ACIP Meeting Update, New Recommendations and Pending Influenza Season

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ACIP Meeting Update, New Recommendations and Pending Influenza Season February 17 th 2011 www.immunizetexas.com

ACIP Upcoming Agenda and New Recommendations

ACIP (February 23-24 th 2011) Topics for meeting Pertussis Proposed recommendations to update Tdap for HCP Proposed recommendation to update Tdap as postexposure prophylaxis in HCP (vote) Overview of Tdap use during pregnancy (currently recommended for preconception or postpartum) Immunization of Healthcare Personnel (vote) Current recommendations are from 1997 Vaccine updates will include influenza, MMR, Pertussis, and Meningococcal recommendations HCP- Healthcare personnel

ACIP (February 23-24 th 2011) Topics for meeting Influenza recommendations 2011-2012 (vote) Vaccine Safety updates concerning febrile seizures following vaccination (mainly w/flu) Herpes Zoster (HZ) Update HZ vaccine safety (VAERS and VSD data) Review vaccine efficacy in persons 50-59 (FDA expected to respond to Merck s request to extend indications to persons 50-59) Economic analysis and review of production capabilities to be considered

ACIP (February 23-24 th 2011) Topics for meeting HPV Update on HPV related cancers HPV vaccine (HPV4) recommendations for males being reconsidered (looking at vaccine cost and coverage levels of women improving) Hepatitis B Vaccine Cost effectiveness and new policy options including recommending hepatitis b vaccination for adults with diabetes under 60 years of age (permissive recommendation for + 60) 13-valent Pneumococcal Conjugate Vaccine (PCV 13) Vaccine expected to be licensed for adults in late 2011 Cost effectiveness, public health and economic impact of PCV 13 of adults > 50

ACIP Updates Since Last TISWG Prevention of Pneumococcal Disease Among Infants and Children-Use of 13- ValentPneumococcal Conjugate Vaccine and 23- Valent Pneumococcal Polysaccharide Vaccine. MMWR 2010;59(RR11):1-18 Updated Tdap Vaccine Recommendations: Pertussis (Tdap: use of Tdap regardless of interval since last Td; Tdap in people 65 yrs; under vaccinated children 7-10 yrs). MMWR 2011;60(01):13-15 Updated Recommendations for Use of Meningococcal Conjugate Vaccines. MMWR 2011;60(03):72-76

ACIP Updates Since Last TISWG Influenza (Use of antivirals for prevention and control of influenza). MMWR 2011;60(RR01):1-24 General Recommendations on Immunization. MMWR 2011;60(RR02):1-60 Recommendation Adult Immunization Schedule. MMWR 2011;60(04):1-4 Recommendation Childhood Immunization Schedule. MMWR 2011;60(05):1-4

Prevention of Pneumococcal Disease Among Infants and Children --- Use of 13-Valent Pneumococcal Conjugate Vaccine and 23- Valent Pneumococcal Polysaccharide Vaccine http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5911a1.htm?s_cid=rr5911a1_e Summarizes the recommendations approved by ACIP on February 24, 2010, for the prevention of pneumococcal disease among infants and children aged 18 years and replaces the previous ACIP recommendations for preventing pneumococcal disease in children Provides updated information regarding changes in the epidemiology of pneumococcal disease in the United States after the routine PCV7 infant vaccination program began in 2000.

Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) ACIP Tdap Recommendations for children and adults: Single Tdap dose for persons aged 11 through 18 years who have completed the recommended childhood (DTP/DTaP) vaccination series and for adults aged 19 through 64 years Use of Tdap in under vaccinated children aged 7 through 10 years. Pertussis vaccination, when indicated, should not be delayed and that Tdap should be administered regardless of interval since the last tetanus or diphtheria toxoid-containing vaccine.

Tdap Recommendation (cont.) ACIP Tdap Recommendations for Aged 65+: Adults aged 65 years and older who have or who anticipate having close contact with an infant less than 12 months of age and who previously have not received Tdap should receive a single dose of Tdap to protect against pertussis and reduce the likelihood of transmission. For other adults aged 65 years and older, a single dose of Tdap vaccine may be given instead of Td vaccine, in persons who have not previously received Tdap. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a3.ht m?s_cid=mm6003a3_e

Updated Recommendations for Use of Meningococcal Conjugate Vaccines Routine vaccination of adolescents, preferably at age 11 or 12 years, with a booster dose at age 16 years and a 2-dose primary series administered 2 months apart for persons aged 2 through 54 years with persistent complement component deficiency (e.g., C5--C9, properidin, factor H, or factor D) and functional or anatomic asplenia, and for adolescents with human immunodeficiency virus (HIV) infection. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6003a3.h tm?s_cid=mm6003a3_e

General Recommendations on Immunizations (1/28/2011) Revision of the 2006 General Immunization Recommendations Topics covered include Vaccine schedules Contraindications and Precautions Preventing and Managing Adverse Reactions Vaccine administration, storage and handling Altered Immunocompetence Vaccination Records Vaccine Programs Vaccine Information Sources and Charts

2011 Childhood and Adolescent Schedule Changes Guidance has been added for the hepatitis B vaccine schedule for children who did not receive a birth dose. Information on use of 13-valent pneumococcal conjugate vaccine has been added. Guidance has been added for administration of 1 or 2 doses of seasonal influenza vaccine based upon the child s history of monovalent 2009 H1N1 vaccination. Use of tetanus and diphtheria toxoids, and acellular pertussis (Tdap) vaccine among children aged 7 through 10 years who are incompletely vaccinated against pertussis is addressed, and reference to a specified interval between tetanus and diphtheria toxoids (Td) and Tdap vaccination has been removed.

2011 Childhood and Adolescent Schedule Changes Footnotes for the use of human papillomavirus (HPV) vaccine have been condensed. A routine 2-dose schedule of quadrivalent meningococcal conjugate vaccine (MCV4) for certain persons at high risk for meningococcal disease, and recommendations for a booster dose of MCV4 have been added. Guidance for use of Haemophilus influenzae type b (Hib) vaccine in persons aged 5 years and older in the catch-up schedule has been condensed.

2011 Adult Schedule Changes The influenza vaccination footnote is revised and shortened to reflect a recommendation for vaccination of all persons aged 6 months and older, including all adults. The high-dose influenza vaccine (Fluzone), licensed in 2010 for adults aged 65 years and older, is mentioned as an option for this age group. The Td/Tdap vaccination footnote has language added to indicate that persons aged 65 years and older who have close contact with an infant aged less than 12 months should get vaccinated with Tdap; the additional language notes that all persons aged 65 years and older may get vaccinated with Tdap. Also added is the recommendation to administer Tdap regardless of interval since the most recent Td-containing vaccine.

2011 Adult Schedule Changes The HPV vaccination footnote has language added to the introductory sentences to indicate that either quadrivalent vaccine or bivalent vaccine is recommended for females. The MMR vaccination footnote has been revised mainly by consolidating common language that previously had been part of each of the three vaccine component sections into one introductory statement. The revaccination with PPSV footnote clarifies that onetime revaccination after 5 years only applies to persons with indicated chronic conditions who are aged 19 through 64 years.

2011 Adult Schedule Changes The meningococcal vaccination footnote has language added to indicate that a 2-dose series of meningococcal conjugate vaccine is recommended for adults with anatomic or functional asplenia, or persistent complement component deficiencies, as well adults with human immunodeficiency (HIV) virus infection who are vaccinated. Language has been added that a single dose of meningococcal vaccine is still recommended for those with other indications. Also, language has been added to clarify that quadrivalent meningococcal conjugate vaccine (MCV4) is a quadrivalent vaccine. The language for the selected conditions for the Hib footnote has been shortened to clarify which persons at high risk may receive 1 dose of Hib vaccine

Seasonal Flu Projections for 2010-2011 GSK: 32 million doses (from 36 M) Medimmune: 16 million doses Merck/CSL: 7 million doses (from 14 M) Novartis: 35-40 million doses Sanofi: 70 million doses TOTAL: 160 to 165 million (from +171M) CSL.25 ml and.5ml multi-dose vials will no longer be available in the United States for 2010-2011 (reduction by 7 million doses) Texas VFC Program doses of this formulation have been replaces by other products

Seasonal Flu Doses Manufactured (2005-2010) Doses/Million 160 140 120 100 80 60 40 160* 115 135.9 140.6 120 91.7 20 0 2010-2011 2009-2010 2008-2009 2007-2008 2006-2007 2005-2006 * Projected doses to be manufactured for the US market as of 10/2010

Texas DSHS Flu Doses Ordered for TVFC 2006-2010 11 different formulations from 5 different manufacturers were pre booked for 2010-2011 Formulation 2010* 2009 2008 2007 2006.25 ml doses: 458,810 383,930 293,960 286,450 316,000.5 ml doses 1,062,270 483,220 459,652 331,370 229,700 Flumist: 480,770 297,270 105,690 55,000 0 TOTAL 2,001,850 1,164,420 859,302 672,820 545,700 Increase 837,430 305,118 186,482 127,120 Texas VFC Eligible Children 0-18: 4,311,446 *120,000 doses of flu vaccine was ordered with ARRA funds in 2010 ** 95% of all 2010 doses have been ordered and shipped Total Texans 0-18: 6,786,953

2011 Seasonal Flu Timeline WHO has made recommendations for 2011-2012 strains in early February FDA will choose strains for use in the US on February 25 th, 2011 (at conclusion of ACIP meeting) Current Recommendations for vaccination of children 6-23 are unchanged. Other changes may be proposed at the ACIP meeting in June (in response to febrile seizures following trivalent inactivated flu vaccine and PCV 13 vaccine. ACIP expected to continue the recommendation of influenza vaccination for all persons 6 months of age and older in the US for 2011-2012 season. CDC expects states to project VFC program need by early March. Texas survey to providers is pending.