Government Information

Testimonies before Congress and the House of Representatives, as well as other Medical and Governmental areas

Congress       House of Representatives       Senate

 IOM (Institute of Medicine)    FDA (Food and Drug Administration)

CBER (Center for Biologics Evaluation and Research)

   CDC (Center for Disease Control)    WHO (World Health Organization)

HHS (Health and Human Services)    NIH (National Institute of Health)

National Academy of Sciences     AMA (American Medical Association)

VRC (Vaccine Research Center)

United Kingdom      General Information

*Questions parents should ask of the NIH, CDC, FDA and IOM by Ray Gallup*

 


Congress

Congressman questions officials at Thimerosal hearings 6/20/2002

Burton reviews federal government track record on vaccines and autism, December 6, 2002

Autism's Angel-Autism's Angel in Washington, Representative Dan Burton of Indiana

Another Congressman Calls for Vaccine Research-This Congressman's Also a Physician

VACCINES--FINDING THE BALANCE BETWEEN PUBLIC SAFETY AND PERSONAL CHOICE

 

House of Representatives

Statement of the Association of American Physicians and Surgeons on Vaccines: Public Safety and Personal Choice, Aug. 3, 1999

Mercury in Medicine-Taking Unnecessary Risks, May 2003

Statement by William Egan, PH.D. Acting Office Director, Office of Vaccine Research and Review, Center for Biologics Evaluation and Review, Food and Drug Administration, Dept. of Health and Human Services July 18, 2000

Conflicts of Interest in Vaccine Policy Making-Majority Staff Report-Committee on Government Reform August 21, 2000

Dr. Paul A. Offit-Testimony to Government Reform Committee Autism – Present Challenges, Future Needs – Why the Increased Rates? April 6, 2000

Opening Statement-Congressman Dan Burton-Committee on Government Reform "The Status of Research into Vaccine Safety and Autism" June 19, 2002

October 8, 2004-Statement Presented to House Committee on Government Reform United States House of Representatives by Howard Pien President and CEO Chiron Corporation

 

Senate

“Bioshield II” legislation threatens our freedom

 

 

IOM

IOM-Institute of Medicine website

Rep. Dave Weldon (R- Florida) Testimony Before the Institute of Medicine Immunization Safety Review Committee, January 11, 2001

Can vaccines cause immune dysfunction resulting in allergies, asthma and anaphylaxis?

Vaccines and Autism - Immunization Safety Review Committee Meeting 9: February 9, 2004

 

FDA

Vaccine Meeting / Workshop Transcripts

Clinical Trial Adverse Event Reporting Improvements To Be Discussed At March Meeting-FDA will hold a public hearing March 21 “to consider the process by which institutional review boards obtain and review information on adverse events that occur during the conduct of clinical investigations” for drugs and devices

FDA-U. S. Food and Drug Administration website

Make No Mistake: Medical Errors Can Be Deadly Serious-FDA Consumer magazine September-October 2000

Vaccine Meeting/Workshop Transcripts

Infanrix DTPa-HepB-IPV Briefing Document

Vaccines and Related Biological Products Advisory Committee March 7, 2001FDA Briefing Document for SmithKline Beecham Biologicals’ DTPa-HepB-IPV Vaccine

Committee Meeting-Vaccines and Related Biological Products Advisory November 5, 1999

Continued Committee Meeting-Vaccines and Related Biological Products Advisory November 5, 1999

Toxoids; Implementation of Efficacy Review; Final Rule-Federal Register January 5, 2004

Draft Guidance-Guidance for Industry Drug Substance Chemistry, Manufacturing, and Controls Information-January 2004.

Managing The Risks From Medical Product Use-Creating A Risk Management Framework-Report to the FDA Commissioner from the Task Force on Risk Management-U.S. Department of Health and Human Services Food and Drug Administration May 1999-Appendix G-Risk Intervention-Examples-A. Restrictions on Product Use-4. Measles, Mumps, and Rubella Vaccine (MMR)

Issue: As a part of the monthly review of reports from the Vaccine Adverse Events Reporting System (VAERS), FDA noted that thrombocytopenia following immunization with measles containing vaccines was more severe than was previously perceived. Approximately 40 percent of reports of postimmunization thrombocytopenia described cases with platelet counts # 20,000, a level that has been associated with spontaneous life-threatening hemorrhage. In reviewing all reported cases of post-MMR thrombocytopenia in VAERS, FDA found one case of
thrombocytopenia that resulted from positive rechallenge with MMR vaccine. FDA also found
two deaths that occurred in children with postimmunization thrombocytopenia; however, these
two children had complicated medical histories, so a direct causal relationship with vaccination
could not be made.

FDA Action: FDA discussed these findings and searched the literature for similar reports. The search showed that investigators in Finland had reported that 30 percent of children with thrombocytopenia after MMR immunization had detectable anti-IIbIIIa platelet antibodies. Following these reports, FDA's Laboratory of Pediatric and Respiratory Diseases initiated a research study to identify the vaccine antigens that might be responsible for inducing antiplatelet antibodies. These studies showed that (1) vitronectin receptor proteins derived from the chick embryo fibroblast cells (CEFs) used as the substrate for production of measles and mumps vaccine cross-react with anti-IIbIIIa platelet antibodies; (2) in mice, immunization with measles vaccine or with CEFs induces anti-IIbIIIa antibodies; (3) antibodies to measles matrix protein also crossreact with platelet protein IIIa; and (4) following immunization with measles vaccine 0.5-1
percent of children develop antibodies that react with human IIbIIIa, indicating that they may be at risk for episodes of immune thrombocytopenia
when reexposed to any vaccine that contains cross-reacting antigens.

Outcome: Based on the review of the VAERS data and the literature, labeling for measles containing vaccines was revised to provide adequate information to warn and inform healthcare providers about the use of measles vaccine in children with thrombocytopenia or with a history of thrombocytopenia following previous doses of MMR. The Center for Biologics research suggested a mechanism as to why there might be an association with thrombocytopenia and MMR vaccines in some individuals.

FDA Approves Certiva Vaccine For Diphtheria, Tetanus And Pertussis-July 30, 1998

 

 

Health and Human Services

HHS-U.S. Department of Health & Human Services website

Promotion of Prescription Drugs Through Payments and Gifts-01/90

International Conference on Harmonisation; Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin

News Release-HHS Issues Rules for Smallpox Vaccine Injury Compensation Program-Dec. 12, 2003

Mainstreaming new immunization technologies…technologies that will facilitate high coverage with safe and effective immunization. Innovative Administration Systems for Vaccines, Rockville, December 2003

Advisory Commission on Childhood Vaccines: Minutes from past meetings

December 4, 2002 minutes

September 4, 2002 minutes

June 6, 2002 minutes

 

CBER (Center for Biologics Evaluation and Research)

CBER-Center for Biologics Evaluation and Research website

Annual Report FY2002 (October 1, 2001 through September 30, 2002)

 Guidance for Industry-Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines March 2001

Vaccine Safety: Neurovirulence Safety Test Development, Validation and Evaluation

Summaries / Presentations:

CBER 101 - Introduction to the Center for Biologics Evaluation and Research - 3/22-24/2004

Tenth Annual Surviving the Challenges of FDA and Other Regulatory Authorities’ GMPs - 3/22-24/2004

Current GMPs for the Pharmaceutical Industry - 2/19-20/2004

Annual PDA Meeting - 2/17/2004

7th Annual FDA and the Changing Paradigm for Blood Regulation - 1/14-16/2004

American Society of Tropical Medicine and Hygiene 52nd Annual Meeting - 12/04/2003

Workshop on Factor VIII Inhibitors - 11/21/2003

PDA Japan Chapter Annual Meeting - 10/28-31/2003

Workshop on Counter Terrorism Products Regulated by the Center for Biologics Evaluation and Research: Effective Strategies to Assist in Product Development - 10/23-24/2003

Workshop on Non-Clinical Safety Evaluation of Preventive Vaccines: Recent Advances and Regulatory Considerations

Influenza Virus Vaccine 2005-2006 Influenza Vaccine Lot Release Status as of September 14, 2005

 

CDC Center for Disease Control

CDC-Centers for Disease Control and Prevention website

Pertussis Infection in Fully Vaccinated Children in Day-Care Centers, Israel-We tested 46 fully vaccinated children in two day-care centers in Israel who were exposed to a fatal case of pertussis infection. Only two of five children who tested positive for Bordetella pertussis met the World Health Organization’s case definition for pertussis. Vaccinated children may be asymptomatic reservoirs for infection.

Flu Activity: Reports & Surveillance Methods in the United States

CDC's Flu Activity: Reports & Surveillance Methods in the United States

CDC Scandal Emerges—Study Attempts Cover Up of Autism-Mercury Link—Congressman Dave Weldon, M.D., Asks CDC for Investigation-Moms on a Mission for Autism

Vaccination Coverage Among Children Entering School --- United States, 2003--04 School Year-CDC

The Vaccine Identification Standards Initiative

 

WHO

WHO-World Health Organization website

Vaccine Adverse Events in the New Millennium: Is There a Reason for Concern?

Policy and Practice: Single-dose versus multi-dose vaccine vials for immunization programmes in developing countries

Status of Non-Clinical Methods for Autoimmunity-Presenter:Paul-Henri Lambert, M.D., Chief, Vaccine Research & Development, WHO

 

NIH

Focus on the Flu: National Institute of Allergy and Infectious Diseases

 

 

National Academy of Sciences

Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism-National Academy of Sciences

 

AMA

 

VRC

 

United Kingdom

Health Protection Agency website

MHRA-Medicines and Healthcare products Regulatory Agency website

European Medicines Agency website

Fluvirin influenza vaccine manufacturer's licence suspended

THE GHOST LOBBY-New Labour and the Pharmaceutical Industry by Martin Walker MA

 

General Information

Medicare Program-Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2003

Global Advisory Committee on Vaccine Safety, 20-21 June 2002

Keeping vaccination rates up: Doctors must keep up the pressure-Childhood vaccines are a victim of their own success, and doctors find themselves spending more time convincing parents of the shots' necessity


 

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