2022-08-23 | NDAQ:ARNM | Press release

mRNA-1273.222 targets Omicron variant BA.4/BA.5 strains

Pending clearance, Moderna Ready to Ship Bivalent Booster mRNA-1273.222 in September

Available clinical data for Moderna’s bivalent COVID-19 booster vaccines met all primary endpoints and met the emergency use authorization request

CAMBRIDGE, MA /ACCESSWIRE/August 23, 2022/ Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has completed its submission to the Food and Drug Administration ( FDA) of the United States for emergency use authorization for its BA.4/BA.5 Bivalent COVID-19 booster vaccine targeting Omicron, mRNA-1273.222. The application is for a booster dose of 50 mcg for adults 18 years and older and is based on preclinical data as well as available clinical trial data for the bivalent booster candidate BA.1 Omicron targeting mRNA- 1273.214 of the company.

“We have worked closely with the FDA to ensure that Americans will have access to Moderna’s updated bivalent booster, which, if cleared, may provide higher, broader, and longer lasting protection against COVID. -19 compared to the currently authorized booster,” said Stéphane Bancel, CEO of Moderna. “Moderna’s mRNA platform has allowed us to develop, study and deploy bivalent booster vaccine candidates that demonstrate superior protection against all COVID variants tested, in record time. Our commitment to using cutting-edge science to protect the world against the current threat of COVID continues.”

mRNA-1273.222 targets both the original strain of SARS-CoV-2 as well as the BA.4/BA.5 subvariants of the Omicron strain. Moderna’s FDA submission is based on preclinical data for mRNA-1273.222 as well as Phase 2/3 clinical trial data studying mRNA-1273.214, a bivalent booster vaccine targeting the Omicron BA.1 sub-variant. In the study, mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) compared to a booster dose of 50 µg mRNA-1273 in previously uninfected participants, as well as potent neutralizing antibody responses against the Comparison between Omicron subvariants BA.4 and BA.5 and the currently licensed booster (mRNA-1273), regardless of infection status prior or age.

Moderna developed mRNA-1273.222 in accordance with US FDA guidelines to develop a bivalent vaccine targeting BA.4/BA.5. A phase 2/3 trial for mRNA-1273.222 is currently underway. Moderna quickly scaled up mRNA-1273.222 manufacturing to be ready, if cleared, to deliver doses in September.

About Moderna

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.

INDICATION (USA)

  • 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 6 months of age and older or as a booster dose in individuals 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) in individuals 6 months of age and older or as a booster dose in individuals 18 years of age and older, as appropriate.

IMPORTANT SAFETY INFORMATION

  • Do not administer the Moderna COVID-19 vaccine to people with a known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Moderna COVID-19 vaccine.
  • Appropriate medical treatment to manage immediate allergic reactions should be immediately available in the event of an acute anaphylactic reaction following administration of the Moderna COVID-19 vaccine.
  • 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 the Moderna COVID-19 vaccine.
  • 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 online Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.

Please see the Moderna COVID-19 vaccine information sheet for health care providers administering the vaccine (vaccine providers) and complete prescribing information for:

  • Booster dose for ages 18 and older
  • Primary series for 12+ and booster dose 18+
  • Primary series for 6 – 11 year olds
  • Primary series from 6 months to 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 with respect to: Moderna’s application to the FDA for emergency clearance of mRNA-1273.222, and potential FDA clearance of mRNA-1273.222; The planned shipment of mRNA-1273.222 by Moderna; the expected timing of nationwide availability of mRNA-1273.222, including prior to anticipated fall surges; the ability of mRNA-1273.222 to provide broad and long-lasting protection against COVID-19; and concrete evidence supporting the efficacy and safety profile of the Moderna COVID-19 vaccine. 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 “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and Quarterly Report on Form 10-K. 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 on 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.

Moderna Contacts

Media:

Elise Meyer

617-852-7041

Senior Director, Corporate Communications

[email protected]

Investors:

Lavina Talukdar

Senior Vice President and Head of Investor Relations

617-209-5834

[email protected]

THE SOURCE: Moderna, Inc.

See the source version on accesswire.com:

https://www.accesswire.com/713254/Moderna-Completes-Application-To-US-Food-And-Drug-Administration-For-Emergency-Use-Authorization-Of-Omicron-Targeting-Bivalent-Covid-19- Reminder-Vaccine-mRNA-1273222

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