Business
Moderna Announces FDA Advisory Committee Unanimously Votes in Support of Emergency Use for a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.
Positive unanimous vote for mRNA-1273 booster at the 50 µg dose level for individuals aged 65 and older as well as individuals aged 18 through 64 at high
About this update from Moderna, Inc.
[{"type":"text","content":"\nPositive unanimous vote for mRNA-1273 booster at the 50 µg dose level for individuals aged 65 and older as well as individuals aged 18 through 64 at high risk of contracting COVID-19 at least 6 months after completion of the primary series\n\nCompany estimates that booster at the 50 µg dose level could result in up to 1 billion additional doses\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nModerna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 whose exposure to COVID-19 puts them at risk for COVID-19 complications or severe illness. The positive vote was unanimous with 19 VRBPAC members recommending EUA. The booster dose is to be administered at least six months after completion of the primary series.\n\n“We are grateful for the opportunity to present the clinical data package for our COVID-19 booster vaccine to the FDA’s advisory committee today. We thank the committee for their review and for their positive recommendation in support of Emergency Use Authorization. This positive recommendation is supported by data on the 50 µg booster dose of our COVID-19 vaccine, which shows robust antibody responses against the original virus, but also against the Delta variant,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2. We look forward to making our booster available to people in the U.S. to help protect themselves against this ongoing public health emergency.”\n\nThe VRBPAC based its recommendation on the totality of scientific evidence, including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6-8 months following their second dose (n=344). Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approx...