21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies
Individuals receiving the product must be informed 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 a
It is unclear whether the public has been made aware that an emergency authorization drug can be refused. The statute cited above indicates that the recipient of such a product must be informed of this refusal option. Hundreds of millions of intrepid souls are being rushed to get a Moderna injection based on an experimental gene therapy, mRNA. This is Moderna's first marketed product. Noubar Afeyan is the co-founder of Moderna, through his venture capital firm, Flagship Pioneering. Stéphane Bancel is a French businessman. Bancel is the Chief Executive Officer and a 9% owner of Moderna. An article appearing in Pharmaceutical Technology dated February 21, 2019 was entitled: “Moderna IPO: can mRNA therapy live up to the hype?” made some perspicacious observations about Moderna. These observations are particularly worth noting because this Pharmaceutical Technology article appeared approximately one year before COVID19 became a household word in America and every other nation across the globe. The Pharmaceutical Technology article began with this sly question:
US-based Moderna Therapeutics raised more than $600m in the biotech industry’s largest IPO. The company creates synthetic mRNA, which is injected into patients so they can create their own therapeutic proteins. Despite having no products on the market, and little clinical data to support the hype, Moderna has built to a mammoth valuation of more than $7bn. But can the firm deliver on its lofty goals?
The Pharmaceutical Technology article also made a pointed reference to Moderna’s track record:
Moderna: a fundraising machine
Moderna’s outsized IPO effectively values the company at around $7.5bn. It’s an immense valuation, particularly for a company that has no products on the market or even in late-stage clinical trials. (emphasis added). The offering is also the cherry topping off Moderna’s distinctive business development strategy and impressive facility for raising money.
Notably, on August 19, 2019, Moderna received FDA Fast Track Designation for Zika Vaccine mRNA-1893. However, the CDC’s website to this very date states: “There is no specific medicine or vaccine for Zika virus.” Apparently, the FDA has never approved Moderna’s Zika virus. Moreover, in an article written by Damien Garde for statnews.com dated January 10, 2017, entitled: “Lavishly funded Moderna hits safety problems in bold bid to revolutionize medicine”, Garde wrote about an effort by Moderna to develop a vaccine to treat a rare and debilitating disease known as Crigler-Najjar syndrome. It was a failure. In the words of Damien Garde: “the Crigler-Najjar treatment has been indefinitely delayed, an Alexion spokeswoman [Alexion Pharmaceuticals was partnering with Moderna] told STAT. It never proved safe enough to test in humans, according to several former Moderna employees and collaborators who worked closely on the project.”
Moderna’s CEO, however, was undaunted. According to Garde, Bancel gave a presentation to a packed room in 2016 at the annual January biotech investor event in San Francisco, the JP Morgan Healthcare Conference. Bancel’s presentation focused on four vaccines that the company was moving through the first phase of clinical trials: two target strains of influenza, a third vaccine for Zika virus, and the fourth remained a secret. Four years later, one can only speculate what that “secret” may have been. Nonetheless, the Nature Biotechnology Journal was decidedly unimpressed with Moderna. In an article dated February 5, 2016, the editors wrote: “
Moderna, Theranos, Kadmon and companies like them may think they are better off if no one knows what they do or how they do it. But there will come a time when they have to decide whether to trust the community with their data. If they don't, the community may start to ask whether these companies themselves can be trusted.”
This background was not talked about in the press as Moderna was given a green light to go ahead and develop a vaccine for COVID19. When it eventually was released to the public in December of 2020, there was no substantive discussion in the press about the fact that the FDA had never licensed it nor had the FDA ever approved it. Instead, the FDA issued an emergency authorization. The fact that this regulatory designation was provided by the U.S. government should have been highlighted and emphasized. That is what the operative statute requires. But it was not done.
No one knows the long-term side effects of these COVID19 injections. People are merely acting on faith. They appear to perceive this "vaccine" to be like that of Jonas Salk and his legendary polio vaccine of the 1950's. If you believe in the COVID19 vaccines, you do not have much data to go on. Similarly, if you do not believe in these products, you do not have much data to go on. But in fact, the usual regulatory approvals were deferred to stop a virus that will not kill 99.5% of the population. What if ultimately these injections have serious long term side effects? Millions of people have received the injection. The long-term result could be a disaster in the making. The time-honored concept of "cost benefit analysis" may have been overlooked. I have received many vaccines during the course of my life. I am glad I did. But here, now, my concerns run deep. Notice that the agencies are not restricting this injection to the elderly or those at high risk. Perfectly healthy young people are going to be getting the injections. Chances are these younger people are not going to get sick anyway. The vaccines are also being administered to people who have already had COVID19. The effect of the COVID19 vaccines on people who have COVID19 antibodies already in their system is a necessary discussion that will have to be put off for another day.