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Last year, Moderna announced a $400 million royalty payment to the National Institute of Allergy and Infectious Diseases (NIAID). More recently, the National Institutes of Health (NIH) reportedly demanded past-due royalties from BioNTech relating to mRNA technology.
Was protecting the NIH’s royalty payments the U.S. Department of Health and Human Services’ (HHS) end game all along?
When the U.S. government’s control of all COVID-19 vaccines ends about the time of the scheduled Dec. 31, 2024, end of the COVID-19 emergency — and presumably the end of liability protection for vaccine makers under the Public Readiness and Emergency Preparedness (PREP) Act — what will happen is anybody’s guess.
According to Reuters, “Moderna and Pfizer have yet to announce a final price for their vaccines in the private market, but said to expect them to be substantially higher than what they charged governments at the height of the pandemic.”
Without government protection from lawsuits, COVID-19 vaccines will disappear as downstream liability will be the curtailing factor in whether or not these injections are available publicly beginning in 2025.
But, I predict vaccine makers and the HHS will find a way to continue the royalty gravy train at our expense.
HHS’ never-ending emergency and Vaccine Adverse Event Reporting System (VAERS) reports of death and serious bodily injury have not been enough to get any government agency to budge an inch to come to the people’s rescue.
Many of us shake our heads in disbelief over the HHS’ complete failure to address the obvious shortcomings of its COVID-19 vaccine policy. The HHS and its component agencies’ working at cross-purposes kludged a tight-lipped stalemate — four years of zero-course correction and zero problem-solving.
HHS is mired in a delicate balancing act — one agency moves and the entire house of cards falls. HHS painted itself into a corner protecting pharma and agency interests while the people get the bum’s rush.
If HHS immediately ended the COVID-19 emergency, I believe the U.S. government would become liable for injury as an indemnitor for any lawsuit and the government would be stuck with huge stockpiles of leftover inventory.
To provide an idea of the extent: 984,444,295 COVID-19 vaccines were distributed but only 676,728,782 have been administered. It is conceivable that tens or even hundreds of millions of doses would need to be tossed since HHS guaranteed both companies must be covered by PREP or there is no COVID-19 vaccine distribution.
Under their government contracts, both Pfizer and Moderna are “protected from liability under a declaration issued under the PREP Act, or a successor COVID-19 PREP Act Declaration of equal or greater scope.”
Under the PREP Act, any act or omission by a manufacturer “shall not constitute ‘willful misconduct’” if the HHS secretary (or the U.S. attorney general) has not brought an enforcement action under 42 U.S. Code Section 247d-6d (c)(5).
If the HHS brings an enforcement action against either of these manufacturers, it will threaten NIH’s royalties and simultaneously expose HHS to a breach of contract case. So it stands to reason that HHS will never take action against mRNA technology, no matter the risk. Any chance for monetary recovery is reduced even further.
A U.S. District Court in Delaware recently explained mRNA technology in Arbutus Biopharma Corp. v. Moderna, Inc.:
“Moderna’s COVID-19 vaccine … belongs to a new class of medicines that deliver nucleic acids … molecules that encode the genetic information essential to sustain life. …
“The mRNA then carries the code to the cell’s protein-making machinery, which assembles the protein from the code stored in the mRNA.”
Royalties are due to the NIAID presumably because, as Dr. Anthony Fauci put it:
“As part of a longstanding collaboration, the NIAID VRC [Vaccine Research Center] worked with the biotechnology company Moderna to develop a vaccine candidate designated mRNA-1273.”
Moderna, in a lawsuit against Pfizer, admitted it “partnered with leading scientists from the NIH to test and develop Moderna’s COVID-19 vaccine.” The case was stayed on April 12, 2024, pending U.S. Patent and Trademark Office determination.
Does this rise to the level of a conspiracy?
Civil conspiracy is an agreement between two or more persons to participate in an unlawful act that caused injury in furtherance of the common scheme.
Either HHS continues COVID-19 PREP emergency protection, the U.S. Food and Drug Administration (FDA) continues COVID-19 vaccine licensure and Emergency Use Authorization — or the NIH forfeits royalties.
Meanwhile, the Centers for Disease Control and Prevention downplays VAERS reports claiming VAERS doesn’t “tell us whether a vaccine caused a medical issue.”
The FDA claims it has not identified any safety signals for fibrous blood clots with COVID-19 vaccines.
HHS cannot break ranks by allowing the FDA to bring an enforcement action without exposing itself and Moderna to liability for willful misconduct under the PREP Act when the Moderna contract provides immunity from suit.
Perhaps neither one of these agencies or manufacturers may be named as a defendant in a lawsuit for willful misconduct if each activity is viewed in a vacuum.
But when viewed together, it is more probable that willful misconduct could be alleged against defendants’ mutual monetary motivations in protecting their mRNA technology that hijacks our cell’s protein-making machinery.
