logo
  

Moderna Files For Authorization For COVID-19 Vaccine In Adolescents With Swissmedic - Quick Facts

Biotechnology company Moderna, Inc. (MRNA) announced Monday that it has submitted an authorization application to Swissmedic for use of its COVID-19 vaccine in adolescents. The submission is based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 in the U.S.

In May, the Company announced that the Phase 2/3 TeenCOVE study of Moderna's COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine.

The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% in the Phase 3 COVE study in adults. The study enrolled 3,732 participants ages 12 to less than 18 years in the U.S.

The Moderna COVID-19 vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults.

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein.

Moderna COVID-19 Vaccine is authorized for use under an EUA for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

The company has recently filed for authorization with the U.S. FDA, Health Canada and the European Medicines Agency and will file with regulatory agencies around the world for this important younger age population.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
While reporting its financial results for the second quarter on Thursday, Kellogg Co. (K) reaffirmed its currency-neutral adjusted earnings growth guidance for the full year 2021. For fiscal 2021, the company now projects currency-neutral adjusted earnings per share growth of about 1 to 2 percent... Moderna Inc. (MRNA) reported a profit for the second quarter compared to a loss in the previous year, reflecting surging revenues on commercial sales of the company's COVID-19 vaccine in the U.S. Quarterly earnings per share and revenues topped analysts' expectations. The company raised its 2021 sales forecast for its COVID-19 vaccine. New Widetech has recalled dehumidifiers sold under various brand names citing fire and burn risks, the U.S. Consumer Product Safety Commission said. The brand names include AeonAir, Amana, Haier, Honeywell, and Whirlpool, among others. The recall was initiated after New Widetech received reports of 107 incidents of the recalled dehumidifiers overheating and/or catching fire.
Follow RTT