COMMUNITIES

Overview

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Special Interest Group in Vaccines

VAXSIG Webpage Information

Objectives:

  1. To foster development and adoption of methods to improve the accurate and efficient collection of vaccine exposure information (e.g., 2D barcodes, vaccine generic names, vaccine doses and dates of delivery) for each vaccinee.  Lot identifiers, in particular, would allow verification of the exact vaccine product (type and manufacturer) as well as linkage to details of vaccine antigens, preservatives, and excipients).
  2. To foster development and sharing of new/existing methods for vaccine safety, effectiveness, usage, cost-benefit, risk-management/mitigation across the life cycle of vaccines from pre- to post-licensure, and from signal detection to hypothesis testing.
  3. To provide a forum for interaction with regulatory authorities and public health agencies to raise awareness and stimulate incorporation of vaccine specific and relevant aspects into regulations and regulatory templates.
  4. To assist low and middle-income countries with development of their data collection and technical expertise in vaccine pharmacoepidemiology.

Mission:

strives to achieve these goals by offering a platform for interested ISPE members to plan educational activities for the ICPE pre-conference courses together with the education committee, shared national and international projects and grant proposals, and joined presentation in form of workshops, symposia or poster walks at annual ICPE meetings.   Whenever possible, the VAX SIG will seek to maximize synergy with existing vaccine institutions and stakeholders.

Committee Leaders

Chair Harry Seifert, MD, MSCE Clinical Safety Sciences GSK
Pennsylvania, USA
harry.a.seifert@gsk.com
Immediate Past-Chair Bob Chen, MD, MA Division of HIV/AIDS Prevention and Control
CDC
Atlanta, USA
rtc1@cdc.gov
Coordinator James Stark, PhD Worldwide Safety and Regulatory
Pfizer
New York, USA
James.Stark@pfizer.com

Workgroup Leaders

Regulatory Guidance Mendel Haag, PhD Epidemiology
Novartis Influenza Vaccines
Amsterdam, Netherlands
mendel.haag@novartis.com
Methodology Patricia Saddier, MD, PhD Pharmacoepidemiology Department
Merck Research Laboratories
Pennsylvania, USA
patricia_saddier@merck.com
Education and Advocacy in Low and Middle Income Countries Andrea Sutherland, MD Astra Zeneca
Gaithersburg, Maryland, USA
andrea.sutherland@astrazeneca.com

Members

Syed Ahmad
Meghan Baker
Laurence Baril
Vincent Bauchau
Jorgen Bauwens
Roger Baxter
Kaat Bollaerts
Jan Bonhoeffer
Bob Brody
Anne Butler
Bob Chen
Jing Chen
Adam Cui
Helene Denis
Caitlin Dodd
Jonathan Duffy
Germano Ferreira
Lourdes Frau
Mendel Haag
P Haber
Eelko Hak
Kui Huang
Wan-Ting Huang
Chris Jankosky
Judith Jones
Alison Kawai
Alena Khromava
Sonali Kochhar
Veronique Kugener
Martin Kuldorff
Andreia Leite
David Martin
Leah McGrath
Mike McNeil
Pedro Moro
Vitali Pool
Patricia Saddier
Daphne Sawlwin
Harry Seifert
Vivek Shinde
Francois Simondon
James Stark
Miriam Sturkenboom
Andrea Sutherland
Lina Titievsky
Sylvie Tomczyk
Danitza Tomianovic
Priscilla Velentgas
Thomas Verstraeten
Alex Walker
Daniel Weibel
Bob Wise
Katherine Yih
Huifeng Yun

Dates of meetings: 

Occurs the first Wednesday of every month at 11:00 am EST (UTC/GMT -5 hours). Interested persons should email James Stark: James.Stark@pfizer.com

Meeting Minutes

March 2, 2016 meeting minutes

April 6, 2016 meeting minutes

June 1, 2016 meeting minutes

July 6, 2016 meeting minutes

Vaccine SIG Board report for April 2016 meeting

Vaccine SIG Board report for August 2016 meeting