Vaccine Safety

 

 

With the ever-increasing volume in data and a growing number of new vaccines entering the market it has never been more important to leverage new technologies and methods to improve the efficiency and accuracy of pharmacovigilance for vaccines.  

This focussed vaccine safety and pharmacovigilance conference will allow you to listen and learn from key thought leaders in this space, as well as to showcase any solutions that are greatly needed in order to revolutionise and replace outdated ways of working.   Furthermore, escalating incidences of vaccine-refusal makes the importance of effective communication paramount, so join us to present your most successful strategies

 

DOWNLOAD DRAFT AGENDA

 

2018 AGENDA

 

Vaccine Safety & Pharmacovigilance, Wednesday 4 April 2018

International Vaccine Safety

Dr Saad B Omer
Vaccine Safety & Pharmacovigilance
10:10

An overview of the use of Sentinel to assess the safety of vaccines

10:40

Networking coffee break

Panel discussion

Methods In Pharmacovigilance

Vaccine Safety & Pharmacovigilance
12:40

Tools for clinical data visualization that improve efficacy and accuracy of safety assessment and allow firms to keep up with changing regulatory requirements

Thomas Verstraeten
Vaccine Safety & Pharmacovigilance
12:55

A systematic review and meta-analysis on the safety of newly adjuvanted vaccines among the elderly

  • We searched the literature for clinical trials (CTs) including new adjuvant systems (AS01, AS02, AS03, or MF59), used in people of 50 years and older, published between January 1995 and September 2017.
  • 12 CTs were retained on AS01/AS02, AS03 and MF59 adjuvants, respectively, covering 92,123 subjects
  • This systematic literature review showed no overall increase in SAEs, fatalities, or unsolicited AEs following newly adjuvanted vaccines.
  • Higher rates for local or general AEs were observed for all newly adjuvanted vaccines, but AEs were mostly mild and transient.
1:10

Networking Lunch & Poster Session

Dr Clifford Sachs
Vaccine Safety & Pharmacovigilance
2:40

Considerations and challenges in pre-clinical safety assessment of vaccines and passive immunization strategies

  • Respiratory Syncytial Virus Infection in Adults and Pediatric populations
  • Demonstration of disease exacerbation in an animal model
  • Species selection
  • Monoclonal antibodies with half-life extension mutations
Dr Jens-Ulrich Stegmann
Vaccine Safety & Pharmacovigilance
3:10

Safety assessment during the clinical development phase of a vaccine

  • Capturing of data
  • Relevance of causality assessment
  • When to build a benefit/risk assessment
  • Different populations vs different approaches
Dr Walter Straus
Vaccine Safety & Pharmacovigilance
3:40

Vaccine pharmacovigilance: the once and future challenges

  • Data sources for vaccine safety are advancing; the introduction of more sophisticated data sources and methods may help address some of the shortcomings of the most established pharmacovigilance tools.
  • The introduction of novel vaccines into an increasingly globalized health market creates an increasing demand for robust and timely vaccine safety monitoring systems.
  • The introduction and impact of successful vaccines and public health implementation programs have been paralleled by advances in communication technologies which have coalesced to raise societal expectations for vaccine safety.
4:10

Networking coffee break

Dr Karen Broder
Vaccine Safety & Pharmacovigilance
4:40

CDC’s post-licensure vaccine safety monitoring systems – addressing 21st century public health needs

  • The Centers for Disease Control and Prevention (CDC) conducts post-licensure vaccine safety monitoring of licensed vaccines in U.S. children, adolescents and adults.
  • The three CDC post-licensure monitoring systems are the Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), and the Clinical Immunization Safety Assessment (CISA) Project. The functions of these systems complement each other and include passive surveillance (VAERS), active surveillance (VSD), clinical and epidemiologic research (VSD and CISA), and individual patient-level clinical case vaccine safety evaluations (CISA).
  • Overview of CDC’s post-licensure vaccine monitoring systems and describe some examples of how the systems have worked together to advance our understanding of vaccine safety.

Interactive Discussion – Mandating Vaccination

6:10

Chair’s closing remarks and close of congress day 2

6:15

Networking Drinks & Party

last published: 20/Feb/18 09:36

Vaccine Safety & Pharmacovigilance, Thursday 5 April 2018

Case Studies In Vaccine Safety

Dr Ashley Wivel
Vaccine Safety & Pharmacovigilance
09:10

Ensuring safety during outbreaks; the EBOLA experience

  • Challenges in vaccine clinical trials during public health emergencies
  • Ebola case study
Dr Neal Halsey
Vaccine Safety & Pharmacovigilance
09:40

The science of causality assessment

  • The science of causality assessment is poorly understood by healthcare providers and the general public
  • Temporal relationships and hypotheses regarding mechanisms are not sufficient to establish causality
  • Journals should establish standard criteria for publishing case reports of alleged causal relationships
  • Decisions to compensate for alleged vaccine injuries should be based on science
  • Safety profiles may vary in different populations
  • All countries should have formal vaccine safety programs
10:40

Networking coffee break

Dr Saad B Omer
Vaccine Safety & Pharmacovigilance
11:30

Safety assessment, communication of risk and interventions around acceptance in maternal immunization

  • Safety of TDaP and IIV vaccine
  • Emerging issues around 1st trimester vaccination, adverse outcomes and how this has informed acceptance
Dr Daniel Salmon
12:30

Networking Lunch & Poster Session

AFTERNOON PLENARY OF CONGRESS

Dr Angela Shen
1:40

Report on U.S. vaccine development and innovation including the current landscape, existing challenges, and drivers and levers to incentivize development

  • A combined effort from HHS, NIH, CDC, FDA, BARDA to promote innovation in the development of vaccines that minimize the burden of infectious disease
  • What is the optimal process to determine which vaccines would be beneficial to public health and how information on such vaccines is disseminated to key stakeholders
  • Identifying whether obstacles exist that inhibit the development of beneficial vaccines
  • Recommendations on how best to promote and incentivize vaccine innovation and development
Dr Jeffrey Stoddard
2:10

Zoster vaccine recombinant, adjuvanted: A journey from research to approval

  • Non-live, recombinant vaccine to help prevent herpes zoster (shingles), combining glycoprotein E with an adjuvant system, AS01
  • Sharing positive results from Phase III revaccination study 
Dr Walter A Orenstein
2:40

With polio eradication succeeding, should measles eradication come next?

  • Changing the perception from polio: Focusing on measles elimination to build our overall immunization program
  • Using a “diagonal” approach when dealing with highly contagious preventable diseases like measles
  • Surveillance -  a weakness in our system?
  • Cost of controlling outbreaks and the consequences
Dr Paul Offit
3:10

Vaccine hesitancy: How to respond to the media to advance better health

  • Challenges to communicating science through the opaque prism of the media
  • How certain cultural biases can influence the perception of science 
3:40

3:40 Chair closing remarks and end of congress

last published: 20/Feb/18 09:36

 

Get Involved At World Vaccine Congress Washington

 

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marc.rhys-evans@terrapinn.com
+44 20 7827 5945

 

 

 

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Tayyab Abbasi
tayyab.abbasi@terrapinn.com
+44 20 7092 1210

 

 

 

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Karina Kusova
karina.kusova@terrapinn.com
+44 20 7092 1071