Moderna’s dual-purpose boosters will be available nationwide in the coming days
mRNA-1273.222 targets Omicron variant BA.4/.5 strains
CAMBRIDGE, MA /ACCESSWIRE/August 31, 2022/ Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for its BA.4/.5 Bivalent COVID-19 Booster Vaccine Targeting Omicron, mRNA-1273.222. Authorization has been given for a booster dose of 50 mcg for adults over the age of 18 who have received either a primary series or an initial booster of one of the authorized or approved COVID-19 vaccines. The 50 µg booster dose of mRNA-1273.222 includes 25 µg of mRNA encoding the spike protein of BA.4/.5 and 25 µg encoding the original SARS-CoV-2 virus strain.
“FDA clearance of our updated bivalent booster, mRNA-1273.222, provides Americans with access to broader protection against Omicron variants,” said Stephane Bancel, CEO of Moderna. “Receiving a booster that specifically targets the Omicron BA.4/.5 variant, currently the most prevalent strain of SARS-CoV-2, is an important public health measure people can take to protect themselves, especially that we are heading into a season filled with indoor gatherings. We are grateful to the FDA for its decisive leadership.
mRNA-1273.222, which targets the BA.4/.5 subvariants of Omicron, was developed under the direction of the US FDA, which based today’s clearance on preclinical data for the mRNA-1273.222 and Phase 2/3 clinical trial data are investigating mRNA-1273.214, another bivalent booster vaccine targeting Omicron developed by Moderna. Additionally, a large and growing body of real-world evidence provides strong evidence for the efficacy and safety of mRNA-1273, the original Moderna COVID-19 vaccine that is the basis of the bivalent vaccines being released. company day. A Phase 2/3 clinical trial for mRNA-1273.222 is fully enrolled and currently underway, with initial data expected later this year.
Moderna’s updated bivalent booster should be available at vaccination sites nationwide in the coming days. Doses of mRNA-1273.222 were purchased by the U.S. Government’s Joint Program Executive Office for Chemical, Biological, and Radiological Nuclear Defense (JPEO-CBRND) and Army Contracts Command under contract number W58P05- 22-C-0017.
In more than 10 years since its inception, Moderna has grown from a research-stage company advancing messenger RNA (mRNA) programs to a company with a diverse clinical portfolio of vaccines and therapeutics in seven modalities, a broad portfolio of intellectual property in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing facility that enables rapid clinical and commercial scale production. Moderna maintains alliances with a wide range of domestic and foreign government and commercial collaborators, which has enabled the pursuit of both breakthrough science and rapid scale-up of manufacturing. Most recently, Moderna’s capabilities have come together to enable the licensed use and approval of one of the oldest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform leverages continuous advancements in basic and applied mRNA science, delivery technology and manufacturing, and has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna was named one of the top biopharmaceutical employers by Science since seven years. To learn more, visit www.modernatx.com.
SPIKEVAX (COVID-19 vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people aged 18 and over. Emergency uses of the vaccine have not been approved or authorized by the FDA, but have been authorized by the FDA, under an emergency use authorization (EUA) to prevent coronavirus disease 2019 ( COVID-19) in individuals aged 6 months and older. or as a booster dose in persons 18 years of age and older, as appropriate.
AUTHORIZED USE IN THE UNITED STATES
Emergency uses of the vaccine have not been approved or authorized 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 licensed in people aged 6 months and older as a primary series. The Moderna COVID-19, bivalent vaccine is authorized as a booster dose in persons 18 years of age and older.
IMPORTANT SAFETY INFORMATION
Do not administer Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (eg, anaphylaxis) to any component of Moderna COVID-19 Vaccine or Moderna COVID-19 Vaccine, Bivalent.
Appropriate medical treatment to manage immediate allergic reactions should be immediately available in the event of an acute anaphylactic reaction following administration of vaccines.
Post-marketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days of the second dose.
Syncope (fainting) may occur in association with the administration of injectable vaccines. Procedures must be in place to prevent injury from fainting.
Immunocompromised people, including people receiving immunosuppressive therapy, may have a diminished response to vaccines.
The Moderna COVID-19 vaccine may not protect all vaccinees.
Adverse reactions reported in clinical trials in children 6 years of age and older following administration of the Moderna COVID-19 vaccine include injection site pain, fatigue, headache, myalgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, injection site erythema, injection site swelling and arthralgia.
Adverse reactions in children 6 months to 5 years after receiving Moderna COVID-19 vaccine include injection site pain, irritability/crying, fatigue, drowsiness, loss of appetite, headache, fever, myalgia, chills, nausea/vomiting, axillary (or groin) swelling/tenderness, arthralgia, injection site erythema and injection site swelling.
Anaphylaxis and other serious allergic reactions, myocarditis, pericarditis, and syncope have been reported after Moderna COVID-19 vaccine administration during mass vaccination outside of clinical trials. The vaccinator 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 Vaccine Information Sheets for Health Care Providers Administering Vaccines (Vaccine Providers) and Complete Prescribing Information for:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including with respect to: the development of the Company’s COVID-19 vaccine targeting Omicron BA.4/BA.5 variants ( mRNA-1273.222); the potential for higher, broader and more durable protection against Omicron variants for mRNA-1273.222 than mRNA-1273; the timing and availability of mRNA-1273.222 for distribution to the US population; the safety, efficacy and tolerability of mRNA-1273.222; and the ability of mRNA-1273.222 to protect against COVID-19. The forward-looking statements contained 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 within Moderna’s control and which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include the 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 United States Securities and Exchange Commission (SEC), and in Moderna’s subsequent filings with the SEC, which are available at the SEC at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility to update or revise the 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.
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THE SOURCE: Moderna, Inc.
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