In early June, UncoverDC reported on a group of twenty-seven scientists, clinicians, and patient advocates, who submitted a formal "Citizen Petition" with the United States Food and Drug Administration (FDA), requesting the agency to halt any consideration of a "full approval" of COVID-19 vaccines. On July 5th, the group submitted an amended petition on behalf of CAALM, the Coalition Advocating for Adequately Licensed Medicines. The move will allow CAALM, which is the updated name of the original 27 signatories, to pursue other potential avenues in addition to the FDA Petition.
The Message Remains the Same
The group's message to the FDA of "slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine" remains the same. The petition points out that the Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) to three COVID-19 vaccines (Pfizer, Moderna, and Johnson & Johnson), enabling accelerated and widespread vaccine rollout across the country. With no pre-set expiration date, the EUA's can continue to be lawfully distributed even after a future date when there is no longer a public health emergency.
CAALM reasserts its belief that the FDA should not "prematurely grant a license to any COVID-19 vaccine until all necessary efficacy and safety studies are completed, and substantial evidence demonstrates the benefits of an individual COVID-19 vaccine product outweigh the harms for the indicated, recipient population." Of concern is that, despite the fact COVID-19 "vaccine" products have only been administered for approximately seven months, at least two vaccine manufacturers now seek licensure (approval) and have submitted Biologics License Applications (BLAs). Other manufacturers have indicated they will follow suit, as well as seek EUAs "for additional pediatric populations."
Efficacy and Safety Measures that Must Be Met Before FDA Approval
CAALM reiterates that a COVID-19 vaccine BLA should be approved when—and only when—substantial evidence proves the benefits of a specific product outweigh the harms for the indicated recipient population. The amended petition outlines efficacy and safety measures that they maintain must be met before serious consideration is given to granting a BLA of any COVID-19 vaccine.
As stated in the petition (with a comprehensive rationale for each item), CAALM outlines the argument for each requested action listed below.
- Confirm, in revised Guidance, that the FDA expects a minimum of 2 years of follow-up of participants enrolled in pivotal clinical trials, even if trials are unblinded and lack a placebo control.
- Require data demonstrating substantial evidence of clinical effectiveness that outweighs harms, in all special populations, as a condition of consideration of including these populations among the indicated populations. Special populations include infants, children, and adolescents; those with past SARS-CoV-2 infection; immunosuppressed individuals; those with a history of or current cancer; individuals with hematological disorders or autoimmune diseases; pregnant or nursing women; and frail older adults.
- Require data on the safety and pharmacokinetic profiles of the spike protein.
- Require data from biodistribution studies investigating the actual COVID-19 vaccines.
- Require data from pharmacovigilance systems in the U.S. and globally documenting a thorough investigation of serious adverse events carried out by independent, impartial individuals.
- Clarify in revised Guidance that safety data from individuals receiving more than 2 vaccine doses must be submitted by vaccine manufacturers.
- Ensure the inclusion of experts in gene therapy in the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
- Ensure that the analysis of data and decisions regarding any COVID-19 vaccine BLA application is informed by experts with no financial or research relationships with any vaccine manufacturers within the last 36 months, both within FDA and amongst the composition of the VRBPAC.
The amended FDA petition allows anyone to comment on the petition and view the comments of others. Likewise, Medscape has a page with the topic "How concerned are you about adverse events related to the vaccines?" Commenting is limited to physicians and other healthcare providers, who must first be granted access to the moderated comment page.
MIT Sr. Researcher's Review of mRNA "Vaccines"
A deeper look at a comment posted on August 3rd on the Medscape page by a healthcare professional, "an immunization nurse for a national healthcare company," directs readers to a May 10, 2021 article in The International Journal of Vaccine Theory, Practice, and Research (IJVTPR). The peer-reviewed article, titled "Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19" is co-authored by Stephanie Seneff (Computer Science and Artificial Intelligence Laboratory, MIT) and contains 30 pages of reviews, technology, and concerns documented and backed up with 12 pages of references from actual biologic studies.
The research details the technology behind mRNA vaccines in further detail, devoting several sections to specific aspects of the mRNA vaccines of concern to the experts surrounding the potential for both predictable and unpredictable negative consequences. The paper closes with a plea to governments and the pharmaceutical industry to consider exercising greater caution in the current undertaking to vaccinate as many people as possible against SARS-CoV-2. A brief snippet from the introduction of the in-depth article reveals:
"Unprecedented. This word has defined so much about 2020 and the pandemic related to SARS-CoV-2. In addition to an unprecedented disease and its global response, COVID-19 also initiated an unprecedented process of vaccine research, production, testing, and public distribution.
The confluence of these unprecedented events has rapidly brought to public awareness the promise and potential of mRNA vaccines as a new weapon against infectious diseases into the future. At the same time, events without precedent are, by definition, without a history and context against which to fully assess risks, hoped-for benefits, safety, and long-term viability as a positive contribution to public health.
Development of mRNA vaccines against infectious disease is unprecedented in many ways. In a 2018 publication sponsored by the Bill and Melinda Gates Foundation, vaccines were divided into three categories: Simple, Complex, and Unprecedented. Simple and Complex vaccines represented standard and modified applications of existing vaccine technologies. Unprecedented represents a category of vaccine against a disease for which there has never before been a suitable vaccine. As the authors bluntly put it, there is a “low probability of success, especially for unprecedented vaccines.”
With that in mind, two years later, we have an unprecedented vaccine with reports of 90-95% efficacy. In fact, these reports of efficacy are the primary motivation behind public support of vaccination adoption (U.S. Department of Health and Human Services, 2020). This defies not only predictions but also expectations. The British Medical Journal (BMJ) may be the only prominent conventional medical publication that has given a platform to voices calling attention to concerns around the efficacy of the COVID-19 vaccines. There are indeed reasons to believe that estimations of efficacy are in need of re-evaluation."
Dr. Seneff, who is a huge advocate against the toxic chemical glyphosate, concludes her study by pointing out an obvious but "tragically ignored" suggestion:
"The government should also be encouraging the population to take safe and affordable steps to boost their immune systems naturally, such as getting out in the sunlight to raise vitamin D levels and eating mainly organic whole foods rather than chemical-laden processed foods. Also, eating foods that are good sources of vitamin A, vitamin C, and vitamin K2 should be encouraged, as deficiencies in these vitamins are linked to bad outcomes from COVID-19."
