Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses

Transcription

1 Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses Monday, November 17, :00 PM ET This activity is supported by an unrestricted educational grant from Novartis Vaccines and Diagnostics, Inc.

2 Webinar Housekeeping Please note that today s webinar is being recorded All phone lines will be placed on mute throughout the program To hear audio: Phone: ; Access code: Computer: Follow WebEx directions After the presentations, there will be a Question and Answer period To ask a question, please use the question and answer box on the right hand side of your screen At the end of the webinar, participants will be automatically redirected to an online evaluation

3 CME Credit/Webinar Evaluation The National Foundation for Infectious Diseases (NFID) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. NFID designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit TM. Online evaluation and post-test will be available following the webinar at: Certificate will be available for print or download following completion of online evaluation and post-test

4 Disclosures Carol J. Baker (faculty) served as an advisor or consultant for Novartis Vaccines and Pfizer Inc. Marla Dalton (NFID staff, content reviewer) served as an advisor or consultant for Pfizer Inc. and owns stock, stock options, or bonds from Merck & Co., Inc. Susan J. Rehm (NFID medical director, content reviewer) served as an advisor or consultant for Cubist, Merck & Co., Inc., and Pfizer Inc., and served as a speaker or a member of a speaker s bureau for Genentech and Pfizer Inc. William Schaffner (faculty) served as an advisor or consultant for Merck & Co., Inc., Pfizer Inc., and Dynavax; and served as a speaker for Sanofi Pasteur. Ellyn Terry (NFID staff, content reviewer) served as an advisor or consultant for MedImmune and has received financial or material support from Sigma-Tau Pharmaceuticals, Inc.

5 Learning Objectives At the conclusion of this webinar, participants will be able to: Describe morbidity and mortality rates associated with meningococcal disease Explain which meningococcal serogroups are covered in the current US vaccination recommendations List challenges and barriers faced by health officials and healthcare professionals during meningococcal outbreaks

6 About NFID Non-profit 501(c)(3) organization dedicated to educating the public and healthcare professionals about causes, treatment, and prevention of infectious diseases across the lifespan Reaches consumers, health professionals, and media through: Coalition-building activities Public and professional educational program Scientific meetings, research, and training Longstanding partnerships to facilitate rapid program initiation and increase programming impact Flexible and nimble organization

7 Managing Meningococcal Disease Outbreaks: Special Challenges Associated with Serogroup B Carol J. Baker, MD Past-President, NFID Professor of Pediatrics, Molecular Virology & Microbiology Baylor College of Medicine Executive Director, Center for Vaccine Awareness & Research Texas Children s Hospital Houston, TX

8 NFID Report nfid.org/meningococcal-b

9 Meningococcal B Vaccine Licensed in the US On October 29, 2014, FDA approved a new Meningococcal B vaccine for use in the US Trumenba manufactured by Pfizer Licensed for ages years Three-dose series Another Meningococcal B vaccine, Bexsero, pending approval in US by FDA New accelerated FDA review, with approval anticipated early 2015 Same vaccine used during the college outbreaks in 2014 under an IND designation, facilitated by CDC

10 CDC Presentation at ACIP Manisha Patel. Presentation to the Advisory Committee on Immunization Practices, October 30, 2014

11 CDC Presentation at ACIP Manisha Patel. Presentation to the Advisory Committee on Immunization Practices, October 30, 2014

12 CDC Presentation at ACIP Manisha Patel. Presentation to the Advisory Committee on Immunization Practices, October 30, 2014

13 A Bad Combination: Meningococcal Bacteria Are Unpredictable and Deadly Rare, but severe Even against a backdrop of low incidence, outbreaks can happen and require substantial public health responses Financial challenges Logistical challenges Fear, anxiety, panic A long period of low incidence is no guarantee of future impact; nature of meningococcal bacteria changing patterns defy prediction When do cases become an outbreak? Public health definition vs. public perception

14 Student had been off-campus 9 days, became symptomatic and went straight to ER Prospective student visiting from another state, with undergrads for 3 days Student on campus. NJ DOH finds connection, declares cluster Student leaving campus after exams. NJ DOH declares outbreak Student on study abroad trip in Greece Student on campus Mar 13 Apr 13 May 13 Jun 13 Jul 13 Aug 13 Sept Oct 13 Nov 13 Dec 13 Jan 14 Feb 14 Mar 14 Hygiene campaign begins Posters in dorm bathrooms Dedicated website Table tents in dining halls Brochures Meetings s CDC begins discussing possibility of vaccine End of term, Reunions, Commencement Website Posters Info packets Hand sanitizers No re-usable cups Summer camps Fall term, Hygiene campaign Mine Not Yours cups Video Pamphlets Posters Student on campus CDC/NJ DOH onsite investigation Student on campus IND agreement approved Legal review Consult with experts Develop plans for communication, vaccination Vaccinations clinics Princeton student Non-affiliate Drexel student had close contact with Princeton students off-campus Princeton vs. Meningitis video featuring 4 survivors Open forums with CDC Vaccine clinics based on experience with Flu Fest Post-vaccination lectures Second dose Half isn t enough campaign National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May Courtesy of Princeton University.

15 Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses: Challenges and Recommendations William Schaffner, MD Past-President, NFID Professor of Preventive Medicine, Department of Health Policy; Professor of Medicine, Division of Infectious Diseases; Vanderbilt University School of Medicine

16 Addressing Serogroup B on Campuses: Challenges and Recommendations Lack of a licensed meningococcal serogroup B vaccine Need for more education and awareness about meningococcal disease presentation Have educational resources at the ready for public education during an outbreak Lack of clarity around FDA licensure pathways and timing Engage media in a thoughtful and positive way National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

17 Addressing Serogroup B on Campuses: Challenges and Recommendations Lack of a licensed meningococcal serogroup B vaccine Need for more education and awareness about meningococcal disease presentation Have educational resources at the ready for public education during an outbreak Lack of clarity around FDA licensure pathways and timing Engage media in a thoughtful and positive way National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

18 Addressing Serogroup B on Campuses: Challenges and Recommendations Lack of a licensed meningococcal serogroup B vaccine Need for more education and awareness about meningococcal disease presentation Have educational resources at the ready for public education during an outbreak Lack of clarity around FDA licensure pathways and timing Engage media in a thoughtful and positive way National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

19 Addressing Serogroup B on Campuses: Challenges and Recommendations Lack of a licensed meningococcal serogroup B vaccine Need for more education and awareness about meningococcal disease presentation Have educational resources at the ready for public education during an outbreak Lack of clarity around FDA licensure pathways and timing Engage media in a thoughtful and positive way National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

20 Addressing Serogroup B on Campuses: Challenges and Recommendations Lack of a licensed meningococcal serogroup B vaccine Need for more education and awareness about meningococcal disease presentation Have educational resources at the ready for public education during an outbreak Lack of clarity around FDA licensure pathways and timing Engage media in a thoughtful and positive way National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

21 Addressing Serogroup B on Campuses: Challenges and Recommendations Capacity for rapid serogroup identification must be maintained Review and possibly redefine what is an outbreak Consider how resource availability influences outbreak management It is essential that prevention programs are implemented as quickly as possible in outbreak situations Universities should consider advance planning about ways to cover costs of managing outbreaks National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

22 Addressing Serogroup B on Campuses: Challenges and Recommendations Capacity for rapid serogroup identification must be maintained Review and possibly redefine what is an outbreak Consider how resource availability influences outbreak management It is essential that prevention programs are implemented as quickly as possible in outbreak situations Universities should consider advance planning about ways to cover costs of managing outbreaks National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

23 Addressing Serogroup B on Campuses: Challenges and Recommendations Capacity for rapid serogroup identification must be maintained Review and possibly redefine what is an outbreak Consider how resource availability influences outbreak management It is essential that prevention programs are implemented as quickly as possible in outbreak situations Universities should consider advance planning about ways to cover costs of managing outbreaks National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

24 National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

25 Addressing Serogroup B on Campuses: Challenges and Recommendations Capacity for rapid serogroup identification must be maintained Review and possibly redefine what is an outbreak Consider how resource availability influences outbreak management It is essential that prevention programs are implemented as quickly as possible in outbreak situations Universities should consider advance planning about ways to cover costs of managing outbreaks National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

26 National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

27 Addressing Serogroup B on Campuses: Challenges and Recommendations Capacity for rapid serogroup identification must be maintained Review and possibly redefine what is an outbreak Consider how resource availability influences outbreak management It is essential that prevention programs are implemented as quickly as possible in outbreak situations Universities should consider advance planning about ways to cover costs of managing outbreaks National Foundation for Infectious Diseases. Addressing the Challenges of Serogroup B Meningococcal Disease Outbreaks on Campuses. May

28 Conclusions Meningococcal disease prevention presents special challenges o The disease is rare, but often very severe o Public fear demands a public health response o Uses a great deal of resources New serogroup B vaccines close a gap in prevention options, but questions need to be answered about how to integrate them into vaccination strategy While serogroup B causes more than 30 percent of current cases, the absolute number of cases in the US is low Nature of meningococcal bacteria changing patterns defy prediction

29 Questions & Answers

30 CME Credit Online evaluation and post-test will be available until February 17, 2015 at: