And here we go with another one of those silly anti-vaxxers tropes – the COVID-19 vaccines are experimental, and the government/Big Pharma/Bill Gates are conspiring to test the vaccine on innocent people. Nothing could be further from the truth.
The claim that the COVID-19 vaccines are experimental probably arises from the fact that most of them received an Emergency Use Authorization (EUA) in the USA and other countries. The anti-vaxxers what to use the EUA to make a strawman argument that EUA is equivalent to “a risky, experimental drug that will cause great harm to you.”
But if these anti-vaccine activists spent just a little bit of time to understand the high-quality science behind these vaccines and the Emergency Use Authorizations, they might move on to some other topic. But in case someone finds this article among all of the nonsense on the internet, looking to find out if COVID-19 vaccines are, in fact, experimental, let’s debunk that with actual facts.
What is an Emergency Use Authorization?
I think that understanding what constitutes an Emergency Use Authorization is critical to our understanding of whether COVID-19 vaccines are experimental or not.
The legal framework for an Emergency Use Authorization is laid out in 21 U.S.C. §360bbb-3(e)(1(A)(ii) of the Federal Food, Drugs and Cosmetics Act. The specific provision is titled “Unapproved product”, and then “required conditions”, and the clause says that the Secretary (of the Department of Health and Human Services) shall “establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:
(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed–
…
(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”
On February 4, 2020, the Secretary of Health and Human Resources (HHS) determined that COVID-19 is a public health emergency with the potential to affect the health and security of U.S. citizens. Thus, the Secretary determined that the EUA was appropriate and justified. Before issuing a EUA, the FDA concluded that the following requirements were met:
- SARS-CoV-2 can cause a serious or life-threatening disease/condition;
- based on the totality of scientific evidence, it is reasonable to believe that the vaccine may be effective in diagnosing, treating, or preventing the disease or condition;
- the known and potential benefits of the vaccine to treat the condition outweigh the known and potential risks; and
- there is no adequate, approved, and available alternative to the vaccine.
Irrespective of a EUA, there is a pernicious myth pushed by anti-vaccine activists that the FDA summarily approves vaccines without even a cursory review. They think that the FDA trusts anything Big Pharma submits to them without thinking. That couldn’t be further from the truth.
Every drug, including the current COVID-19 vaccines available in the USA from Pfizer, Moderna, and JNJ, is almost always reviewed by an expert committee of scientists alongside career FDA scientists. These reviews are thorough, scientific, and open.
For vaccines, the Vaccines and Related Biological Products Advisory Committee, also known as VRBPAC, are made up of experts in vaccines, public health, and statistics. There are around 30 individuals on the committee (although several may not attend ) including one vaccine industry scientist (not from JNJ) and one consume representative. All voting members of VRBPAC are scientists, statisticians, physicians, and FDA experts.
Because it will be a thing, Dr. Paul Offit, MD, who has been designated a Big Pharma shill by anti-vaxxers, is a member of the committee. Dr. Offit is one of the world’s experts on vaccines, who developed one of the rotavirus vaccines that have saved hundreds of thousands of lives across the world every year.
According to the FDA, the committee is charged with:
The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of immunology, molecular biology, rDNA, virology; bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry.
These experts are not industry shills. They are some of the leading experts in all fields of vaccinology, not amateurs with a 15-minute education on vaccines. VRBPAC is a dignified committee that puts scientific evidence above all else.
But there’s more.
EUA Process
Viridiana Ordonez, a J.D. candidate at the University of California, Hastings College of Law, wrote an excellent article outlining the EUA process for COVID-19 vaccines, and as you will see, it’s not even close to being experimental.
There is a three-step process for a vaccine candidate to be even considered for an Emergency Use Authorization.
First, show that the vaccines are safe
The Biologic Control Act (BCA) and Public Health Service Act (PHSA) authorized the FDA to license vaccines if the vaccines are shown to be safe, pure, and potent. To determine that, vaccines have to first be tested in non-clinical studies and then, in addition, on humans.
Further, sponsors of a vaccine must submit data before a vaccine can be licensed, including but not limited to:
- data derived from nonclinical and clinical studies showing the product’s safety, purity, and potency;
- a description of manufacturing methods for the vaccine;
- data establishing the product’s stability through the dating period; and
- a representative sample of the product and summaries of results of tests.
After this data is submitted, the FDA reviews and evaluates the sponsor’s data and information to determine whether the vaccine is in fact safe, pure, and potent. Only after that determination can a vaccine finally be licensed. Finally, vaccines continue to be safe even after licensure because the FDA continues to monitor vaccines to detect any “rare, serious, or unexpected adverse events” through the use of multiple surveillance methods.
Second, follow the process for Investigational New Drugs
Before the FDA approves a vaccine for public use, the vaccine must undergo a rigorous and extensive development program to determine safety and effectiveness including preclinical research and clinical studies. Before a clinical investigation can even begin, the sponsor must submit an Investigational New Drug (IND) application to the FDA. The application must describe the proposed study, the protection, and the rights of the subjects, and must also include information on the clinical protocols.
After the submission of the IND, there is a 30-calendar day waiting period in which the FDA reviews the application. Only after this review can the sponsor conduct a clinical investigation divided into three phases.
Phase I focuses on immunogenicity studies performed on a small number of subjects; Phase II includes several hundreds of individuals to determine any short-term side effects; Phase III requires a sample size of thousands or tens of thousands of people and provides data on the effectiveness and safety of the vaccine. If at any point there is a significant concern about safety or effectiveness, the FDA can request additional studies or stop the clinical trials.
Third, EUA is issued only if it meets statutory standards.
The FDA has made clear that the issuance of a COVID-19 vaccine requires a demonstration of clear and compelling safety and efficacy throughout Phase III of the clinical trial. Phase III involves a large number of participants that receive either an investigational vaccine or a control.
The efficacy is studied by comparing both groups and the FDA has recommended that the vaccine should be at least 50% more effective than the control. Participants are monitored for safety events during the entire study, and if evidence from the clinical trial’s safety profile is acceptable, then the results can then be submitted to the FDA in support of the EUA. Following the submission and issuance of a EUA, the FDA expects that the vaccine sponsor will continue to evaluate the vaccine and work towards submitting a Biological License Application (BLA).
The COVID-19 vaccines are not experimental
I think too many people believe that the EUAs for the COVID-19 vaccines were cursory, rushed, and uncritical. In fact, the clinical trials for all of the COVID-19 vaccines approved in the USA included over 100,000 people – that is far larger than any clinical trial that I’ve ever seen in my long life on this planet.
For most drugs, 3-5 thousand participants, divided into two or three arms including a placebo, is enough to consider it a pivotal phase 3 study that can be submitted to the FDA. At that number, the statistical differences between the drug and placebo groups become significant.
Of course, the anti-vaccine world wants to use silly gambits such as claiming these experimental COVID-19 vaccines violate the Nuremberg Code – Dorit Rubinstein Reiss and Orac both say no. It’s not even close.
Getting an Emergency Use Authorization is complex, time-consuming, and rigorous. Massive amounts of data were presented to the VRBPAC for examination before the committee could meet and vote on the EUA.
Furthermore, and this is very important, the process to get that authorization did not involve any shortcuts – large clinical trials and data analysis was actually more comprehensive than employed by any other vaccine IND submission. In fact, I have a worry that future vaccines, unrelated to COVID-19, may require a similar size for clinical trial and create massive delays in approval.
So, let’s be perfectly clear – there is nothing in the science and regulatory review that comes close to calling these COVID-19 vaccines “experimental.” And let’s not forget that, as of today (12 August 2021), over 4.5 billion vaccinations have been given.
Of course, as my girlfriend said, without these vaccines, and modern medicine, this COVID-19 pandemic would have made the 1919 Flu Pandemic, which killed 50-100 million people worldwide, look like a blip.
Experimental or not, I, and billions of others, would take the vaccine. But it is not experimental, so that’s one more reason to get it.
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