Moderna data has arrived at the FDA.... I'll be tweeting about the 54-page document by the FDA https://t.co/rh3K9BvqgO The brief from Moderna is much smaller than BNT/Pfizer's - only 84 pages (+ a 7-page presentation) https://t.co/EWDYzYwf2g 1/n

..Efficacy data is for 27,817 people randomized to either vaccine or placebo; & there's safety data for 30,350 people. I'll get started with the adverse events data, because that has been a question mark for this vaccine...2/n

...The FDA raises lymphadenopathy & Bell's palsy again. More people with lymphadenopathy with Moderna's vaccine than BNT/Pfizer's: 173 in vaccine group, 95 in placebo. Bell's palsy similar. Frequency of serious adverse events (SAEs) low: 1.0% in vaccine & placebo arms...3/n

...FDA expressed no concern about any SAE: 7 SAEs were determined by FDA to be vaccine-related or potentially so (more than the sponsor deemed related) - several from nausea/vomiting. People died at the same rate as would expected for their age groups, the FDA concluded...4/n

...A developmental/reproductive toxicity study report was included: FDA identified no serious concern about adverse impact on pregnancy or perinatal/postnatal development. All up, no safety concern that would prevent emergency authorization... 5/n