EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for the Use of Moderna's Omicron-Targeting Bivalent Booster in the European Union
- Study results show mRNA-1273.214 has demonstrated significantly higher antibody titers against Omicron BA.1 and BA.4/5 subvariants when compared with mRNA-1273
- Positive recommendation follows recent amendment to European Commission (EC) COVID-19 vaccine agreement to supply Omicron-targeting bivalent candidates
- In addition to the CHMP positive opinion, Moderna has received approvals for mRNA-1273.214 in Australia, Switzerland, and the UK
CAMBRIDGE, MA / ACCESSWIRE / September 1, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization for Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), the company's next-generation bivalent vaccine candidate that contains mRNA-1273 and a vaccine candidate targeting the Omicron variant of concern (BA.1). Following the CHMP's positive opinion, the European Commission will make an authorization decision on the use of mRNA-1273.214 as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older, who have previously received at least a primary vaccination course against COVID- 19.
"We are thankful for the CHMP's positive recommendation, which reinforces the body of the clinical data supporting mRNA-1273.214 and its potential role in protecting people across Europe from disease and severe outcomes associated with COVID-19," said Stéphane Bancel, Moderna's Chief Executive Officer. "We look forward to the European Commission's first authorization decision on an Omicron-targeting bivalent booster and working with countries across Europe to provide this next-generation booster candidate in the fight against COVID-19."
The decision from the CHMP is based on clinical trial data from a Phase 2/3 trial, in which mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to the currently authorized 50 microgram booster dose of Spikevax (mRNA-1273) in previously uninfected participants. A booster dose of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214) increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. In addition, Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214) elicited higher neutralizing antibody titers against the Omicron subvariants BA.4 and BA.5 when compared to Spikevax (mRNA-1273) regardless of prior infection status or age, including in those aged 65 and older. mRNA-1273.214 was generally well tolerated, with a reactogenicity and safety profile consistent with the currently authorized booster.
The recommendation follows a recent agreement between Moderna and the European Commission to convert contractually agreed doses of Moderna's COVID-19 vaccine (Spikevax, mRNA-1273) to the Company's Omicron-targeting bivalent vaccines for supply in 2022, pending regulatory approval. In addition, the European Commission agreed to purchase an additional 15 million doses of Omicron-targeting vaccine booster candidates from Moderna.
Moderna has received approval for omicron-targeting bivalent boosters in the United States, Australia, Switzerland, and the UK to date and has completed regulatory submissions worldwide.
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. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators. 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 autoimmune 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: development of the Company's COVID-19 Vaccine (mRNA-1273.214, or Spikevax bivalent Original/Omicron BA.1); the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adoption of a positive opinion recommending conditional marketing authorization for Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214) as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older; the potential authorization of mRNA-1273.214 as a booster dose for immunization to prevent COVID-19; the ability of mRNA-1273.214 to induce higher neutralizing antibody titers against Omicron subvariants BA.4 and BA.5 than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273); the safety, efficacy, and tolerability of mRNA-1273.214; and the ability of mRNA-1273.214 to protect against COVID-19. 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 for the fiscal year ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each 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.
Luke Mircea Willats
Director, Corporate Communications
Senior Vice President & Head of Investor Relations
SOURCE: Moderna, Inc.
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