Moderna Announces Its Global Public Health Strategy

Moderna announces commitment to advance vaccines targeting 15 pathogens identified as biggest public health risk by WHO and CEPI into clinical studies by 2025

Moderna launches mRNA Access, a new collaborative enabling researchers around the world to utilize Moderna's mRNA technology platform to pursue research in their own labs on emerging and neglected infectious diseases

Moderna expands commitment to never enforce COVID-19 patents in the Gavi COVAX AMC for 92 low- and middle-income countries

Moderna has entered into a Memorandum of Understanding with the Government of the Republic of Kenya to establish its first mRNA manufacturing facility on the continent of Africa

CAMBRIDGE, MA / ACCESSWIRE / March 7, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced its global public health strategy through four new initiatives aimed at advancing mRNA vaccines for the prevention of infectious diseases. First, Moderna is announcing a commitment to expand its global public health portfolio to 15 vaccine programs targeting priority pathogens[1] that threaten global health, advancing these vaccines into clinical studies by 2025. Second, to accelerate research with the aim of advancing additional vaccines, Moderna is launching a new program, mRNA Access that will offer researchers use of Moderna's mRNA technology to explore new vaccines against emerging or neglected infectious disease. Third, Moderna is expanding its patent pledge to never enforce COVID-19 patents in the Gavi COVAX AMC for 92 low- and middle-income countries. Fourth, Moderna announced that with the assistance of the U.S. government, it has entered into a Memorandum of Understanding with the Government of the Republic of Kenya to establish Kenya as the location for its mRNA manufacturing facility.

The World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI) have issued calls to action to develop vaccines against priority pathogens that pose a threat to public health. Moderna's clinical portfolio already includes vaccines targeting COVID-19, HIV, Nipah and Zika. Moderna's expanded global health strategy will advance programs against the remaining pathogens by 2025. Moderna is also continuing its prototype vaccine approach, using preliminary versions of vaccines developed against representative viruses, which are rapidly adapted to tackle other related pathogens, in this way, preparing for Disease X[2]. The value of this prototype vaccine approach was demonstrated when early research on SARS-CoV-1 and MERS enabled Moderna's rapid response to SARS-CoV-2. Moderna is committing, in part through mRNA Access, to continue research and early development toward pandemic preparedness through a prototype pathogen approach to creating vaccine libraries.

"Despite the rapid development timelines of our COVID-19 vaccine, and substantial efforts undertaken to scale up our manufacturing, the human toll of COVID-19 has been devastating and we must not assume that the COVID-19 pandemic will be the last pandemic that will impact global health. We are dedicated to pursuing innovative vaccine solutions to address infectious diseases that pose the greatest risk to public health through collaborative research and development," said Stéphane Bancel, Chief Executive Officer of Moderna. "Since our beginning, we have focused on developing a global health vaccine program and today, we are renewing that focus by expanding our work to develop vaccines against priority pathogens that threaten global health and by launching our new mRNA Access program to create a community of global scientists to access our mRNA vaccine technology from anywhere in the world. At Moderna, we believe the world needs novel, innovative approaches to address both known and emerging infectious diseases and we know that we can't go it alone. We are committed to bringing the full force of our mRNA vaccine platform to combat infectious diseases of public health concern and we look forward working with global partners to be part of the solution to prevent future pandemics and help millions of people around the world."

New global public health program to address priority pathogens and pandemic preparedness by 2025

Moderna has spent a decade refining its mRNA platform to accelerate the pace and success of mRNA medicines. The speed, scale and flexibility of Moderna's mRNA platform is uniquely suited for rapid response to Disease X. The Company's early clinical programs against pandemic influenza, chikungunya and Zika represent a long-standing commitment to pandemic preparedness and global health. In early 2020, Moderna began working on development of a SARS-CoV-2 vaccine, and in 11 months, after demonstrated clinical safety and efficacy, Moderna's COVID-19 vaccine was authorized and hundreds of millions of people around the world have now received the vaccine. Moderna is committed to being part of the solution in helping to prevent another global pandemic.

Moderna is committing to advancing into clinical studies a portfolio of 15 vaccine programs targeting emerging or neglected infectious diseases by 2025, advancing vaccines that address current diseases of significant impact to low- and middle-income countries, and those that prepare for Disease X. Moderna will prioritize development efforts against pathogens identified as persistent global health threats, including HIV, tuberculosis (TB) and malaria, neglected tropical diseases and the priority pathogens of the WHO and the CEPI.

mRNA Access, Powered by Moderna

To further expand the potential impact of mRNA vaccines, the mRNA Access program will open Moderna's preclinical manufacturing capabilities and research and development expertise to global partners, to together explore the possibility of mRNA to tackle the world's greatest global public health threats. Through the program, researchers at partnering institutions are invited to take advantage of Moderna's mRNA platform to develop mRNA medicines for existing neglected diseases. These programs will leverage Moderna's Early Development Engine to accelerate vaccine development to the clinic. mRNA Access will also allow scientists around the world to explore novel vaccine designs against prototype viral families in preparation for Disease X.

mRNA Access partners are working to accelerate innovation and enable new vaccines and medicines for emerging and neglected infectious diseases through collaborative research and preclinical development.

Moderna invites government and academic institutions to visit www.mrna-access.modernatx.com to learn more and request to become an mRNA Access partner.

Moderna's Updated Patent Pledge

To further underscore Moderna's commitment to low- and middle-income countries, and as part of the Company's continued support for achieving global health equity, Moderna is now updating its patent pledge to never enforce its patents for COVID-19 vaccines against manufacturers in or for the 92 low- and middle-income countries in the Gavi COVAX Advance Market Commitment (AMC), provided that the manufactured vaccines are solely for use in the AMC 92 countries.

In non-AMC 92 countries, vaccine supply is no longer a barrier to access. In these countries, the Company expects those using Moderna-patented technologies will respect the Company's intellectual property. Moderna remains willing to license its technology for COVID-19 vaccines to manufacturers in these countries on commercially reasonable terms. Doing so enables Moderna to continue to invest in research to develop new vaccines, prepare for the next pandemic, and meet other pressing areas of unmet medical need.

"We are committed to defeating the pandemic across the globe, and we are fulfilling that through our pledge not to enforce our COVID-19-related patents in low-and middle-income countries but also through our delivery of the most vaccine doses to COVAX at the lowest price per dose," said Stéphane Bancel, Chief Executive Officer of Moderna. "We have taken significant steps to increase supply and broaden global access and scaling up our capacity enabling us to make billions of doses of our vaccine each year. Our pledge further highlights our commitment to global access. I'm so proud of what our team of 3,000 employees has accomplished since the pandemic began. We are dedicated to combatting COVID-19 globally and preparing for the next pandemic."

Moderna's mRNA Manufacturing Facility in Kenya, Africa

Moderna also announced that with the assistance of the U.S. government, it has entered into a Memorandum of Understanding with the Government of the Republic of Kenya to establish Kenya as the location for its mRNA manufacturing facility. Moderna is building this state-of-the-art mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines each year at the 50 µg dose level. The Company anticipates investing up to $500 million in this new facility which is expected to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company's plans to expand its portfolio of global public health vaccines to 15 total programs; the timing for advancing these vaccine programs; the potential ability to leverage the platform to advance development in different vaccine programs, including to address Disease X; the Company's mRNA Access initiative to allow researchers access to Moderna's mRNA platform; the Company's plans to construct an mRNA manufacturing facility in Kenya; the Company's commitment not to enforce its COVID-19 patents in the Gavi COVAX AMC 92 low- and middle-income countries; and the potential licensing of COVID-19 patents to third parties. The forward-looking statements in this press release 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 those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K 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 www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release 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 hereof.

Moderna Contacts:

Media:
Colleen Hussey
Director, Corporate Communications
617-335-1374
Colleen.Hussey@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

[1] Moderna expects the 15 pathogens to include Chikungunya virus, COVID-19, Crimean-Congo haemorrhagic fever, Dengue, Ebola virus disease, HIV, Malaria, Marburg virus disease, Lassa fever, Middle East respiratory syndrome coronavirus (MERS-CoV), Nipah and henipaviral diseases, Rift Valley fever, Severe fever with Thrombocytopenia syndrome, Tuberculosis, Zika

[2] "Disease X" was named by the WHO to represent the knowledge that a serious international epidemic could be caused by a pathogen currently unknown to cause human disease. https://www.who.int/activities/prioritizing-diseases-for-research-and-development-in-emergency-contexts

SOURCE: Moderna, Inc.