Covid: One label still persists
Moderna's Q1 2022 SEC Filing still references "Gene therapy" and contains worse news
In November 2021 I published an article based around Moderna’s admission in its June 2020 SEC Filing that the FDA considered mRNA products as gene therapies.
Covid: One label to rule them all
I argued that:
language itself was being subverted and definitions changed at whim by both big pharma and regulatory authorities including the FDA, MHRA and EMA; in order to
deliberately categorise mRNA and DNA-based technologies as “vaccines”; so that
these technology platforms and the Covid-19 treatments being deployed would circumvent - deliberately - the appropriate level of regulatory investigation that should otherwise be applied.
Moderna itself admitted that as of June 2020, no regulatory pathway existed for mRNA gene therapy products. The implication of this statement is extremely far-reaching. It meant that either:
regulators needed to build robust regulatory testing and approval processes for these products, which would inherently take significant time and effort; or
some other existing regulatory pathway would have to be applied to these products - possibly modified in some appropriate and approved way - even if such pathways were inherently inappropriate or inadequate.
mRNA and DNA-based Covid-19 gene therapies were globally categorised as “vaccines” and therefore subject to insufficient regulatory testing and approval. This is demonstrated in FDA, MHRA and EMA regulatory documentation that was published in Q1 2021, in which it was stated that many forms or aspects of testing were either not required of done to extremely limited degrees.
Fast forward to today.
Courtesy of the Lioness of Judah Ministry substack we can quickly check out Q1 2022 Moderna’s SEC Filings, which state:
Page 59
Item 1A. Risk Factors
We may be delayed or prevented from receiving full regulatory approval of our COVID-19 vaccine in certain jurisdictions or for certain demographics
Efficacy, effectiveness, safety, and immunogenicity data with respect to our COVID-19 vaccine, as well as real-world evidence, continue to accumulate. Further results from clinical trials, as well as the experience of vaccinated individuals, could show diminished protection compared to the results released to date, as efficacy and antibody persistence wane over time.
Additionally, we may observe new, more frequent or adverse events of greater severity in subjects participating in ongoing clinical trials or among those individuals vaccinated with our COVID-19 vaccine. For example, some studies have suggested that our vaccine may be associated with higher rates of myocarditis and pericarditis in young males compared to other COVID-19 vaccines.
Unexpected safety issues could significantly damage our reputation and that of our mRNA platform, and lead to other issues, including delays in our other programs, the need to re-design our clinical trials and the need for significant additional financial resources.
The assays used to estimate the effectiveness of COVID-19 vaccines have only recently been developed and continue to evolve. Validation reports for these assays have been submitted for review to regulatory agencies.
Results obtained in clinical studies of mRNA-1273 with later versions of these assays may be less positive than the results we have obtained to date.
The future results in clinical studies of mRNA-1273 may not be as positive when compared to the antibody levels in other blood samples.
We may be unsuccessful in developing future versions of our COVID-19 vaccine to protect against variants of the SARS-CoV-2 virus, or booster doses of our vaccine may not protect against such variants, and a market for vaccines and boosters against these variants may not develop.
…Additionally, administration of booster doses of our vaccine may prove to be ineffective, or less effective than desired, against certain variants. We have several development candidates against variants of concern, and may develop others in the future. If these efforts are unsuccessful, we are slower to develop variant-specific vaccines than competitors, or these vaccine candidates prove less effective than competitors’ vaccines, these shortcomings may lead to reputational harm, loss of market share, and adverse financial results.
Page 64
mRNA drug development has substantial clinical development and regulatory risks due to the novel nature of this new class of medicines, and the negative perception of the efficacy, safety, or tolerability profile of any investigational medicines that we or others develop could adversely affect our ability to conduct our business, advance our investigational medicines, or obtain regulatory approvals.
No mRNA medicine has been granted full or conditional approval by the FDA or other regulators, other than COVID-19 vaccines. Successful discovery and development of mRNA medicines by us or our strategic collaborators is highly uncertain and depends on numerous factors, many of which are beyond our or their control. We constantly make business decisions and take calculated risks to advance our development efforts and pipeline, including those related to mRNA technology, delivery technology, and manufacturing processes, which ultimately may be unsuccessful.
Page 65
Some of our investigational medicines are classified as gene therapies by the FDA and the EMA. The association of our medicines with gene therapies could result in increased regulatory burdens, impair the reputation of our investigational medicines, or negatively impact our platform or our business.
There have been few approved gene therapy products in the United States or foreign jurisdictions, and there have been well-reported significant adverse events associated with their testing and use. Regulatory requirements governing gene and cell therapy products have evolved and may continue to change in the future, and the implications for mRNA-based therapies are unknown.
So, that’s essentially worse than the situation Moderna presented in June 2020 based on both clinical trials and real world data post rollout.
If these things aren’t gene therapies, why does Moderna continue to use the term in a manner which implies overlap between its “Covid-19 vaccine” and its other products?