"But is it experimental?"
"Yes," I answered, "with every fiber of my being, I am telling you. It is experimental." and here is the article from the journal Nature that shows why
A quick glance at the mRNA history timeline in the Nature article, “The tangled history of mRNA vaccines” published on September 14, 2021, one can clearly see how mRNA technology has been investigated since the 1960's, but not widely tested or applied until 2020 through emergency use authorization (EUA).
Link to article: https://www.nature.com/articles/d41586-021-02483-w
I will include just one excerpt from the article:
An industry is born
By the late 2000s, several big pharmaceutical companies were entering the mRNA field. In 2008, for example, both Novartis and Shire established mRNA research units — the former (led by Geall) focused on vaccines, the latter (led by Heartlein) on therapeutics. BioNTech launched that year, and other start-ups soon entered the fray, bolstered by a 2012 decision by the US Defense Advanced Research Projects Agency to start funding industry researchers to study RNA vaccines and drugs. Moderna was one of the companies that built on this work and, by 2015, it had raised more than $1 billion on the promise of harnessing mRNA to induce cells in the body to make their own medicines — thereby fixing diseases caused by missing or defective proteins. When that plan faltered, Moderna, led by chief executive Stéphane Bancel, chose to prioritize a less ambitious target: making vaccines.
That initially disappointed many investors and onlookers, because a vaccine platform seemed to be less transformative and lucrative. By the beginning of 2020, Moderna had advanced nine mRNA vaccine candidates for infectious diseases into people for testing. None was a slam-dunk success. Just one had progressed to a larger-phase trial.
But when COVID-19 struck, Moderna was quick off the mark, creating a prototype vaccine within days of the virus’s genome sequence becoming available online. The company then collaborated with the US National Institute of Allergy and Infectious Diseases (NIAID) to conduct mouse studies and launch human trials, all within less than ten weeks.
BioNTech, too, took an all-hands-on-deck approach. In March 2020, it partnered with New York-based drug company Pfizer, and clinical trials then moved at a record pace, going from first-in-human testing to emergency approval in less than eight months.
Consider that the traditional vaccine development process would normally take:
2 years in pre-clinical trials with non-human subjects
1-2 years testing if it is safe (Phase I)
2-3 years testing does it activate an immune response (Phase II) and
2-4 years testing does it protect against disease (Phase III)
Coincidentally, in Subtitle C—Modern Trial Design and Evidence Development of the 21st Century Cures Act (2015-2016), in Section 3022, “Real world evidence” is defined as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials.”
Furthermore, in the proposed Cures 2.0 Act (2021-2022), “Sec. 304. Increasing Use of Real-World Evidence: builds on FDA’s efforts by:
requiring HHS to outline approaches to maximize and expand the use of RWE; and
establishing a task force to develop recommendations on ways to encourage patients to engage in real-world data generation.”
By stating, “Increasing Use of Real-World Evidence”, this means the engagement of patients in real-world data generation has already begun.
Moreover, at 38:00 minutes at a Tennessee State House Health Subcommittee meeting (https://tnga.granicus.com/MediaPlayer.php?view_id=610&clip_id=26334), Dr. Richard Urso explained that the COVID-19 vaccine studies of Pfizer, Moderna, and Johnson & Johnson all eliminated patients with natural immunity from their studies. Therefore, a random sample well-representative of the general population was not represented in their clinical trials.
Given the information presented above, my question is this:
How can a new, complex, fast-paced drug that hasn’t been tested long term and lacked randomized clinical trials be described as “safe” to patients before knowing the potential risks?
The answer is:
It should not be.
Plain and simple.
To do so is misleading.
It is experimental with unknown risks, and should have been and should be described as such.