Opportunities and Challenges in the Future of mRNA Technology

Current applications of mRNA in vaccines

Current applications of mRNA technology in vaccines are exemplified by the FDA-approved COMIRNATY for COVID-19 and Moderna's mRESVIA for RSV. Companies like Pfizer, BioNTech, and AstraZeneca are leveraging mRNA to innovate and enhance vaccine efficacy, showcasing its critical role in modern immunization strategies.

"INDICATION, AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION INDICATION COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine for use in people 12 years of age and older to protect against coronavirus disease 2019 (COVID-19)." --- (BNTX, press release, 2024/08/22)

"Moderna has filed for mRNA-1345 marketing authorization applications in multiple markets worldwide.About mRESVIA® (Respiratory Syncytial Virus Vaccine)mRESVIA® is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein." --- (MRNA, press release, 2024/08/23)

"(b) In September 2023, Pfizer and BioNTech announced the FDA approved a regulatory application for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 12 years of age and older (Comirnaty (COVID-19 Vaccine, mRNA, 2023-2024 Formula))." --- (PFE, sec filing, 2024/Q2)

"We believe that differentiated innovative vaccines also built on our experience both with Befortus and the monoclonal antibodies in COVID as well as understanding and that closeness to the business in the respiratory or other segments in the company will give us a competitive advantage and a different edge, if you want, for the commercial model." --- (AZN, event transcript, 2024/05/21)

"INDICATION, AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION INDICATION COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine for use in people 12 years of age and older to protect against coronavirus disease 2019 (COVID-19)." --- (BNTX, press release, 2024/06/27)

Therapeutic applications beyond vaccines

mRNA technology is poised to expand beyond vaccines, with applications in oncology, rare diseases, and autoimmune disorders. Companies like Moderna and Pfizer are developing innovative mRNA-based therapies and formulations for cancer immunotherapy and other diseases, highlighting the potential to address significant medical needs.

"This selection highlights the promise of Moderna's innovative mRNA platform beyond vaccines and the potential this novel medicine may have in addressing the serious and unmet medical needs of MMA," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology." --- (MRNA, press release, 2024/06/06)

"Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules." --- (PFE, press release, 2024/06/27)

"By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases." --- (MRNA, press release, 2024/06/03)

"Having an ability to create low dose DPX™+B cell epitope formulations is an attractive approach for packaging antigens for cancer immunotherapeutics and therapeutic vaccines such as for influenza, Zika virus, RSV, HSV, and many other viral or bacterial pathogens." --- (MRNA, press release, 2024/05/01)

"Together, our vaccines and therapeutic portfolio have a potential to impact hundreds of millions of people each year." --- (MRNA, earning call, 2024/Q1)

Operational challenges in mRNA technology

Operational challenges in mRNA technology include the need for rapid adaptation to emerging viral strains, as highlighted by GSK's focus on technical hurdles and Pfizer's acknowledgment of substantial risks in developing combination vaccines. Companies like BioNTech are also strategizing to integrate mRNA therapies, indicating ongoing operational complexities.

"mRNA is an adaptable vaccine technology with demonstrated application in emerging and constantly changing viral pathogens due to its ability to support rapid strain change." --- (GSK, press release, 2024/07/03)

"So again, we think this is down the middle of the fairway in terms of the technical challenges that we need to address." --- (AMGN, earning call, 2024/Q1)

"mRNA-based combination vaccine candidate for influenza and COVID-19, the flu and COVID/flu combination programs, Pfizer's respiratory vaccines portfolio and mRNA technology, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements." --- (PFE, press release, 2024/08/16)

"Most importantly, as Ugur also noted, it is a strategic goal for us to explore BNT327 as part of novel and novel combinations, in particular with our ADC assets and mRNA therapies." --- (BNTX, earning call, 2024/Q2)

"Focused business development has continued as well. We strengthened our respiratory pipeline with the acquisition of Aiolos Bio for their long-acting T-slip antibody anticipated to start Phase II in 2025, and we gained full control of our candidate mRNA vaccines by restructuring our collaboration with CureVac." --- (GSK, earning call, 2024/Q2)

Market competition and research directions

The mRNA market is increasingly competitive, with established players like Moderna facing pressure from rivals in COVID and RSV vaccines. Companies are focusing on combination vaccines and expanding research efforts, particularly in regions like Africa, to enhance their market positions and drive future growth.

"And as the market moves toward combination, which our research indicates it should, with multiple seasonal diseases out there that people are trying to protect themselves against that having a product where you can combine multiple antigens in with a very nice tolerability profile potentially versus competitors is very important in the marketplace for consumers, as they make a decision on which combination vaccine they may want." --- (NVAX, earning call, 2024/Q2)

"We’ve just seen much more intensity and pressure on COVID versus last year, and on RSV, as you know, we’re entering a market where there’s two large established players, one with very large market share where of course [indiscernible], the other one who, as indicated, they want to gain market share because they are not pleased with their market share last year, and so we have been working really actively on that." --- (MRNA, earning call, 2024/Q2)

"Through our joint commitment to equitable access, CEPI's investment in BioNTech's forward-looking efforts in Africa will boost regional capacity for end-to-end research, development and rapid manufacturing of mRNA vaccines." --- (BNTX, press release, 2024/05/29)

"And then, how do you think about potential competition coming into the market for vaccines and treatments, does that impact your future growth projections for the franchise?" --- (PFE, earning call, 2024/Q1)

"Via this agreement, we generate significant near-term cash flow, a strengthened balance sheet as well as the opportunity to strategically pivot to a new lean operating model, focusing more on our strength in research and development and pipeline expansion to accelerate our growth and generate long-term value for our shareholders." --- (NVAX, earning call, 2024/Q1)

Public perception and acceptance of mRNA technology

Public perception of mRNA technology is shaped by pandemic experiences and vaccine politicization, which may overshadow scientific data. Regulatory approvals, like the EMA's positive opinion on Moderna's RSV vaccine, are crucial for building trust. Advancements in mRNA technology could further enhance acceptance over time.

"of this, which is perception or experience that having gone through the pandemic and maybe to some extent that politicization vaccination that happened there that was not related to the science of mRNA and not even related to the amount of data we have, but really related to the number of years." --- (MRNA, conference, 2024/06/10)

"So as Ruud mentioned, the growing burden of chronic disease coupled with advances in science and technology means that we have a tremendous opportunity to create transformative medicines for the tens of millions of people that need them." --- (AZN, event transcript, 2024/05/21)

"CAMBRIDGE, MA / ACCESSWIRE / June 28, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization in the European Union for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection." --- (MRNA, press release, 2024/06/28)

"Coming as a 2nd generation or 3rd generation modernized technology could be a bit advantage." --- (AZN, event transcript, 2024/05/21)

"I think if you fast forward a year, and this would be my perception, but if you fast forward a year, if you look at the rates of waning for the other two vaccines than ours, there is clearly a decline from year one to two, and from year two to three." --- (MRNA, earning call, 2024/Q2)

Future opportunities in mRNA technology

Future opportunities in mRNA technology are promising, with companies like Pfizer and Moderna focusing on rapid vaccine development, cancer therapies, and novel therapeutics. Pfizer highlights mRNA's potential for quick manufacturing during pandemics, while Moderna emphasizes ongoing clinical advancements and partnerships, indicating a robust pipeline for future innovations.

"The flexibility of mRNA technology and its rapid manufacturing could potentially allow better strain matches in future years, and in a pandemic influenza situation, mRNA technology could enable rapid, large-scale manufacturing of vaccines." --- (PFE, press release, 2024/08/16)

"Now we're going to spend almost all of our time today in focused on INT because we have some exciting data, clinical data and obviously the presentations from today, and we're looking forward to questions on that. But we did want to take the opportunity today to give a sense of all of the other efforts that we've got advancing in clinical development, including cancer antigen specific therapies, some novel therapeutics that have been working on actually even before INT and then some new and exciting technology partnerships that we think will translate into clinical studies very quickly here." --- (MRNA, event transcript, 2024/06/03)

"Of course, we are also working to develop future breakthroughs where we have opportunities to bring the most important new therapies to patients in need." --- (PFE, earning call, 2024/Q2)

"And that's one of the most difficult parts of my job often as the Head of R and D is working with a team to say, we can't quite prioritize that program now and we hope to get it in the future." --- (MRNA, conference, 2024/06/10)

"We have several potential key growth drivers for this year and into 2025. With Abrysvo, we're very pleased with the positive data in the 18 to 59 age group that differentiates our product and we're encouraged by our opportunities to continue increasing overall RSV market growth and market share." --- (PFE, earning call, 2024/Q1)

Economic impact of mRNA technology

The economic impact of mRNA technology is significant, as companies like BioNTech are heavily investing in late-stage clinical trials and innovative mRNA platforms. The potential benefits of mRNA vaccines, including combination formulations for influenza and COVID-19, highlight both opportunities and associated risks in this evolving market.

"Our focus remains on our late-stage clinical trials and to invest in our mRNA platform approaches that represent the core capability of BioNTech and differentiates us from others in the industry." --- (BNTX, earning call, 2024/Q1)

"This release contains forward-looking information about Pfizer's investigational modified RNA (modRNA) influenza vaccine candidates, potential next-generation mRNA flu and combination vaccine formulations, Pfizer's and BioNTech's mRNA-based combination vaccine candidate for influenza and COVID-19, the flu and COVID/flu combination programs, Pfizer's respiratory vaccines portfolio and mRNA technology, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements." --- (BNTX, press release, 2024/08/16)

Global collaboration in mRNA research

Global collaboration in mRNA research is exemplified by partnerships among key players like Moderna and BARDA for pandemic vaccines, AstraZeneca and Ecogene for mRNA development, and BioNTech's diverse vaccine initiatives. Pfizer's investments in global manufacturing further underscore the collaborative efforts driving mRNA technology forward.

"We are pleased to continue our collaboration with BARDA to expedite our development efforts for mRNA-based pandemic influenza vaccines and support the global public health community in preparedness against potential outbreaks. In 2023, Moderna initiated a Phase 1/2 study to generate safety and immunogenicity data of investigational pandemic influenza vaccine (mRNA-1018) in healthy adults 18 years of age and older." --- (MRNA, press release, 2024/07/02)

"And we have been working in collaboration between our outstanding team in AstraZeneca together with our colleagues at Ecogene." --- (AZN, event transcript, 2024/05/21)

"manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline." --- (BNTX, press release, 2024/06/01)

"As part of our strategy for COVID-19, we are continuing to make significant investments in breakthrough science and global manufacturing." --- (PFE, sec filing, 2024/Q1)

"Generative AI will help advance Moderna's broad and diverse portfolio to maximize the Company's impact on patients. Moderna embeds OpenAI's generative AI tools throughout its organization and sees early success with broad adoption of ChatGPT Enterprise. CAMBRIDGE, MA AND SAN FRANCISCO, CA / ACCESSWIRE / April 24, 2024 / Moderna, Inc. (NASDAQ:MRNA) and OpenAI today announced their ongoing collaboration to co-innovate with a shared vision of AI's transformative potential in the future of business and healthcare." --- (MRNA, press release, 2024/04/24)