Moderna to apply for FDA emergency use authorization for COVID-19 vaccine candidate
Following analysis of additional primary efficacy data for its mRNA-1273 COVID-19 vaccine candidate, Moderna Inc. today said it will apply for emergency use authorization from the Food and Drug Administration; a review of its safety and efficacy package is scheduled for Dec. 17. Moderna said that its candidate showed 94.1% efficacy against COVID-19, with a 100% efficacy against severe cases. In the event of approval, it is expected that 20 million mRNA-1273 doses will be available in the U.S. by the end of 2020, with a total of 500 million to 1 billion doses available globally in 2021.
Related News Articles
Headline
The Department of Health of Human Services Aug. 21 issued a request for information seeking feedback on immunization categories within the Aug. 10 executive…
Headline
For the 2025-2026 school year, exemptions from one or more vaccines among U.S. kindergartners was at 4.2%, increasing from 3.6% for the previous school year,…
Headline
The Department of Health and Human Services June 30 announced it will terminate emergency use authorization declarations for certain drugs and medical devices…
Headline
The Centers for Disease Control and Prevention Feb. 19 released a report on the low use of COVID-19 antiviral drugs among individuals age 65 and older, a…
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 Advisory Committee on Immunization Practices Sept. 19 recommended that patients should consult their health care provider if they want to receive a COVID-…