TGA in Australia has granted provisional registration for Spikevax COVID 19 vaccine for children aged 6-11 years old – Moderna

Moderna, Inc., announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in a 50 µg dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years. The TGA authorization for the use of the COVID-19 vaccine in children 6-11 years old […]

Moderna provides update on timing of U.S. Emergency Use Authorization of its COVID-19 Vaccine for adolescents

Moderna, Inc. provided an update that the FDA has notified the Company that it will require additional time to complete its assessment of Moderna’s Emergency Use Authorization (EUA) request for the use of the Moderna COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of age. The FDA has informed Moderna that the agency […]

Moderna announces positive top line data from phase II/III study of COVID-19 vaccine in children 6 to 11

-Moderna Inc. announced positive interim data from the Phase II/III study, called the KidCOVE study, of mRNA-1273 , the Company’s vaccine candidate against COVID-19, in children 6 to under 12 years of age. This interim analysis showed a robust neutralizing antibody response after two doses of mRNA-1273 at the 50 µg dose level with a favorable safety profile. Moderna plans […]

FDA Advisory Committee unanimously votes in support of emergency use for a booster dose of Moderna’s COVID-19 Vaccine in the U.S

Moderna, Inc. confirmed that the FDA’s 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 […]

Moderna highlights new clinical data on SpikeVax, its COVID-19 vaccine

Moderna, Inc. highlighted a new analysis suggesting that the Moderna COVID-19 vaccine is highly effective against circulating variants of concern , including in a vaccine effectiveness study conducted in partnership with Kaiser Permanente Southern California (KPSC) and in a separate recent publication by the U.S. Centers for Disease Control and Prevention (CDC). Additionally, the Company shared a new analysis of […]

Moderna announces submission of initial data to the FDA for mRNA-1273 at the 50 µg dose level

Moderna, Inc., announced it has initiated its submission to the FDA for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level. The Company expects to submit data to the European Medicines Agency (EMA) and other regulatory authorities around the world in the coming days. </p. The Phase II study of mRNA-1273 […]