Thread by @hildabast

It's another ENSEMBLE-watch day! The FDA meets on 26th to discuss the evaluation of the J&J single-shot vaccine - 3rd vaccine for FDA - & they aim to publish report 2 days ahead, which they achieved for the last 2. So 🤞 all will be revealed in a few hours ... 1/n

...This is where reports will be posted: fda.gov/advisory-commi…

Trial protocol: jnj.com/coronavirus/en…

Press release with trial efficacy readout: jnj.com/johnson-johnso…

My thread on it:

https://twitter.com/hildabast/status/1355145451628969984

Records on this vaccine: zotero.org/groups/2528572… ...2/n

...Things I'll be watching out for. By far the biggest set of "events" (people with symptomatic Covid-19) of any trial. So it'll be the strongest data yet on questions past that top line efficacy - efficacy in severe disease, for example, which others had too few to answer ...3/n

...Hoping there will already be more detailed data on variants - definitely on the "SA" variant, but perhaps also on "Brazil"? There has been a lot of not-so-accurate reporting on this trial, because of specific aspects of that press release... 4/n

...For example, primary efficacy results were specifically at 14 & 28 days. For others, it had been any time *after* immunity might have kicked in. How different will this look? (One hint that it might have continued to improve in the press release.) ... 5/n

...The primary outcome was moderate-to-severe Covid-19, & it was reportedly not all that different to what other vaccines have reported as symptomatic Covid-19, but that's something to watch out for...6/n

...The rate of adverse events is another thing I'm keen to see. J&J reported on one, fever: 9%, with 0.2% grade 3 (severe). For eg Moderna, that was 16% (after 2nd dose), with over 1% grade 3 or 4.

(My recent explainer post on those grades etc absolutelymaybe.plos.org/2021/02/21/a-r…) /7