Interim results report 94% efficacy with Moderna/NIH mRNA vaccine: FDA hearing on 17 December
9 December 2020. Related: COVID-19: vaccine research, COVID-19.
Simon Collins, HIV i-Base
On 16 November 2020, a press statement from the UK NIH (a partner with Moderna for the mRNA-1273 vaccine) announced 94% efficacy in an interim analysis from the ongoing phase 3 COVE study. [1]
The results, released from the trial’s Data and Safety Monitoring Board (DSMB) reported 95 cases of symptomatic infection: 90 vs 5 cases in the placebo vs vaccine groups, respectively.
Additionally, all 11/95 cases of severe COVID-19 were in placebo recipients.
The study was launched on 27 July 2020 and has enrolled 30,000 participants at 100 sites in the US. [2]
The FDA advisory committee hearing for this vaccine is due on 17 December 2020. Meeting amterials are posted online and the hearing is webcast. [3]
References
- NIH press statement. Promising interim results from clinical trial of NIH-Moderna COVID-19 Vaccine/ (16 November 2020).
https://www.nih.gov/news-events/news-releases/promising-interim-results-clinical-trial-nih-moderna-covid-19-vaccine - clinicaltrials.gov. A study to evaluate efficacy, safety, and immunogenicity of mRNA-1273 vaccine in adults aged 18 years and older to prevent COVID-19.
https://clinicaltrials.gov/ct2/show/NCT04470427 - Vaccines and related biological products advisory committee: December 17, 2020 meeting announcement.
https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement#event-information