The state of the vaccines

Oh wow, you didn't seem to understand that my beef is with the 9,000 deaths claim (just, the news on it in this source I posted put it together with the other stuff about "a coup." I couldn't care less for the other stuff. Like I said, as a healthcare worker my focus is on health. And sure, shoot the messenger, the horrible New York Times! It doesn't make it any less true that Trump did endorse the 9,000 deaths idea. I used the Yahoo aggregator for expediency but the same claim by Trump that only 9,000 people have died of COVID-19 in America was reported by multiple news organizations.

 

Great that you want a vaccine.

Just one piece of unsolicited advice: beware of KN95s. That's the Chinese standard, and the number of counterfeit KN95s that do not even follow their own standard is said to be much larger by several folds, than the number of legitimate KN95s that do follow the standard. Also, KN95s have ear loops which are less efficacious for good seal than the straps that go on the back of your head which is the method used by all NIOSH N95s and all FFP2s (the European Union standard).

I'd stick with legitimate NIOSH N95s and legitimate FFP2s (surprisingly, both are commercially available to the general public if you are persistent enough in looking them up, starting from the CDC page on authorized makers and clicking on their links; many makers of legitimate N95s also make legitimate FFP2s).

 

There is another topic on where the 9000 death thing is from: http://www.politicalforum.com/index...alone-94-occurred-with-co-morbidities.577776/

It's like "Jack" LaLanne didn't do enough, and even fat people are subtracted because they didn't watch him... The information is from the CDC, the link is in that topic's source. You said, "So now Trump is saying that we had only 9,000 COVID-19 deaths because the others had underlying medical conditions or were old!!" It somewhat kind of true, with regard to Covid-19 only deaths.

I don't want to die, I have some of those underlying conditions.

 

They were the first to be available easily. Up to that point I was just wearing a full face motorcycle helmet, which has some advantages, if avoiding places with stagnant aerosols floating around like a ray of light though a window amazes a kid with the show.

 

People misinterpreted the CDC data willingly and knowingly (the ones who initiated this outcry; likely others are just naive and gobbled it all up) because the CDC never said that these people didn't die of COVID-19. They merely said that 94% of the death certificates listed co-morbidity.

Did you see my posts about how to write a death certificate and what it all means? Most death certificates in America list co-morbidity except in situations such as a young and healthy person who died of being shot in the head. Duh, most people who die, die in their older years of one of their diseases, but have other diseases too. That's why there is a Part I and a Part II in death certificates, where Part II is for co-morbidity and Part I is cause of death.

Practically all the 180,000+ COVID-19 deaths in the US were indeed caused by COVID-19 (helped by co-morbidity, duh) except for the rare cases where a physician may be poorly trained enough, or not that used to writing death certificates (certain specialties do it rarely) to screw up and write up one that is not very accurate.

If those fringe cases exist, plus the very rare fringe cases of someone trying to beef up some funding line (which is not excluded but is fraud and physicians are weary of committing this kind of fraud against Medicare and Medicaid because it's a federal felony and they can end up in prison and deprived of their license to practice). Regardless of fringe cases that are way outweighed by the undercounting that went on, especially in the beginning when we didn't have enough tests, it is extremely likely that rather than having fewer true cases of death by COVID-19, we're actually undercounting and probably have more than 200,000.

Trump endorsing this misleading claim that only 9,000 people died of COVID-19 is so incredibly irritating, so self-serving, and so irresponsible, that he is indeed losing my vote.

 

I understand that, but now that you *can* find NIOSH N95s and FFP2s, please toss your KN95s as soon as you get hold of some of the guaranteed ones.

I mean, some of the KN95s come with certificates... in Chinese. I have no way of looking up if the maker is legit. Given that it's been estimated that 90% of them that are coming to the US market are counterfeit, I wouldn't trust them at all.

Apparently the main method of counterfeiting is that they do not have an inner layer of blown melt, which makes them completely unable to filter out particulates of the size of a coronavirus. This is because blown melt is expensive so the fakers simply put together a mask that externally looks like a KN95 but doesn't have the blown melt, print a fake certificate in Chinese knowing that Americans won't be able to look it up, and ship it to the naive Americans, making a bigger profit because they don't have to spend money with the blown melt.

 

If he, and other Republicans, don't want your vote it's their problem. It will be ours later, considering the majority of us have many other issues than Trump's Twit mouth.

If one rides a motorcycle with conditions, if they go down without a helmet, one of those conditions may kill them, but if they had a helmet it might not. I would expect to see in the statistics of motorcycle deaths, those without helmets, whether they died of a preexisting brain aneurysm or not, and all they needed was the guy's head bouncing to pop the bubble.

 

There is a certain segment of very cold people that looks at the other underlying conditions as their fault, and basically dismiss the unfit as deserving a Darwin Award. In the end though 1/3 might skip the vaccines and get the award eventually for themselves.

 

Well, Duke University (one of our best universities, called "The Harvard of the South"), extremely reputable, just published a long study analyzing the response to COVID-19 and containment measures in... ALL US counties. They criticized the University of Washington model because that one only based their predictions on a few counties. They said it's almost like a randomized controlled trial (as a way of speaking; they perfectly know the difference) because we can see in real life the results of what some counties did and some others failed to do. It's the perfect "with and without helmet" of your analogy, and it leaves no doubts...

The conclusion is upsetting for those who decry the economic impact of containment measures, because ONLY the counties that implemented BOTH strict and enforced orders to stay home AND mask mandates achieved sustained decrease in infection rate and death toll. Even partial measures such as closing down businesses (gyms, restaurants, bars) did not work in the absence of enforced orders to stay home and mask mandates. The paper of course doesn't go into the economic impact and the political will (it is not authored by the faculty of their school of economics or their department of political sciences but rather by epidemiologists); they simply present the data of what worked and what didn't, and it is impressive.

Sorry, the link is in my computer at home and it came from a newsletter I receive, to which I have no access while at work like I am now. I promise that I'll come back with the link once I recover it later today when I go home.

I haven't been for mask mandates for ideological reasons (free country and all) but instead I've been for educational campaigns. Sadly we didn't have these either, in most of the country, except for some isolated initiatives. Also, prolonged lockdown orders come with an intolerable economic cost and also have dire consequences including despair and suicide, lost jobs increasing homelessness, hunger, and loss of health coverage which can also kill, so the issue is complex.

I understand that state, county, and city actions or lack thereof are not compatible with strictly crediting or blaming the federal government, but I also believe in leadership and coordination; so I do see ways to act better on this including from the federal government standpoint, with their attitude and executive actions.

Maybe some of my ideas on this are Monday Morning Quarterbacking, but I think not. To my defense, I've issued them in conversations with my wife (can't prove it here, though) in real time at the time, while there was still time to do something. I wasn't a member of this forum at the time given that I only joined on July 21st, so I can't show you anything that goes past that date, but believe me, I was already seeing at the time how we might fail, and we did fail. This ship has sailed. We don't have the political or economic disposition to go back to those measures. We missed the window of opportunity to do this right.

Maybe at some other point I'll detail what I think should have been done, but for now, I'll just say this: I blame the federal government (and for some things I praise them), and also the state governments regardless of party, and city and county officials, and we, the people. We've been really stupid about it, and it is disappointing, given that I also used to believe in American exceptionalism. We fell way short of our standards, and it is impressive that we're managing to do worse than many third world countries.

 

Well, what these people don't realize is that close to two-thirds of our population is made of unfit people, health-wise. If the cocky and mighty one-third who are young and healthy think that the country (and its economy) can survive the demise of the other two thirds, they are out of their minds. Also, some of the people who think they are fit, are not. Take hypertension for example. It is estimated that it hits 100 million Americans but only half of them know that they have it.

This kind of thinking is typical of arrogant millennials. They just don't know better. They are not considering the unintended consequences, including for their generation, of a large number of older people dying or getting permanent organ damage from this. They need to exist in a functioning economy to be able to achieve their goals in life, and they seem to have no clue about the HUGE economic impact - which may be a generation-long to recover from - if a large number of older Americans either die or survive this pandemic with severe and long-lasting sequelae.

 

I remember the call to close bathhouses, the screaming on that Downey show, and refusing to stop going when they were told they had GRID, on camera told they had it, and allowed to walk, and "no reported case" being science for so long doctors looked like total blithering idiots. It took weeks for the retards to finally admit a dentist could give it to a virgin. God forbid someone suggest a condom or less promiscuity of a lifestyle; getting married was the cure for a Biblical Plague, so even this Republican supports it. Telling people they can't do something, doesn't always work. They have to sucky dicky, no matter what. It's human nature...

And "stay at home," seriously, it's like saying beef, masks, toilet paper, the doctor's green crap clothes, vaccines, the stuff needed to make vaccines, cars, parts for the doctor to fix his own fracking car, and money to pay for all this crap grows on trees.

The added problem of not dealing with economics, is the places shut down (by the virus and by the terrorism of treasonous Democrats/BLM) didn't get all the stimulus, the "protesters" that ventilated store and car windows sure didn't deserve a single penny of it.

We need a vaccine, "Stay at Home" won't get it done; figuring out how to do an autopsy of a Covid-19 case, sure that was scary, but it is the same thing we need should something like this never end, the ability to work through it.

 

The paper considered "stay at home" to be efficacious, if enforced.

In my red county of my purple state, the governor, a Democrat, issued stay at home orders. He did not couple the orders with any sort of enforcement. People simply completely ignored the order. This way, it doesn't work.

Lockdowns - temporarily, not indefinitely of course - could have worked better if better and more homogeneously implemented and enforced, and could have had a smaller economic impact if paired with a very robust (much more than what was done) program of payroll protection with substantial grants to businesses that would be forgiven if they didn't fire anybody, but would be collected back as a loan if they did fire somebody (given the right of defense of showing good cause to fire someone, if the person were fired for reasons unrelated to the pandemic).

This ship has sailed, though. Too late to do it right. As of now, I do not support trying to go back to that. What was done (or not done) is done (or not done).

It should have been done as a bipartisan effort; not with one side trying to screw the other. We should have engaged in a nation-wide, non-partisan effort to defeat a common enemy, like we had in World War II.

Sure, we need a vaccine... but we could have managed this better, while we waited for one, to minimize the damage, both in lives and morbidity, and in economic terms.

 

DivineComedy, I tried to send you a Private Message but I think your account does not grant permission for others to contact you this way, apparently. I would like to give you some pointers on how to find an excellent and legitimate (non-counterfeit) N95 respirator, if you are interested. I do not post this kind of thing in the open because it could be seen as spam or I could be suspected of trying to advertise for these companies (although I have no vested interest whatsoever and no relationship with them) but if you are interested, I can let you know about a very reputable maker with all the proper CDC-NIOSH and FDA certificates (which I verified, and they are legitimate), that is selling to the regular public too (some only sell to healthcare professionals, hospitals, and clinics). This is a high quality N95 with an additional layer of protection with zinc and copper ions for virus inactivation. It is expensive, though. Anyway, if you are interested, start a private conversation with me and I'll let you know. If you aren't, then, never mind.

As promised, here is the Duke University paper (I do know some of the authors and they are very reliable; some from Duke, some from Spain, and a couple of other places including one from Johns Hopkins). It hasn't been peer-reviewed yet, though:

https://www.medrxiv.org/content/10.1101/2020.08.18.20177600v1

Here is an article about the paper, published by the Duke Global Health Institute:

https://globalhealth.duke.edu/news/study-only-most-aggressive-covid-19-responses-reduced-cases-deaths-us?utm_source=newsletter&utm_medium=email&utm_content=Closed for COVID sign&utm_campaign=dukedailySept1_20

Correction - my mistake, I read it all too fast this morning, late to go to work. It doesn't seem like they measured whether or not orders were enforced. Anyway, shelter-in-place, mask mandates, OR travel restrictions (not AND as I thought, but OR) were the interventions that work; no other did. In ALL counties that practiced those, there was reduction in death and infections.

 

Obviously "Stay at Home" works, if enforced, but the police can't even enforce the laws they have and are forbidden to do so in riots and vandalism repeatedly, even to the point of standing down the street and doing nothing when people are being dragged out of cars beaten to death. There is evidence "stay at home" helps, there is no evidence whatsoever you can force the BLM/Democrats to stay at home and not loot...

Most of the people who need to stay home, or die, are the ones with other conditions and the elderly.

We simply were unprepared for this kind of thing, not enough domestic manufacture... Not even mentioning masks. Like say a hood for a PAPR is like $200, many places of work could have similar hoods with the air supply filtered and supplied like air for power tools in manufacturing plants...eliminating the need for many $2000 portable units; work in more comfort than a hot mask. Plus airflow has a lot to do with inside vs outside, an attic fan...might suck the Covid cloud right out of a bar like the "Smoke Monster" from the show Lost. Finding a way to work is easy for some where it can be done at home, but others can lose everything, their businesses, and get foreclosed on...

If the government tells someone they can't work, the government must see to it they don't lose a penny. {period}

Now as to a vaccine, don't know if anyone has an answer, can catch it twice is scary enough, is this thing anywhere near likely to be like the flu, with us forever?

 

Yeah, I have all that turned off.

Smart people are out there working on stuff for sure.
https://www.fastcompany.com/9050270...gn-a-face-mask-that-can-rip-coronavirus-apart

It's just we need to manufacture our protection here, even if we have to subsidize it. Everyone needs good stuff, not just a few.

 

Agreed with pretty much all that you've said with some caveats. There's been enforcement in some places, with fines, and other countries have showed that it is possible. Yes, maybe mutations will derail the whole thing and the virus will be endemic and will be with us forever. Scary.

 

Agreed. Anyway I guess you don't need the advice, you seem resourceful enough to get to it yourself. I was just trying to help. And yes, the one I was about to recommend uses some of the principles that your source mentions.

 

Ok, back to vaccines. This piece of news greatly encourages me: the CDC is already getting ready to implement vaccine distribution as early as late October; if not, should be November or December:

https://www.yahoo.com/news/u-cdc-tells-states-prep-221140497.html

 

Its a No News.
All it means States and local Government should starting to plan how they manage distribution.
Same as the rules the Government put out who gets the vaccine first.
Nothing to show, just preparations, get a plan.

 

Yes, so?
It's nice to see the plans getting ready, including, if you bothered reading the link, getting the -70 degress and -20 degrees issue squared out.
Of course plans need to be drawn before it all starts, but it's nice to see that the CDC is telling states to get ready. And the link also talks about how well the stage 3 trials are going in terms of enrollment numbers.

Why exactly are you trying to downplay this? It's good news. The vaccines are coming... in certain countries even sooner. Brazil is already gearing up for the production and delivery of 45 million doses of the CoronaVac (Sinofarm/Instituto Butantan) in December. And that one has 97.4% of conversion rate.

I just hope the vaccines get well-distributed and well-accepted (which is an uphill battle) in time to dramatically decrease the contagion before the virus mutates too much.

 

It's so sad that because of all the false statements by the US government that if the vaccine is available Nov. 1st the thoughts that will do through people's heads are:

1. Thank God. I'm getting my shot today.
2. The timing of 2 days before the election is rather too coincidental.
3. Is it ready because they've suspended liability laws and testing rules to get it done faster?
4. Trump is in a high risk group, has he gotten his shot yet?

I'm in the 2, 3 and 4 slots. I have so little faith in the honesty of the administration that I would not in the least be surprised if large numbers of people will suffer nasty side effects and the admin will blame the manufacturer and the manufacturer will blame the admin for pushing ahead before they were ready and nobody will have any recourse. Also, it would cause Americans to shun other vaccines that are effective and safe and prolong the suffering.

 

That's precisely why I said I had mixed feelings about any emergency authorization.
Scientifically speaking an emergency authorization makes sense if there is a dangerous pandemic, people are dying, and preliminary data look extremely good; it would be unethical to linger and linger while people die; that's precisely what an emergency authorization is for - so that high risk people like the elderly and the infirm who are much more likely to die if they get the disease, can be protected.

The thinking is, let's say certain segments of the population have a 20% chance of dying from the disease (older people with say, three underlying medical conditions) and even a very BAD vaccine would kill not more than 1% of them (which is EXTREMELY bad as far as vaccines go). Still, for this population, that would mean that even a bad vaccine would still save the lives of 19% of these people, or 95% of those who would otherwise have died. So it's humanitarian to provisionally approve it for the high risk people while research continues.

With much better reason, emergency authorizations should be considered for vaccines that are actually looking very good.

Look at the Novavax vaccine: they released phase 1 results this week. ALL participants showed excellent seroconversion! All of them! And with 3 to 4 times more neutralizing antibodies than what people get from the natural infection! That's 100% efficacy. 83 people. ONE of them had a mild fever for one day and there were no other reactions!

So, phase 1 shows the Novavax product as 100% safe and 100% harmless. So, hold your horses, this is just phase 1. We'll see what happens in phase 2 with hundreds of people,and phase 3 with 30,000 people.

But let's suppose the Novavax product confirms this excellency in phase 2, and then halfway through phase 3, with 15,000 subjects, the Data and Safety Monitoring Board (which does get the preliminary results) finds that the Novavax product is still showing 100% seroconversion and 100% safety.

Well, the Board might then recommend an emergency approval for the vaccine to start protecting critical populations sooner rather than latter. This is all ethical and reasonable.

THE PROBLEM THOUGH LIKE YOU SAID IS:

- Can we trust this Administration to act solely with the science in mind and not politically?
- Is it worth doing anyway, under the penalty of undermining public trust in the vaccine?

I say, scientifically it makes sense but politically it doesn't, which is why I have mixed feelings.

 

As someone has already pointed out a lot of people have lost confidence in Trump after the Hydroxychloroquine debacle and are going to be reluctant to line up for this vaccine

 

Yes, I was debating with Chris today and he said "so what if Trump had this rhetoric, no consequences" but no, the freaking POTUS, when he speaks, there are consequences...
And the convalescent serum controversy is fanning the flames even more.
By the time it's a vaccine, even if it is an emergency authorization that makes all the scientific sense in the world, people will be weary of it.
Credibility matters.
Consistent leadership matters.

 

OK, folks, let's talk NOVAVAX. Extremely promising phase 1 results released this week (NEJM) and they've started phase two. So what is it?

It's a protein subunit vaccine (same platform as the HPV, varicella-zoster (shingles) and Ebola ones). Its full name:

FULL-LENGTH RECOMBINANT SARS COV-2 GLYCOPROTEIN NANOPARTICLE VACCINE ADJUVANTED WITH MATRIX M

a.k.a.: NVX-COV2373

Who is making it? A consortium.

NOVAVAX (primarily, aided by
EMERGENT BIOSOLUTIONS
PRAHA VACCINES
SERUM INSTITUTE OF INDIA
AGC BIOLOGICS
FUJIFILM DIOSYNTH BIOTECHNOLOGIES
SK BIOSCIENCE

Who is funding it?

The Coalition for Epidemic Preparedness (CEPI)
The US Department of Defense
The Bill and Melinda Gates Foundation

All right, phase 1. Impressive. Here are the numbers:

131 healthy adults (under 60) in Australia got the vaccine or placebo. 83 people got it with an adjuvant (it's an irritant that intends to recruit T-cells to flock to the site of the injection, to boost efficacy). 25 got it without the adjuvant. 23 got the placebo. A booster shot was given 21 days later. At day 35, no reactions except for one mild fever that lasted only one day. Two got headache, malaise, and fatigue for two days. Two people got fatigue, malaise, and tenderness. That's it.

After the second shot, one person had tenderness and eight had joint pain and fatigue.

ALL the people who got the active vaccine got neutralizing antibodies after the second dose, at levels more than 4 to 6 times greater than the average of people who recovered from the initial infection. (I mistakenly quoted 3 to 4, it's 4 to 6 - and I mistakenly said 83 people, no, all 25 that got the pure vaccine also seroconverted, so all 10.

The vaccine also generated effective T-cells in all 16 people who were randomly selected to look at their T-cells. The people who got the vaccine with the adjuvant got bigger responses than the ones who took the pure vaccine.

So, with 100% conversion to neutralizing antibodies and only ONE person out of 108 with a mild and short fever, all other reactions just pains and aches and malaise and fatigue, we may have another winner, actually converting MORE than the outstanding CoronaVac by Sinovac (97.4%).

Oh wow, are we going to have vaccines that are 100% efficacious or close?

I mean, maybe not... older populations seroconvert less. We'll see. But this phase 1 is HUGELY promising!

I'm feeling less certain about the mRNA approach... It looks like the two best vaccines so far (pending later phase confirmation, of course) are both vaccines that used traditional methods, the CoronaVac with inactivated virus, and the NVX-COV2373 with protein subunit.