Cambridge, September 15, 2023.
The positive opinion follows the recommendation of global public health and regulatory bodies to develop monovalent XBB.1.5 COVID-19 vaccines for the autumn/winter 2023 vaccination campaigns. Clinical trial data from the research trial confirmed that the Moderna's updated COVID-19 vaccine showed an 8.7- to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and FL.1.5.1 variants
Moderna, Inc. (Nasdaq:MRNA) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Spikevax, its COVID vaccine. Updated -19 containing spike proteins for the XBB.1 .5 sublineage of SARS-CoV-2 for active immunization to prevent COVID-19 caused by SARS-CoV-2 in people aged six and older months of age. Following the positive CHMP opinion, the European Commission will make an authorization decision on the use of Moderna's updated COVID-19 vaccine by autumn/winter 2023. "The CHMP's positive recommendation for our updated COVID-19 vaccine is a milestone key as we see increased SARS-CoV-2 transmission in Europe Our updated COVID-19 vaccine generates a strong human immune response against circulating variants including BA.2.86, EG.5 and FL.1.5.1 , and will be a fundamental tool for protection," said Stéphane Bancel, CEO of Moderna. "We are working with governments across Europe to include our updated COVID-19 vaccine in national vaccination programmes, to ensure a diversified portfolio offering vaccine choice and access to single-dose vial formats. that can limit residues."Moderna has generated clinical data for its monovalent vaccine candidate XBB.1.5 showing an immune response against sublines XBB.1.5, XBB.1.16 and , EG.5 and FL.1.5.1. Public health authorities are closely monitoring the BA.2.86 variant, a highly mutated strain of COVID-19 with more than 30 mutations compared to previous Omicron strains, and some governments are accelerating COVID-19 vaccination campaigns due to its potential to break the protective immunity generated by vaccination or previous infection with COVID-19. The most frequent requested local adverse event for Moderna's updated COVID-19 vaccine was pain at the injection site. The most common requested systemic adverse effects include fatigue, headache, myalgia, arthralgia, and chills. The safety profile of Moderna's updated COVID-19 vaccine is consistent with Spikevax's previous formulations. To date, Moderna has received authorizations for its updated COVID-19 vaccine in the United States, Canada, Japan and Taiwan, and has submitted regulatory filings around the world.About Moderna In the more than 10 years since its inception, Moderna has grown from a research-stage company developing programs in the field of messenger RNA (mRNA) to a company with a portfolio diverse clinical vaccine and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities enabling rapid clinical and commercial production at scale. Moderna maintains alliances with a wide range of domestic and foreign government and commercial collaborators, which has enabled it to carry out both innovative scientific advances and rapid manufacturing expansion. Most recently, Moderna's capabilities have come together to enable the authorized use and approval of one of the first and most effective vaccines against the COVID-19 pandemic. Moderna's mRNA platform is based on continued advances in basic science and applied mRNA, delivery technology and manufacturing, and has enabled the development of therapies and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical company by Science for the past eight years. For more information, you can visit www.modernatx.com.
ContactContact name: Luke Mircea-WillatsContact description: Senior Director, International Communications
