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CHMP positive for Spikevax, the updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 for active immunization to prevent COVID-19 – Moderna

Written by | 19 Sep 2023

Moderna, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Spikevax, its… read more.

Myocarditis rare after Covid vaccination, with differences between ages and vaccines

Written by | 21 Nov 2022

Development of myocarditis after SARS-CoV-2 vaccination is rare but appears to be more frequent among males aged 18-29 and especially after the second mRNA-1273 (Moderna) vaccine. The study… read more.

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

Written by | 28 Feb 2022

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… read more.

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

Written by | 4 Nov 2021

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)… read more.

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

Written by | 31 Oct 2021

-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… read more.

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

Written by | 27 Oct 2021

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… read more.

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

Written by | 20 Sep 2021

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… read more.

Moderna files CMA to EMA for mRNA 1273 booster dose in COVID-19

Written by | 8 Sep 2021

Moderna announced it has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19… read more.

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

Written by | 7 Sep 2021

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… read more.

FDA updates emergency use authorisation for mRNA 1273 in COVID-19 – Moderna

Written by | 29 Aug 2021

Moderna announced that the FDA has approved an update to the emergency use authorization for the Moderna mRNA 1273 COVID-19 vaccine to include a third dose for immunocompromised… read more.

TGA Australia grants provisional approval to COVID-19 Vaccine Moderna to prevent COVID 19 – Moderna Inc

Written by | 17 Aug 2021

Moderna, Inc. announced that the Therapeutic Goods Administration (TGA) has granted provisional registration to the COVID-19 Vaccine Moderna in Australia for active immunization to prevent COVID-19 caused by… read more.

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