Vaccine Development and Production
description
Transcript of Vaccine Development and Production
![Page 1: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/1.jpg)
February 1-2, 2006L’Enfant Plaza Hotel
Washington, DC
![Page 2: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/2.jpg)
Vaccine Development and Production
Moderator: Arnold MontoDiscussant: John TreanorRapporteur: Kristin Nichol
![Page 3: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/3.jpg)
Vaccine Development and Production Issues to Consider
• Can a “strain change” approach work?
• If not, what pre-licensure data are needed?
• Is a “pandemic-only” approach commercially viable
• How can better correlates of immunity be derived?
• How can evaluation of live vaccines for pandemic influenza be facilitated?
• What is the liklihood of significant heterosubtypic/variant protection?
![Page 4: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/4.jpg)
Vaccine Development and Production Issues to Consider
• Production Issues– How to increase US production, assuming
nationalization of supplies in a pandemic• Role of cell culture-based vaccines and use
of adjuvants
• Regulatory challenges in an era of rapid response
– How to ensure distribution according to priority recommendations for use
– Animal vs human vaccination• Regulatory issues for avian vaccines
![Page 5: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/5.jpg)
Vaccine Deployment Issues to Consider
• How much vaccine should be stockpiled?
• How often should the stockpile be updated?
• What would be an appropriate trigger for deployment of the stockpile? For population wide vaccination?
• Should we consider pre-priming?
![Page 6: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/6.jpg)
What is the Time frame for Development of a Vaccine and How Can it be Shortened?
![Page 7: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/7.jpg)
What is the Feasibility for Developing an H5N1 Vaccine?
![Page 8: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/8.jpg)
What is the Potential for Flexibility of the Backbone for a Foreign Avian Insert?
![Page 9: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/9.jpg)
How Do We Increase US Production of a Vaccine?
• What is the potential for cell culture-based vaccines and the use of adjuvants?
• What are the regulatory challenges in an era of rapid response?
![Page 10: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/10.jpg)
How Can Distribution According to Priority Recommendations be Ensured?
![Page 11: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/11.jpg)
Recommendation for Vaccine Priorities
Tier 1 Sub-Tier A Vaccine and antiviral manufacturing (~40,000)
Medical workers with direct patient contact (8-9 million)
Sub-Tier B Persons 65 years with a risk condition, other age groups with two or more high risk conditions. (18.2 m, 6.9 m)
Sub-Tier C Pregnant women, contacts of children < 6 months of age, of immunocompromised. (3 m, 2.7 m, 6.9 m)
Sub-Tier D Public health emergency response workers (150,000)
Key government leaders
Tier 2 Sub-Tier A Others age groups with risk one condition (35.8 million)
Healthy 65 years and older (17.7 million)
Healthy 6-23 year olds (5.6 million)
Sub-Tier B Other emergency, utility and transportation workers. (7 m)
Sub-Tier C Other key governmental decision makers.
Funeral directors, etc. (62,000)
Sub-Tier D Rest of population (180 million)
![Page 12: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/12.jpg)
Antiviral Priority Recommendations
1. Patients admitted to hospital Treatment
2. Health care workers with direct patient contact Treatment
3. Highest risk outpatients Treatment
4. Pandemic health responders, Public safety Treatment
5. Increased risk outpatients Treatment
6. Outbreaks in nursing home PEP
7. Healthcare workers – critical settings Prophylaxis
8. Critical infrastructure workers Treatment
9. Other outpatients Treatment
10. Highest risk outpatients Prophylaxis
11. Other healthcare workers with direct patient contact Prophylaxis
![Page 13: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/13.jpg)
How Should We Prioritize Animal vs Human Vaccination to Control a
Pandemic?
![Page 14: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/14.jpg)
February 1-2, 2006L’Enfant Plaza Hotel
Washington, DC
![Page 15: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/15.jpg)
Education and Communication
Moderator: John BartlettDiscussant: Jeffrey Levi
Rapporteur: Michael Osterholm
![Page 16: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/16.jpg)
Education and CommunicationIssues to Consider
• Communication of the national plan
• Outreach to public and private schools and to community services
• Professional groups: medical systems, HMOs, community-based organizations
• Liaison relations with national societies and organizations (i.e. Rotary Club, Kiwanis, Lions, Chamber of Commerce, etc.)
• Enduring materials
• Professional Societies
![Page 17: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/17.jpg)
How will the National Plan be Communicated and by Whom?
![Page 18: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/18.jpg)
COMMUNICATION: VEHICLES
• Public: TV, radio, newspapers and Internet
• Other: Phones (?), beepers
• Electronic networks: CDC, WHO CIDPAP, IDSA, SHEA, ProMed, ATS, SCCM
![Page 19: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/19.jpg)
Who Will Provide Outreach to Public and Private Schools and to Community Services?
![Page 20: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/20.jpg)
COMMUNICATION: PUBLIC
• Update
• Directions: Recommendations
• Antivirals/vaccines – who, where, how, when
• Evaluations – OPDs, hospital, EW, designated facilities
• Social distancing
• Travel
• Penalties
![Page 21: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/21.jpg)
Who Will Communicate with Professional Groups, Such as Medical Systems, HMOs, and CBOs?
![Page 22: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/22.jpg)
COMMUNICATION: MEDICAL PERSONNEL
• Guidelines from authorative sources (DHHS)
• Policies: Regional, local institutional
• Medical updates
• Specifics: Personnel, supplies, beds, medical data, risks, resources
![Page 23: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/23.jpg)
Who Will Handle Liaison Relations with National Societies and Organizations
(i.e. Rotary Club, Chamber of Commerce, etc.)?
![Page 24: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/24.jpg)
Who Will Develop and Distribute Enduring materials?
![Page 25: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/25.jpg)
COMMUNICATION: LEADERSHIP
• International: WHO
• National: DHHS
• State: Health Department
• City: Health Department
• Institutional: Appoint
• HMO: Appoint
![Page 26: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/26.jpg)
Who Will Interface with Professional Societies?
![Page 27: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/27.jpg)
COMMUNICATION: LESSONS
• Credibility: Mayor Guiliani (Anthrax)
• Sensitivity: St. Louis, MO (Smallpox) and 1918 pandemic flu
• Pre-plan: Baton Rouge (Katrina)
• Clarity: NYC (anthrax, WNV)
• SARS
![Page 28: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/28.jpg)
February 1-2, 2006L’Enfant Plaza Hotel
Washington, DC
![Page 29: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/29.jpg)
Surveillance and Diagnostics
Moderator: Michael TapperDiscussant: Isaac Weisfuse
Rapporteur: Cathy Petti
![Page 30: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/30.jpg)
Surveillance and DiagnosticsIssues to Consider
• Accuracy (sensitivity and specificity)
• Point of care vs. referral (confirmatory)
• Networks & uniform reporting tool (centralized data base)
• Discrimination regarding etiology of presenting respiratory illnesses
• Reporting: who, what, where, how, when
• Specimen repository (resistance testing)
• Timeliness and transparency
![Page 31: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/31.jpg)
Surveillance and DiagnosticsIssues to Consider
• Clinical vs. laboratory diagnosis
• Point of care vs. referral (confirmatory)
• Bidirectional reporting: who, what, where,
how, when
![Page 32: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/32.jpg)
Clinical vs. Laboratory Diagnosis
![Page 33: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/33.jpg)
Will Diagnosis and Treatment Occur at the Point of Care or after a Confirmatory Referral?
![Page 34: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/34.jpg)
How Will the Reporting of Cases be Handled and by Whom?
![Page 35: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/35.jpg)
February 1-2, 2006L’Enfant Plaza Hotel
Washington, DC
![Page 36: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/36.jpg)
Use of Antivirals and Antiviral Development
Moderator: Andy PaviaDiscussant: John Beigel
Rapporteur: Anne Moscona
![Page 37: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/37.jpg)
Use of Antivirals and Antiviral Development Issues to Consider
• Resistance evaluation for seasonal and pandemic influenza• Dose and duration of therapy• Special populations: elderly, pediatrics, immunocompromised• Pandemic Strategy Questions
– Therapy vs. prophylaxis– How large should drug stockpile be and what specific drugs
should it contain?– Do you agree with the NVAC guidelines for priority groups
and strategies for antiviral use as detailed in HHS Pandemic Plan?
• New compounds in development that might be available in the next 1-2 years
• Is there an adequate pipeline and development of new targets?
![Page 38: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/38.jpg)
How Should Resistance be Evaluated for Seasonal and Pandemic Influenza?
![Page 39: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/39.jpg)
What is the Appropriate Dose and Duration of Therapy?
![Page 40: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/40.jpg)
How Should Antivirals be Used for Special Populations, Including the Elderly, Children, and Those Who Are Immunocompromised?
![Page 41: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/41.jpg)
Pandemic Strategy Questions
• Therapy vs. prophylaxis
• How large should drug stockpile be and what specific drugs should it contain?
• Do you agree with the NVAC guidelines for priority groups and strategies for antiviral use as detailed in HHS Pandemic Plan?
![Page 42: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/42.jpg)
What New Compounds Might be Available in the Next 1-2 Years?
![Page 43: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/43.jpg)
Is There an Adequate Pipeline and Development of New Targets?
![Page 44: Vaccine Development and Production](https://reader036.fdocuments.in/reader036/viewer/2022062803/568147c0550346895db50358/html5/thumbnails/44.jpg)
February 1-2, 2006L’Enfant Plaza Hotel
Washington, DC