Clinical data show physically powerful immune responses against several circulating variants, including EG. 5, FL. 1. 5. 1, and BA. 2. 86. An updated vaccine will be available in pharmacies and care centers in the U. S. in the coming days. UU.
CAMBRIDGE, MA / ACCESSWIRE / September 11, 2023 /Moderna, Inc. (NASDAQ: MRNA) today announced that the U. S. Food and Drug Administration will be released in a new state of the company. The U. S. Food and Drug Administration (FDA) approved the Biologics Supplemental License Application (sBLA) for Spikevax® for 12-year-olds. of age and older. An emergency use authorization (EUA) was also obtained for the Moderna COVID-19 vaccine for Americans aged 6 months through 11 years. Moderna’s updated COVID-19 vaccine comprises spike proteins for SARS-CoV-2. subline XBB. 1. 5 to help save COVID-19 in others 6 months of age and older. With the U. S. FDA decision, Moderna will begin shipping doses to vaccination sites across the U. S. The U. S. and updated vaccines are expected to be available in the coming days.
“COVID-19 remains one of the leading causes of death in the United States and poses a significant risk to vulnerable populations, especially as we enter peak respiratory virus season. As the number one strain in circulation continues to evolve, updated vaccines will be needed. “”We appreciate the FDA’s timely review and inspire Americans who want to get a flu shot to get their updated COVID-19 vaccine as well. vaccine at the same time. “
In June 2023, the U. S. FDA has decided to do so. The U. S. Department of Health requested that COVID-19 vaccines be updated with an XBB. 1. 5 monovalent composition for the 2023-2024 vaccination season. At the June VRBPAC, Moderna presented clinical data that appeared its updated vaccine physically elicited powerful immune reactions in several XBB sublineages, adding XBB. 1. 5 and XBB. 1. 16. In August, Moderna announced more clinical trial data showing that the company’s updated COVID-19 vaccine was triggering an immune reaction in humans contrary to EG. 5 and FL. 1. 5. 1, currently the dominant variant in the United States. Last week, the company shared additional data from clinical trials confirming that the updated vaccine also triggered a human immune reaction contrary to BA. 2. 86.
The most requested local adverse event for Moderna’s updated COVID-19 vaccine was pain at the injection site. The most common systemic adverse events requested include headache, fatigue, myalgia and chills, which is consistent with previous formulations of Spikevax.
Outside the U. S. , regulatory programs for Moderna’s updated COVID-19 vaccine are under review through other regulatory agencies and decisions are expected in the coming weeks.
About Moderna
In more than 10 years since its founding, Moderna has evolved from a study-stage corporation advancing messenger RNA (mRNA) box systems to a corporation with a diverse clinical portfolio of vaccines and therapeutics in seven modalities, from a broad portfolio. And incorporated production services that allow immediate clinical and advertising production at scale. Moderna maintains partnerships with a wide variety of domestic and foreign government and advertising partners, which has allowed innovative clinical studies and an immediate increase in production. Most recently, Moderna’s features were combined to enable legal use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform is built on continued advances in fundamental and deployed mRNA science, delivery technology and manufacturing, and has enabled the progression of therapies and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. has been named one of Science’s Top Biopharmaceutical Employers for the past 8 years. For more information, www. modernatx. com.
USE PERMITTED IN THE UNITED STATES
Emergency uses of the Moderna COVID-19 vaccine (2023-2024 formula) have been approved or legal through the FDA, but have been legal through the FDA, under an Emergency Use Authorization (EUA) for use in Americans 6 months through 11 years of age. age. age.
INDICATION (United States)
SPIKEVAX (COVID-19 vaccine, mRNA) is a vaccine indicated for active immunization to save coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Americans 12 years of age and older. .
IMPORTANT SAFETY INFORMATION
The maximum adverse reactions reported (≥ 10%) after any dose were injection site pain, headache, fatigue, myalgia, chills, arthralgia, axillary swelling/tenderness, nausea/vomiting, injection site swelling, injection site erythema, and fever.
See full prescribing information for SPIKEVAX.
See the Moderna COVID-19 Vaccine Fact Sheet (2023-2024 Formula) for Healthcare Professionals Administering the Vaccine for more information.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, among other things, regarding: the ability of Moderna’s updated COVID-19 vaccine to generate responses physically powerful immune systems. facing multiple variants in traffic, adding EG. 5Array FL. 1. 5. 1 and BA. 2. 86, and to provide armor this season; the shipment of Moderna doses to vaccination sites across the United States and the availability of the updated Moderna vaccine in pharmacies and brick-and-mortar locations across the United States in the coming days; the ability of modern vaccines to protect against SARS-CoV-2 as the virus continues to evolve; and decisions expected in the coming weeks related to regulatory programs for Moderna’s updated COVID-19 vaccine outside the United States. The forward-looking statements contained in this press release are neither promises nor guarantees, and you should not place undue reliance on such forward-looking statements. as they involve known and unknown dangers, uncertainties and other points, many of which are beyond Moderna and which may cause actual effects to differ materially from those expressed or implied by such forward-looking statements. These dangers, uncertainties and other items come with other dangers and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the United States Securities and Exchange Commission. (SECOND). ), as well as in Moderna’s upcoming filings with the SEC, which can be found on the SEC’s online website at www. sec. gov. Except as required by law, Moderna disclaims any objective or duty to update or revise any forward-looking statements contained in this press release whether as a result of new information, long-term developments or otherwise. These forward-looking statements are based on Moderna’s existing expectations and speak only as of the date of this press release.
Moderna Contacts
Media:Elise MeyerSr. Director of Communications empresariales617-852-7041Elise. Meyer@modernatx. com
Investors: Lavina TalukdarSenior Vice President and Head of inversores617-209-5834Lavina. Talukdar@modernatx. com Relations
SOURCE: Moderna, Inc.