Thread by @Laurie_Garrett

From doxs submitted to @US_FDA on b ehalf of the J&J #COVID19 #vaccine application, some highlights:
1.) Genomic sequencing of viruses found in South African clinical trials came up 94% B.1.351 variant. But the vax was 52% effective against mild disease & 73% anti-severe.
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2.) Some of the clinical trials were done in Brazil, where 69% of viruses they sequences were mutant P.2 variants.
3.) Data coves nearly 40,000 volunteers, half receiving placebo or 1 dose vax, followed for a mean of 2 months.
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4.) "#Vaccine efficacy (VE) against lab-conf'ed moderate to severe/critical #COVID19 across all geographic areas in which the trial was conducted was 66.9% [for] cases occurring at least 14 dys after vaccination & 66.1%
[for] cases occurring at least 28 dys after vax."
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5.) "As of Feb 5, there were 7 #COVID19 related deaths in the placebo group & no COVID-19 related deaths in the #vaccine group."
6.) No significantly different responses seen based on the race or age of the vaccine recipients.
7.) No signif. side effects seen in anybody.
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8.) Vaccine ingredients are:
-a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the #SARSCoV2 spike protein - citric acid monohydrate
- trisodium citrate dihydrate
- ethanol
- 2-hydroxypropyl-β-cyclodextrin
- polysorbate 80
-sodium chloride
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- sodium hydroxide
- hydrochloric acid
9.) The #vaccine can be stored in a normal fridge at 36°F to 46°F. Unpunctured vials may be stored between 47°F to 77°F for up to 12 hrs
10.) Can be used on anyone aged 18+. No pediatric use studied
11.) "Efficacy" based on case definitions

My takeaway: It's not as effective as the 2-dose mRNA #COVID19 #vaccines from @moderna_tx & @pfizer . But the J&J vax seems powerful, safe, can be kept in routine fridges, requires only 1 dose -- So it has a real, positive role to play in the #pandemic.