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Jeff Kelly
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I'm an apathetic, hedonistic, utilitarian, nihilistic existentialist.


Reply #945 on: November 09, 2020, 11:08:18 AM

Fun fact: the company which made the vaccine - Biontech - was founded by two second generation Turkish immigrants.

They decided to work on a COVID vaccine in January when there were still no confirmed cases in Europe.
Trippy
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Reply #946 on: November 09, 2020, 01:50:28 PM

A few "cons" for this vaccine:

* It's one of the mRNA vaccines, like Moderna's version, which have never been approved for use in humans before -- i.e. it's unproven technology as a human vaccine

* It requires two doses, not one, separated by 21 days, to be effective

* It requires ultra-low temperature freezers (at -70C or below), which are rare, for longer-term storage, and needs to be used within a day or two of being thawed. Pfizer will be shipping the vaccine in special "suitcases" that can keep the vaccine at temperature for 10 days so the special freezers aren't an absolute requirement but it still makes handling the vaccine more complicated than some of the others.

In contrast, Johnson and Johnson's vaccine is a single dose, can be stored at -20C for long-term storage (~2 years), and at normal biological / vaccine storage temperatures (~5C) for up to 3 months. Basically J&J is going for the slower "ease of use and distribution will win the day" strategy while others are racing to be first to market.

https://www.rollcall.com/2020/10/13/deep-freezers-and-dry-ice-for-pfizer-vaccine-may-face-shortages/
https://www.fiercebiotech.com/biotech/j-j-starts-covid-19-vaccine-phase-3-eyes-early-2021-approval
Chimpy
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Reply #947 on: November 09, 2020, 01:54:23 PM

The J&J one is the one that I am hoping works because it is a more standard vaccine and, like you mentioned, it is the only vaccine in late stage trials right now that is a single dose and able to be distributed in developing countries.

'Reality' is the only word in the language that should always be used in quotes.
Jeff Kelly
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I'm an apathetic, hedonistic, utilitarian, nihilistic existentialist.


Reply #948 on: November 09, 2020, 03:41:49 PM

and that’s great. No need to turn everything into a two horse race.
Trippy
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Reply #949 on: November 09, 2020, 03:54:32 PM

There are a crap-ton of vaccines in development right now with 30 already in trials (9 in Phase 3) and another 30 still in development. There's going to be a bunch on the market initially before things settle down to just the handful of best ones.

https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
Khaldun
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Reply #950 on: November 09, 2020, 04:15:39 PM

Just to show you the pressures that are going to come to bear on this, we had students asking today if they could take it by January and be on campus without restrictions by the end of the month. People REALLY want to get back to normality. If the first vaccine that gets to market widely screws the pooch ultimately and either has terrible side effects or doesn't really work, it's going to be a catastrophe, but at the same time, waiting for the highest standard of clinical certainty is going to be a disaster too.
01101010
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Reply #951 on: November 09, 2020, 04:43:34 PM

There are a crap-ton of vaccines in development right now with 30 already in trials (9 in Phase 3) and another 30 still in development. There's going to be a bunch on the market initially before things settle down to just the handful of best ones.

https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker


This scares me the most - or at least has me concerned. I am convinced a lot of these companies are in it for the free development funds and might actually get a vaccine in testing that in no way ever would be cleared for it. Granted, those will be filtered out before it goes into human trials, but with so many running out there... inevitably one shitty one will get through.

Does any one know where the love of God goes...When the waves turn the minutes to hours? -G. Lightfoot
Cyrrex
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Reply #952 on: November 10, 2020, 03:05:09 AM

A few "cons" for this vaccine:

* It's one of the mRNA vaccines, like Moderna's version, which have never been approved for use in humans before -- i.e. it's unproven technology as a human vaccine

* It requires two doses, not one, separated by 21 days, to be effective

* It requires ultra-low temperature freezers (at -70C or below), which are rare, for longer-term storage, and needs to be used within a day or two of being thawed. Pfizer will be shipping the vaccine in special "suitcases" that can keep the vaccine at temperature for 10 days so the special freezers aren't an absolute requirement but it still makes handling the vaccine more complicated than some of the others.

In contrast, Johnson and Johnson's vaccine is a single dose, can be stored at -20C for long-term storage (~2 years), and at normal biological / vaccine storage temperatures (~5C) for up to 3 months. Basically J&J is going for the slower "ease of use and distribution will win the day" strategy while others are racing to be first to market.

https://www.rollcall.com/2020/10/13/deep-freezers-and-dry-ice-for-pfizer-vaccine-may-face-shortages/
https://www.fiercebiotech.com/biotech/j-j-starts-covid-19-vaccine-phase-3-eyes-early-2021-approval


Reading your points above, and I leap automatically to "ah....this is the vaccine for the super rich".  Doesn't sound like something that can be mobilized without a lot of resource behind it.

But fine, whatever, there are better solutions on the way.

"...maybe if you cleaned the piss out of the sunny d bottles under your desks and returned em, you could upgrade you vid cards, fucken lusers.." - Grunk
Jeff Kelly
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Reply #953 on: November 10, 2020, 05:19:47 AM

The proposed cost per treatment for the vaccine is $20 which is in line with other vaccinations.
Also dry ice exists is dirt cheap (waste byproduct of oxygen liquefaction) and has been used for decades to transport and store refrigerated items.
Draegan
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Reply #954 on: November 10, 2020, 05:51:21 AM

There are a crap-ton of vaccines in development right now with 30 already in trials (9 in Phase 3) and another 30 still in development. There's going to be a bunch on the market initially before things settle down to just the handful of best ones.

https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker


This scares me the most - or at least has me concerned. I am convinced a lot of these companies are in it for the free development funds and might actually get a vaccine in testing that in no way ever would be cleared for it. Granted, those will be filtered out before it goes into human trials, but with so many running out there... inevitably one shitty one will get through.

This is how conspiracy theories are born.
Jeff Kelly
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I'm an apathetic, hedonistic, utilitarian, nihilistic existentialist.


Reply #955 on: November 10, 2020, 06:18:34 AM

This is why we didn’t rush deployment of a vaccine candidates by skipping clinical trial steps. You know, what China and Russia did. while also forcing soldiers to be their Guinea pigs.
01101010
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Reply #956 on: November 10, 2020, 07:00:19 AM

There are a crap-ton of vaccines in development right now with 30 already in trials (9 in Phase 3) and another 30 still in development. There's going to be a bunch on the market initially before things settle down to just the handful of best ones.

https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker


This scares me the most - or at least has me concerned. I am convinced a lot of these companies are in it for the free development funds and might actually get a vaccine in testing that in no way ever would be cleared for it. Granted, those will be filtered out before it goes into human trials, but with so many running out there... inevitably one shitty one will get through.

This is how conspiracy theories are born.

Yeah, my worry is the fuel this can provide to the anti-vacc insanity. Cheetolini's handling of this is also to blame.

Does any one know where the love of God goes...When the waves turn the minutes to hours? -G. Lightfoot
Chimpy
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Reply #957 on: November 10, 2020, 07:30:34 AM

I think that the only company that really was in it for the 'grift' aspect was Moderna, because they are shady as fuck and the whole "warp speed" thing was being run by one of their board members (who resigned to run the thing).

'Reality' is the only word in the language that should always be used in quotes.
Jeff Kelly
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Reply #958 on: November 10, 2020, 09:05:05 AM

My last comment comes over very hostile and that wasn’t my intention. Sorry
Gimfain
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Reply #959 on: November 11, 2020, 12:52:13 PM

Given that they have done a lot of testing they would have spotted the most common negative effects so I'm not that worried about uncommon side effects, I'm not worried about costs, I'm only concerned about the effectiveness of the vaccine. When you have lots of people dying while simultaneously having a fucked up economy any cost-benefit and risk analysis will tell you that waiting years isn't an option.

If it gets approved its done by people that have knowledge and definitely are a hell of a lot smarter than I am.

When you ask for a miracle, you have to be prepared to believe in it or you'll miss it when it comes
Khaldun
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Reply #960 on: November 11, 2020, 03:28:21 PM

The effectiveness thing is huge. If we say "vaccinated people are hereby cleared to have anal sex in the middle of a huge crowd of people drinking in a badly ventilated interior space where half of them are over 75 and have high blood pressure" and it turns out the vaccine only provides about 50% of the vaccinated with real protection from infection, we're right back where we started only we wasted a lot of time and money and public goodwill.
01101010
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Reply #961 on: November 11, 2020, 03:30:41 PM

The effectiveness thing is huge. If we say "vaccinated people are hereby cleared to have anal sex in the middle of a huge crowd of people drinking in a badly ventilated interior space where half of them are over 75 and have high blood pressure" and it turns out the vaccine only provides about 50% of the vaccinated with real protection from infection, we're right back where we started only we wasted a lot of time and money and public goodwill.

whoa... that escalated pretty quick.

Does any one know where the love of God goes...When the waves turn the minutes to hours? -G. Lightfoot
HaemishM
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Reply #962 on: November 11, 2020, 03:49:31 PM

I see someone has filled out their "first thing I'm doing when we're free from Covid restrictions" list. why so serious?

Khaldun
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Reply #963 on: November 11, 2020, 05:18:56 PM

People with a mature fetish have no doubt been really suffering.
MahrinSkel
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Reply #964 on: November 11, 2020, 05:49:02 PM

"Mature" and "lemon party" are very different fetishes, I think.

--Dave

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Jeff Kelly
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Reply #965 on: November 12, 2020, 02:18:11 AM

The effectiveness thing is huge. If we say "vaccinated people are hereby cleared to have anal sex in the middle of a huge crowd of people drinking in a badly ventilated interior space where half of them are over 75 and have high blood pressure" and it turns out the vaccine only provides about 50% of the vaccinated with real protection from infection, we're right back where we started only we wasted a lot of time and money and public goodwill.


All of the current projections assume a 50% effectiveness of a vaccine, like you get with e.g. Indluenca vaccines. It’s usually enough to prevent full blown pandemic outbreaks at that point. Vaccines for less volatile diseases have usually a much higher effectiveness.

Also influenza vaccines for example make it so that the symptoms and progression of the disease is  less severe even in cases where an outbreak couldn’t be prevented entirely. Cases where a vaccine simply doesn’t work at all are extremely rare even with vaccines like influenza that depending on the current strain and vaccine mix is anywhere from 50-80% effective.

In addition the vaccination rate for influenza is low compared to other diseases like measles and it’s still effective in preventing large scale outbreaks
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Reply #966 on: November 12, 2020, 04:19:18 AM

I'm not sure influenza vaccines do stop outbreaks, my understanding was they primarily try to protect the most vulnerable from an inevitable outbreak.

The hard thing with a covid vaccine is that plans being talked about seem to imply that getting to the point of sufficient coverage to stop transmission will take years.

And protecting the espeicially vulnerable might still be achievable but covid still really sucks for everyone else who won't immediately get access to a jab.

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Mandella
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Reply #967 on: November 12, 2020, 07:14:28 PM

The effectiveness thing is huge. If we say "vaccinated people are hereby cleared to have anal sex in the middle of a huge crowd of people drinking in a badly ventilated interior space where half of them are over 75 and have high blood pressure" and it turns out the vaccine only provides about 50% of the vaccinated with real protection from infection, we're right back where we started only we wasted a lot of time and money and public goodwill.

whoa... that escalated pretty quick.

Pretty much the last few Ramones shows I saw. Maybe. I was drinking pretty heavy....
Trippy
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Reply #968 on: November 16, 2020, 11:43:15 AM

Moderna's interim trial results are in:

https://www.nih.gov/news-events/news-releases/promising-interim-results-clinical-trial-nih-moderna-covid-19-vaccine
Quote
The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers. The DSMB reported that the candidate was safe and well-tolerated and noted a vaccine efficacy rate of 94.5%. The findings are statistically significant, meaning they are likely not due to chance. 90 of the cases occurred in the placebo group and 5 occurred in the vaccinated group. There were 11 cases of severe COVID-19 out of the 95 total, all of which occurred in the placebo group.
94.5% efficacy is slightly higher than the BioNTech/Pfizer reported results of "above 90%". Moderna's version, despite also using mRNA, is also easier to store being able to last 30 days in a refrigerator while the BioNTech/Pfizer has to be used within 5 days once thawed.

Moderna's analysis was 95 cases from >30,000 participants while BioNTech/Pfizer was 94 cases from >38,000 participants (receiving both doses). Moderna's reported results includes the count of those infected after they were vaccinated of 5 while BioNTech/Pfizer has not yet so far released that data and is presumably higher than Moderna (probably around 9 people) which is why their reported efficacy is lower.

Edit: that 9 number above comes from this article:
https://www.nationalgeographic.com/science/2020/11/pfizer-biontech-interim-report-promising-but-lack-of-data-very-concerning/

Edit 2: More analysis from Derek Lowe:
https://blogs.sciencemag.org/pipeline/archives/2020/11/16/modernas-vaccine-efficacy-readout
« Last Edit: November 16, 2020, 11:56:34 AM by Trippy »
slog
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Reply #969 on: November 16, 2020, 12:10:26 PM

90%+ is greater than the 50% being tossed around earlier. I hope these become available soon.

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Trippy
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Reply #970 on: November 16, 2020, 12:34:01 PM

50% is the minimum for approval by the FDA, assuming it's safe. Fauci was hoping for at least 75%.

https://www.cnbc.com/2020/08/07/coronavirus-vaccine-dr-fauci-says-chances-of-it-being-highly-effective-is-not-great.html
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Reply #971 on: November 16, 2020, 12:45:58 PM

Sky
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Reply #972 on: November 16, 2020, 01:39:24 PM

I was posting it as more of a 'yeah but it'll still be a few months before we can get excited' thing...the schism in "presidential" posts was just an added chuckle. Sorry! (I'm avoiding the Politics sub for a while)
slog
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Reply #973 on: November 17, 2020, 05:35:05 AM

If we have vaccines that are 90% effective and we get 60% of the population to take the vaccine and we also assume 15% of the population has been infected, is that enough?

Doing napkin math, 90%*60% gets us to 54%.  Then 15%* (1-60%) = 6% (removing the people who had the virus and got the vaccine) gets us to 60% of the population have some form of immunity.  I have no idea if this is how the math actually works, but I've seen that 55% number tossed around as enough to get out of this mess.

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Reply #974 on: November 17, 2020, 06:36:56 AM

These "90% effective" numbers are not really indicative of immunity as what they deemed "effective" was not "makes person totally immune", it was whatever their trial protocol deemed the goal. And this efficacy information we have so far is all based on press releases that reference preliminary data that has not been peer reviewed.

In at least one of the vaccine trials it was "prevented mild symptoms".

There is also no indication yet of if these vaccines block transmission or just inhibit symptoms. Nor do we know how effective they are even a few months out.

I am not trying to say these vaccines are not important, but we need to be realistic that this is not just magically going away quickly.

'Reality' is the only word in the language that should always be used in quotes.
HaemishM
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Reply #975 on: November 17, 2020, 06:56:25 AM

Anyone that thinks we'll be even close to "take your masks off and fly free!" stage of normal before late summer to end of 2021 is being wildly delusional and optimistic, and that's IF the vaccines are as effective as claimed. Even if the vaccines worked with that exact efficacy rate on most of the population, having the ability to produce that much vaccine AND get enough people to take it is going to require a massive mobilization. I mean, luckily we'll have people who actually believe in work doing it, but the real trick is somehow convincing 70+ million that some certain someone is not using the vaccine to track their movements or harvest their stem cells to create an army of transStalin clones.

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Reply #976 on: November 17, 2020, 11:20:29 AM

If we have vaccines that are 90% effective and we get 60% of the population to take the vaccine and we also assume 15% of the population has been infected, is that enough?

Doing napkin math, 90%*60% gets us to 54%.  Then 15%* (1-60%) = 6% (removing the people who had the virus and got the vaccine) gets us to 60% of the population have some form of immunity.  I have no idea if this is how the math actually works, but I've seen that 55% number tossed around as enough to get out of this mess.
The basic formula for calculating herd immunity is 1 - 1/R0[1]. Estimating R0 however is extremely complicated[2]. WHO currently estimates it between 2.0 and 4.0[3]. The CDC current "best guess" is 2.5[4]. We'll go with 3.0 for this estimate so that puts the herd immunity threshold at 66.67% or 67% rounding up. Estimates of seroprevalence of SARS-CoV-2 in US currently varies wildly by region. We'll go with 9.0% here[5], and we're assuming immunity is long lasting.

So if we get a vaccine that's 90% "effective" where effective means those with the vaccine do not spread the virus to others then we would need:

(67% - 9%) / 90% = 64.4% of the population to get the vaccine for herd immunity to kick in

However the percentage needed to "get out of this mess" is potentially lower if we're willing to live with some restrictions. E.g. if "large" gatherings continue to be restricted for some period of time even after vaccines are widely available then COVID-19 may stop spreading at a lower vaccination level.

[1] https://en.wikipedia.org/wiki/Herd_immunity#Mechanics

[2] Examples of some of the models used in the UK to estimate R0: https://royalsociety.org/-/media/policy/projects/set-c/set-covid-19-R-estimates.pdf

[3] https://www.who.int/docs/default-source/coronaviruse/risk-comms-updates/update-28-covid-19-what-we-know-may-2020.pdf?sfvrsn=ed6e286c_2

[4] https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html

[5] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32009-2/fulltext
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Reply #977 on: November 18, 2020, 10:47:20 AM

Pfizer / BioNTech Phase 3 study completed. Efficacy now at 95% from the 170 COVID-19 cases studied (162 placebo, 8 vaccine) which is on-par with the Moderna vaccine, though the Moderna one currently has fewer cases studied (95). One person in the Pfizer / BioNTech vaccine group had a "severe" COVID-19 case while so far none that have been studied in the Moderna vaccine phase 3 trial have.

https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
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Reply #978 on: November 20, 2020, 12:07:52 PM

Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine
Quote
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE

(Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201120005370/en/

The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis was based on 170 confirmed cases of COVID-19. This submission also is supported by solicited safety data from a randomized subset of approximately 8,000 participants ≥18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. The submission also includes solicited safety data on approximately 100 children 12-15 years of age. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine.
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Reply #979 on: November 21, 2020, 01:09:42 AM

I am glad we are getting closer to a vaccine, and also glad I won't be one of the poor fuckers who get the first real doses. These things have been rushed so much that I fear there are a ton of undiscovered (or unreported) side effects. The really scary part is if there are major long term effects that no one will know about until everyone has it coursing through their veins. Between that and the virus, that might just do for humankind. Happy holidays!

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