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Moderna Receives FDA Authorization for Emergency Use of Omicron-Targeting Bivalent COVID-19 Booster Vaccine for Adults 18 Years and Older
Moderna's Bivalent Booster Shots to be Available Nationwide In Coming DaysmRNA-1273.222 Targets BA.4/.5 Strains of Omicron VariantCAMBRIDGE, MA / ACCESSWIRE /
About this update from Moderna, Inc.
[{"type":"text","content":"Moderna's Bivalent Booster Shots to be Available Nationwide In Coming DaysmRNA-1273.222 Targets BA.4/.5 Strains of Omicron VariantCAMBRIDGE, MA / ACCESSWIRE / August 31, 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 U.S. Food and Drug Administration (FDA) for its BA.4/.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222. Authorization has been given for a 50 µg booster dose for adults over 18 years of age who have received either a primary series or an initial booster of any of the authorized or approved COVID-19 vaccines. The 50 µg booster dose of mRNA-1273.222 includes 25 µg of mRNA encoding for the spike protein of BA.4/.5 and 25 µg encoding for the original strain of the SARS-CoV-2 virus.\"The FDA's authorization of our updated bivalent booster, mRNA-1273.222, provides Americans with access to broader protection against Omicron variants,\" said Stéphane Bancel, Chief Executive Officer of Moderna. \"Receiving a booster that specifically targets the Omicron BA.4/.5 variant, currently the most prevalent strain of SARS-CoV-2, is an important public health measure that people can take to help protect themselves, especially as we head into a season filled with indoor gatherings. We are grateful to the FDA for their decisive leadership.\"mRNA-1273.222, which targets the BA.4/.5 subvariants of Omicron, was developed under guidance from the U.S. FDA, which based today's authorization on pre-clinical data for mRNA-1273.222 as well as clinical trial data from a Phase 2/3 studying mRNA-1273.214, another Omicron-targeting bivalent booster vaccine developed by Moderna. In addition, a vast and growing body of real-world evidence provides strong evidence for the effectiveness and safety of mRNA-1273, the original Moderna COVID-19 vaccine which is the basis for the company's updated, bivalent vaccines. A Phase 2/3 clinical trial for mRNA-1273.222 is fully enrolled and currently underway, with initial data expected later this year.Moderna's updated, bivalent booster is expected to be available at vaccination sites nationwide in the coming days. Doses of mRNA-1273.222 have been purchased by the U.S. Government's Department of Defense Joint Program Executive Office for Chemical...