Just starting to read briefing materials for Moderna presentation to Vaccines and Related Biological Products Advisory Committee Meeting on Thursday. If you are interested, document is available at
https://www.fda.gov/media/144434/download
Noticed one difference right off the top, this EUA submission is for those 18 and older, where Pfizer is for those 16 and older. Last week committee vote had 4 vote against the EUA with 2 or 3 confirmed they voted against because of the sparse results in the 16 and 17 year old subjects.
The proposed use under an EUA is for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The proposed dosing regimen is 2 doses, 100μg each, administered 1 month apart.
Other items that seem important to me
- Early analysis (Nov 7th) showed 5 cases found in vaccine group and 90 in placebo group.
- Severe COVID-19, 0 cases in vaccine group and 11 in placebo group.
- With cutoff of 21 Nov 11 Cases of COVID-19 in vaccine group, 185 in placebo group.
- 30,400 participants vs 44,000 for Pfizer.
- Severe COVID-19 zero (0) in vaccine group and eleven (11) in placebo group.
- Protection seems to start about 14 days after first shot.
- 3 reports of Bell's palsy in vaccine group and 1 in placebo group.