Moderna Receives FDA Clearance for Emergency Use of Bivalent COVID-19 Booster Vaccine Targeting Omicron for Children and Adolescents 6-17 Years Old


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

Authorization is based on clinical and preclinical data of Moderna’s bivalent vaccine candidates

CAMBRIDGE, MA/ACCESSWIRE/October 12, 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/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222, in children and adolescents 6-17 years of age. Authorizations are based on a 25 ¼g booster dose for children 6-11 years old and a 50 ¼g booster dose for adolescents 12-17 years old, each after a complete primary series of one of the vaccines COVID-19 authorized or a previous booster. The mRNA-1273.222 booster doses each contain mRNA coding for the BA.4/BA.5 spike protein as well as mRNA coding for the original SARS-CoV-2 virus strain.

“We are proud to have received clearance for our updated bivalent COVID-19 booster for children and teens ages 6-17,” said Stephane Bancel, CEO of Moderna. “With bivalent boosters available for most age groups, families have access to updated tools as they head into the winter months and holiday gatherings. We are grateful to the FDA for its thorough and timely consideration.”

Last month, mRNA-1273.222, which targets Omicron’s BA.4/BA.5 subvariants, received EUA from the FDA for adults over 18. The pediatric and adolescent EUA application is based on clinical trial recall data for Moderna’s original vaccine, Spikevax, which was administered to more than a thousand participants in each cohort. In addition, the EUA application included preclinical data for mRNA-1273.222 as well as Phase 2/3 clinical trial data investigating mRNA-1273.214another bivalent booster vaccine targeting Omicron developed by Moderna.

Moderna is currently working to finalize its EUA app for children ages 6 months to 5 years old. The application is expected to be completed later this year.

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 has been named one of Science’s Top Biopharmaceutical Employers for the past 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 6 and over.

IMPORTANT SAFETY INFORMATION

  • Do not administer to persons with a known history of severe allergic reaction (eg, anaphylaxis) to any component of the vaccine.
  • Appropriate medical treatment to manage immediate allergic reactions should be immediately available in the event of an acute anaphylactic reaction following vaccine administration.
  • Post-marketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days of the second dose. The observed risk is higher in men under 40 than in women and older men. The observed risk is highest in men aged 18 to 24.
  • 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 vaccine.
  • The vaccine may not protect all vaccinees.
  • Adverse reactions reported in clinical trials following vaccine administration include injection site pain, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, swelling/ axillary tenderness, fever, injection site swelling and injection site erythema. site and rash.
  • 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 consult the Complete SPIKEVAX Prescribing Information. For more information on authorized emergency uses of the Moderna COVID-19 vaccine, please see the EUA Fact Sheet.

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: the potential US FDA approval of mRNA-1273.222 as a vaccination booster for children 6 months of age 5 years of age and time of submissions to the US FDA for emergency use authorization; and the potential of mRNA-1273.222 to provide protection in pediatric and adolescent populations 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 “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the United States 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 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
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/720084/Moderna-Receives-FDA-Authorization-for-Emergency-Use-of-Omicron-Targeting-Bivalent-COVID-19-Booster-Vaccine-for-Children-and-Adolescents- 6 to 17 years old

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