Moderna

The top 20 global innovative bio/pharma companies* reported a 24.9% growth in aggregate market capitalisation (MCAP)—from $2.8 trillion on 31 December 2020 to $3.4 trillion as of 31 December 2021, according to GlobalData.   The data and analytics company notes that a positive year-on-year MCAP growth was reported for 14 of the top players, with five […]

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Moderna’s Spikevax, an mRNA vaccine for prevention of Covid-19 in individuals 18 years of age and older.  Official comments   “Our Covid-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from Covid-19 infection, hospitalisation […]

IAVI and Moderna have announced that first doses have been administered in a clinical trial of experimental HIV vaccine antigens at George Washington University (GWU) School of Medicine and Health Sciences in Washington, DC.  The trial  The Phase I trial, IAVI G002, is designed to test the hypothesis that sequential administration of priming and boosting […]

Moderna has dosed the first participant in a Phase II study of the company’s Omicron-specific booster candidate (mRNA-1273.529). Additionally, Moderna announced the publication of neutralising antibody data against the Omicron variant six months following a booster dose in The New England Journal of Medicine.   The mRNA-1273.529 trial  This extension of an earlier study will evaluate the immunogenicity, safety, and reactogenicity of […]

Moderna has announced a revised supply agreement with the UK government for up to 60 million doses of its Covid-19 vaccine, which may include authorised booster vaccine candidates, with up to 29 million doses expected to be delivered in 2022 and up to 31 million doses expected to be delivered in 2023.  The agreement  Under the agreement, the […]

Moderna has announced updates to its strategy to address SARS-CoV-2 variants of concern, given the emergence of the B.1.1.529 (Omicron) variant.   What is Omicron?  The recently described Omicron variant includes mutations seen in the Delta variant that are believed to increase transmissibility and mutations seen in the Beta and Delta variants that are believed to […]

Moderna has announced positive interim data from its Phase II/III study (KidCOVE) of mRNA-1273, the company’s vaccine candidate against Covid-19, in children six to 12 years of age.   This interim analysis showed a robust neutralising antibody response after two doses of mRNA-1273 at the 50µg dose level with a favourable safety profile. Moderna plans to submit this data […]

Health Canada has approved Moderna’s New Drug Submission (NDS-CV) for Spikevax (elasomeran mRNA vaccine), it has granted full approval (Notice of Compliance or NOC) for Pfizer’s Comirnaty, and it has approved the AstraZeneca vaccine, which will be named Vaxzevria.  “Health Canada’s approval of our Covid-19 vaccine is an important milestone as it is our first full approval for Spikevax. I […]

New analysis suggests 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 US Centers for Disease Control and Prevention (CDC).   Additionally, the company shared a new analysis of follow-up through one year in […]

Moderna has submitted a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna Covid-19 vaccine (mRNA-1273) at the 50 µg dose level.  “We are pleased to submit for a conditional marketing approval with the EMA for our booster candidate at the 50 µg dose level. The amended Phase II study and […]