(AGENPARL) - Roma, 3 Luglio 2023 - (AGENPARL) – lun 03 luglio 2023 [Moderna Logo]
Moderna has added a new press release to its website:
Moderna Submits Regulatory Application to the European Medicines Agency for Its Updated COVID-19 Vaccine
The filing follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 vaccines
Pending approval, Moderna’s updated COVID-19 vaccine will be available for fall vaccination with ample and timely supply
Preliminary clinical data show that the company’s XBB1.5 monovalent vaccine induces an immune response against viruses of the XBB lineage
CAMBRIDGE, MA / ACCESSWIRE / July 3, 2023 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted a regulatory application to the European Medicines Agency (EMA) for its updated COVID-19 vaccine encoding the spike protein for the XBB.1.5 sublineage of SARS-CoV-2.
“We are proud to announce this filing for our updated COVID-19 vaccine and continue to support the European Union in protecting citizens against COVID-19,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Our preliminary clinical testing showed that our updated COVID-19 vaccine is effective in generating an immune response against the current XBB variants of concern, and we believe it will play a critical role in protecting against severe disease and hospitalization. We look forward to working with the EMA to bring our updated vaccine to people across the European Union.”
Moderna is in the process of submitting data to regulators worldwide to advance its updated COVID-19 vaccine in time for the autumn/winter vaccination season and has recently filed with the U.S. Food & Drug Administration, Health Canada, and other health authorities.
About Moderna
In over 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 and integrated manufacturing facilities that allow 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.
Forward-Looking Statements
Moderna Contacts
Media:
Luke Mircea-Willats
Sr. Director, International Communications
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
SOURCE: Moderna, Inc.