Insider Media

First mRNA vaccine manufactured in UK approved by regulators

The first mRNA vaccine to be manufactured in the UK has been approved by regulators. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has given Moderna's Covid-19 mRNA vaccine Spikevax the go-ahead in time for this year's NHS vaccine campaign.

FDA refuses Moderna's application for new mRNA flu vaccine

The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.
Healio

More data show mRNA COVID-19 vaccination during pregnancy is safe

The messenger RNA COVID-19 vaccine is not tied to neurodevelopmental disorders in youth whose mothers who were vaccinated immediately before or during pregnancy, data show.The study, presented at The Pregnancy Meeting and “conducted through a rigorous scientific process in an NIH clinical trials network,

Moderna’s work developing seasonal vaccines is ‘risky’ under current FDA, analyst says

The biotech announced Tuesday evening that in a rare move, the Food and Drug Administration won’t review its application for a mRNA-based flu vaccine over concerns about the choice of vaccine tested against the experimental vaccine in Phase 3 clinical trials. Moderna described the FDA as “inconsistent” in its communications.

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna