Moderna

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 […]

Moderna has initiated its submission to the US Food and Drug Administration (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 shortly.  “We are pleased to initiate […]

The National Institutes of Health (NIH) has begun a clinical trial to assess the antibody response to an extra dose of an authorised or approved Covid-19 vaccine in people with autoimmune disease who did not respond to an original Covid-19 vaccine regimen.   The trial will also investigate whether pausing immunosuppressive therapy for autoimmune disease improves the antibody […]

News round-up by DDW’s Megan Thomas for 23-27 August  The Covid-19 pandemic has undoubtedly put virology back on the drug discovery map and this week, DDW’s Megan Thomas has rounded up five stories which show updates and advancements in the fight against the virus.   1. Moderna’s Covid-19 vaccine maintains antibodies against variants  New data has […]

Japan has suspended the use of around 1.63 million doses of the Moderna vaccine due to contamination, which the health ministry confirmed resulted from “foreign materials” in an unused batch of roughly 560,000 vials, according to BBC reports.   According to the news site, Takeda Pharmaceutical, which sells and distributes the vaccine in Japan, said Moderna had put […]

Moderna has completed the rolling submission process for its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the full licensure of the its Covid-19 vaccine for active immunisation to prevent Covid-19 in individuals 18 years of age and older. As part of the completed BLA submission, Moderna has requested Priority Review designation.   “This BLA submission for our Covid-19 vaccine, […]

New data has been published on the durability of the Moderna Covid-19 vaccine in generating neutralising antibodies against variants. The manuscript was published in Science.   “We are pleased with these new data showing that people vaccinated with two doses of the Moderna Covid-19 vaccine maintained antibodies through six months, including against variants of concern such as the Delta variant. Along with our partners, we […]

A pilot study has begun to assess the antibody response to a third dose of an authorised Covid-19 mRNA vaccine in kidney transplant recipients who did not respond to two doses of the Moderna or Pfizer-BioNTech Covid-19 vaccine. The Phase II trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the […]