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.
MORE
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.
MORE
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."
MORE
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.
MORE
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
MORE
- 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.

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More from @Laurie_Garrett

25 Feb
ATTN, New Yorkers: There's a new type of #SARSCoV2 in town -- a mutant that may outwit our #COVID19 #vaccines.
Here's what we know so far:
1.) A @Caltech team has been screening viral samples from USA and noted a new mutant appeared in November in NYC, dubbing it B.1.526.
MORE Image
2/ The @Caltech team says B.1.526 variant is spreading fast in NYC, now ='ing 27.8% of all new infections.
This virus has 2 key mutations that may make it dangerous. Both, alter the spike proteins that protrude from #SARSCoV2 & attach to human cells.
MORE
biorxiv.org/content/10.110… Image
3/ One mutation in NY's B.1.526 variant form of #SARSCoV2 is E484K -- this is the mutation point that makes the so-called South African and Brazil variants capable of evading antibodies and rendering some of the #COVID19 #vaccines far less effective.
MORE Image
Read 10 tweets
24 Feb
Listening to a @melindagates talk now --- she says 47 million women have dropped out of the labor force worldwide due to #COVID19 & needs to care for ailing families and kids home from school.
continues
"People are in crisis around the world. People are going hungry!"
Because of #COVID19 #pandemic
and says "there have been 15 million unexpected pregnancies in the world [during #COVID19 ] due to loss of family planning."
Read 4 tweets
19 Feb
Today @DrMikeRyan -- who heads up @WHO #COVID19 response -- received Ireland's Trócaire’s Romero Award. His speech was extraordinary. Some is in the clip below. And in a thread, here are key transcriptions.
MORE
Ryan/2
#COVID19 does not discriminate. We too cannot, must not, discriminate in our fight against this #pandemic. Doing so will only work in the pandemic’s favour. The last eight months have shown us that unity, not singularity, defeats pandemics.”
MORE
Ryan/3
“We are pushing nature to its limit. We are pushing population to its limit. We’re pushing communities to their limits. We’re stressing the environment. We are creating the conditions in which epidemics flourish. We’re forcing & pushing people to migrate away from..."
MORE
Read 7 tweets
16 Feb
In a letter circulated yesterday #PeterDiamondis apologized for holding his annual Abundance 360 brainstorming for CEOs: it turned into a #COVID19 superspreader event. But when you read what he did to make the gathering safe, you'll see why this virus is SO hard to control.
MORE
2/excerpts
"I thought creating a #COVID19 'Immunity Bubble' for a small grp in a TV studio setting was possible. I was wrong. If any of you have an impulse to lower your vigilance w/masks & social distancing after receiving a negative PCR test, you need to read this."
MORE
3/excerpts
Diamondis in January in LA switched his annual mtg to a studio, with virtual attendance. But some CEOs wanted an in-person experience, so they set up a rigorous series of PCR #COVID19 testing protocols, testing every person daily starting 72 hrs b4 the mtg.
MORE
Read 7 tweets
8 Feb
3/More Tampa @SuperBowl #COVID19 superspreading.
As with every big sports victory, men partied wildly all night. Fine. But in the Age of #coronavirus masks, social distances should...SIGH
Read 4 tweets
7 Feb
Preprint but BIG: Calif researchers study the B117 mutant #SARSCoV2 virus in USA & find, "there have been multiple introductions of B.1.1.7 into the
U.S., with the earliest dating back to the end of November, 2020."
MORE
doi.org/10.1101/2021.0…
2/
"These analyses revealed large clades of closely related #SARSCoV2 lineages clustering w/in states, as well as
natl spread...consistent w/community transmission
following several of these introductions, including spread across U.S. states.
MORE
3/ "...coincide with increased periods of travel, where the U.S. Transportation Security Admin reported
over 1 million travelers crossing checkpoints for several days during the peak Thanksgiving
season and for 12 of 18 dys surrounding the Christmas &
New Year’s holidays..."
MORE
Read 4 tweets

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