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

Vaccines are a national security issue, says global health official

LONDON, Feb 13 () - Vaccines are a matter of national security, a leading global health figure said this week, warning that rising anti-vaccine sentiment worldwide could undermine efforts ‌to fight
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.
STV News

First mRNA vaccine to be manufactured in UK approved by regulators

Darius Hughes, UK general manager of Moderna, said: “With this approval from the MHRA, we are incredibly proud that our LP.8.1 vaccine will be the first commercially available mRNA vaccine manufactured within the UK.