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Ministry of Health, Labour and Welfare in Japan Approves Partial Change Application for Moderna’s COVID-19 mRNA Vaccine Targeting SARS-COV-2 Variant JN.1

Moderna, Inc. (NASDAQ:MRNA) today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change application for an updated formulation of its COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1.

“We appreciate the Ministry of Health, Labour and Welfare approval decision for our updated COVID-19 mRNA vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “It is important that people are vaccinated with the latest updated COVID-19 vaccines that can protect against circulating strains. With COVID-19 vaccination becoming a routine inoculation similar to seasonal flu vaccines, individuals will be able to receive their updated COVID-19 vaccine alongside their flu vaccine this fall.”

In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated to target the JN.1 family of Omicron subvariants for the 2024/2025 national immunization program (NIP). This guidance aligns with the recommendations from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) on the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition.

The NIP in Japan will offer COVID-19 vaccination to individuals aged 65 and older, as well as qualifying individuals aged 60 to 64.[1] Japan has the highest proportion of older adults worldwide, with approximately 30% of its population aged 65 and above. Given that respiratory viruses are a leading disease burden in people older than 65, NIPs are crucial in reducing the burden of disease and, ultimately, future pressure on the health system. Individuals requesting COVID-19 vaccination outside of the regular program will have the option of voluntary vaccination at their own expense.

In July, Moderna entered into an agreement with Mitsubishi Tanabe Pharma Corporation to support the co-promotion of Moderna’s mRNA respiratory vaccine portfolio in Japan, including Moderna’s COVID-19 vaccine, Spikevax.

About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. 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. With a unique culture and a global team driven by Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Moderna 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 statements regarding: the authorization of Moderna’s updated JN.1-targeting COVID-19 vaccine by the Ministry of Health Labor and Welfare in Japan; the ability of Moderna’s updated COVID-19 vaccine to induce an immune response and provide protection against circulating SARS-CoV-2 variants; and Moderna’s ability to supply its COVID-19 vaccine to support Japan’s COVID-19 national immunization program. 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, 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 and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, 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 of this press release.

Moderna Contacts
Media :
International media
Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com

Moderna Japan
Communications & Media
japan-pr@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

[1]Qualifying individuals include those aged 60-64 with severe cardiac, renal or respiratory impairments that significantly restrict daily activities, or those with immune deficiencies due to Human Immunodeficiency Virus (HIV), making daily life exceedingly difficult.

SOURCE: Moderna, Inc.

Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine

mRNA-1283 induced a more robust immune response compared to Spikevax® COVID-19 vaccine, mRNA-1273.222
Next-generation mRNA vaccine design offers the potential of longer shelf life and storage advantages, and paves the way for combination vaccine against influenza and COVID-19, mRNA-1083

Moderna, Inc. (NASDAQ:MRNA) today announced that mRNA-1283, the Company’s next-generation COVID-19 vaccine, has successfully met the primary endpoints of its Phase 3 clinical trial, demonstrating a higher immune response against SARS-CoV-2 when compared to mRNA-1273.222, Moderna’s licensed COVID-19 vaccine.

“We are excited to announce our fourth infectious disease vaccine program with positive Phase 3 data, further validating our robust mRNA platform,” said Stéphane Bancel, Chief Executive Officer of Moderna. “mRNA-1283 is a critical component of our combination vaccine against flu and COVID-19, mRNA-1083, and this milestone gives us confidence in our ability to bring this much needed vaccine to market.”

In the NextCOVE (NCT05815498) Phase 3 pivotal trial, mRNA-1283 was shown to elicit a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2, compared to mRNA-1273.222. Importantly, this benefit was most acutely seen in participants over the age of 65 years, the population that remains at highest risk for severe outcomes from COVID-19. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events included headache, fatigue, myalgia and chills.

The NEXTCove clinical trial is a randomized, observer-blind, active-controlled study of approximately 11,400 individuals aged 12 years and older in the United States, United Kingdom and Canada. mRNA-1283 was found to have a similar safety profile to Moderna’s approved COVID-19 vaccines.

The storage, shelf life and pre-filled syringe presentation of mRNA-1283 could alleviate healthcare provider burden and potentially increase access into new settings to serve public health. A detailed analysis of the Phase 3 clinical trial data for mRNA-1283 will be shared at the Company’s Vaccines Day event on March 27 and presented at upcoming scientific conferences.

Moderna’s mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Spikevax®is a registered trademark of Moderna.

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 statements regarding: the potential longer refrigerator shelf life and storage advantages of mRNA-1283 compared to Spikevax; and the ability of mRNA-1283 to maintain effectiveness compared to Spikevax. 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, 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 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 of this press release.

Moderna Contacts
Media:
Elise Meyer
Sr. Director, Corporate Communications
+1 617-852-7041
Elise.Meyer@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

Moderna Reviews its Environmental, Social and Governance (ESG) Progress and Ambitions at Second ESG Investor Event

The Company’s ESG strategy demonstrates its efforts to advance global health and environmental sustainability, as well as its commitments to employees and communities

Moderna, Inc. (NASDAQ:MRNA) today will provide an update on its Environmental, Social and Governance (ESG) strategy at its second ESG Investor Event. Building off its inaugural ESG Day in November 2022, the Company will highlight the year’s progress on its ESG journey and future work to further impact global health and protect the environment.

“Our mRNA platform science has benefited patients around the world and with that comes great responsibility as science alone will not solve the world’s greatest health challenges,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are committed to moving beyond the power of our technology – tackling enduring health disparities, engaging with our communities, and recognizing that human health and planetary health are intricately linked. We look forward to building on our substantial ESG progress to become the best version of Moderna.”

Moderna’s ESG strategy is articulated around five areas:
Medicines for Patients: Moderna is leveraging its platform for many medicines, from vaccines to protect hundreds of millions of people from common viruses for which no vaccines are available today, to several rare disease therapies with tremendous opportunity for impact. Within its clinical trials, Moderna believes a committed approach to offering equal healthcare accessibility is achievable and necessary. The Company is also committed to using its platform to help rapidly respond to the greatest public health threats, pursuing a pipeline of priority programs relevant for outbreak response and pandemic preparedness. Moderna has long prioritized strategic collaborations to benefit global health, including its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI), and Moderna’s mRNA Access program, a collaborative effort that enables researchers around the world to utilize Moderna’s mRNA technology.

Environment: Moderna is progressing on its journey toward net-zero carbon emissions (Scopes 1 & 2) by 2030. The Company has advanced its overall environmental sustainability program, including through implementing its sustainability strategy, enhancing its disclosure of key performance indicators, submitting its first CDP Climate Change questionnaire, and initiating a climate risk and scenario analysis. These efforts support internal and external stakeholder expectations for sustainable operations and Moderna’s adaptation to a low-carbon economy.

Employees & Culture: Moderna consistently ranks as a top employer and achieves above benchmark scores on engagement, culture and belonging. Moderna continues to foster a culture where every employee can meaningfully contribute to the Company’s mission, an effort that serves to attract and retain the best talent. By living the Company’s values and mindsets every day, the Moderna team is not only advancing mRNA science, but also building an organization that cares deeply for patients, employees, the environment, and the community.

Community: Moderna is committed to having a positive impact on communities around the world. Moderna’s purpose-driven employees continue to exemplify the Company’s mission, with nearly two out of three employees participating in volunteering activities or contributing as part of Moderna’s newly instituted employee matching program. The Moderna Charitable Foundation continues to provide financial support to organizations and causes that promote public health, advance scientific education, and advocate for belonging, inclusion, and diversity.

Governance & Ethics: Moderna prioritizes accountability and transparency around its ESG efforts, including through the publication of its second annual ESG report and continued commitment to disclosing key metrics. Moderna has initiated an ESG materiality assessment, which includes broad stakeholder surveys, and is also leveraging AI to build a dynamic analysis of material topics.

“Delivering on our ESG ambitions is made possible by a strong culture that embeds the values of transparency, accountability and ownership at all levels of the organization,” said Shannon Thyme Klinger, Moderna’s Chief Legal Officer, Corporate Secretary and President of the Moderna Foundation. “The same determination that goes into our innovation carries over into our commitment to positively impact the communities in which we work and live.”

Webcast Information
To register for the live webcast of Moderna’s ESG Investor Event, visit https://moderna-esg-day-2023.open-exchange.net/registration. The archived webcast will be available under “Events and Presentations” in the Investors section of the Moderna website for one year following the call: https://investors.modernatx.com.

Moderna’s mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

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 statements regarding: Moderna’s ability to leverage its mRNA platform for pandemic preparedness; Moderna’s commitment to achieving net-zero carbon emissions in its global operations for Scopes 1 and 2 by 2030; the potential of Moderna’s mRNA platform for addressing rare diseases and common viruses for which no vaccines are available today; and Moderna’s implementation of its environmental sustainability program. 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, 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, 2022, 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 of this press release

Moderna Contacts
Media:
Chris Ridley
Vice President, Communications
617-800-3651
Chris.Ridley@modernatx.com

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

Moderna Announces Global Regulatory Submissions for Its Respiratory Syncytial Virus (RSV) Vaccine, MRNA-1345

Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, Swissmedic, and the Therapeutic Goods Administration in Australia
The Company has also initiated a rolling submission of a Biologics License Application to the U.S. Food and Drug Administration for mRNA-1345
mRNA-1345 met primary efficacy endpoints, demonstrating vaccine efficacy of 83.7% against RSV lower respiratory tract disease in older adults in the Phase 3 pivotal efficacy trial, ConquerRSV
The Company plans further regulatory submissions for mRNA-1345 worldwide

Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today provided an update on regulatory submissions for mRNA-1345, a vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older.

The Company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia and has initiated the rolling submission process for a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the licensure of the mRNA-based RSV vaccine.

“We are proud to announce these filings for the use of our RSV vaccine candidate, mRNA-1345, in the European Union, Switzerland, Australia, and the U.S. RSV is a major cause of lower respiratory tract infections in older adults and can cause a significant burden to health systems through hospitalizations and emergency care admissions,” said Stephane Bancel, Chief Executive Officer of Moderna. “Our mRNA platform has allowed us to move from initial clinical testing to our first international Phase 3 trial to initiation of regulatory submissions for mRNA-1345 in just two years, enabling us to tackle this pervasive public health burden with speed and clinical rigor. mRNA-1345 represents the second product coming from our mRNA platform to seek global approval, and with recent positive data in rare disease and cancer, we expect more in the future – further demonstrating the tremendous potential of mRNA to combat disease.”

The regulatory applications are based on positive data from a prespecified interim analysis of the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries. The primary efficacy endpoints were based on two definitions of RSV-LRTD, defined as either two or more symptoms or three or more symptoms of disease. The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms. The vaccine was well tolerated with a favorable safety profile. Most solicited adverse reactions were mild or moderate, and the most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia. The ConquerRSV study is ongoing, and additional efficacy analyses are planned as cases accrue, including for severe RSV. In addition to older adults, mRNA-1345 is being investigated in a fully enrolled, ongoing Phase 1 trial in pediatric populations.

In January 2023, the U.S. FDA granted mRNA-1345 Breakthrough Therapy Designation for the prevention of RSV-LRTD in adults aged 60 years or older, and mRNA-1345 was previously granted Fast Track designation by the U.S. FDA in August 2021. In Australia, the TGA submission will be evaluated under the Priority Pathway, following approval of the Priority Determination application for mRNA-1345 in April 2023.

Moderna’s respiratory disease vaccine pipeline includes Phase 3 trials against influenza and a next-generation COVID-19 candidate. The pipeline also includes four additional influenza vaccines with expanded antigens, vaccines against other respiratory pathogens, and five combination vaccine programs.

About mRNA-1345
mRNA-1345 is an investigational RSV vaccine that consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein. The vaccine uses the same lipid nanoparticles (LNPs) as in the Moderna COVID-19 vaccines. The F glycoprotein is on the surface of the virus and is required for infection by helping the virus to enter host cells. It exists in two states, prefusion and postfusion. The prefusion conformation is a significant target of potent neutralizing antibodies, and the protein sequences are largely similar across both RSV-A and RSV-B subtypes.

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 and integrated manufacturing facilities that allow 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 eight years. To learn more, visit www.modernatx.com.

Moderna 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 regulatory process with respect to mRNA-1345, including the potential for regulatory approval; Moderna’s plans for further regulatory submissions for mRNA-1345 worldwide; the efficacy and safety and tolerability profile of mRNA-1345; the ongoing ConquerRSV study; and Moderna’s expectations regarding future potential products, including in the areas of rare disease and cancer. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2022, 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 of this press release.

Moderna Contacts
Media:
Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com

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

Moderna Announces Establishment of an Enterprise Solutions Hub and Commercial Operations in The Philippines

The Enterprise Solutions Hub in the Philippines will support the Asia Pacific region and complements Moderna’s Enterprise Solutions Hubs in Warsaw, Poland, and Atlanta, U.S.
The Philippines was selected due to its mature global business service environment, favorable infrastructure and business climate, and accessibility of broad and diverse talent
The Company also plans to establish a commercial presence in the Philippines

Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced plans to establish an Enterprise Solutions Hub in the Philippines. The Moderna Enterprise Solutions Hub will provide business services across the Asia Pacific region, where Moderna currently has operations in six markets. Moderna also plans to establish commercial operations in the Philippines.

“We are pleased to expand our footprint into the Philipines by establishing an Enterprise Solutions Hub and commercial operations. The Philippines has a critical mix of talent and global business service expertise, which makes it an excellent location to scale efficiently and provide regional support,” said Stephane Bancel, Chief Executive Officer of Moderna.”The Asia Pacific region is integral to Moderna’s business, with established subsidiaries in Australia, Hong Kong, Japan, Singapore, South Korea, and Taiwan. We look forward to further solidifying our presence. The addition of the Philippines site completes our strategy to provide regional solutions across the business, complementing our existing locations in Atlanta, Georgia, which services the Americas, and Warsaw, Poland, which covers Europe, the Middle East, and Africa.”

“We are very pleased that Moderna has selected the Philippines as the location for its third Enterprise Solutions Hub, serving the Asia Pacific market. We are confident that the Philippines has the talent and the capabilities to support Moderna’s operations and drive its expansion throughout the region. The Philippines is well-positioned to host global services and facilities that advance health and pharmaceutical technology. Our partnership with Moderna underscores the Philippines’ position in promoting healthcare and addressing emerging health threats. It also highlights Moderna’s role in delivering life-saving vaccines during the COVID-19 pandemic and the ability and promise of their mRNA platform,” said Jose Manuel G. Romualdez, Ambassador of the Republic of the Philippines to the United States.

Moderna will provide enterprise solutions in the Philippines, similar to its counterparts in Warsaw, Poland, and Atlanta, US, which were established in May 2021 and March 2022, respectively. The Hub will initially house finance, pharmacovigilance, medical, and HR personnel, in addition to commercial-focused roles, to support its direct presence in the market. Moderna will continue to identify opportunities to host additional functions and business services as the Company grows and operations mature. The Company expects to employ approximately 40-50 employees in the Philippines in 2023.

The Moderna Enterprise Solutions Hub Philippines will provide new capabilities, service lines, and capacity to help meet the growth of Moderna’s commercial and business operations in the Asia Pacific region. Moderna plans to begin operations in the Philippines in the second/third quarter of 2023.

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, and integrated manufacturing facilities that allow 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 eight years. To learn more, visit www.modernatx.com.

Moderna 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 statements regarding: the Company’s plans to establish an Enterprise Solutions Hub in the Philippines and anticipated hiring and staffing for the Hub; and the plans to establish commercial operations in the Philippines. 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 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, 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, 2022 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 of this press release.

Contacts
Media:
Luke Mircea Willats
Senior Director, Corporate Communications
Luke.Mirceawillats@modernatx.com

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

SOURCE: Moderna, Inc.

Therapeutic Goods Administration Grants Provisional Approval for Moderna’s COVID-19 Vaccine in Children Aged Six Months to Five Years

Announcement follows recent authorization of the Company’s mRNA COVID-19 vaccine in Argentina, Canada, Israel, the US, and Taiwan for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to five years

Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in a two-dose series of 25 ug per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to 5 years. Until now, children under six were the only age group not eligible for vaccination against COVID-19 in Australia.

“We are pleased that our vaccine for children under six years of age has received provisional approval by the TGA,” said Michael Azrak, General Manager of Moderna for Australia and New Zealand. “The continued evolution of COVID-19 represents an emergent threat to global public health, including young children. Since the onset of the pandemic, we have worked with a deep sense of responsibility to deliver on the promise of mRNA science to all Australians. The approval from TGA helps extend an opportunity to all parents and caregivers in Australia to protect their young children against SARS-COV-2.”

Positive interim results from the Phase 2/3 KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6-month to 5 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile. The antibody titers in the pre-specified 6 month to 23 month and 2 years to 5 years of age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study. Preliminary efficacy analysis on PCR-confirmed cases collected during the Omicron wave showed similar efficacy estimates against Omicron in the 6-month to 5 years of age group to those in adults after two doses of mRNA-1273.

The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The ClinicalTrials.gov identifier is NCT04796896.

Moderna is committed to supporting the Australian Government on the COVID-19 program implementation in children aged 6 months to five years upon receiving a recommendation from the Australian Technical Advisory Group on Immunisation (ATAGI).

The TGA previously approved the use of Moderna’s mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged six years or over.

Authorized Use
Therapeutic Goods Administration has provisionally approved the use of Moderna’s mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.

About Moderna
In 10 years since its inception, Moderna has transformed from a science 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 ground-breaking 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 post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the development of the Company’s COVID-19 Vaccine (mRNA-1273, or Spikevax); the approval of the vaccine in children ages 6 months to 5 years by the Therapeutic Goods Administration; and the safety, efficacy, and tolerability of the vaccine in children ages 6 months to 5 years of age. 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 post 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:
Luke Mircea-Willats
Director, Media Relations & Communications
Luke.mirceawillats@modernatx.com

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

SOURCE: Moderna, Inc.

Therapeutic Goods Administration of Australia Authorizes Moderna’s Covid-19 Vaccine in Children (6-11 Years)

Moderna, Inc., (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in a 50 ug dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years.

“The TGA authorization for the use of our COVID-19 vaccine in children 6-11 years old in Australia is an important milestone for Moderna as it is the first regulatory authorization for the use of our vaccine in this age group. We are grateful to the TGA for their diligence and the Government of Australia for its continued confidence in our mRNA platform,” said Stephane Bancel, Chief Executive Officer of Moderna. “We are grateful for the opportunity to provide protection against COVID-19 to this important age group, keeping children safe and able to continue life as normally as possible.”

Professor Robert Booy from the Immunisation Coalition commented, “I welcome this decision by the TGA and look forward to the uptake of vaccination in children increasing even more to provide protection of children and maximize school attendance.”

Moderna’s vaccine was investigated in the ongoing Phase 2 “KidCOVE” study, a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of two 50 ug doses of Spikevax (mRNA-1273) given to healthy children 28 days apart. The study population was divided into three age groups (6 to under 12 years, 2 to under 6 years, and six months to under 2 years).

Data submitted to the TGA demonstrated that vaccination of children 6 to under 12 years of age with a 50 ug mRNA-1273 primary series is associated with non-inferior anti-SARS-CoV-2 neutralizing antibody responses when compared to that in individuals 18-25 years old from the Phase 3 Cove study. The geometric mean ratio (GMR) comparing the response in children to the response in young adults from the Phase 3 COVE study was 1.5 (95% CI: 1.3, 1.8), with a seroresponse rate of 99.3%. Two 50 ug doses of mRNA-1273 were generally well tolerated.

The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). The ClinicalTrials.gov identifier is NCT04796896.

Moderna’s vaccine has already received regulatory approval for adults and adolescents in Australia. On 9 August 2021, the TGA granted provisional registration to the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. On 3 September 2021, the provisional registration was extended to individuals 12 years of age and older.

About Moderna
In 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 both clinical and commercial production at scale and at unprecedented speed. 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.

AUTHORIZED USE
The Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six years of age and older.

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 development of a vaccine against COVID-19 (mRNA-1273, or Spikevax); the ability of Spikevax to trigger a neutralizing antibody response in children similar to that in older populations and to protect against COVID-19; and the safety and tolerability profile for Spikevax. 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 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 lings 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:
Luke Mircea Willats
Director, Corporate Communications
Luke.Mirceawillats@modernatx.com

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

SOURCE: Moderna, Inc.

Moderna Announces Plan to Expand Footprint in Asia with Four Additional Subsidiaries

Announcement reinforces Moderna’s commitment to Asia and vision as a global commercial enterprise
New subsidiaries to be established in Malaysia, Taiwan, Singapore, and Hong Kong; providing local presence to support the delivery of mRNA vaccines and therapeutics

Moderna, Inc., (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced plans to expand its commercial network across Asia with the addition of four new subsidiaries in Malaysia, Taiwan, Singapore, and Hong Kong. This expansion comes as the Company continues to scale up the manufacturing and distribution of its COVID-19 vaccine and future mRNA vaccines and therapeutics.

The Asia-Pacific region represents an integral part of Moderna’s business, with established subsidiaries in Japan, South Korea, and Australia. In 2021, Moderna and the South Korean government announced a collaboration to explore local opportunities for research and manufacturing in South Korea. More recently, the Company announced an agreement in principle with the Australian Government to build a state-of-the-art mRNA vaccine manufacturing facility in Victoria, Australia.

“2021 was a year of impact for Moderna, and I am proud to see continued growth in 2022 as we expand our presence in Asia. After a decade of pioneering the development of our mRNA platform, we were ready to play a critical role in combating the COVID-19 pandemic globally,” said Stephane Bancel, Chief Executive Officer of Moderna. “With the addition of four subsidiaries in Asia, we look forward to new opportunities to leverage our mRNA platform to help solve health challenges, including those with a high burden of disease in the Asia-Pacific region.”

Asia bears the highest burden of infectious diseases, and the burden of non-communicable diseases is increasing as the population ages. Moderna’s growing portfolio in prophylactic vaccines, cardiovascular diseases, oncology, and rare diseases presents an unparalleled opportunity to use mRNA technology to maximize the potential impact the Company can have on human health in the region.

Moderna’s broader pipeline currently includes 40 development programs, of which 25 are in clinical trials. The Company continues to update its COVID-19 strategy to address variants of concern such as Omicron and pioneer new vaccines and therapeutics for a range of diseases and conditions. Moderna is developing mRNA medicines to potentially prevent and treat diseases with significant unmet needs across infectious diseases, immuno-oncology, rare and ultra-rare diseases, and autoimmune diseases.

Moderna currently has a presence in twelve markets globally. Regulators have approved Moderna’s COVID-19 vaccine in more than 70 markets, including Canada, Japan, the European Union, the UK, and Israel. In 2021, 807 million doses of Moderna’s COVID-19 vaccine were shipped globally, with approximately 25% of those doses shipped to low- and middle-income markets.

About Moderna’s Strategic Pillars
Moderna’s has four strategic pillars guiding the Company’s focus and impact for 2022 and beyond. Our strategic pillars are:

Developing a pan-respiratory annual booster vaccine and continuously customizing it. A pan-respiratory annual single booster vaccine covering multiple viruses, such as COVID-19, Flu, and Respiratory Syncytial Virus, could create value for the healthcare system through compliance, convenience to the customer (one vs. three injections), and reduction in vaccine administration cost
Developing first-in-class vaccines against latent viruses for which there are no approved vaccines today. Latent viruses infect the body, lay dormant, and do not replicate but possess the capacity to activate, causing disease. In addition, new emerging evidence highlights that latent viral infections may have yet unknown negative effects. Moderna has clinical candidates in development for several latent viruses, including Epstein-Barr Virus (Phase 1), human immunodeficiency virus (Phase 1), and Cytomegalovirus (Phase 3)
Developing therapeutics based on mRNA-encoded proteins across oncology, cardiovascular, auto-immune disorders, and rare genetic diseases
Developing therapeutics based on mRNA-encoded proteins across oncology, cardiovascular, auto-immune disorders, and rare genetic diseases

About Moderna
In 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 both clinical and commercial production at scale and at unprecedented speed. 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 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 commercial network across Asia with the addition of four new subsidiaries in Hong Kong, Malaysia, Singapore, and Taiwan. 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:
Luke Mircea Willats
Director, Corporate Communications
luke.mirceawillats@modernatx.com

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

SOURCE: Moderna, Inc.