https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid-19-vaccine-this-year/
A group of 27 clinicians, researchers and advocates last week filed an urgent Citizen Petition with the U.S. Food and Drug Administration (FDA) urging the agency not to prematurely grant full approval to any COVID vaccine.
“Premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety of U.S. residents, with global ramifications considering the international importance of FDA decisions,” the group said.
The FDA citizen petition process, described in Title 21 of the Code of Federal Regulations (21 CFR Part 10), allows individuals and community organizations to request the agency make changes to health policy. At any time, any “interested person” can request the FDA “issue, amend or revoke a regulation or order,” or “take or refrain from taking any other form of administrative action.”
In their petition, the group outlined many unanswered questions surrounding the efficacy and safety of COVID vaccines, and detailed how data must be collected before the FDA considers granting any vaccine full approval.
“We are concerned that the premature licensure of a COVID-19 vaccine can seriously undermine public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure,” petitioners wrote.
In an op-ed published today in The BMJ, four of the petition’s signatories, writing on behalf of the group, said:
“The message of our petition is ‘slow down and get the science right — there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.’ We believe the existing evidence base — both pre- and post-authorization — is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.”
The petition states a COVID vaccine should be fully approved only when substantial evidence demonstrates the benefits of a specific product outweigh the harms for the indicated, recipient population. The petitioners “respectfully” requested the FDA act on the petition by June 11. They plan to seek judicial relief if the petition is denied.
The FDA granted Emergency Use Authorization (EUA) to three COVID vaccines — Pfizer, Moderna and Johnson & Johnson (J&J) — allowing rapid and widespread vaccine rollout across the U.S. However, the EUAs were granted without a built-in expiration date, which means they can lawfully be distributed even after a “public health emergency” no longer exists.
The 20-page citizen petition and supporting documents are filed under Docket ID FDA-2021-P-0521 on regulations.gov. Anyone can comment on the petition, or read others’ comments, including the FDA’s official reply once it arrives.
Petitioners ask the FDA to implement eight efficacy and safety measures before granting a COVID vaccine full FDA approval:
- 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.
- 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.
- 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.
- Complete vaccine biodistribution studies from administration site and safety implications of mRNA translation in distant tissues.
- Require data of all severe adverse reactions reported following COVID vaccination, such as deaths, reported in VAERS and other pharmacovigilance systems.
- Assess safety in individuals receiving more than two doses.
- 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.
- 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.
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The petitioners provided a rationale for each requested action and a list of what they said were invalid reasons for rushing full approval of COVID vaccines. They explained that approving COVID vaccines for the purpose of ensuring they are accessible after the public health emergency has ended, or in an effort to ensure adequate access to vaccines across the population, are two objectives that can be accomplished with current EUAs.
The group also said giving full approval to a COVID vaccine in an effort to pave the way for vaccine mandates or to bolster public confidence were outside the scope of the FDA’s purview.
“Premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety of U.S. residents, with global ramifications considering the international importance of FDA decisions,” the group said.
The petition author and co-authors include:
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- 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.
Earlier this month, Children’s Health Defense Chairman (CHD) Robert F. Kennedy, Jr. and Dr. Meryl Nass, on behalf of CHD, filed a Citizen Petition with the FDA requesting the agency not only refrain from licensing COVID vaccines, but also immediately revoke the vaccines’ EUAs.
CHD submitted 72 references supporting the request for revocation and restraint. To read the full CHD petition text, download it from the FDA website or read the full petition here — then submit your comments using this form.