Moderna, Inc.
mRNA-1273.214 Exhibited a Greater Than 5-Fold Boost in Neutralizing Antibodies Against BA.4 and BA.5 Subvariants in Phase 2/3 Study
Data Being Submitted to Regulators and for Peer Reviewed Publication
CAMBRIDGE, MA / ACCESSWIRE / June 22, 2022 / Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced new clinical data on its bivalent (Omicron) COVID booster candidate, mRNA-1273.214. One month after administration in previously vaccinated and boosted participants, a 50 µg booster dose of mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 in all participants regardless of prior infection. Based on this and prior data, the Company is working to complete regulatory submissions in the coming weeks requesting to update the composition of the booster vaccine to mRNA-1273.214.
In today's data, mRNA-1273.214 boosted neutralizing titers against BA.4/BA.5 by 5.4-fold (95% CI: 5.0, 5.9) above baseline in all participants regardless of prior infection, and by 6.3-fold (95% CI: 5.7, 6.9) in the subset of seronegative participants. Neutralizing titers against BA.4/BA.5 were approximately 3-fold lower than previously reported neutralizing titers against BA.1. One month after an mRNA-1273.214 booster, neutralizing geometric mean titers (GMT) against BA.4/BA.5 were 941 (95% CI: 826, 1071) in all participants, and 727 (95% CI: 633, 836) in seronegative participants. For context, prior studies of a third dose of the prototype booster induced neutralizing GMT against BA.1 of 629 (95% CI: 526, 751) and against Delta of 828 (95% CI: 738, 928)[1]. A third dose of the prototype booster was shown to be effective against Delta and BA.1 infection and hospitalization in observational studies [2],[3].
"In the face of SARS-CoV-2's continued evolution, we are very encouraged that mRNA-1273.214, our lead booster candidate for the fall, has shown high neutralizing titers against the BA.4 and BA.5 subvariants, which represent an emergent threat to global public health," said Stéphane Bancel, Chief Executive Officer of Moderna. "We will submit these data to regulators urgently and are preparing to supply our next generation bivalent booster starting in August, ahead of a potential rise in SARS-CoV-2 infections due to Omicron subvariants in the early fall."
Today's data add to results shared earlier this month from the Company's ongoing Phase 2/3 study in approximately 800 participants. Previous results showed a 50 µg booster dose of mRNA-1273.214 met all pre-specified primary endpoints, including superiority in neutralizing antibody GMT against Omicron (BA.1) when compared to a 50 µg booster dose of the prototype booster (mRNA-1273). The bivalent booster was generally well tolerated, with a reactogenicity and safety profile that was consistent with the prototype booster. Moderna believes these data collectively support updating the composition of the Company's booster to bivalent (Omicron) mRNA-1273.214 for the fall.
The Company has already shared these data with regulators and is submitting a manuscript for peer reviewed publication.
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 development of a bivalent booster vaccine targeted at the Omicron variant of the SARS-CoV-2 virus (mRNA-1273.214); the ability of mRNA-1273.214 to trigger an antibody response against the Omicron subvariants BA.4 and BA.5; the Company's submission of data to regulators in support of authorization of mRNA-1273.214 as a fall booster; and the safety and tolerability profile of mRNA-1273.214. 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:
Chris Ridley
617-800-3651
Vice President, Corporate Communications & Head of Media
Chris.Ridley@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
View source version on accesswire.com:
https://www.accesswire.com/706099/Moderna-Announces-Bivalent-Booster-mRNA-1273214-Demonstrates-Potent-Neutralizing-Antibody-Response-Against-Omicron-Subvariants-BA4-And-BA5
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
eComplete Partners with Sourceful to build AI-Native Creative Operations Across Portfolio18.11.2025 15:00:00 CET | Press release
MANCHESTER, UK / ACCESS Newswire / November 18, 2025 / eComplete, the private equity firm behind Current Body's £300 million London Stock Exchange listing, has announced a strategic partnership with Sourceful, the Manchester-based technology company whose Riverflow 1 model ranks as the world's leading AI image editing model. The partnership brings Sourceful's AI-native creative platform to eComplete's portfolio of direct-to-consumer brands, enabling them to generate brand-accurate, production-ready creative assets at scale across e-commerce, social, marketplace and retail. This makes eComplete the first major private equity investor to adopt AI-native creative infrastructure as a core operational advantage. Why this matters Every consumer brand today faces the same constraint: producing thousands of creative assets, product images, ads, videos, packaging, that feel authentically on-brand across every channel and market. This challenge has intensified dramatically over the past three ye
IXOPAY Appoints George Hansen as Chief Revenue Officer to Accelerate Global Growth in Tokenization, Orchestration, and Compliance18.11.2025 06:00:00 CET | Press release
Seasoned payments executive joins IXOPAY to lead global revenue strategy amid rapid growth and the rise of agentic commerce. LEHI, UTAH / ACCESS Newswire / November 18, 2025 / IXOPAY, a global leader in enterprise-grade payment orchestration, today announced the appointment of George Hansen as Chief Revenue Officer (CRO). A veteran of the payments and fintech industries, Hansen brings more than two decades of leadership experience driving growth, transformation, and customer-centric innovation at a global scale. In his new role, Hansen will drive IXOPAY's global revenue strategy, leading sales and partnerships and aligning with marketing and customer success to support enterprise merchants and partners worldwide. His appointment reinforces IXOPAY's commitment to giving merchants full control of their payment strategy through a vendor-neutral architecture designed for scale, flexibility, and intelligence. Hansen has held senior leadership positions at companies including American Expres
General Holdings Limited and NewOak Capital Form Strategic Joint Venture to Launch CMXG, an $800M Commodities Investment Platform18.11.2025 06:00:00 CET | Press release
DUBAI, AE / ACCESS Newswire / November 18, 2025 / General Holdings Limited (GH), a Dubai International Financial Centre-based multi-strategy private investment holding company, and NewOak Capital LLC, a New York collateralized private debt asset management and structured financing and capital markets firm, today announced the formation of Common Commodities CMXG (CMXG), a vertically integrated tech-enabled commodities investment platform designed to deliver risk-controlled, scalable institutional commodity-linked real yield and growth equity to qualified global investors. The partnership combines General Holdings' strategic capital and governance expertise with NewOak Capital's structured asset-based supply-chain financing capabilities and distribution platform. This sets the foundation for "a globally scalable, integrated and transparent institutional trade finance platform facilitating sustainable and inclusive cross-regional growth." Strategic Capital Deployment and Fund Launch CMXG
OBI-902 Has Been Granted by US FDA for Orphan Drug Designation for the Treatment of Cholangiocarcinoma17.11.2025 13:00:00 CET | Press release
OBI-902 is the first ADC utilizing OBI's proprietary GlycOBI® glycan-based ADC enabling technology for evaluation of safety and efficacy in patients with Cancer. TAIPEI, TW / ACCESS Newswire / November 17, 2025 / OBI Pharma, a clinical-stage oncology company (4174.TWO) received notification from the US FDA stating that the request for Orphan Drug Designation of OBI-902 TROP2 ADC for the treatment of Cholangiocarcinoma has been granted. OBI-902 is the first OBI-developed ADC that incorporates our proprietary site-specific glycan-conjugated ADC enabling technology. Cholangiocarcinoma is a rare and lethal malignancy with fewer than 50,000 patients in the United States and a 5-year survival rate ranging from 2% and 23% depending on disease stage, histological subtype, and localization 1 . At present, there are no FDA approved ADC therapies for cholangiocarcinoma. To encourage the industry to develop new treatment options for rare diseases, the US FDA grants Orphan Drug Designation to exper
Camino Completes C$5.6 Million Investment with Strategic Investors17.11.2025 12:00:00 CET | Press release
VANCOUVER, BC / ACCESS Newswire / November 17, 2025 / Camino Minerals Corporation (TSXV:COR)(OTC:CAMZF) ("Camino" or the "Company") is pleased to announce the closing of its -brokered private placement (the "Financing") of common shares in the capital of the Company (the "Shares") previously announced in its news release dated November 12, 2025. Under the Financing, the Company issued an aggregate of 15,554,666 Shares at an issue price of $0.36 per Share, for aggregate gross proceeds of C$5,599,680. Participants in the Financing included two new key shareholders, Elemental Royalties (formerly EMX Royalty Corp.) and Continental General Insurance Company, as well as certain insiders of Camino. The gross proceeds of the Financing will be applied towards corporate working capital, legal expenses, engineering studies, project development, and general administrative expenses. The Shares issued pursuant to the Financing are subject to a statutory hold period expiring on March 15, 2026, in acc
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom