Petition calling on FDA to Slow Down COVID Vaccine Approval Process

6-15-21

Please everyone write a comment on this petition!

This is a very big deal, and it needs our full support and promotion. Spread this widely and send to all media outlets!

27 science and health experts have submitted a petition to the FDA calling for the government agency to slow down the process of giving full approval to any COVID vaccine. All of these experts are staunchly pro-vaccine scientists, but believe the approval process is currently moving too fast to thoroughly consider all safety and efficacy concerns of the “warp speed” COVID vaccines.

You can submit your own comment in support of the petition here – https://www.regulations.gov/commenton/FDA-2021-P-0521-0001

You can download and read the entire, long, scientifically detailed petition here – https://www.regulations.gov/document/FDA-2021-P-0521-0001

Here are the 8 major points this petition calls for:

  1. Complete at least two years of follow-up of participants originally enrolled in pivotal clinical trials, even if the trials were unblinded and now lack a placebo control. All vaccine manufacturer phase 3 trials were already designed with this planned duration.
  2. Prior to including in the list of populations for which a vaccine is approved, ensure there is substantial evidence that clinical effectiveness outweighs harms in special populations including: infants, children and adolescents; those with past SARS-CoV-2 infection; immunocompromised; pregnant women; nursing women; frail older adults; and individuals with cancer, autoimmune disorders and hematological conditions.
  3. Require thorough safety assessment of spike proteins being produced by body tissues following vaccine administration, and spike proteins’ full biodistribution, pharmacokinetics and tissue specific toxicity.
  4. Complete vaccine biodistribution studies from administration site and safety implications of mRNA translation in distant tissues.
  5. Require data of all severe adverse reactions reported following COVID vaccination, such as deaths, reported in VAERS and other pharmacovigilance systems.
  6. Assess safety in individuals receiving more than two doses.
  7. Include gene delivery and therapy experts in the Vaccines and Related Biological Products Advisory Committee (VRBPAC), in recognition of the fact that the novel COVID vaccines work on the premise of gene delivery, in contrast to conventional vaccines.
  8. Enforce stringent conflict-of-interest requirements to ensure individuals involved in data analysis and BLA-related decision-making processes have no conflict of interests with vaccine manufacturers.

The petition author and co-authors include:

  • Linda Wastila, BSPharm, MSPH, PhD and professor at University of Maryland School of Pharmacy
  • Peter Doshi, PhD, associate professor at University of Maryland School of Pharmacy
  • Patrick Whelan, MD, PhD associate clinical professor of pediatrics David Geffen School of Medicine at UCLA
  • Hamid A. Merchant, BPharm, MPharm, PhD, RPh, CQP, PGCertHE, FHEA, SRPharmS and subject leader department of pharmacy at University of Huddersfield
  • Donald W. Light, PhD and professor of comparative health policy and psychiatry at Rowan University School of Osteopathic Medicine
  • Florence T. Bourgeois MD and associate professor of pediatrics at Harvard Medical School
  • Robert M. Kaplan, PhD and distinguished research professor UCLA Fielding School of Public Health
  • Peter A. McCullough, MD and professor at Texas A & M College of Medicine
  • Anthony J Brookes, PhD and professor of genetics University of Leicester
  • David Healy, MD, FRCPsych and professor of psychiatry McMaster University Ontario, Canada
  • Byram Bridle, viral immunologist and associate professor at University of Guelph, Ontario
  • Kim Witczak, founder and CEO of Woodymatters and global drug safety advocate
  • Christine Stabell Benn, MD, PhD and professor of global health at University of Southern Denmark
  • Matthew Herder, JSM, LLM, Director, Health Law Institute at Dalhousie University Nova Scotia, Canada
  • Tom Jefferson, MD, MRCGP FFPHM, British epidemiologist who works with the Cochrane Collaboration, advisor to the Italian National Agency for Regional Health Services and is senior associate tutor at University of Oxford
  • Peter Collignon, infectious disease physician, microbiologist at Canberra Hospital and professor at the Australian National University Medical School
  • Peter C. Gøtzsche, Professor, DrMedSci, MD, MSc Director Institute for Scientific Freedom Copenhagen, Denmark
  • Peter Aaby, MSc, DMSc, Head of Bandim Health Project, Guinea-Bissau University of Southern Denmark
  • Ulrich Keil, MD, MPH, PhD, FRCP professor emeritus University of Münster, Germany
  • Juan Erviti, PharmD, PhD Unit of Innovation and Organization Navarre Health Service, Spain
  • Iona Heath, CBE FRCGP and past president of the Royal College of General Practitioners London, UK
  • Joseph A. Ladapo, MD, PhD associate professor of Medicine David Geffen School of Medicine at UCLA
  • Barbara Mintzes, BA, MSc, PhD, associate professor, School of Pharmacy at the University of Sydney, Australia
  • Huseyin Naci, MHS, PhD associate professor of Health Policy London School of Economics and Political Science
  • Angela Spelsberg, MD, Comprehensive Cancer Center Aachen, Germany
  • Erick Turner, MD, associate professor of psychiatry at Oregon Health & Science University
  • Allyson M Pollock, MBChB, FRCPH, FRCP,  FRCGP, clinical professor of Public Health Institute of Health and Society, Newcastle University and director of the Newcastle University Centre for Excellence in Regulatory Science.

6 thoughts on “Petition calling on FDA to Slow Down COVID Vaccine Approval Process

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