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*
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
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
“Bioshield II” legislation threatens our freedom
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
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
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
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-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
Focus on the Flu: National Institute of Allergy and Infectious Diseases
Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism-National Academy of Sciences
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
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
The Diseases The Vaccines ThePharmaceutical Company's VAERS
Vaccine Ingredients Autism Vaccine Info Journal Articles Vaccine Recommendations
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