Patents on the soles of your shoes...: FDA Advisory Committee-recommended! The Moderna COVID-19 vaccine.

Moderna filed for an Emergency Use Authorization from the FDA on November 30th, 2020, just a few days after Pfizer-BionTech. On December 17, 2020 the request was reviewed by a panel of twenty experts (Hearing Announcement). At the conclusion of the hearing, the Committee of experts voted 20 to 0 to recommend the Moderna vaccine for FDA Emergency Use Authorization.

Moderna, a biotechnology company headquartered in Boston MA, is specialized in the design of mRNA as a vaccine and drug. Since their foundation, in 2010, they have designed mRNA vaccines and treatments for a host of diseases and conditions, such as methylmalonic acidemia, Zika and cytomegalovirus (CMV) (Moderna Clinical Trials). Within the context of the COVID-19 pandemic Moderna has officially stated that they will not enforce any of their intellectual property rights against others, who are also part of the scientific emergency response, designing vaccines and treatments for COVID 19, and that they will license the technology post-pandemic (Moderna Statement on IP).

The Moderna COVID-19 vaccine is designated mRNA- 1273. It is currently undergoing phase 3 clinical testing. Like the Pfizer-BioNTech COVID-19 vaccine, it is an mRNA vaccine, which means that Moderna scientists have also engineered mRNA to code for the SARS CoV2 surface spike protein. The engineered mRNA strands are then delivered via Lipid NanoParticle (LNP) technology, in an intramuscular injection, to human cells, where they instruct cells to produce (harmless) spike glycoproteins, that will trigger an immune response. An immune response that will then be able to recognize viral spikes attached to the (dangerous) CoV-2, in view of binding and preventing the coronavirus replication, and thus preventing infection with COVID-19 (see diagram below).

One of the most significant differences between the Moderna and Pfizer BioNTech vaccines is the issue of cold storage. The Moderna vaccine does not have to be stored at extremely cold temperatures. Thus, the Moderna vaccine is a good candidate for Third World countries, providing that costs, or availability, become commensurate with Third World public health budgets.

The mRNA-1273 vaccine is made available as a frozen suspension, in multi-dose vials, each containing ten 0.5 mL doses. Two 0.5 mL injections are required, 28 days apart (FDA Briefing Document). The first is intended to prime the production of antibodies. The second is to boost, or significantly increase, the effectiveness of the vaccine's protection.

The following US design patents, listed on the Moderna website, cover the various inventions specifically related to research and development of the Moderna mRNA COVID -19 vaccine.

According to Moderna CEO Stéphane Blancel, in a 2013 TEDx lecture, Moderna is a company that knew they had a game-changing idea, when they started researching the possibility of mRNA as a drug, whether for vaccination, or the design of drugs for cancer or rare metabolic and genetic diseases (Blancel, TEDx 2013). What they probably did not anticipate, seven years ago, was just how soon their drug contributions would be saving the world from potential extinction and economic collapse, within the context of the COVID 19 pandemic.

Most importantly, Moderna is also leveling the playing field a bit, setting its agenda on rare diseases, and making vaccination possible, within the context of the COVID 19 pandemic, in the Third World. Thus, Moderna is slated to prevent much human suffering in traditionally forsaken places, and to design treatments for previously incurable patients.

Cheers Moderna!

References

Blancel, S. (Dec. 27, 2013) What if mRNA could be a drug? TEDX lecture - Youtube video https://youtu.be/T4-DMKNT7xI

FDA ADvisory Committee hearing on Dec. 17. 9 to 6 pm - For Moderna Vaccine – Public hearing https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement

FDA Briefing Document - Moderna COVID-19 Vaccine https://www.fda.gov/media/144434/download

Moderna (Company website) https://www.modernatx.com

Moderna’s mRNA technology https://www.modernatx.com/modernas-mrna-technology

Moderna’s IP (for mRNA & delivery technologies). https://www.modernatx.com/mrna-technology/modernas-intellectual-property

Moderna Statement of IP matters during COVID-19 pandemic. https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19

Moderna Clinical Trials https://www.modernatx.com/pipeline/modernas-mrna-clinical-trials-cmv-mma-zika-several-types-cancer-and-other-diseases