Data indicate durable immune response from bivalent booster after three months of follow-up
mRNA-1273.214 also demonstrated potent response to Omicron BA.2.75
CAMBRIDGE, MA / ACCESSWIRE / October 19, 2022 / Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced new clinical data on its bivalent Omicron-containing booster, mRNA-1273.214. Ninety days after administration as a fourth booster dose in previously vaccinated and boosted participants, a 50 µg booster dose of mRNA-1273.214 elicited a superior neutralizing antibody response against Omicron BA.1 when compared to a 50 µg booster dose of mRNA-1273 in all participants regardless of prior infection. Superior performance against Omicron BA.1 was also durable, with higher antibody titers sustained through three months.
In addition, mRNA-1273.214 demonstrated significantly higher neutralizing antibody responses against Omicron BA.4/BA.5 compared to mRNA-1273 28 days after administration, as previously reported. Potent responses were also seen against Omicron BA.2.75 28 days after administration, suggesting that the bivalent booster elicits broad cross-neutralization against Omicron variants.
"Our bivalent boosters continue to demonstrate a strong, enduring response to COVID-19 variants of concern," said Stéphane Bancel, Chief Executive Officer of Moderna. "Clinical trial data now indicates that the superior immune response produced by our bivalent booster has durability for at least three months. As COVID-19 remains a global threat and a leading cause of death globally, this is an encouraging development, showing that a bivalent booster dose will offer important protection leading into the winter months."
Observed side effects of mRNA-1273.214 were similar or less severe than those of either a second or third dose of the original vaccine. Additionally, no new safety concerns were identified in the three-month follow-up.
The complete data set will be presented during a breakout session on October 20, 2022 at ID Week. In addition, data will be submitted for peer-reviewed publication and shared with regulators around the world.
The Company expects interim safety and immunogenicity results of its Omicron BA.4/BA.5-targeting bivalent vaccine, mRNA-1273.222, to become available later this year. Data will be generated from a clinical study designed in accordance with regulatory guidance for bivalent booster vaccines against COVID-19.
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 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.
AUTHORIZED USE IN THE U.S.
Emergency uses of the vaccine have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19). The Moderna COVID-19 Vaccine is authorized in individuals 6 months of age and older as a primary series. The Moderna COVID-19 Vaccine, Bivalent is authorized as a booster dose in individuals 6 years of age and older.
IMPORTANT SAFETY INFORMATION
- Do not administer the vaccines to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
- Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine.
- Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second primary series dose or first booster dose.
- Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
- Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the vaccines.
- The vaccines may not protect all vaccine recipients.
- Adverse reactions reported in clinical trials for individuals children 6 years of age and older following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, erythema at the injection site, swelling at the injection site, and arthralgia.
- Adverse reactions in children 6 months through 5 years of age following administration of Moderna COVID-19 Vaccine include pain at the injection site, irritability/crying, fatigue, sleepiness, loss of appetite, headache, fever, myalgia, chills, nausea/vomiting, axillary (or groin) swelling/tenderness, arthralgia, erythema at the injection site, and swelling at the injection site.
- Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.
- The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.
Please see the Moderna COVID-19 Vaccine Fact Sheets for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information for:
- Booster dose for 6+ years
- Primary series for 12+ and Booster dose 18+ years
- Primary series for 6 - 11 years
- Primary series for 6 months - 5 years
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 bivalent vaccine candidates against COVID-19 (mRNA-1273.214 and mRNA-1273.222); the ability of mRNA-1273.214 to induce higher neutralizing antibody titers against Omicron subvariants, including BA.1, BA.4, BA.5 and BA.2.75 than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273) over time and to trigger a strong immune response, regardless of prior infection and across age groups; the tolerability and safety profile for mRNA-1273.214; the Company's bivalent booster strategy and its ability to offer strong protection against anticipated virus surges in the winter; the anticipated submission of data for mRNA-1273.214 to regulators for review and the timing of such submissions and review; and the timing for readouts from clinical trials for mRNA-1273.222. 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 and the Quarterly Report on Form 10-Q for the quarter 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 of this press release.
Senior Director, Corporate Communications
Senior Vice President & Head of Investor Relations
SOURCE: Moderna, Inc.