FDA panel recommends EUA for Moderna’s COVID-19 vaccine candidate
The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee Dec. 17 recommended the approval of Moderna’s mRNA-1273 COVID-19 vaccine candidate.
The panel voted 20-0, with one abstention, that FDA issue an emergency use authorization.
Once the EUA is issued by the FDA, which could happen as soon as today, Operation Warp Speed expects to begin shipping immediately to U.S. hospitals and other sites as designated by state and jurisdictional leaders. The vaccine is administered in two doses 28 days apart.
Related News Articles
Headline
The Centers for Disease Control and Prevention Dec. 11 released a report that found last year’s version of the COVID-19 vaccine was 76% effective in preventing…
Headline
The AHA provided recommendations to the Food and Drug Administration Dec. 1 in response to a request for information on the measurement and evaluation of…
Headline
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through…
Headline
The Food and Drug Administration yesterday published an announcement from Otsuka ICU Medical saying that the company issued a voluntary recall for a mislabeled…
Headline
The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations…
Headline
The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial…