2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine
Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.
The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product.
While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.
Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says “Comirnaty,” it’s a licensed product. If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse.
If it comes from Moderna or Johnson & Johnson (marketed as Janssen), Americans have the right to refuse.
An extract. Authors: By: Robert F. Kennedy, Jr. & Meryl Nass, M.D
Medicines assessed as having a higher level of risk must be registered. The degree of assessment and regulation they undergo is rigorous and detailed, with sponsors being required to provide comprehensive safety, quality and efficacy data.
All registered medicines:
- must display an ‘AUST R’ number on the label as proof of registration
- are evaluated as either ‘high risk’ or ‘low risk’ registered.
Prescription (high risk) registered
Prescription medicines fit into the sub-category of registered medicines as high risk registered products. This group includes all prescription medicines and some specified products such as sterile injectables.
Non-prescription (lower risk) registered
Lower risk registered products do not require a prescription. Products in this category are considered to be lower risk than prescription medicines. However, they still require a high level of scrutiny, for example to ensure adequate labelling for appropriate use.
Examples of products in this category are mild analgesics, cough and cold medicines, and anti-fungal creams.
Clinical trials conducted in Australia are subject to various regulatory controls to ensure the safety of participants. We regulate the use of therapeutic goods supplied in clinical trials in Australia under the therapeutic goods legislation.
Clinical trial sponsors must be aware of the requirements to import, export, manufacture and supply therapeutic goods in Australia.
The following avenues provide for the importation into and/or supply in Australia of ‘unapproved’ therapeutic goods for use in a clinical trial:
- Clinical Trial Notification (CTN) scheme; and
- Clinical Trial Approval (CTA) scheme.
Clinical trials that do not involve ‘unapproved’ therapeutic goods are not subject to requirements of the CTN or CTA schemes. It is the responsibility of the Australian clinical trial sponsor to determine whether a product is considered an ‘unapproved’ therapeutic good.
Information about clinical trials for consumers, health care providers, researchers, industry and sponsors is available on the National Health and Medical Research Council’s Australian clinical trials website(link is external).
COAG Health Council Revitalised Clinical Trials Agenda
While there have been sector improvements resulting from collaborations to date, there still remains work to be done to improve the environment for clinical trials in Australia. The goal remains to make Australia a preferred destination for clinical trials to benefit participants and stimulate jobs and business growth arising from health and medical research.
In April 2016 the Council of Australian Governments (COAG) Health Council noted that while jurisdictions have worked to improve the environment for clinical trials, issues of fragmentation and inefficiencies remain, that impact on Australia’s attractiveness as a preferred location for trials. Health Ministers agreed to develop approaches to organise sites to better support and streamline clinical trials processes in Australia.
In response to the April 2016 decision of the COAG Health Council noted above, the CTPRG developed a set of Principles and Priority Action Areas to underpin regional redesign of jurisdictional clinical trial systems. Priority Action Areas include:
- Coordination units – new models to centralise and coordinate trial management.
- Networks and partnerships – maximised collaboration with trial networks, communities of expertise/practice and registries, with an emphasis on cross-jurisdictional and discipline cooperation.
- Enhancement of data and knowledge systems – fast-tracked agreed metrics collection and improved data linkage capability, and support for mutual acceptance of ethical review.
- Research as essential health system business – embedding research and clinical trials into core hospital governance arrangements, including the use of performance measures.
- Embedding clinical trials in safety and quality approaches – collaboration with the Australian Commission on Safety and Quality in Health Care to establish a clinical trials governance framework to support research in public hospitals.
These Principles and Priority Actions were endorsed by COAG Health Council in March 2017 and provide a unique level of national agreement on priorities for streamlining of clinical trials processes, building national cohesion and advancing the clinical trials environment in Australia.
Jurisdictions and the Commonwealth are collaborating on key measures to address Priority Action Areas. This includes further strengthening Australia’s clinical trial sector using stimulus from the Australian Government’s Encouraging More Clinical Trials in Australia initiative, under which $7 million is available nationally to assist State and Territory governments achieve system redesign in accordance with the revitalised COAG Health Council clinical trials agenda. Among other things, this agenda seeks to establish central points of contact to improve system navigation for sponsors and participants, streamline trial processes and time to trial start-up, and improve workforce capacity.
National Health and Medical Research Council
The National Health and Medical Research Council (NHMRC) issues advice on ethical issues relating to health and develops guidelines for the conduct of research involving humans and animal research. There are more than 200 HRECs in institutions and organisations across Australia.
The NHMRC issues the National Statement on Ethical Conduct in Human Research (the National Statement) that sets out the requirements for the composition of an HREC and the relevant ethical principles and values by which research should be designed and conducted and to which HRECs should refer when reviewing research proposals.
What should you consider when thinking of participating in a clinical trial?
It is important that you have an in-depth discussion with your health provider (for example, GP or specialist) as well as the medical researchers undertaking the trial regarding the benefits and risks. There are some possible risks for consumers participating in clinical trials and it is very important that you seek advice and guidance to ensure that you understand these. You should also consider both immediate and long-term side effects.
Some possible risks include:
• The treatment in the clinical trial may have
different, unpleasant or more serious side
effects than those known with the best
• The consumer may be more inconvenienced
and may have to undergo more treatment,
tests, hospital visits or complicated medication
requirements. For example, participants may
need to keep a symptom diary, collect 24 hour
urine specimens or wear a monitor overnight.
• The treatment in the clinical trial may not work.
Who can participate in a clinical trial?
A clinical trial is designed for a specific group of people and there are strict guidelines about who is eligible to participate. These guidelines normally outline inclusion criteria that allow an individual to participate in the trial. These could be factors such as age, gender, the type and stage of a disease, previous treatment history and other medical conditions. Exclusion criteria are also often identified in the guidelines. These are the factors that would prevent an individual from participating. The inclusion and exclusion criteria are to ensure all consumers in the clinical trial have the same characteristics so that the trial will generate reliable results for future medical practice or to have a new treatment approved by health authorities. Informed consent Before agreeing to participate in a clinical trial, it is important that you are informed of all the essential facts about the trial. The medical researchers undertaking the study must ensure that you are aware from the beginning and throughout the trial of all the details of the study. For example, you will want to know the study’s purpose, duration, required procedures and key contacts.
Potential risks, benefits to you and effects on your family or carers when participating in a clinical trial must also be clearly explained before you agree to participate. This is called informed consent. The information you need is usually given to you in a Patient Information Statement provided by the people conducting the trial. It should be written clearly in a way that you can understand. It is important to understand that only some consumers in a trial will receive the new treatment and others may receive either a placebo (a medical treatment that is inactive) or the standard medication for that disease. You should ask about anything that is not clear to you. It is also important to know that you are able to leave a clinical trial at any time and are not obliged to remain in a trial if you no longer wish to participate. If you choose to leave a clinical trial there will be no impact on your access to standard treatments for your condition.