Moderna, Inc.
22.6.2022 14:03:42 CEST | ACCESS Newswire | Press release
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
Chervon Names Devin Murray Director of Sales - Northern Division19.10.2026 15:00:00 CEST | Press release
NAPERVILLE, IL / ACCESS Newswire / October 19, 2026 / Devin Murray joins Chervon as Director of Sales - Northern Division, effective October 19, 2026, reporting to Thomas Kentouris, Vice President of Field Sales. Murray joins Chervon after completing a six-year fast track career in TTI sales and sales management. Most recently, he was a Key End User Account Manager for Milwaukee charged with growing the pro tool business with large end users. Murray's exceptional recruiting skills and leadership skills enabled him to build, manage and inspire highly effective sales teams at the store level. His account management prowess resulted in outstanding sales results and strong partnerships with multiple national accounts. "Early in his impressive career, Devin was identified as a high potential future superstar executive," said Thomas Kentouris. "His large end user pro tool experience is exactly what we need to help build our pro tool leadership position. His inspiring leadership skills combin
Chervon Names Krystle Adams Director of Sales Recruiting19.10.2026 15:00:00 CEST | Press release
NAPERVILLE, IL / ACCESS Newswire / October 19, 2026 / Krystle Adams joins Chervon as Director of Sales Recruiting, effective October 19, 2026, reporting to Matt DeFeo, SVP of Sales, Training and Recruiting. Over the past 9+ years, Adams has advanced through a series of increasingly responsible sales and recruiting positions at TTI. Earlier in her impressive career, Krystle distinguished herself as an outstanding sales representative and sales manager delivering consistently strong results. Most recently, she was a National Recruiting Operations Manager responsible for leading, coordinating, and implementing recruiting efforts across campuses nationwide. Krystle has demonstrated exceptional skills in developing and leading campus and field sales recruiting efforts. She also designed and executed a thriving national college internship program. "I feel incredibly fortunate to now have Krystle Adams in place to launch Chervon campus recruiting," said Matt DeFeo, SVP of Sales, Training and
Chervon Names Terry Lucero Director of National Accounts - Industrial19.10.2026 15:00:00 CEST | Press release
NAPERVILLE, IL / ACCESS Newswire / October 19, 2026 / Terry Lucero joins Chervon as Director of National Accounts - Industrial, effective October 19, 2026, reporting to Jeff Campbell, Senior Vice President of Industrial Commercial Sales. Lucero brings 25+ years of extensive experience in building professional tool businesses at national accounts, regional accounts, at the store level and at the end user level. Lucero started his career at Dewalt where he advanced through a series of sales, sales management and end user marketing positions over 5 years driving professional tool growth. Lucero went on to WW Grainger where he progressed through a series of business development and sales management positions. He was also a sales manager of professional equipment at United Rentals. Most recently, Lucero served as a director of sales at APEX Tool Group for the Americas. "Terry's impressive pro tool experience in industrial distribution, national account management and end user marketing make
Tenstorrent Announces a $1.5B Series E at a $6.2B Valuation19.10.2026 14:00:00 CEST | Press release
SANTA CLARA, CA / ACCESS Newswire / October 19, 2026 / Tenstorrent, the AI computing company, has closed $1.5B in Series E funding at a $6.2B post-money valuation. The round was led by Trace Capital and Innovation X, with participation from new and existing investors including Agostinelli Group, ARK Invest, Brett Barna, Cadence Ventures, Eclipse, Fidelity Management & Research Company, Maverick Silicon, Morgan Stanley, Protagonist, Sandisk, T. Rowe Price*, Tether Investments, Troluce Capital, Virtu Financial, and XTX Markets. Tenstorrent will use the capital to deploy Galaxy servers at scale, continuing to serve open-weight models across LLMs and video generation, and advance the AI and CPU IP it licenses to customers designing their own silicon. Tenstorrent sells AI compute at every level of the stack - from a single card or workstation to racks, superclusters, and custom IP. With an open-source software stack, developers can run frontier models locally and enterprises can deploy mode
OxyDew Analyzer: One Compact Instrument, Two Critical Gas Measurements19.10.2026 08:00:00 CEST | Press release
NAVAN, IE / ACCESS Newswire / October 19, 2026 / DwyerOmega introduces the new Ntron OxyDew Analyzer, a fully integrated solution that combines oxygen and moisture dew-point measurement in a single, compact wall-mountable analyzer. The result: fewer instruments to install, wire, and maintain, without sacrificing the accuracy and reliability that critical gas quality monitoring demands. By uniting two proven sensing technologies in one instrument, OxyDew cuts equipment costs, simplifies installation, and reduces ongoing maintenance, all without compromising performance. Operators monitor oxygen concentration and dew point simultaneously through a 3-inch color touchscreen, giving them a single point of control instead of two separate systems. OxyDew is available now throughout Europe and Asia Pacific. Integrated Dual Measurement for Reliable Process Monitoring At the heart of OxyDew is the integration of the proven Ntron SenzTx Oxygen Transmitter and Michell Easidew Dew-Point Transmitter
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