Influenza: A recap of the season

Transcription

1 Influenza: A recap of the season March 22, 2013 Debra Blog MD, MPH Director Division of Epidemiology What are we going to talk about The Influenza Vaccine Influenza Activity and Surveillance NYS Activities during the Influenza Season ACIP Updates Studies and Reports the take home messages What is coming for

2 Vaccine Composition/Distribution The influenza vaccine is composed of: A/California/7/2009 / / (H1N1) pmd09 like lk virus; A/Victoria/361/2011 (H3N2) like virus; B/Wisconsin/1/2010 like virus (obtained from B/Yamagata lineage of viruses) Manufacturers projected as many as 145 million doses of flu vaccine to be produced. 135 million doses have been distributed (as of 02/22/13) This includes doses produced by all US licensed manufacturers distributed in public and private sectors. 2

3 MMWR Update on Influenza Activity: September 30, 2012 February 9, 2013 Influenza activity began increasing in mid November The influenza season has been H3N2 predominant The percentage of outpatient visits to doctors for influenza like illness equaled/exceeded the national baseline for 12 consecutive weeks Influenza associated hospitalizations: most affected group were those 65 and older (accounting more >50% of those hospitalized) 3

4 MMWR Update on Influenza Activity (cont.) Between September 30 and February 9, the weekly percentage of deaths attributed to pneumonia and influenza (P&I) ranged from a low of 5.8% to a high of 9.9%. Exceeded the epidemic threshold for 6 consecutive weeks. Previous five seasons: range from 7.9% 9.1%. 64 influenza related pediatric deaths were reported 16 influenza A (H3N2) virus infection, 19 influenza A virus infection (not subtyped), 29 influenza B virus infection NYS Flu Activity & Surveillance Influenza activity in the state: Sporadic: until the week ending October 20,2012 Local: until the week ending November 10,2012 Regional: until the week ending November 17, 2012 Widespread: as of the week ending November 24, 2012 Reports of patient visits for influenza like like illness from ILINet providers has been above the regional baseline since early December 8 4

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6 Lab testing for Influenza at the Wadsworth Center (excluding NYC) * *=for the week ending 3/9/

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8 Flu doses shipped to NYS VFC/CHP providers season: Influenza vaccines for 6months and older: 581,720 doses season: Influenza vaccines for 6months and older: 684,365 doses season: Influenza vaccines for 6months and older: 561,670 doses season: Influenza vaccines for 6months and older: 597,600 doses 15 NYSIIS: NYS data Number of children with at least one influenza immunization administered this season*: 6mths <19years of age: 714,605 Estimated coverage: 26.8% (vs. 23.6% for the season) 6mths <6years of age: 274,687 Estimated coverage: 38.7% (vs. 36.2% for the season) *= 8/1/2012 2/28/

9 NYS Activities to Combat Influenza 1/12/13: Governor Cuomo Declares State Public Health Emergency in Response to Severe Flu Season Allowing Pharmacists to Vaccinate Children 1/12/13: Thimerosal Waiver 2/12/13: Statewide Non Patient Specific Order for Pharmacists Administration of Influenza Vaccine ( Season) Vaccine Supply BI was getting feedback that vaccine supply was an issues Plenty of VFC vaccine was available Harder to get private vaccine The intensity of disease burden and the concerns The intensity of disease burden and the concerns about vaccine were factors that led to the declaration of emergency and the series of executive orders. 9

10 1/12/13: Public Health Emergency EO allowed qualified pharmacists to administer influenza i t hild d 8 f vaccine to children under 18 years of age. Guidance issued which specifically targeted pharmacists in an effort to facilitate influenza vaccination for children Information was also disseminated on: Available influenza vaccine for purchase Influenza vaccine redistribution VFC influenza vaccine transfer program (use of VFC vaccine in non VFC eligible pediatric populations with prior approval from the CDC) Reporting requirements (NYSIIS/CIR) Standing Orders Expiration: April 14, 2013 (unless extended) 01/12/13: Thimerosal Waiver Commissioner of Health, pursuant to Public Health Law 2112 authorized the use of influenza vaccines containing more than the mercury levels described in PHL 2112 due to insufficient amounts of thimerosal free vaccine. Expiration: When influenza outbreak has ended. An advisory was distributed regarding the permissible administration of vaccines containing more than trace amounts of thimerosal to children less than 3 years of age and women who know they are pregnant. 10

11 2/12/13: Statewide Non Patient Specific Order for Pharmacists Executive Order No. 93: the Commissioner of Health has prescribed a state wide non patient specific standing order and protocol to allow vaccination of patients six months of age and older against seasonal influenza by all licensed pharmacists with a certificate of administration issued by the NYS Department of Education. Expiration: April 14,

12 ACIP Updates October 2012 Vote VFC vote to update the current VFC resolution to include quadrivalent influenza vaccines. The current VFC resolution uses the abbreviation TIV for trivalent inactivated vaccine. This language is not inclusive of potential future quadrivalent vaccines. The terminology, inactivated influenza vaccines (IIVs), was introduced so as to incorporate both trivalent and quadrivalent inactivated vaccines appropriately ACIP Updates: February 2013 Votes Four newly approved influenza vaccines were added to the guidance for the season: the guidance for the season: Flucelvax (Novartis): a trivalent, cell culture based inactivated influenza vaccine approved for use in individuals 18 and older. Flublok (Protein Sciences Corp): a trivalent, recombinant hemagglutinin (protein) vaccine approved for use in adults ages 18 to 49. FluMist Quadrivalent (MedImmune): a quadrivalent LAIV approved for healthy, nonpregnant individuals ages 2 to 49 (all FluMist will protect against two A strains and two B strains for the upcoming season). Fluarix Quadrivalent (GSK) a quadrivalent, inactivated influenza vaccine approved for individuals ages 3 and older. 12

13 ACIP Updates: February 2013 Items for Future Consideration Some proposed language presented td at the meeting detailing information that could be used to choose between the various vaccines Discussion about new evidence pointing to waning effectiveness of influenza vaccination over the course of a flu season, which could have implications for timing the start of annual vaccination campaigns. Data are too preliminary to make a firm recommendation on when influenza vaccination should start each year. That stance makes it likely that the guidance will be a continuation of the current advice, which is for healthcare professionals to offer vaccination as soon as vaccine becomes available. 13

14 CIDRAP Report 10/2012 publication 2009: grant provided to the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota to support the CIDRAP Comprehensive Influenza Vaccine Initiative (CCIVI). Primary objectives were to provide a comprehensive review of pandemic influenza vaccine preparedness and response and to review the scientific and programmatic basis for the current seasonal influenza vaccine efforts. CIDRAP Report Key findings During some influenza seasons vaccination offers substantially more protection than being unvaccinated, however, influenza vaccine protection is markedly lower than for most routinely recommended vaccines A major barrier to the development of game changing influenza vaccines is the perception that current vaccines are already highly effective in preventing influenza infection. ACIP has expanded the populations recommended to receive influenza vaccine, however, this was not based on scientifically sound data. 14

15 CIDRAP Report Key findings (cont.) Novel antigen influenza vaccines in investigational research offer the potential of lasting, broad, and potent protection, however, substantial research support is needed to further develop and evaluate these vaccines. Current government regulatory processes for approving influenza vaccines presents a barrier to the development of game changing vaccines. Substantial financial risks and inadequate incentives create significant barriers to bringing game changing vaccines to market. CIDRAP Report Key findings (cont.) Coordinated partnerships will be critical to move new vaccines through clinical trials and the licensure process. Current policy goals for influenza vaccines focus on increasing production and have not addressed challenges related to the effectiveness of current vaccines. Significant barriers must be overcome to achieve novel antigen game changing influenza vaccines. Pandemic influenza remains a clear and compelling threat and requires prioritization and an unprecedented coordinated efforts to mitigate this threat. 15

16 CIDRAP Report Recommendations Recommendation 1. Novel antigen game changing influenza vaccines that have superior efficacy and effectiveness are urgently needed. Recommendation 2. Scientifically sound estimates of influenza vaccines efficacy and effectiveness must become the cornerstone of policy recommendations regarding vaccine use and for driving efforts to develop new, more protective vaccines. CIDRAP Report Recommendations (cont.) Recommendation 3. Any pandemic influenza vaccine should demonstrate high efficacy and effectiveness for different pandemic patterns. Recommendation 4. A newly designed model adapted specifically to the development and licensure of novel antigen influenza vaccines must be implemented. 16

17 CIDRAP Report Recommendations (cont.) Recommendation 5. The US government should assume a primary leadership role in moving the global influenza vaccine enterprise forward to develop game changing influenza vaccines and bring them to market. Recommendation 6. An internationally accepted standard d for evaluating influenza vaccine efficacy and effectiveness should be used for calculating costeffectiveness of influenza vaccines Interim Analysis of Vaccine Effectiveness (VE) CDC MMWR: 02/22/13 / 2,697 participants in the U.S. Influenza Vaccine Effectiveness Network (12/03/12 01/19/13) Overall vaccine effectiveness was 56% after adjustment for age, study site, race/ethnicity, self rated health, and days from illness onset to enrollment. VE was 47% for influenza A viruses predominantly H3N2 and 67% for Influenza B viruses. Of study participants, 41% tested positive for Influenza and of those, 32% had been given flu vaccine, compared with 50% of Influenza negative controls. 17

18 VE in the 65+ Population Although effectiveness was largely consistent across age groups, the estimated VE against influenza A viruses for individuals 65 and older was only 9% (not statistically significant). In general, VE estimates for adults aged 65 and older have been lower than VE estimates in younger adults, but estimates have varied between years, studies and by virus types. VE Study Take Home Messages How well the flu vaccine works can vary by year, virus y y y, type/subtype, age, season, host immunity, and the outcome being measured. Recent studies show vaccine can reduce the risk of flu illness by about 60% among the overall population during seasons when most characterized circulating influenza viruses are like the viruses included in the vaccine. 18

19 FDA Recommendations Trivalent vaccines for the season: Retain current vaccine strain A/California/7/2009pdm09 like (2009 H1N1) virus Replace current vaccine strain A/Victoria/361/2011 (H3N2) like virus with A/Victoria/361/2011 (A/Texas/50/2012) Replace current vaccine strain B/Wisconsin/1/2010 like virus with a B/Massachusetts/2/2012 like (B/Yamagata lineage) virus. The committee also recommended that quadrivalent vaccines, contain a B/Brisbane/60/2008 like (B/Victoria lineage) virus in addition to the viruses recommended for the trivalent vaccines. 19

20 New Regulations for Health Care Personnel Requires health care personnel (HCP) in Article 28s and long term care facilities to wear a mask when flu is widespread in the state, if not vaccinated. Is in the public comment period Please send supportive comments Who: those who engage in activities such that if they were infected with influenza they could potentially expose patients or residents to the disease. Who are paid or unpaid, including but not limited to employees, members of the medical and nursing staff, contract staff, students, and volunteers Masks Who: are affiliated with a facility or agency licensed under Article 28 of the Public Health Law (including but not limited to general hospitals, nursing homes, diagnostic and treatment centers, and adult day healthcare services), Article 36 of the Public Health Law (including but not limited to certified home health agencies, long term home healthcare programs, acquired immune deficiency fii syndrome (AIDS) home care programs, licensed home care service agencies, and limited licensed home care service agencies) and hospices licensed under Article 40 of the Public Health Law, and 20

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