CDC Seeking Opinions on Vaccine Safety

Several people from the autism advocacy community, including
Barbara Loe Fisher from NVIC, Mark Blaxill from Safe Minds, Rob Beck from ASA and Peter Bell from CAN attended a “Blue Ribbon Panel” on vaccine safety hosted by Dr. Judy Gerberding of CDC, this last June. The objectives of that meeting, along with the slide presentations provided, are posted on the CDC web site for public comment.

In consultation with outside stakeholders, the CDC has undertaken a
review of vaccine safety activities at CDC. As part of this effort, the
CDC is seeking public comments regarding the current state of the agency’s
vaccine safety program and to identify ways in which excellence in vaccine
safety monitoring, research and communication can be maximized and
sustained in the future. Comments should focus on the objectives listed below:

1. Review the structure, function, credibility, effectiveness,
efficiency and support of CDC’s vaccine safety program and assess how it
can be maximized and sustained.
· Assess the program’s ability to detect emerging or rare adverse
events.
· Assess the capacity of the program to provide comprehensive
monitoring of the growing number of vaccines.

2. Review the intramural and extramural collaborative activities of
the vaccine safety program and determine their effectiveness and
efficiency.
· Assess additional steps CDC can institute to enhance
coordination with other federal agencies and partners, including consumer and advocacy
groups.

3. Determine the optimal organizational location for vaccine safety
activities within the CDC to ensure scientific objectivity, transparency
and oversight while at the same time ensuring that program priorities are
appropriately established and are relevant to the immunization program and
other stakeholder needs.

Background
The Director of CDC asked that a group of individuals convene to
review Vaccine Safety activities at CDC, to provide their individual
opinions regarding the current state of the agency’s vaccine safety
program and identify how CDC’s excellence in vaccine safety monitoring, research and communication can be maximized and sustained in the future.
In an effort to obtain broader public input, CDC committed to post
the objectives for public comment. The presentations provided at the meeting
are available on this website. We request that you follow the instructions to
provide your comments and input.

http://www.cdc.gov/od/vaccsafe/comments.htm

A summary of the public comments will be provided to the Director of
CDC. The public comment period will end on October 12, 2004.

Presentations
Below is a list of the presentations used during the meeting to
review vaccine safety activities at CDC and HHS.
http://www.cdc.gov/od/vaccsafe/ppt.htm

HHS Vaccine Safety Activities (PDF-207k/14p) (PowerPoint) Benjamin
Schwartz, MD
Overview of CDC Vaccine Safety Activities (PDF-301k/18p)
(PowerPoint)
Gina Mootrey, DO, MPH
Immunization Safety Branch (PDF-1.6mb/50p) (PowerPoint) Robert T. Chen,
MD, MA
Monitoring the Safety of the Growing Number of Vaccines: Responding
to the Challenges (PDF-691k/40p) (PowerPoint) John Iskander, MD, MPH
What Is Our Ability to Detect Rare Vaccine Adverse Reactions?
(PDF-274k/13p) (PowerPoint) Vitali Pool, MD
Evaluation of Vaccine Safety Signals (PDF-281k/14p) (PowerPoint)
Frank DeStefano, MD, MPH
Vaccine Safety Research Process Considerations (PDF-203k/12p)
(PowerPoint)
Stephen L. Cochi, MD, MPH
Options for Organizational Location of Vaccine Safety at CDC
(PDF-175k/23p) (PowerPoint) Melinda Wharton, MD, MPH