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31 May 2024

Introducing the World’s First mRNA Vaccine Against RSV

By Stéphane Bancel, CEO of Moderna
RSV Blog

With the approval of mRESVIA® in the United States, Moderna is the first and only company in the world with two approved mRNA vaccine products. It is an exciting time for this new generation of transformative medicines and our platform’s continued impact on human health.

mRESVIA is Moderna’s mRNA vaccine approved in the U.S. to protect adults aged 60 years and over from severe lower respiratory tract disease (LRTD) caused by respiratory syncytial virus, or RSV, infection. RSV is highly contagious and affects approximately 64 million people around the world each year, with older adults more likely to develop severe complications that could require hospitalization. Further, it is estimated that 470,000 adults aged 60 or older are hospitalized, and 33,000 die from RSV infections in high-income countries annually.¹

This timely approval will help ensure older adults in the U.S. have an effective tool to help build protection against RSV illness and its potential serious complications throughout this coming respiratory virus season. Positive data from Moderna’s ConquerRSV trial, which was published in the New England Journal of Medicine in December 2023, contributed to the approval.

I recently sat down with Lavina Talukdar, our Head of Investor Relations, to discuss the importance of today's approval to our platform’s continued impact on human health

Our Platform is Working

Our mRNA platform continues a remarkable track record across our broad vaccine portfolio. Moderna’s vaccine portfolio includes 28 vaccines to address respiratory, latent and other pathogens.

In our respiratory franchise, we are four for four on advancing respiratory disease programs to positive Phase 3 data:

  • In November 2020, we announced mRNA-1273 as our first respiratory vaccine program with a positive Phase 3 readout and promptly requested Emergency Use Authorization from the U.S. FDA and filed with international regulatory agencies. Our COVID-19 vaccine, Spikevax®, is now approved in markets across the world.

  • In January 2023, we announced mRNA-1345 as our second respiratory vaccine program with positive Phase 3 trial results. Our RSV vaccine is now approved in the U.S.We are awaiting regulatory review in multiple countries, and pending approval we look forward to launching in additional markets.

  • In September 2023, we announced mRNA-1010 as our third respiratory vaccine program demonstrating positive Phase 3 data, with our investigational flu vaccine meeting its primary endpoint. We are in ongoing discussions with regulators and intend to file in 2024.

  • In March 2024, we announced mRNA-1283 as our fourth respiratory vaccine program with positive Phase 3 data. mRNA-1283 is our investigational next-generation COVID-19 vaccine and a critical component of our combination vaccine against flu and COVID-19, mRNA-1083. We are engaging with regulators on next steps.

In our latent and other franchise, we recently announced positive clinical trial data from three new vaccines against viruses that cause significant burden (Epstein-Barr virus, Varicella-Zoster virus, norovirus) and we are advancing these programs toward Phase 3 development.

These milestones across respiratory, latent and other vaccines have further validated our robust platform and given us confidence in our efforts to bring these much needed vaccines to market.

Moderna’s rate of success with our platform technology overall has been higher than the industry standard. In Phase 1 trials, Moderna has a 70% success rate with 20 candidates, which is 2x the industry average of 35%. In Phase 2, we are nearly 3x the industry average with a 78% success rate across nine candidates. In Phase 3, we have demonstrated an 80% success rate with five candidates, versus the industry average of 69%.² Although it is still a relatively small population size, these results are very encouraging, and why we continue to invest in our platform.

Moderna Rate of Success

Our Strategy is Clear

After over a decade of investment in science, technology and manufacturing capabilities, we have demonstrated the power of our platform. Our strategy is clear and each day we are working with discipline to deliver on our Mission for patients and improve human health.

We are developing a portfolio of respiratory mRNA vaccines to target the most significant viruses causing respiratory disease, including COVID-19, RSV and flu. We are committed to helping address the substantial public health burden associated with respiratory disease. We are also advancing vaccine candidates against five viruses that cause latent infections, all of which are in clinical trials. When latent, a virus is present in the body but exists in a resting state, typically without causing any noticeable symptoms. Latent viruses can reactivate and cause clinical symptoms as a person ages, during times of stress or when immunity is compromised.

Vaccines serve an incredible purpose for patients and the health care system as well as the overall economy. They have the potential to save lives, reduce morbidity, save health care costs, and increase the economic output for an individual or an economy at large.

What’s Next

The approval of our RSV vaccine in the U.S. marks a significant milestone for Moderna, mRNA medicine and human health. My deepest gratitude goes to the Moderna team for relentlessly pursuing the development and delivery of mRESVIA.

Since the beginning, we have believed our mRNA technology could change the future of medicine, and we would not be a one-product company. That vision has become a reality.

With 10 late-stage programs, and additional new programs advancing toward pivotal studies, we continue to expect numerous product milestones this year across our vaccines and therapeutics portfolio. This is the start of a banner year for our vaccine platform as we continue to advance mRNA medicines for patients. This is just the beginning.

²Statistics for Moderna based upon internal data and are based upon 20 Phase 1 trials, 9 Phase 2 trials, and 5 Phase 3 trials; last update March 27, 2024. Only concluded trials for unique molecular entities are included in data; strain updates for a program are not counted separately. Early trials establishing platform technology not intended for commercialization are excluded from Phase 1 trial counts. Industry statistics derived from Wong et al., Biostatistics (2019) 20, 2, pp 273-286.

Forward-Looking Statements

This post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: mRESVIA’s ability to provide protection throughout the coming respiratory virus season; the advancement of Moderna's programs under clinical development; the timing for anticipated approvals of vaccine candidates; the efficacy, safety and tolerability of vaccine candidates; and the efficiencies and advantages of Moderna's mRNA platform, including Moderna’s rate of success. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this post are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date of this post.