by Dr. Joel S. Hirschhorn
America’s Frontline Doctors
In the global COVID pandemic there has not been a more important action to protect public health than the current Citizen Petition to FDA to stop the full approval of COVID vaccines until many serious concerns and issues are genuinely addressed.
There has been no significant coverage of this historic petition by mainstream and corporate social media. This cancel action is itself as remarkable as the petition itself. This is a concerted effort to keep the public uninformed about the many problems with the COVID vaccines. Any person who spends the time to peruse the 20-page petition would most likely have a very negative view of the vaccines. For the unvaccinated this awareness would greatly increase vaccine hesitancy and rejection. For the vaccinated it would produce concern and regret.
The political system would literally go crazy if the petition was seriously covered by big media. Big drug companies would jump into action to suppress political and media attention to the petition. The goal of this article is to better inform the public and motivate people to take action.
Before delving into the substance provided in the petition context is needed to fully understand the critical importance of the petition and make the case for individuals to officially express their support for it as part of the federal regulatory process.
One rational reaction to reading the very detailed, 20-page petition signed by 27 physicians and medical researchers from the US and other nations is this: Why not use all the detailed concerns about the COVID vaccines to demand FDA take the experimental vaccines off the market?
Indeed, the biggest name on the list of signatories is the esteemed Dr. Peter McCullough of Baylor University. He has been very outspoken and honest about many pandemic issues. He has said that, considering the high numbers of deaths and serious health impacts associated with taking the vaccines, FDA should do what it has done in the past when new medicines and vaccines had high negative impacts. Take them off the market.
Why not petition FDA to do this? Just imagine what stopping the whole COVID vaccine effort worldwide would cause. Political and public health systems would not know what to do. They would be totally stunned and flummoxed. So, though the current petition does not do this, it definitely took considerable courage to make the case to FDA to not move quickly from an emergency use authorization to full approval of the COVID vaccines.
People who have not fallen victim to the endless propaganda of the political, big media and public health systems promoting COVID vaccine jabs may not be willing to seriously examine the medical and scientific details of the petition. The problem is cognitive dissonance. Too many people will not easily resolve their propaganda induced positive views of the vaccines with the medical and science details in the petition. But that is what must happen. People must temper their fear of COVID infection with awareness that vaccines are now experimental and have not been sufficiently proved safe for all users.
The potential frustration and fear if the vaccines were deemed insufficiently safe could be mitigated by advocating for early home/outpatient treatment and preventive use of a number of cheap, safe and fully approved generic medicines. The government and public health system have blocked their wide use in favor of the wait-for-the-vaccine strategy that serves the financial interests of vaccine manufacturers. As presented in detail in Pandemic Blunder and this website, there are mountains of medical evidence to justify the treatment protocols. They are legitimate, proven alternatives to experimental and insufficiently tested vaccines that might be fully approved by FDA.
To achieve true protection of public health we need an avalanche of official public support for the petition. More details later on how people can do this.
WHAT THE PETITION EMPHASIZES
A week after the June 1 petition, lead authors of the petition published an editorial in the British Medical Journal with the title “Why we petitioned the FDA to refrain from fully approving any covid-19 vaccine this year.” Here are some key statements that use plain language to summarize key parts of the petition:
“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.”
“We focus on methods and processes, outlining the many remaining unknowns about safety and effectiveness—and suggest the kinds of studies needed to address the open questions.”
“Trials by vaccine manufacturers were designed to follow participants for two years, and should be completed before they are evaluated for full approval.”
“We also call on FDA to require a more thorough assessment of spike proteins produced in-situ by the body following vaccination—including studies on their full biodistribution, pharmacokinetics, and tissue-specific toxicities.”
“We all agree that there remain many open, unanswered questions surrounding the efficacy and safety of covid-19 vaccines that must be answered before the FDA gives serious consideration to granting full approval.”
“Some surveys suggest that vaccine hesitancy in the United States is due, in part, to lack of full FDA approval. While approval might lead to increased public confidence in covid-19 vaccines, as well as provide legal support for employer-instituted vaccine mandates, to approve a medical product for these reasons is outside FDA’s regulatory purview. Approval decisions must be driven by the safety and efficacy data. The potential unintended consequences of a rushed approval may contribute to growing mistrust of the US public health and regulatory institutions.”
“For each covid-19 vaccine, the benefits may ultimately outweigh the harms. Or not. Or we may end up in a more nuanced position, finding that benefits outweigh harms for some populations, but not others. Only time—and better evidence—will tell.”
Now, some key parts of the petition itself are presented to further illustrate what medical and science perspectives have been formulated to pressure FDA to better evaluate the COVID vaccines.
A most important point made in the petition is this. Work must be done to show that there is “substantial evidence of clinical effectiveness that outweighs harms in special populations such as: 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.” This is so important because so many of the deaths and harmful impacts have occurred in these groups.
Most importantly: “The widespread use of a COVID-19 vaccine under EUA, particularly for a limited amount of time, also is not a valid reason to approve a product.”
And here is a critical point that many critics of the vaccines have focused on: “In-situ production of SARS-CoV-2 spike protein is the target mechanism of action of all COVID-19 vaccines with an EUA at present. Therefore, the safety profile of spike protein itself (i.e., in the absence of virus) must be thoroughly understood [in all populations]. Recently, evidence of systemic circulation of spike protein or its components in subjects post-immunization was reported. All studies we are aware of to date raise concerns about the safety of spike protein, and the concentration of circulatory spikes was correlated to the disease severity in COVID-19 patients.”
WHAT PEOPLE CAN DO
Though FDA cannot ignore the petition, there is no assurance that it will genuinely address all of the issues and concerns in it. Or that it will postpone approval of the vaccines until there is sufficient research and analysis into all the points in the petition.
It must be appreciated that the petition is authorized by federal law. 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. 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.” Granting full approval of the COVID vaccines is a major FDA administrative action with both national and global significance.
What is needed is a massive number of people officially registering their support of the petition on the proper FDA website. This can be done anonymously. Here are important links for the petition:
- The Citizen Petition (Docket ID: FDA-2021-P-0521)
- To comment on the petition
- To read others comments on the petition
- Main FDA docket for the petition (Docket ID: FDA-2021-P-0521)
Dr. Joel S. Hirschhorn, author of Pandemic Blunder and many articles on the pandemic, worked on health issues for decades. As a full professor at the University of Wisconsin, Madison, he directed a medical research program between the colleges of engineering and medicine. As a senior official at the Congressional Office of Technology Assessment and the National Governors Association, he directed major studies on health-related subjects; he testified at over 50 US Senate and House hearings and authored hundreds of articles and op-ed articles in major newspapers. He has served as an executive volunteer at a major hospital for more than 10 years. He is a member of the Association of American Physicians and Surgeons, and America’s Frontline Doctors.