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Covid-19 #17: Covid Is For Ever


Tywin Manderly

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5 hours ago, The Anti-Targ said:

What are they failing to get from the normal phase 3 trial that would necessitate even thinking about a challenge trial?

The two trials have different advantages and disadvantages. The normal phase 3 is extremely slow and only a tiny fraction of the volunteers end up contributing (they expect something like a few hundred events among thirty thousand volunteers), but the infection means are more realistic and so is the nature of the sample. Challenge trials are fast, but the infection is necessarily artificial, the sample needs to be of people who aren't likely to get very sick and even within this group there might be complications. If I had to guess, the main concern is speed.

1 hour ago, Zorral said:

Will the rich go on their traditional ski-spa winter vacays in 2021, like last year?

This is why it's important to have a vaccine by January -- it really won't do to have to cancel Davos.

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10 minutes ago, Altherion said:

The two trials have different advantages and disadvantages. The normal phase 3 is extremely slow and only a tiny fraction of the volunteers end up contributing (they expect something like a few hundred events among thirty thousand volunteers), but the infection means are more realistic and so is the nature of the sample. Challenge trials are fast, but the infection is necessarily artificial, the sample needs to be of people who aren't likely to get very sick and even within this group there might be complications. If I had to guess, the main concern is speed.

This is why it's important to have a vaccine by January -- it really won't do to have to cancel Davos.

The other main difference would be adverse events.  A larger sample size of a normal phase 3 trial will help identify serious but rare adverse events from the vaccine.  A challenge study may miss these rare but serious adverse events due to a smaller sample size.  Even with phase 3 trials, rare adverse events may not be detected until millions are given the vaccine (eg RotaShield).  I would not feel comfortable with a vaccine being approved based on data from a pivotal challenge trial.

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1 hour ago, Fragile Bird said:

I heard an interview on the CBC program As it Happens 2 or 3 days ago with an Englishman who was getting his Covid-19 exposure shot in the human challenge program the next day. If anyone is interested I’ll look it up.

Can you find a link?  All the articles stated that the challenge trials hadn't yet been approved.  They were just considering the possibility.

Eta: Maybe he was getting a shot of the vaccine.  You would need to wait at least about a month after completing the course of vaccine shots (two shots for Oxford vaccine) before being challenged with SARS-CoV-2. 

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28 minutes ago, Mudguard said:

Can you find a link?  All the articles stated that the challenge trials hadn't yet been approved.  They were just considering the possibility.

Eta: Maybe he was getting a shot of the vaccine.  You would need to wait at least about a month after completing the course of vaccine shots (two shots for Oxford vaccine) before being challenged with SARS-CoV-2. 

I thought he said in the interview he was being exposed to Covid-19 the next day and the interviewer asked him how he was feeling about that. But I could be wrong. I’m not home now, I’ll look it up and post a link when I get back.

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Maybe they are calling in people who got vaccinated in the Phase 3 trial who fit the criteria for a challenge trial to get a dose of the virus. But that means they would need to be able to identify who got the vaccine and who got the placebo, I assume they are doing a placebo trial with the vaccine? That way they could potentially be dosing people with the virus now.  Seems like it might be unusual for participants to switch trials like this though.

The other explanation would be that they decided to do challenge trials a couple of months ago before they even had preliminary phase 3 data and they are only just talking about it now that the participants are getting exposed to the virus.

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4 hours ago, Mudguard said:

Can you find a link?  All the articles stated that the challenge trials hadn't yet been approved.  They were just considering the possibility.

Eta: Maybe he was getting a shot of the vaccine.  You would need to wait at least about a month after completing the course of vaccine shots (two shots for Oxford vaccine) before being challenged with SARS-CoV-2. 

Ok, I tracked down the episode. I was in the car and driving when I heard it, and I was not remembering the interview correctly, sorry. The young man (he's 18) has volunteered for the trial which will likely start in January. He an organizer for One Day Sooner, which advocates for human challenge trials in the UK and also in Canada. While he has volunteered he may not be chosen. He would get a vaccine and then be deliberately exposed to the virus.

Here's a link to the As It Happens page. The day you are looking for is Sept. 23, and the interview starts at the 52:25 mark. At one point near the end he says, "I am going to be exposed to the coronavirus tomorrow" which stuck in my mind, but he was talking about not backing down when the day comes.

https://www.cbc.ca/listen/live-radio/1-2-as-it-happens

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In the meantime, per the usual here, the Orthodox screaming because forced to wear a mask when entering a public place nazis! anti-semitism! and we are too special to be asked to regard anyone but ourselves. In the meantime covid in every Orthodox community and area here is spiking like crazy.

https://gothamist.com/news/orthodox-anti-maskers-crash-nyc-covid-outreach-scream-racial-epithets

Cops doing nothing. Though I've been told the NYPD is scared of going into these communities.

There was a lot of that in Mormon communities until the LDS leadership declared for masks.  It's still considered bigotry to object to a guy marrying 15 15-year-old girls though, and I think it is now legal again to do in Utah?  I can't keep up with this stuff.

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Color us unsurprised by Governor Cuomo's announcement:

https://www.nydailynews.com/coronavirus/ny-coronavirus-cuomo-20200928-7s2uvqxjc5c75jd5ny42c4qnre-story.html

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....The state recorded an overall 1.5% positive test rate Sunday, which is more than a 50% increase over previous recent daily rates. Brooklyn had a shocking 2.6% daily positive test rate. Orange and Rockland counties were even higher.

The top 10 zip codes in the state had an average 15% positivity rate. That includes a shocking 17% rate in 11219 in Brooklyn, which encompasses the predominantly Orthodox Jewish neighborhood of Borough Park. Upstate Spring Valley clocked in at an eye-popping 30%.

Even though the zip codes represent just 2% of the state’s population, they contributed 25% of the entire state’s new positive cases....

.... The governor said 834 New Yorkers in all tested positive for COVID-19 on Sunday. That number came with a relatively modest 52,000 tests, suggesting the virus is spreading much faster than it had in recent weeks and months.

Eleven people died in the state, another number that is far higher than recent daily totals in the state.....

.... Cuomo said he suspects Labor Day gatherings may have also played a role in the spiking positive test rates. Colleges have also recently returned to session...

 

And yet --

https://www.nydailynews.com/coronavirus/ny-coronavirus-restaurant-cuomo-20200928-2l24iuoj5vc5fk5b23fwnuonry-story.html

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Restaurant owners and workers plan to march on Gov. Cuomo’s Manhattan office Monday to demand a fast-track relaxation of restrictions in New York City to limit the spread of coronavirus.

A coalition of eateries says it will march from to the governor’s office to spotlight a push for an indefinite extension of outdoor dining and much higher capacity for indoor dining....

....Cuomo hit back by warning restaurant owners that safety has to come first, especially with infection rates rising again.

“We sympathize with these business owners, but it’s clear they haven’t been paying attention,” said Jack Sterne, a spokesman for Cuomo....

 

How long will it take before the heat lamps, space heaters etc. keeping warm the now year-round closed streets and sidwalks diners war, that also block the fire hydrants, burn down a goodly amount of real estate?  As well as indoor-indoor dining, one can already see tents are enclosed on all four sides and tops these 'outdoor' dining spaces -- which take more and more and more of the real estate. They are packed, all the time now, with crowds standing around waiting to get a table. So why are they whining?

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The hospitality industry *is* dying and if there isn't a workable solution for winter more and more restaurants, bars, independent hotels, and other related businesses are going to shutter and never come back. Leaving even that many more people stranded without work or safety net. An absolutely devastating number of restaurants have closed down for good in DC.

And while there might be millionaire restaurant owners, they are not the rule. At all. It's heartbreaking. And New York is no different. 25% indoor capacity is best case scenario when you factor in social distancing requirements between tables and diners per table. Many will not be able to seat at 25%.

https://www.theguardian.com/us-news/2020/sep/27/new-york-city-restaurants-indoor-dining-coronavius

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Many restaurants have not survived the tumult.

At least 1,796 restaurants permanently closed in the New York-Newark-New Jersey metropolitan area between 1 March and 31 August, according to research by Yelp. This includes about 500 since early July.

 

As restaurants and bars collapse, so do the Chef's Warehouses, Baldors, Syscos, produce purveyors, the fish guy who delivers to local restaurants, and the Amish farmers with their clover-raised pigs and on and on..And while some of these suppliers can pivot like Baldor did with home delivery of items it's not sustainable to have warehouses and drivers bringing less stuff to less places. 

Anyways this is a sensitive topic in our home for obvious reasons and we haven't even begun to shed our final tears over the demise of the restaurant industry. 

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No question about it. The problem is, there’s a pandemic going on. The millionaire restaurant owners talk about how they’re fine in Florida because people can eat outdoors all year long, but restaurants in New York can’t survive on 25% capacity. It’s a problem. Blaming Cuomo and Di Blasio, as they do, isn’t going to solve the problem. I’m sure they are aggressively pushing for NY and other states to throw open their doors just like Florida. But who’s going to eat there and how many are going to die?

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48 minutes ago, Crixus said:

Though there was stuff in the Torygraph last week, comments by Dido Harding that companies may need to pay to have people tested, ‘the cost of doing business’x

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