap or Td? When this child turns 11 years old, do you give any more vaccine against Diphtheria, Tetanus and Pertussis? A 14 year old child received Td vaccine at age 13 years old (his first Td dose ever). He now presents to your office for his annual check up and you do not see evidence of him receiving Tdap vaccine in the past. Can you give Tdap vaccine today?

DTaP and Tdap Administration Errors Error Action DTaP given to person >7 years Count dose as valid Tdap given to child <7 years as DTaP #1, 2, or 3 Do not count dose; give DTaP now Tdap given to child <7 years as DTaP #4 or 5 Count dose as valid

INFLUENZA

Universal Recommendation Influenza vaccine is recommended for everyone 6 months and older (without contraindications to the vaccine) 7/19/2012

Influenza Vaccine strains for the 2012-13 Season WHO: Feb 23, 2012 recommendations for Northern Hemisphere s 2012-2013 influenza vaccine to contain: an A/California/7/2009 (H1N1)pdm09-like virus; an A/Victoria/361/2011 (H3N2)-like virus; a B/Wisconsin/1/2010-like virus (from the B/Yamagata lineage of viruses) FDA (VRBPAC): Feb 28 2012 agreed with recommendation 7/19/2012

DOSING IN CHILDREN 6 MONTHS THROUGH 8 YEARS OF AGE

DRAFT ONLY SUBJECT TO CHANGE 7/19/2012

HEPATITIS B VACCINE IN ADULTS WITH DIABETES

HepB vaccine in Adults with DM Hepatitis B vaccination should be administered to unvaccinated adults with diabetes mellitus who are aged 19 through 59 years Hepatitis B vaccination may be administered at the discretion of the treating clinician to unvaccinated adults with diabetes mellitus who are aged 60 years 7/19/2012

Human Papillomavirus and HPV Vaccine National Center for Immunization and Respiratory Diseases Education, Information, and Partnership Branch

ACIP Updated HPV Vaccine Recommendations 10/25/2011 Only HPV4 (Gardasil) should be administered to males HPV2 is not approved for males of any age Routinely administer HPV4 vaccine to boys ages 11-12 years to prevent HPV and HPV related diseases May be administered as young as 9 years of age Catch up: Young men 13 through 21 years of age who have not completed a HPV4 series http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a3.htm

ACIP Update HPV Vaccine Recommendations 10/25/2011 ACIP went on to routinely recommend HPV4 vaccination for immunosuppressed males 22 through 26 years and MSM through age 26 years HPV4 may be administered to healthy males 22 through 26 years of age

HPV Vaccine Special Situations Vaccine can be administered to females with: equivocal or abnormal Pap test positive HPV DNA test genital warts immunosuppression breastfeeding MMWR 2010;59(No. 20):626-9

HEALTH CARE WORKER RECOMMENDATIONS

ACIP Recommendations Nov 2011 http://www.cdc.gov/mmwr/preview/mmwrhtml/r r6007a1.htm?s_cid=rr6007a1_e

Pop Quiz 14 year old previously unvaccinated twins from Russia (one male, one female) come to your office. You have Tdap, MCV4, HPV2 vaccines available. What vaccine(s) should they receive today?

Overview Introduction ACIP overview who is the ACIP? 2012 Immunization Schedules Feb 2012 and June 2012 ACIP Meeting Updates Updated ACIP recommendations Tdap adults and adolescence Influenza Updates PCV13 in Immunocompromised Adults HepB adults with diabetes HPV4 routine recommendation for males Health Care Worker Recommendations Vaccine Administration (S and H) Resources Q and A

STORAGE AND HANDLING VACCINE ADMINISTRATION

Cold Chain Vaccines are fragile They must be stored properly from the time they are manufactured until they are given Manufacturer to distributor Distributor to office Office to patient

Vaccine Storage Equipment Do NOT use a dormitory unit for permanent storage of vaccines Small combination freezer/refrigerator unit with one exterior door An icemaker compartment (freezer) within the refrigerator

Knowledgeable Staff Assign S&H responsibilities to a staff person Designate a back-up person Train all staff on vaccine storage and handling Including new staff orientation annually, and ongoing updates as needed

Ordering and Accepting Vaccine Deliveries Choose vaccines that best meet the needs of patients the facility serves Order enough vaccines to meet the needs of the facility s patients Store vaccines at the recommended temperature range IMMEDIATELY on arrival

Temperature Monitoring 1. Post a refrigerator and freezer temperature log 2. Read and record the temperature twice daily 3. Store temperature logs for at least 3 years unless state statutes or rules require a longer period

Take IMMEDIATE Action for Out-of-range Temperature

Vaccine Administration The Right Patient The Right Vaccine The Right Time The Right Dosage The Right Route The Right Technique The Right Documentation

Administer the Vaccine Correctly Prepare vaccine just prior to administration Choose the correct vaccine based on patient s age and health status Check the label 3 times! Vial mix-up charts: www.eziz.org

Right Route for Right Vaccine Rotavirus Vaccine Oral Route LAIV Vaccine Intranasal Route

IMMUNIZATION RESOURCES

General Recommendations on Immunization

The Pink Book

Resources www.cdc.gov/vaccines State Immunization Program Website www.immunize.org

Questions nipinfo@cdc.gov 1-800-CDC-INFO

Thank You! Please complete the online evaluation and CME questionnaire. You will receive an email with a link to the evaluation/questionnaire. If you are requesting CME credit, you MUST complete the evaluation and all the CME questions to receive credit. Contact Shannon Kolman, CHAMPS Clinical Programs Director, at 303-867-9583 or Shannon@CHAMPSonline.org with questions. 7/19/2012

Provider Resources for Vaccine Conversations with Parents Developed with partners: AAP and AAFP Primary Target Audience: Healthcare Professionals Information to help HCW talk to parents about vaccines, vaccine-preventable diseases, and vaccine safety Dual purpose: resources hcps can provide to parents Based on formative, mixed methods research Using risk communication principles Extensively reviewed by subject matter experts 7/19/2012

Talking with Parents about Vaccines for Infants During the Office Visit Take time to listen Solicit and welcome questions Keep the conversation going Use a mix of science and personal anecdotes Acknowledge benefits and risks Respect parents authority After the Office Visit Document parents questions/ concerns Follow up a few days after the visit 7/19/2012

Materials: Provider Resources for Vaccine Conversations with Parents Understanding Vaccines and Vaccine Safety How Vaccines Work The U.S. Recommended Childhood Immunization Schedule Ensuring the Safety of U.S. Vaccines Understanding the Vaccine Adverse Reaction Reporting System (VAERS) Understanding MMR Vaccine Safety Understanding Thimerosal, Mercury, and Vaccine Safety Understanding Vaccine Ingredients Understanding the Advisory Committee on Immunization Practices (ACIP) Diseases and the Vaccines that Prevent Them 14 vaccine-preventable disease sheets 2 versions (one for high-information seeking parents and other plain language) 83

Provider-Targeted Materials Topics of concern/interest to providers and parents Q&A format Summary of key points Date Co-branded with AAFP and AAP The science 84

Parent-Targeted Materials Date Quotes from health care professional s VPD risks Current stories from families affected by VPDs 7/19/2012 Co-branded with AAFP and AAP Vaccine risks and benefits References

Parent-Targeted Materials Providers requested more plain-language pieces for parents More basic overview of disease and vaccine Most have no story (or an abbreviated version) Clearly shows benefits and risks 7/19/2012

7/19/2012 Other Parent-Targeted Resources

More Parent-Targeted Resources Well Child Visit Tracker Growth Chart Parent-friendly immunization schedules 7/19/2012

www.cdc.gov/vaccines/conversations 89

Website Email alerts sent to subscribers when materials are added to site Feedback requested Comments will inform future plans 7/19/2012

We Can All Make Our Vaccine Conversations More Effective Start conversations early (prenatal visits) Give resources prior to the vaccination visit Use language parents understand/prefer Layer information Use personal stories Provide your recommendation Use credible resources to reinforce your messages Encourage other health care professionals to talk to parents 7/19/2012

Questions nipinfo@cdc.gov 1-800-CDC-INFO