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Rajeev Venkayya MD Profile picture
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12 Dec, 7 tweets, 7 min read
I've participated in some great discussions on #COVID19 and #vaccines on #Clubhouse recently. I’ll use this thread to share some references I’ve mentioned and/or plan to bring up in future rooms. @joinClubhouse 1/

@JorgeCondeBio
First up is a new tool from @bhrenton that tracks #CovidVaccine allocations to US states, and *some* distribution sites, based on publicly-available sources and pending a federal tracking website. 2/

Next up is a link to the Black Coalition Against Covid (@BCAgainstCOVID), which I learned about when I was on a panel with its cofounder @DrReedTuckson. It has a number of good resources including a great town hall on COVID-19 vaccine development. 3/
Here’s a tool many people found helpful around the Thanksgiving holiday, which is even more relevant in December: what’s my risk of being exposed to COVID during a holiday gathering? 4/
And here's a great resource on COVID safety in schools from @HarvardChanSPH. Lots of useful guidance & tools, from how to create a pandemic resilient teaching environment to calculators for portable air cleaners. 5/

@j_g_allen @ashishkjha @HarvardGH

schools.forhealth.org
Here's the @nytimes tool I mentioned in today's #Clubhouse discussion. It helps *estimate* where you are in the priority list for a vaccine based on where you live and your risk factors. 6/

@joinClubhouse @JorgeCondeBio
We also discussed dexamethasone, which was shown to benefit persons with #COVID19 requiring oxygen or intubation. The @NEJM article is here and Nature coverage below. nejm.org/doi/full/10.10… 7/

#Clubhouse @joinClubhouse @JorgeCondeBio

nature.com/articles/d4158…

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Rajeev Venkayya MD Profile picture
6 Dec
THREAD

Swiss cheese is great for explaining how to slow a virus, as @MackayIM's fantastic graphic shows.

There's a history. Dr. Carter Mecher first applied Swiss cheese to pandemics in 2006 at the White House. I told the story @statnews in April. 1/

statnews.com/2020/04/24/swi…
Carter came across James Reason's work in human failures and complex systems when he worked on patient safety at the Dept of Veterans Affairs.

Swiss cheese was a good way to explain the power of early coordinated NPIs in a pandemic, which was called "community mitigation." 2/
Community mitigation came out of @DrRHatchett's work to understand the impact of combined NPIs. In 2006 Richard commissioned NIH-funded MIDAS modelers (3 groups) to model NPIs at different points in time. 3/

@PNASNews @betzhallo @neil_ferguson @ilongini

pnas.org/content/105/12…
Read 6 tweets
Rajeev Venkayya MD Profile picture
1 Dec
Fully agree that a human challenge trial *would not* have resulted in an authorized/approved vaccine any sooner.

Disagree that every smart person was recommending a human challenge trial to speed up the approval process. 1/
It is not a simple undertaking to establish a human challenge model, particularly with a novel virus for which the pathophysiology is not well-understood and where a targeted therapeutic is not available for what could be a lethal disease. 2/
Safety is obviously a major issue to be worked out, and this is tightly linked to ethical considerations. Beyond this, it takes time to determine the baseline infection/disease parameters that you hope to modify with the vaccine. 3/ thelancet.com/journals/lanin…
Read 6 tweets
Rajeev Venkayya MD Profile picture
29 Nov
@bnallamo Fair question. Here are a few thoughts from a non-regulator. First, @US_FDA, led by Peter Marks and Operations Warp Speed, led by Moncef Slaoui, recognize that every day matters for HCWs and high-risk groups and are moving with extraordinary speed. 1/
@bnallamo @US_FDA An EUA (Emergency Use Authorization) for a vaccine is not the same as a therapeutic, given that the vaccine is being given to subgroups of people who are “healthy” and may or may not be exposed to the virus. The bar for safety & efficacy data is therefore higher than for Rx. 2/
@bnallamo @US_FDA The dataset is very large (44K participants), and thorough analyses of safety & efficacy take time. Moreover, the studies aren’t powered to conclude efficacy in the subgroups being considered for EUA, yet convincing benefit-risk assessments for those groups need to be shown. 3/
Read 10 tweets
Rajeev Venkayya MD Profile picture
12 Nov
THREAD
In light of the Pfizer #vaccine news, a natural question is whether it's feasible to develop “better” #COVID19 vaccines after the first ones are approved?

The answer is yes. It can be complicated but there are ways to do it. 1/

First let’s break this down into three questions:
▪️ Why might we want better vaccines?
▪️ Why would it be hard to study new vaccines?
▪️ What are the options for doing this? 2/
WHY MIGHT WE WANT BETTER VACCINES?

After we’ve seen full Phase 3 datasets on the first vaccines, we may desire better efficacy in certain populations, longer protection, greater impact on transmission, improved dosing schedule, or an improved safety profile. 3/
Read 24 tweets
Rajeev Venkayya MD Profile picture
9 Nov
This is very good news indeed, and the *potential* implications go well beyond the @pfizer #COVID19 vaccine.

While we just have the press release, it's worth reviewing what this *could* mean for the pandemic and beyond. A thread. 1/

@BioNTech_Group
First, it shows vaccines *can* prevent COVID illness in humans, and it validates the spike protein target. We didn't know these things before today, and it's good news for all #COVID19 vaccines in development. 1/
Second, the early efficacy is quite high, although it may wane over time. We can't say anything about duration of protection yet, but it helps to start from a high level of efficacy. Higher efficacy reduces the uptake needed to significantly dampen virus transmission. 2/
Read 8 tweets
Rajeev Venkayya MD Profile picture
23 Oct
This is extraordinarily optimistic.
To be clear, it's not impossible, and OWS surely has assumptions to support this. And yes we must be ambitious.

But many will assume and/or communicate that these *targets* are what they can *expect* to happen, when there are many unknowns and execution risks. 1/
A few big ones: (1) we don't have *any* efficacy data, incl in elderly; (2) manufacturing scale-up is complex and delays very common; (3) first-time cold-chain, distribution and logistics; and (4) presumably more than one vaccine needs to succeed for this to happen; etc. 2/
Read 5 tweets

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