US Rotavirus Vaccination Program

Transcription

1 US Rotavirus Vaccination Program 1

2 Rotavirus Vaccines in US Feb 2006 Feb 2006 April 2008 June 2008 RotaTeq licensed by FDA RotaTeq recommended by ACIP Rotarix licensed by FDA ACIP to consider Rotarix 2

3 US Immunization Schedule

4 Monitoring Adoption and use Coverage Safety Impact and effectiveness 4

5 Physicians Attitudes Regarding Rotavirus Vaccine: Dec 2007 A Kempe, M. Daley, L Crane, B Beatty, S Stokeley, J Tate, M Patel, S. Berman, U Parashar ACIP presentation Feb

6 Design National survey of pediatricians and family medicine physicians Network recruited from random sample of 2500 AAP and AAFP members Designed to be representative: Region of country (NE, S, MW, W) Location (urban, suburban, rural) Survey administered by mail/ 80% response rate 6

7 Strength of Recommendation Peds FM 100% 80% 70% 60% 40% 20% 0% 22% Strongly recommend 18% 33% Recommend, but not strongly 10% 37% Inform, but make no recommendation 2% 8% Recommend against Distributions between Peds and FM are different at p=<

8 Current Administration Practices Peds FM 100% 80% 85% 60% 40% 45% 42% 20% 0% Routinely administer 3% 14% Offer, but not routinely 11% Do not offer Distributions between Peds and FM are different at p=<

9 Perceived Barriers to Giving Rotavirus Vaccine Definitely a Barrier Failure of insurance coverage Up-front costs to purchase the vaccine Lack of adequate reimbursement Concern about safety Addition of another vaccine to the schedule Peds (n=359) 19% 17% 15% 9% 5% FM (n=264) 22% 22% 18% 25% 22% 9

10 Vaccine Uptake & Adherence with Age Recommendations H Clayton, D Bartlett, M Cortese, D Payne, L Stockman, J Baggs, M Wang, W Williams, U Parashar Clayton et al, MMWR

11 National Immunization Survey Gold standard to assess coverage Annual survey of US children months of age First data on rotavirus in late 2008, which will reflect coverage in

12 Sentinel Immunization Information Systems (IIS) Confidential, computerized records of vaccine administration 6 sites (Michigan, Arizona, Minnesota, Montana, Washington DC, Orgeon) >10,000 children <6 years of age, > 90% participation 12

13 First dose rotavirus vaccination coverage among children aged Months in IIS Sentinel Sites, by quarter and site % Vaccinated Q Q Q Q Q Q Arizona DC Michigan Minnesota Montana Oregon Sentinel Site 13

14 Dose 1 coverage for different vaccines among infants aged 3 months, IIS, May 15, % Vaccinated RV DTaP PCV7 0 Arizona DC Michigan Minnesota Montana Oregon Sentinel Site 14

15 US Recommendations for RotaTeq: Administer dose 1 at 6-12 weeks of age Number of doses % Dose 1 given between ages 6-12 wks (~23,000 total Dose 1s) < Age in weeks 15

16 Safety Monitoring P Haber, M Patel, H Izurieta, J Baggs, E Weintraub, M Cortese, M Braun, B Ball, J Iskander, U Parashar Haber et al. MMWR 2007, ICAAC 2007, NIC 2008, Pediatrics June 2008 (in press) 16

17 Data Sources Passive Surveillance Vaccine Adverse Events Reporting System (VAERS) Active Surveillance Vaccine Safety Datalink (VSD) Merck phase IV study 17

18 IS Reports to VAERS, Feb 2006-Jan 2008 (N=226) 6 Dose Dose 1 (N=65) Onset Interval (days) after RotaTeq Vaccination Dose Dose 2 (N=100) Onset Interval (days) after RotaTeq Vaccination Dose Onset Interval (days) after RotaTeq Vaccination Dose 3 (N=61) 18

19 Comparison of IS Reports to VAERS with Rotashield and RotaTeq Proportion of total VAERS intussusception cases 70% 60% 50% 40% 30% 20% 10% 0% >78 Onset interval (days since vaccination) RotaTeq vaccination Rotashield vaccination 19

20 Interpreting VAERS Data Compare observed IS rates with expected rates Expected rates derived based on Number of vaccine doses administered Background rates of intussusception Data assumptions Completeness of reporting to VAERS Proportion of vaccine doses sold that have been administered 20

21 Observed versus Expected 1 to 7 Days (any dose) % reporting % doses given VAERS cases Expected cases RR (95% CI) ( ) ( ) ( ) 21

22 Observed versus Expected 1 to 7 Days (dose 1) % reporting % doses given VAERS cases Expected cases RR (95% CI) ( ) ( ) ( ) 22

23 Vaccine Safety Datalink ~165,000 RotaTeq vaccinations by Feb 15, IS reports in days after vaccination, compared with 5.7 expected No IS report days after vaccination ~130,000 first doses including clinical trial Irving et al, NIC 2008 (poster) 23

24 Post-licensure cohort sample size Risk window: 7 days of dose 1 Risk ratio Sample Size Attributable cases* Rotavirus hospitalizations million 25 50,000 to 70, , (20 to 60 deaths) Sample Size n = 222, Risk Ratio * Assumption: entire US birth cohort (~4 million) were vaccinated with dose 1 of a rotashield vaccine 24

25 Monitoring Impact on Disease and Viral Strains C Panozzo, D Payne, J Tate, M Staat, K Edwards, P Szilagyi, A Curns, M Cortese, M Patel, M Widdowson, R Glass, U Parashar, J Gentsch MMWR in preparation 25

26 National Respiratory and Enteric Virus Surveillance System (NREVSS) >100 US laboratories Weekly reporting Number of rotavirus tests performed Number testing positive 26

27 Annual Seasonality of Rotavirus in US Nov Dec Jan Feb Mar Apr May

28 Median, Max, and Min Percent of Rotavirus Positive Tests, versus Season, by Week Max Median Min Season % of Tests Rotavirus Positive Week of Year

29 Number of Positive and Total Rotavirus Tests, United States, , 33 Continuously Reporting Labs 900 Total N Tests Total N Positive RotaTeq introduced

30 US AGE outpatient visit trends Preliminary data from SDI 40% sample of US outpatient visits billed to insurance companies ICD-9 9 codes used to define diarrhea visits 30

31 Weekly RAW COUNT of all-cause diarrhea outpatient visits in SDI databas for children <5 years old, Jan 2005 through April 2008 Source: SDI medical claims data - a 40% sample of outpatient visits QuickTime and a decompressor are needed to see this picture All US Regions /2/05 2/2/05 3/2/05 4/2/05 5/2/05 6/2/05 7/2/05 8/2/05 9/2/05 10/2/05 11/2/05 12/2/05 1/2/06 2/2/06 3/2/06 4/2/06 5/2/06 6/2/06 7/2/06 8/2/06 9/2/06 10/2/06 11/2/06 12/2/06 1/2/07 2/2/07 3/2/07 4/2/07 5/2/07 6/2/07 7/2/07 8/2/07 9/2/07 10/2/07 11/2/07 12/2/07 1/2/08 2/2/08 3/2/08 4/2/08 5/2/08 Courtesy Lone Simonsen and Laurel Edelman, SDI Week during Jan 2005 through April 2008

32 Surveillance at sentinel hospitals in 3 US counties AGE cases enrolled from inpatient, ED, and clinic setting Fecal specimen obtained and tested for rotavirus

33 Total AGE and Rotavirus AGE cases in NVSN, Jan-April, Total AGE Rotavirus Number of cases

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