Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children 6 Months Through 5 Years of Age
mRNA-1273.222 Targets the BA.4/BA.5 Strains of Omicron Variant
Authorization Is Based Upon Clinical and Pre-Clinical Data for Moderna's Bivalent Vaccines
CAMBRIDGE, MA / ACCESSWIRE / December 8, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, in children 6 months through 5 years of age. The authorization is based on a 10 μg booster dose following a completed primary series of Moderna's original vaccine. The booster dose of mRNA-1273.222 contains mRNA encoding for the spike protein of BA.4/BA.5 as well as mRNA encoding for the original strain of the SARS-CoV-2 virus.
"With the FDA's decision, children and adolescents of all age groups in the U.S. will now be eligible for our updated bivalent COVID-19 booster, providing families with an important protective tool as we continue through the winter months," said Stéphane Bancel, Chief Executive Officer of Moderna. "We appreciate the FDA's timely review."
mRNA-1273.222, which targets the BA.4/BA.5 subvariants of Omicron, has also received FDA EUA for children and adolescents aged 6 through 17 years old, as well as adults over the age of 18. The pediatric EUA application is based upon clinical trial booster data for Moderna's original vaccine, Spikevax. In addition, the EUA application included pre-clinical data for mRNA-1273.222 as well as clinical trial data from a Phase 2/3 studying mRNA-1273.214, another Omicron-targeting bivalent booster vaccine developed by Moderna.
Last month, Moderna announced results from a Phase 2/3 trial in over 500 adults, which showed mRNA-1273.222 induced significantly higher neutralizing antibody titers against BA.4/BA.5 compared to a booster dose of Moderna's original vaccine. A Phase 2/3 trial evaluating Omicron-targeting bivalent vaccines as booster and primary series in children 6 months through 5 years of age is currently underway, with initial results expected in early 2023.
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 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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight 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 months through 5 years of age at least 2 months after the Moderna COVID-19 Vaccine primary series and is authorized in individuals 6 years of age and older at least 2 months after any authorized or approved vaccine.
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 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:
- Bivalent Booster dose for 6 months - 5 years
- Bivalent Booster dose for 6+ years
- Primary series for 6 months - 5 years
- Primary series for 6 - 11 years
- Primary series for 12+
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-1273.222 and mRNA-1273.214); the ability of mRNA-1273.222 to protect children against COVID-19; and the ability of mRNA-1273.222 to induce higher neutralizing antibody titers against Omicron variants in adults than the Company's vaccine candidate against the ancestral strain of SARS-CoV-2 (mRNA-1273). 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.
Vice President, Corporate Communications
Senior Vice President & Head of Investor Relations
SOURCE: Moderna, Inc.