1. CVD Testing the H1N1 Pandemic Flu Vaccines Mini-Med School Karen Kotloff, MD University of Maryland School of Medicine Center for Vaccine Development September 8, 2010 Mexico City, Time Magazine, April 2009

2. CVD Unfolding of the H1N1 flu pandemic Feb 2009: First cases in Mexico April 15: First cases detected in U.S. April 26: DHHS declares Public Health Emergency May 29: Cases in 49 U.S. states and 53 countries June 11:WHO declares a Global Pandemic Aug 4:  Global: 162,380 confirmed cases and 1,154 deaths  U.S.:6,506 hospitalizations and 436 deaths

3. CVD What is Influenza? Viral infection of respiratory tract Spreads person-to-person by coughing and sneezing Usually wintertime Symptoms: Fever, runny nose, cough, sore throat, body aches 20,000-40,000 deaths each year

4. CVD Triple reasssortant swine flu viruses (genes from human, swine, and birds) have been identified in swine in the US since 1998 12 cases in humans were identified in 2005-9 On April 15 and 17, two cases were identified in US with a new combination of gene segments

5. CVD How does H1N1 flu behave differently from standard, “seasonal” flu?

6. May 1, 2009 Ventured into warmer months Percentage of Visits for Influenza-like Illness (ILI) Reported by the U.S. Outpatient ILI Surveillance Network (ILINet), National Summary 2008- 2009 and Previous Two Seasons, until Week Ending August 1, 2009)

7. CVD Affected people are younger than with seasonal flu From EU July 2009

8. CVD Distribution of deaths from H1N1 flu in U.S. by age group

9. CVD H1N1 is more contagious than season flu 2009 H1N1

10. CVD The result is..

11. CVD Risk groups for H1N1 pandemic 2009 flu People with chronic conditions in the particularly those that compromise their immunity or respiratory function, including severe or morbid obesity Pregnant women Young children (particularly those less than 2 years of age)

12. CVD Vaccines are highly effective in preventing flu Flu strains expected to circulate in community Weakened Killed Split Purified H1N1 vaccine is made the same way Live, nasal spray vaccine Inactivated flu shot

13. CVD Studies are needed to inform policy People with some immunity respond better to flu vaccines – we need to know the best way to vaccinate a population that has little pre-existing immunity How many doses are needed in different age groups Can the standard strength be used or is a higher strength vaccine needed? Can H1N1 vaccine be given at the same time as the seasonal flu vaccine? Is it safe and effective in persons at increased risk? Are there ways to make the vaccine work at lower doses so there’s more to go around?  Studies at the Vaccine Testing and Evaluation Units will attempt to answer these questions

14. CVD NIAID Vaccine Testing and Evaluation Units

15. CVD Study Overview 200 subjects age 18-64 years old 200 subjects age ≥ 65 years old 200 subjects 6-35 months 200 subjects 3-9 years 200 subjects 10-17 years Multiple Sites If safe,

16. CVD Rationale for This Study 1)Explore two dose levels: 15 mcg “standard” 30 mcg “high-dose” 2)Explore 1 dose or 2 doses: 3)Explore how quickly immune responses likely to be protective are elicited Dose 1Dose 2 21 days

17. CVD Methods 1.Safety and Reactogenicity 7-day Diary after each dose Adverse Effects at each of 5 visits plus phone calls for 7 months Changes in Medical History and Medications 2.Immunogenicity Serum Antibody Week 1Week 2Week 3Week 4Week 5Week 6

18. CVD Impact SummerSchoolWinter starts Cases Vaccine available Study results available

19. CVD How to avoid contracting swine H1N1 flu

20. CVD How to avoid contracting swine H1N1 flu