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COVID-19/Coronavirus thread


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2 hours ago, greg775 said:

We are taking about restaurants and stores. I've been in restaurants eating and there's nobody near me There are waitresses though and the people I'm eating with, never a full cramped table of 4 or anything. This is what confuses me. We're expressing problems with dining and shopping and having 3 in a pew at church, but I haven't sensed any angst about flying. Cmon. You are packed like sardines on planes. How can planes not be a HUGE problem. I still think this is all political and all screwed up about where is 'safe' and where 'isn't.'

Say wat?

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22 hours ago, pcq said:

My amazement around the city downtown is how many people and esp. younger people prefer to wear a mask around their neck. Perhaps they want to be seen? 

Of course they want to be seen. Can't use your youth and good looks to get attention from others if you have a mask around your face. Younger me would definitely drop my face mask in the presence of attractive women if we were outside.

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The vaccine trials have gotten billions in public money already and they’ve got an increasingly skeptical public atmosphere. One of the easiest things they could do to assuage those doubts is to be open on the processes they’re using and how their public statements are justified, for example Pfizer in one case wants to add additional candidates to their vaccine trial but also has a ceo saying this will be done in October, both of those can’t be true. Letting outside scientists review should be a key step, so it’s good that the press is asking why none of that is happening.

https://www.nytimes.com/2020/09/13/science/coronavirus-vaccine-trials.html?referringSource=articleShare

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22 minutes ago, Balta1701 said:

The vaccine trials have gotten billions in public money already and they’ve got an increasingly skeptical public atmosphere. One of the easiest things they could do to assuage those doubts is to be open on the processes they’re using and how their public statements are justified, for example Pfizer in one case wants to add additional candidates to their vaccine trial but also has a ceo saying this will be done in October, both of those can’t be true. Letting outside scientists review should be a key step, so it’s good that the press is asking why none of that is happening.

https://www.nytimes.com/2020/09/13/science/coronavirus-vaccine-trials.html?referringSource=articleShare

I agree. Transparency is vital when it comes to the vaccine. There are so many people who won't take any vaccine, and the situation is worsened if the vaccine is used for monetary or political gain. I, for one, will not take a vaccine released two days before the election. The response to the pandemic has been bad enough.

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52 minutes ago, Tony said:

Someone a few months back got into a debate about “What more could have The President really have done to slow the spread of this thing?” 
 

This is why words matter, setting an example matters. 

especially since he even admitted he sandbagged this on purpose. 

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I have just taken shots for flu and pneumonia. In two weeks, I will get a shot for shingles. I refuse to take any witchcraft vaccine that is meant to come out right at election time. I will not take part in this insanity or anything this fake medicine-man tries to force on the American people.

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1 hour ago, NWINFan said:

I have just taken shots for flu and pneumonia. In two weeks, I will get a shot for shingles. I refuse to take any witchcraft vaccine that is meant to come out right at election time. I will not take part in this insanity or anything this fake medicine-man tries to force on the American people.

There will be no vaccine this year.  It is another lie.

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This whole vaccine debate. I don't know. I think it's too abstract right now. Will I take "a vaccine" that arrives before election day? Probably not.

But if, you know, astrozeneca or moderna or J&J publish their clinical trials and it looks good and you can get it in december or so, yes I'd get it. They should have been able to pull off huge, relevant trials due unfortunately to how prevalent covid still was in US and other areas.

 

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16 minutes ago, bmags said:

This whole vaccine debate. I don't know. I think it's too abstract right now. Will I take "a vaccine" that arrives before election day? Probably not.

But if, you know, astrozeneca or moderna or J&J publish their clinical trials and it looks good and you can get it in december or so, yes I'd get it. They should have been able to pull off huge, relevant trials due unfortunately to how prevalent covid still was in US and other areas.

 

https://www.nytimes.com/2020/09/17/health/covid-moderna-vaccine.html?smid=tw-share

Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial

edit: I have no idea why this is nesting the quotes but they're all from the same article. Short story: Moderna will likely have initial efficacy results in late December. Don't expect everyone to be able to get a vaccine until late summer 2021 if everything goes well.

Quote

The biotech company Moderna released a 135-page document on Thursday that spells out the details of how it is conducting the late-stage trial of its coronavirus vaccine, and how safety and efficacy will be determined.

The document suggests that the first analysis of the trial data may not be conducted until late December, and that there may not be enough information then to determine whether the vaccine works. Subsequent analyses, scheduled for March and May, are more likely to provide an answer.

Those timelines mesh with the cautionary estimates from many researchers, and stand in sharp contrast to President Trump’s predictions that a vaccine will become widely available before the end of this year.

 

Pfizer said on Saturday that it planned to expand its trial to 44,000 participants from 30,000, but that it still expected to have efficacy results by the end of October.

 

Dr. Eric Topol, a clinical trial expert at Scripps Research in San Diego, gave the company “big kudos” for sharing the information, but said that he was disappointed by some of the details. For example, the company intends to include in its data people who developed relatively mild cases of Covid-19. Dr. Topol said more compelling evidence of the vaccine’s effectiveness would be produced if the company counted only moderate to severe cases.

In addition, the protocol allows for the possibility of stopping the trial early after a relatively small number of cases. Stopping early could lead to an exaggerated perception of the vaccine’s efficacy, and could also miss safety problems that could turn out to be significant later if the vaccine is given to millions and millions of people.

“Take the time, the extra weeks,” Dr. Topol said. “No shortcuts. Nobody will regret it. I’ve been doing clinical trials for decades. I don’t know if there’s ever been a more important one than this one. I’d like to see it done right, and not stopped early.”

 

A total of 151 cases — spread between the vaccine and placebo groups — would be enough to determine whether the vaccine is 60 percent effective. The Food and Drug Administration has set the bar at 50 percent.

But if the vaccine turns out to be highly effective, with a statistically significant difference emerging between the two groups with fewer than 151 cases, efficacy could be proved sooner, Dr. Zaks said.

The numbers will be watched by a panel of independent experts picked by the National Institutes of Health. The same group will also monitor several other trials.

The panel, called a data-safety monitoring board, will perform its first analysis of the efficacy data once 53 cases have occurred.

Mr. Bancel said the company would report publicly on the results of this so-called interim analysis, and the next one, when they are conducted.

 

Dr. Zaks and Mr. Bancel said that the first analysis would probably not take place before November. In theory, the vaccine could be found effective at that point, though the odds of demonstrating 60 percent effectiveness at the first analysis are not high, Dr. Zaks said.

If the data are not conclusive, the panel will look again after there have been a total of 106 cases. If there is still no answer, the next and final analysis will occur after 151 people contract Covid.

How long it takes to reach any of those case counts depends on the trajectory of the pandemic and how likely participants are to be exposed to the virus.

It will probably take five months from the study start — when the first participant received the first shot — to reach 53 cases, eight months to reach 106 and 10 months to reach 151, the protocol states. Those estimates depend on certain assumptions being correct, including that in a six-month period, the incidence of Covid in the placebo group will be 0.75 percent.

The study began in late July, which would suggest that the first interim analysis may not occur until late December, and the final one in late May.

Regardless of whether the vaccine is effective or not, the participants’ health will be monitored for two years after the second shot, the protocol states.

 

Moderna and other companies have already begun making their vaccines “at risk,” meaning financial risk, because if the trials find that the products do not work, they will have to be thrown away. Both Moderna and Pfizer have projected that millions of doses will be ready early in 2021. But the world population is 7 billion, and everyone will need two doses.

“In the first half of next year, at least maybe until Labor Day next year, I anticipate that the world is going to be massively supply-constrained, meaning not enough vaccine to vaccinate everybody,” Mr. Bancel said.

Edited by StrangeSox
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I also recapped a recent TWiV that had a detailed review of a recent call with 8 of the top 9 vaccine candidates.

 

Another good TWiV

https://www.microbe.tv/twiv/twiv-663/

Daniel Griffin's clinical update right out of the gate provides information on:


-big spike in younger people after schools open (duh)
--dying teachers
--young people can become infected and transmit (duh) including rates of hospitalization, long-term care, and death for young people

-Testing and false positives; how to handle, how to reduce (retest!)
--Developing an online calculator to see outcomes from # of tests, how many people, specificity, frequency, etc. to prevent X number of infections
--Rapid test centers opening up
--NY state covering screening testing for COVID for the individual still

-Vaccines
--Reviews typical vaccine study length before licensure (1-4 years) and the potential risks of EUA'ing any of the potential candidates (let's be real, nobody is waiting around until late 2022 when the full Phase 3 trial studies are completed)
--Thorough primer on the various vaccine platforms out there
--Statistical significance/power for the trials will need ~30k people and 200 infections
--Vaccine risk assessment, and balancing the risk of COVID-19 and what the vaccine side effects might be

-Long-haulers
--This isn't a short-term illness for a decent minority of people
--More people developing migraine-like headaches

Alan Dove goes deep on a media conference call with 8 of the 9 leading vaccine candidate companies, recapping where they're at, what they're doing, what they're looking for, when we can expect preliminary information and what some end results might be. AstraZeneca was the only one not present and Alan speculates that it's because they didn't want to get asked a whole bunch of questions about their paused trial that they couldn't answer and would take the majority of the time of the call.

-Not out-right stated, but seems like there's at least some behind-the-scenes collaboration

-All 8 are running "neck-and-neck" and following similar standards

-Big, important one: their primary endpoint is prevention or mitigation of disease, not infection
--Threshold is 80% effective at prevention/mitigation of disease
--We could very well end up like the annual flu vaccine, that only works 30% of the time to prevent infection, but is 80% effective in reducing disease impact
--That means there will still be a whole lotta spread going on out there, even after many or even most of us are vaccinated. Adjust our expectations accordingly. A vaccinated healthcare worker may now just be assymptomatic and spread to patients. We will still need massive testing.
--Wasn't covered on call/TWiV of what counts as "serious" disease but it should be available in the trial info online


-Distribution chains
--Everyone is expecting EUA at some point as they go for final approval, which likely won't come until 2022.
--Possible EUA by end of year, maybe
--Some of these (especially mRNA) do need -70C or -20C in the distribution chain up to the final distributor to the pharmacy/clinic, where it would then be fridge-stable for a day or two at least.
----These are conservative estimates from manufacturers, hope to test and prove that they're ok at higher temps, regular refridge
----Protein-based ones are all refridge-grade (like flu)
----Innovio has a platform they're trying for COVID on that can be stored at 37C for two months and 25C for a year (fantastic for poorer countries), but we haven't gotten DNA vaccines to work for people yet (boo)
--Almost all of these expect 2 doses, 3-4 weeks apart
--Many of the manufacturers are ramping up to produce 100M doses a year. That means 50M vaccinated a year per manufacturer. One of them that already does flu is targeting 1B/year.
--Multi-dose vials will be initial shipments, which means you need a trained immunizer to mix and dose properly (problem in poorer countries)
--No cross-testing of the various vaccine candidates right now (what happens if I get more than one vaccine?)
--Our vaccine database/tracking sucks horribly

-Enrollments
--Pfizer at 25k enrolled already (updated: they've gotten 30k and now plan to expand to 44k)
--Moderna at 21k already, but slowing down to hit demographic targets
--Efficacy clock starts 10 days after second dose

That's just the first 1.5 hours or so, skipping over the let's say standard liberal critiques of the GOP being an anti-science party and the damage that can do to our society.

also lol at the two of them that have "gamer" chairs instead of actual good office chairs

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3 minutes ago, StrangeSox said:

https://www.nytimes.com/2020/09/17/health/covid-moderna-vaccine.html?smid=tw-share

Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial

edit: I have no idea why this is nesting the quotes but they're all from the same article. Short story: Moderna will likely have initial efficacy results in late December. Don't expect everyone to be able to get a vaccine until late summer 2021 if everything goes well.

Yeah so January or something is still ahead of where it looked in March.

I think, realistically we should be rooting for Moderna to have a successful vaccine, right (even if not first)? mRNA seems like a huge breakthrough to finally work and scale vaccines faster in the future.

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2 minutes ago, bmags said:

Yeah so January or something is still ahead of where it looked in March.

I think, realistically we should be rooting for Moderna to have a successful vaccine, right (even if not first)? mRNA seems like a huge breakthrough to finally work and scale vaccines faster in the future.

There are a few new platforms. The TWiV episode I just posted goes into depth on them first with Dr. Griffin at the start and then with the conference call review starting 1 hour in. If I remember correctly, mRNA is the platform that's never been successfully deployed in humans but would be a big breakthrough for future rapid development. The problem with mRNA is that it's fragile and requires -70C storage temps for most of the distribution chain. Probably ok in most of the US, but it's more expensive, and it's a non-starter in poorer countries. The other platform that's worked for horse vaccinations (again, IIRC), but not for people yet was a simple DNA-based one. The huge upside to that is that it can survive at room temp for a year.

 

For SARS-Cov2-2/Covid-19, we should be hoping that multiple early leading candidates hit because the production capacity is going to be a huge, huge bottleneck.

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There are still people saying masks and social distancing are not necessary. I guess you can ask Herman Cain that after he attended the Trump rally with no mask. Oh, wait. You can't. He's dead. And White House staff have been exposed although the Administration doesn't want to talk about it. Apparently one exposed works in the White House cafeteria. That is really reassuring. Someone working around food has been exposed. Yep. Who needs a mask and social distancing?

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Baylor-Houston called off; Baylor offensive lineman group all have covid. Florida State coach has it. Sports are going on, but a game can be canceled at any moment. Looks like baseball and NBA have it all under control. Weird.

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17 hours ago, greg775 said:

Baylor-Houston called off; Baylor offensive lineman group all have covid. Florida State coach has it. Sports are going on, but a game can be canceled at any moment. Looks like baseball and NBA have it all under control. Weird.

It is weird. I never thought they would get the baseball season in. If all goes well, and they get the World Series in, that will be a huge accomplishment. People lament that there are no fans, but that had to help. We, as a society, just have to realize that we have to do the best we can, and also realize things will be far from perfect for a time. Do some simple things, and the situation will improve. Stay in denial and things will only linger and more people will die.

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