• Home
  • Victims
    • Vaccine Victims Memorial
    • Gardasil & Silgard
      • G / S Australasia
        • G / S Australia
        • G / S New Zealand
      • G / S Europe
        • G / S Czech Republic
        • G / S Denmark
        • G / S France
        • G / S Germany
        • G / S Ireland
        • G / S Italy
        • G / S Norway
        • G / S Scotland
        • G / S Spain
        • G / S United Kingdom
      • G / S N. America
        • G / S Canada
        • G / S Mexico
        • G / S United States
      • G / S S. America
        • G / S Brazil
        • G/S Colombia
    • Cervarix
      • Cervarix Asia
        • Cervarix India
        • Cervarix Philippines
      • Cervarix Europe
        • Cervarix Czech
        • Cervarix Netherlands
        • Cervarix Scotland
        • Cervarix Slovakia
        • Cervarix Spain
        • Cervarix UK
      • Cervarix N. America
        • Cervarix Mexico
  • Resources
    • HPV Testing Resources
      • Pre-HPV Vaccination
      • Post-HPV Vaccination
    • Medical Professionals
    • Vaccine Injury Attorneys
    • Political Action Groups
    • Vaccine Groups
    • Vaccine Victims Hotline
  • SANE Vax Press Releases
  • Videos
    • Vaccine Safety Videos
    • Vaccine Victim Videos
    • Pharma Videos
  • About
    • About Us
    • Who We Are
    • Press Releases
    • SANE Vax in the News
    • Contact Us

SaneVax, Inc.

The First International HPV Vaccine Information Clearinghouse

  • NEWS
    • Government Agencies
      • African
      • Asian
      • Australasian
      • European
      • North American
      • South American
      • United Nations
      • WHO
    • Pharmaceutical Companies
      • CSL Biotherapies
      • GlaxoSmithKline
      • Inovio Pharmaceuticals
      • Liquidia Technologies
      • Merck & Co.
      • Novartis
      • Pfizer
      • Qiagen
      • Sanofi Aventis
      • Sanofi Pasteur MSD spmsd
      • Wyeth Laboratories
    • Science & Medicine
      • Cancer
      • Clinical Trials
      • Environmental Health
      • Heavy Metal Toxicity
      • HPV Science
      • Influenza
      • Meningitis
      • Pertussis
      • Pharmaceuticals
      • Rotavirus
      • STD’s
      • Vaccine Science
      • Women’s Health
    • Vaccine Adverse Events
    • Vaccine Injury Reporting
      • VAERS
      • VAMPSS
    • Vaccine Litigation
    • Vaccine Marketing
    • Vaccine Politics/People
    • Vaccine Victims
      • Cervarix Injuries
      • DTP/DTaP Injuries
      • Fluvax Injuries
      • Fluzone Injuries
      • Gardasil / Silgard Injuries
      • Menomune Injuries
      • MMR Injuries
      • Polio Vaccine Injuries
      • Synflorix Injuries
      • Yellow Fever Vaccine
    • Vaccines
      • Anthrax
      • Breast Cancer
      • Chicken Pox
      • Cholera
      • Combination Vaccines
      • Diphtheria
      • Hepatitis B
      • HPV
      • Influenza Vaccines
      • Malaria
      • Measles
      • Meningitis Vaccines
      • MRSA
      • Mumps
      • Norovirus
      • Pertussis Vaccines
      • Pneumococcal Disease
      • Polio
      • Rotavirus Vaccines
      • Shingles
      • Smallpox
      • TB
      • Tetanus
      • Typhoid
      • Yellow Fever Vaccine
    • Vaccines and the Media
  • WORLD NEWS
    • Africa
    • Asia
    • Australasia
    • Europe
    • North America
    • South America
  • RESEARCH
    • Cancer Research
    • Cervarix Vaccine
    • Gardasil/Silgard Vaccine
    • Human Pap. Research
    • Immunization Practices
    • Neurology
    • Vaccine Adjuvants
    • Vac. Ingredient Research
    • Vaccine Injuries
    • Vaccine Preservatives
    • Vaccine Related Research
    • Vaccine Safety
  • CITIZENS SPEAK
    • Cervical Cancer Debate
    • HPV Vax
      • Australian Concerns
      • Canadian Concerns
      • Irish Concerns
      • Spain Concerns
      • UK Concerns
      • United States Concerns
You are here: Home / NEWS . . . . . . . . / Science & Medicine / Cancer / Cervical Cancer / ‘Serious lapses’ in HPV vaccine trial

‘Serious lapses’ in HPV vaccine trial

May 11, 2011 By Jonathan Leave a Comment

The Tribune
India

Aditi Tandon/TNS

New Delhi, May 9

The government’s inquiry into linkages, if any, between the administration of HPV (Human Papilloma Virus) vaccine to seven adolescent tribal girls in Andhra Pradesh and Gujarat last year and their deaths has found serious lapses in the conduct of the said trial by partners-foreign NGO PATH and the Indian Council for Medical Research (ICMR).

Though proclaimed as a “post-licensure observational study of HPV vaccination against cancer of the cervix”, the project, suspended in April last following deaths, was indeed a clinical trial and needed to have followed protocols mandated by the Drugs and Cosmetics Act, 1954 which it didn’t, a government inquiry has concluded, without fixing anyone’s responsibility despite evidence of violation by PATH and ICMR members.

The inquiry voices concerns over hidden agenda (vaccines came free from pharma giants Glaxo Smith Kline and Merck Sharp and Dohme) to push the expensive injections into India’s Universal Immunisation Programme (UIP). Considering 1.25 crore girls enter 9 to 15 years target group annually, and vaccination per girl costs Rs 9,000, annual financial benefit to pharma majors would be Rs 11, 250 crore, were the Government to buy injections under the UIP.

Though the Committee doesn’t link vaccinations to deaths in Andhra’s Khammam (where 13, 791 girls were vaccinated) and Gujarat’s Vadodara (where 9,637 were vaccinated), it doesn’t rule it out either, observing: “The reported deaths were most probably unrelated to the vaccine. However, the cause of death in all cases could not be established with certainty”.

Read this with a shocking observation by Dr Y.K. Gupta of AIIMS, an expert assisting the inquiry, who said it was most unusual for a large observational study to not have diary card-based reporting of serious adverse events (SAE) and for it to target “vulnerable” girls despite directions that no research would be done on tribals unless of specific use to them.

Gupta concludes that the “project design didn’t take the issue of SAE seriously nor appointed an independent monitoring agency which caused unacceptable delays in the reporting of deaths. It resulted in gross underreporting of adverse events and didn’t provide insurance to girls though PATH had a cover.”

Another expert, Dr Rani Kumar, found serious discrepancies in consent forms of the vaccinated girls. Of the 100 forms from Andhra Prasdesh she studied, witness signatures were missing in 69. Over 2,763 forms out of 14,253 in Andhra had been signed by wardens/principals on the behalf of children (by the state government’s order). Kumar concludes: “The project team was very casual in its approach and ignored many ethical issues.”

Read Full Article…

Related

Filed Under: Cervical Cancer, HPV Science, Pharmaceuticals, Vaccine Politics/People Tagged With: Cervical Cancer HPV, immunizations, pharmaceuticals, vaccinations, Vaccine Adverse Reactions

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Follow Us

SaneVax on FacebookSaneVax on TwitterSaneVax on LinkedInSaneVax on YoutubeSaneVax RSS Feed

Help Support SaneVax

Notice: We need your support. This massive research & presentation comes from a team of volunteers. We need your help to keep this critical information available.



SaneVax relies on support from participants like you. We are a 501 (c)(3) non-profit corporation, donations are tax deductible. Help keep this venue available and support the spirit – Thank you!

This Week’s Survivor

Sarah from the UK

Categories

Links

  • Creating an HPV Industry
  • File a VAERS Report
  • Gardasil and Unexplained Deaths
  • HPV Industry Timeline
  • HPV Mechanisms of Action in Women
  • HPV Vaccine Fact Sheet
  • Petition: Rescind HPV Vaccine Approval
  • Presentation to the FDA
  • Supreme Court Arguments

HPV Vaccine VAERS Reports

Description 12/14/2019  TOTAL
Disabled 3,092
Deaths 523
Did Not Recover 13,072
Abnormal Smear 695
Cervical Cancer 186
Infertility 52
Life-threatening 1,001
Emergency Room 15,419
Hospitalized 6,448
Extended Hosp. Stay 304
Serious 9,497
Total Adverse Events 64,270

Access expanded report here.

Related

Subscribe2


 

Log In

Featured Video

girls interviewed about cervarix and gardasil

Meet the Gardasil and Cervarix Girls Interviewed

News

SaneVax News Blog!
News

Videos

Safety • Victims • Pharma
No Genetic Epidemic

Contact

Contact S.A.N.E.Vax
S.A.N.E.VAX log thumbnail

Copyright © 2025 SaneVax, Inc. · Site by TheWebElves.com a div. of KalaRhythms.org · Log in