On the Vaccine

[Latrinsorm]

In my first post (http://forum.gsplayers.com/showthread.php?125271-This-is-the-End) I talked briefly about vaccine schedules; to wit, "A vaccine will be released before the election. It will be brought to us by the same people who were wrong about travel bans and not masks preventing the spread of the virus, who were wrong about not needing FDA approval for testing kits for the virus, and who were wrong about hydroxychloroquine being a treatment for the virus."

After lots of "soons" dating back to June, the President recently put a specific date on when "we'll have" a vaccine: Election Day! (https://www.voanews.com/2020-usa-votes/trump-ties-covid-19-vaccine-timing-november-election) To this point he's still couching it in terms of hopes and optimism, but I thought that more specific timeline warranted a look at specific timelines from various places.

THE University of Oxford (with AstraZeneca) began phase III testing in late June and expects to know whether it's good or not by late (https://theconversation.com/covid-19-vaccine-trial-in-south-africa-everything-you-need-to-know-142305) November (https://www.nationalgeographic.com/science/2020/07/oxford-vaccine-enters-final-phase-of-covid-19-trials-in-brazil-cvd/), or in 2Q 2021 at the latest.

Moderna was the first U.S.A. of America effort to reach phase III in late July (https://thehill.com/homenews/coronavirus-report/509124-first-phase-3-test-of-coronavirus-vaccine-begins-in-us). Now, you might think American efforts could have an advantage because transmission is so much higher here than pretty much everywhere, so if the vaccine does work it can get to statistical significance over placebo quicker than if e.g. Germans were being tested, but the Brits are no dummies and are testing in places like Brazil so we probably don't have an actual advantage there.

Pfizer announced phase III within hours (https://thehill.com/policy/healthcare/public-global-health/509292-pfizer-launches-phase-3-trial-of-coronavirus-vaccine), but even before starting them had confidently (https://www.fiercepharma.com/pharma/after-positive-early-data-pfizer-biontech-ceos-sound-off-vaccine-timelines) declared they'd have proof by September(!!!) and approval by October. An important caveat here is their German partner firm BioNTech puts the proof point in December (https://www.wsj.com/articles/german-biotech-sees-its-coronavirus-vaccine-ready-for-approval-by-december-11594373400), and it is well known that no one who speaks German could be an evil man. It's also I think pretty compelling that their phase III to proof to timeline matches the Ox's exactly if it is in fact December.

.

As demonstrated with Pfizer, in every case proof isn't the end, everyone's cured and everything's great. After proof comes regulatory approval, manufacturing, and distribution. Everyone has already started mass manufacturing (100m+ or in the metric system a cor blimey tiddlywinks a-boffin) of doses so we'll have a big head start there, probably big enough to keep us at full distribution speed throughout. It looks very unlikely reality will match anything the President could have meant by "we'll have", but widespread distribution is certainly a 2021 timeline, and not January 1 2021 either.

Which brings us back to hydroxychloroquine, which the President is somehow still advocating as a cure (https://www.whitehouse.gov/briefings-statements/remarks-president-trump-meeting-u-s-tech-workers-signing-executive-order-hiring-american/), and whose initial justification for it all the way back in April (https://www.whitehouse.gov/briefings-statements/remarks-president-trump-vice-president-pence-members-coronavirus-task-force-press-briefing-20/) included "We don’t have time to go and say, 'Gee, let’s take a couple of years and test it out. And let’s go and test with the test tubes and the laboratories.' ... What do you have to lose?"

His timeline is Election Day. This was always obvious but now he's said it out loud.
His grasp of cost benefit analysis has been repeatedly demonstrated - anything that costs you and benefits him is fine regardless of the cost.
His advisors have been marginalized to the point that the only ones listening to Dr. Fauci et al aren't going to believe him in the first place.
It's possible we'll get a mass resignation of even loyalists when he releases an untested or even fraudulent vaccine early.
Fingers crossed, I guess ;D

[Gelston]

Ok thanks.

[Methais]

Yeah Latrin, thanks.

[RichardCranium]

Hurray capitalism.

[Suppa Hobbit Mage]

Gracias.

[Latrinsorm]

In the Financial Times (https://www.ft.com/content/f8ecf7b5-f8d2-4726-ba3f-233b8497b91a) FDA Commissioner Stephen Hahn said he would be willing to authorize a coronavirus vaccine for public use before phase III trials are complete.

He said he would do so if officials believe the benefits outweigh the risks.

Of course, the whole point of phase III trials is to establish specifically what the benefits and risks are. Per the FDA (https://www.fda.gov/patients/drug-development-process/step-3-clinical-research), "Phase 3 studies provide most of the safety data.", while Phase 2 studies "aren't large enough to show whether the drug will be beneficial."

It cannot be overstated how dangerous and ill-advised this is.

[Suppa Hobbit Mage]

Spasibo

[Methais]

Maybe I'm remembering something wrong, but I'm pretty sure I read in a few places earlier this year that we've never been able to create a working vaccine for any type of coronavirus.

Now suddenly it's possible to just whip one up after a few months with this one?

https://i.imgur.com/ZlUUWAf.gif

[Latrinsorm]

Maybe I'm remembering something wrong, but I'm pretty sure I read in a few places earlier this year that we've never been able to create a working vaccine for any type of coronavirus.

Now suddenly it's possible to just whip one up after a few months with this one?



What makes vaccines for previous coronaviruses tricky is we have to hurt less people than we help, usually a lot less (depending on the laws we're working under). Since for example common cold deaths are extremely rare and it's really easy to prevent the common cold in the first place with basic hygiene, the cost benefit ratio just isn't there. It's kind of like how the picornavirus that causes polio has had a vaccine for decades, but the picornavirus that causes a different version of the common cold nobody's really bothered with. The coronavirus family just hasn't really had its polio until now, so there haven't been any vaccines yet.

One prior exception of course is SARS-CoV-1, which did have enormous resources expended towards finding a vaccine, but thanks to President George W. Bush's well known knack for international cooperation we drove the virus into extinction the old fashioned way, so with literally nobody in the entire world to test a vaccine on pretty much everyone gave up about a year into it. One advantage of our much, much, much worse scenario with SARS-CoV-2 is that since we know for a fact we're going to need billions of doses of the vaccine, they're already being manufactured approaching that scale for many different versions of the vaccine - that alone cuts six months off our timeline. Throw in an open tap of $$$ and the timeline we've seen of January 2021 is pretty reasonable... but some steps just can't be accelerated, and phase III trials are one of those. We've gotta go out and stick people, we've gotta follow them around for months to see what happens, and if that means the vaccine isn't available before a random day in November, those are just the breaks.

Overall we'd obviously still rather Bush have been in charge and saved 150,000+ American lives, but a responsibly accelerated vaccine program isn't the worst outcome. Someday we'll be able to have a beer with that guy again!

[Neveragain]

Overall we'd obviously still rather Bush have been in charge.

No, no we wouldn't.

[Suppa Hobbit Mage]

No, no we wouldn't.

Over Trump? I think you would take Bush before Trump.

[Neveragain]

Over Trump? I think you would take Bush before Trump.

https://media3.giphy.com/media/3o7btT1T9qpQZWhNlK/giphy-downsized.gif

[Suppa Hobbit Mage]

Too funny, I would have never guessed.

[Neveragain]

Too funny, I would have never guessed.

After how that administration handled 9/11, no fucking way.

I don't think anyone could have contained covid-19.

[Suppa Hobbit Mage]

Bra, Shillary would tell you, 1000x, how she would have done better. All while explaining how she won the popular vote. THE FIX WAS IN BRA.

[Suppa Hobbit Mage]

After how that administration handled 9/11, no fucking way.

I don't think anyone could have contained covid-19.

And for the record, kidding aside. I was living just outside of DC during 9/11. I literally heard the Pentagon get hit. What would you have had Bush do differently?

Armchair quarterbacking is really easy, IMO. I thought he did OK, considering intel at the time.

[Neveragain]

And for the record, kidding aside. I was living just outside of DC during 9/11. I literally heard the Pentagon get hit. What would you have had Bush do differently?

Armchair quarterbacking is really easy, IMO. I thought he did OK, considering intel at the time.

I'm specifically referring to Iraq and the misleading information that got us there. Bush Sr. literally hand picked Saddam Hussein when he was director of the CIA. I find it extremely difficult to believe that we didn't have a good measure of Iraq's capabilities.

I like neither the Bushes or Clintons, we've been under their "leadership" since the 80's. It's been one disaster after another.

[Taernath]

And for the record, kidding aside. I was living just outside of DC during 9/11. I literally heard the Pentagon get hit.

Yes, but did you evacuate a building?


Armchair quarterbacking is really easy, IMO. I thought he did OK, considering intel at the time.

Intel was the problem. Rumsfeld, Bolton, and others pushed super hard for Iraq to be invaded. They exaggerated and fabricated reports of WMDs while hiding reports to the contrary, and the American public by and large fell for it. I did.

Whether or not I'd prefer another Bush... dunno.

[Suppa Hobbit Mage]

Yes, but did you evacuate a building?.

im not sure what this means. I, along with most of DC, evacuated. Like, someone came over the PA in our building and said go home, someone attacked the pentagon. Is that the same as a building being on fire? No.

[Taernath]

im not sure what this means. I, along with most of DC, evacuated. Like, someone came over the PA in our building and said go home, someone attacked the pentagon. Is that the same as a building being on fire? No.

Sorry, it was a joke. I guess you weren't here for it. Disregard.

[Tgo01]

im not sure what this means.

A certain member of our community tried to claim they had expertise in foreign relations or terrorism or some bullshit like that because they evacuated a building on 9/11.

This person didn't specify if by "evacuated" they meant they simply left the building, or if they were in charge of making sure everyone evacuated the building, but it sure sounded like the person was claiming the latter.

The clues as to who this mystery person is are all there.

[Latrinsorm]

After how that administration handled 9/11, no fucking way.

I don't think anyone could have contained covid-19.

This is remarkable for two reasons.

Surely how President Bush handled a pandemic of a novel and extraordinarily lethal coronavirus is more relevant to how he would handle this pandemic of a novel and extraordinarily lethal coronavirus, no?

And even if we focus on 9/11, that President rallied not only the whole country but the whole world in taking decisive and overwhelming action against the perpetrator - in the war in Afghanistan we were on the same side as Russia(!) and Iran(!!!), meanwhile this President can't manage to be on the same side as a Texas Senator and Arkansas Governor.

I'm not telling you you have to like what we did with Iraq, but that point in our timeline isn't until September 2021, and in this analogy it would be like the President going full tilt to discover an Ebola vaccine (i.e. a deadly disease that wasn't posing much threat to Americans), which... doesn't really seem that bad?

[Neveragain]

This is remarkable for two reasons.

Surely how President Bush handled a pandemic of a novel and extraordinarily lethal coronavirus is more relevant to how he would handle this pandemic of a novel and extraordinarily lethal coronavirus, no?

And even if we focus on 9/11, that President rallied not only the whole country but the whole world in taking decisive and overwhelming action against the perpetrator - in the war in Afghanistan we were on the same side as Russia(!) and Iran(!!!), meanwhile this President can't manage to be on the same side as a Texas Senator and Arkansas Governor.

I'm not telling you you have to like what we did with Iraq, but that point in our timeline isn't until September 2021, and in this analogy it would be like the President going full tilt to discover an Ebola vaccine (i.e. a deadly disease that wasn't posing much threat to Americans), which... doesn't really seem that bad?

You used far too many "but's" in this reply. Your response has been filed under G.

[Latrinsorm]

You used far too many "but's" in this reply. Your response has been filed under G.

...two?

[Neveragain]

...two?

1 is too many.

You're basically saying "Bush's administration used misinformation to mislead the people and get us into a needless war but that's OK because a virus didn't spread."

This may work for you but try telling that to the families that needlessly lost family members to an illegal war. It doesn't go over so well.

Now you should tell us all, with your vast experience in child rearing, how to run our families.

[Latrinsorm]

1 is too many.

You're basically saying "Bush's administration used misinformation to mislead the people and get us into a needless war but that's OK because a virus didn't spread."

This may work for you but try telling that to the families that needlessly lost family members to an illegal war. It doesn't go over so well.

Now you should tell us all, with your vast experience in child rearing, how to run our families.

I'm explicitly saying Bush's administration was spectacularly successful dealing with a coronavirus pandemic, so I wish they were dealing with this coronavirus pandemic.

I'm also explicitly saying that a 9/11 comparison is not relevant, and if you insist on bringing it up as an analogy it works against you. Case in point: a needless death comparison between the Iraq War and the war on COVID-19 is going to dramatically favor the handling of the Iraq War. President Bush united the country and the world, acted rapidly and decisively, and then a year and a half later mistakes were made. President Trump never got above 50% domestic approval and has been dithering for six months for Pete's sake, he's not fit to stoop and unlace Bush's cowboy boots.

I don't know what I said On the Children to strike such a nerve with you, because I never once told anyone how to run their families. Clearly you're too emotional to think clearly about it, so I sincerely hope you can cool down at some point and let the facts in, mostly on that topic (because it doesn't really matter how much better a President George W. Bush was) (he was SO MUCH better though).

[Neveragain]

I'm explicitly saying I'm willing to ignore that the Bush administration destabilized one of, if not, the most unstable regions of the world by lying about weapons of mass destruction. I'm OK that we are still letting our children die in the longest military action in US history. Life has been grand since 9/11 because I have no skin in the game.

https://media0.giphy.com/media/l2JhqT3ESCM8hLOaQ/giphy.gif

[Methais]

im not sure what this means. I, along with most of DC, evacuated. Like, someone came over the PA in our building and said go home, someone attacked the pentagon. Is that the same as a building being on fire? No.

time4fun is an expert on 9/11 because she supposedly evacuated a building.

Nobody actually believes her, because she’s a pathological liar, but yeah.

[Methais]

Now you should tell us all, with your vast experience in child rearing, how to run our families.

I would suggest that people teach their children how to buy ham and bologna from the grocery store before they’re in their 30s as a good starter.

[Latrinsorm]

I would suggest that people teach their children how to buy ham and bologna from the grocery store before they’re in their 30s as a good starter.

waste of time, if jabiden's gonna ban hamburgers he's gonna ban ham sure as malarkey

[Tgo01]

I'm explicitly saying Bush's administration was spectacularly successful dealing with a coronavirus pandemic, so I wish they were dealing with this coronavirus pandemic.

That's largely because China reported the outbreak early. With SARS-CoV-2 they waited months before telling the world, even going so far as to arrest doctors and journalists who tried to warn the world. Not to mention even after they finally told the world about the outbreak they at first tried to downplay the severity of it by claiming human-to-human transmission was unlikely.

China wanted to act like they were part of the big boy's club and could contain an outbreak all on their own without having to notify other countries. But Democrats sure did a good job of running cover for them in this regards.

[Latrinsorm]

That's largely because China reported the outbreak early. With SARS-CoV-2 they waited months before telling the world, even going so far as to arrest doctors and journalists who tried to warn the world. Not to mention even after they finally told the world about the outbreak they at first tried to downplay the severity of it by claiming human-to-human transmission was unlikely.

China wanted to act like they were part of the big boy's club and could contain an outbreak all on their own without having to notify other countries. But Democrats sure did a good job of running cover for them in this regards.

woof

the first case of SARS-CoV-1 was identified November 2002, the WHO was notified February 2003
the first case of SARS-CoV-2 was identified November 2019, not only was the WHO notified January 2020 but China published the entire genetic sequence in that month
January is the month that comes before February

or, and stay with me here, a two term governor turns out to be more competent at governing than a trust fund baby who never worked a day in his life

it's a radical theory, but i think it just might be right!

[Tgo01]

the first case of SARS-CoV-1 was identified November 2002, the WHO was notified February 2003
the first case of SARS-CoV-2 was identified November 2019, not only was the WHO notified January 2020 but China published the entire genetic sequence in that month

The first case of atypical pneumonia was reported November 16th, 2002. It's misleading to say the first case of SARS was "identified" in November because they didn't yet know what was going on. China notified WHO on February 10th. You're comparing a few cases of SARS to an already out of control outbreak of SARS-CoV-2 and saying China was faster to warn the world about SARS2 compared to SARS.

Yes China dragged their feet reporting SARS as well but they warned the world well before the virus was widespread in their country.

[Suppa Hobbit Mage]

Neither know that shit and googled it. Fucking be real.

[Tgo01]

Neither know that shit and googled it. Fucking be real.

Of course I Googled the dates, I don't have the dates of first infected patients memorized. I'm not Rain Man!

[Latrinsorm]

The first case of atypical pneumonia was reported November 16th, 2002. It's misleading to say the first case of SARS was "identified" in November because they didn't yet know what was going on. China notified WHO on February 10th. You're comparing a few cases of SARS to an already out of control outbreak of SARS-CoV-2 and saying China was faster to warn the world about SARS2 compared to SARS.

Yes China dragged their feet reporting SARS as well but they warned the world well before the virus was widespread in their country.

There were 100 SARS-CoV-2 total cases in China in 2019. Not confirmed in 2019, cases that happened in 2019. The WHO was notified before China even knew what COVID-19 was, because they saw 7 cases of unusual pneumonia.

https://imgur.com/MHhvy9Q.png
source: https://medium.com/@tomaspueyo/coronavirus-act-today-or-people-will-die-f4d3d9cd99ca

By comparison, there were 305 confirmed SARS-CoV-1 cases in China by the time they reported it to the WHO.
https://www.who.int/csr/don/2003_03_21/en/

.

And if you really think 100 cases a month is an "out of control outbreak", I'd love to see the panic porn fear mongering you'd use to describe 30,000 cases a day.

[SteelCross]

If you haven't seen the Movie Vaxxed or it's Sequel, Vaxxed 2, then if it's the very last thing that you do before making your final decision then it will have been enough.

Trust me you won't regret taking the time to watch either one.

[Wrathbringer]

There were 100 SARS-CoV-2 total cases in China in 2019. Not confirmed in 2019, cases that happened in 2019. The WHO was notified before China even knew what COVID-19 was, because they saw 7 cases of unusual pneumonia.

https://imgur.com/MHhvy9Q.png
source: https://medium.com/@tomaspueyo/coronavirus-act-today-or-people-will-die-f4d3d9cd99ca

By comparison, there were 305 confirmed SARS-CoV-1 cases in China by the time they reported it to the WHO.
https://www.who.int/csr/don/2003_03_21/en/

.

And if you really think 100 cases a month is an "out of control outbreak", I'd love to see the panic porn fear mongering you'd use to describe 30,000 cases a day.

I like turtles.

[Latrinsorm]

As mentioned previously, we've got the manufacturing the vaccine part pretty much set already, because we started giving those companies billions of dollars to make doses of vaccines we wouldn't find out were any good for six months. This is a smart thing to do! Six more months of pandemic at a five hundred deaths a day (a wildly optimistic death rate) means this cost provides the benefit of saving 90,000 lives. It's an incredible return on investment at 1000x the price.

The act of distributing can only go so quickly because we have to physically put the doses on trucks, physically drive them around, set up physical locations where the vaccine is stored locally, set up (possibly different) physical locations people can physically go to be vaccinated, have people physically stick needles in other people, physically keep track of who's gotten doses yet and how many and when. Trucks can only be loaded so quickly, they can only drive so fast, sticking a needle in someone really isn't something we want to rush.

But we can plan all that stuff out at least, and we are! Unfortunately it's not going extremely well. (https://www.mcclatchydc.com/news/coronavirus/article245406245.html) The biggest red flag is the CDC has told state governors and delivery firms to be ready to go by November 1st. Nobody knows exactly when vaccines will finish their phase III trials, but nobody thinks they can do so by then, which is why we keep getting 'we can approve it if it's safe even if the trials aren't finished' doublespeak. November 1st is a Sunday 66 days after the CDC communication was sent.

It also happens to be two days before Election Day.

For their part, these state governments and companies have raised what seem like pretty reasonable questions of the CDC, namely:
-how many doses of the vaccine are individual states going to get? if the U.S. has 10,000,000 November 1st, how many go to Peoria? how many to Manhattan?
-how is the CDC setting the priority of vaccinations? who goes first? who goes last? do states make it up for themselves?
-how do we nationally keep track so as to prevent people from getting doses in different states, or overwhelming more lenient states? if we don't, how can we reasonably predict how many doses an individual state gets?
-how strict will the storage conditions of the vaccine be, both for shipping and storage? does it have to be kept at -20°C? -80°C? for how long?
-how are we paying for that shipping? storage? health care workers to do the injections?
As of yet, there are no answers.

.

As Steelcross illustrates, a significant portion of the population aren't getting vaccinated no matter what. Another significant portion literally can't get vaccinated for various health reasons. It is imperative that absolutely everyone else gets the vaccine when it becomes available so we can keep everyone safer, which is why it is so irresponsible and just plain stupid to be playing these games with the release. If you were trying to undermine public trust in the vaccine you could hardly do a better job of it.

[Latrinsorm]

A quick update on Pfizer, who as previously mentioned on July 27th claimed they would have proof for their vaccine by September (i.e. the month we're in now). At the time this was eyebrow raising considering Oxford/AstraZeneca started a month earlier and put their closing timeline two months later, and the Pfizer CEO today walked their proof date back to the end of October (https://www.foxbusiness.com/healthcare/pfizer-biontech-look-to-expand-late-stage-covid-19-vaccine-trial). This is still a much shorter timeline than anyone else, but it doesn't appear the CEO considers himself bound by his previous comments, i.e. required to release a vaccine in September regardless of the state of clinical trials.

So we've got that going for us!

[Keller]

That is good news. Thanks for sharing Latrin.

[Latrinsorm]

An update on distribution: the CDC's guide for states has been released! (https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf) Section 1 includes this gem:

It is not yet known which vaccines will be available, in what volumes, at what time, with what efficacy, and with what storage and handling requirements."
And we're off! Let's evaluate the five questions from before:

-how many doses of the vaccine are individual states going to get? if the U.S. has 10,000,000 November 1st, how many go to Peoria? how many to Manhattan?

The federal government will determine the amount of COVID-19 vaccine designated for each jurisdiction. The amount allotted will change over time.
That clears it right up, thanks very much.

.

-how is the CDC setting the priority of vaccinations? who goes first? who goes last? do states make it up for themselves?

The CDC says "critical populations may include but are not limited to" which means states make it up for themselves. They do give suggestions but they're useless since they include everyone from essential workers to underlying medical conditions to age 65 or older to racial/ethnic minorities to the underinsured to no joke "people living and working in other congregate settings" and this is far from a complete list: by the time a state adds up all these "critical populations" there will barely be any non critical, and they immediately follow this list by acknowledging how limited the supply will be at first with the following illustration...

Jurisdictional considerations for Phase 1 subset groups may include, for example: Phase 1-A: Paid and unpaid people serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials and are unable to work from home. ... There may be insufficient COVID-19 vaccine supply initially to vaccinate all those who fall into the Phase 1-A subset, so jurisdictions should plan for additional subsets within that group.Which ones? Who knows! Yikes!

.

-how do we nationally keep track so as to prevent people from getting doses in different states, or overwhelming more lenient states? if we don't, how can we reasonably predict how many doses an individual state gets?

This one we're doing pretty well with! Vaccine providers are required to enter every dose of vaccine in the CDC's Immunization Information Systems (https://www.cdc.gov/vaccines/programs/iis/index.html), which requires name, address, and date of birth. Obviously people could lie and providers could fail to enter the information either by choice or by dint of by being overwhelmed by the clerical work, but at least we've got a solid and pre-existing system in place to address the issue.

.

-how strict will the storage conditions of the vaccine be, both for shipping and storage? does it have to be kept at -20°C? -80°C? for how long?

early in the response, some ultra-cold (-60°C to -80°C) vaccine (if authorized for use or approved) may be shipped directly from the manufacturer in larger quantities. CDC will share more information on these shipments as it becomes available.i.e. we don't know. Obviously! We won't know until a vaccine is approved, but the CDC is now saying states have a month to plan out a way to store and distribute these vaccines without knowing anything about them! Lots of luck!

.


-how are we paying for that shipping? storage? health care workers to do the injections?

Vaccines and "ancillary supplies" (i.e. needles) will be procured and distributed by the federal government. That's good! Gloves and other personal protective equipment will NOT be provided, and the CDC "does not pay for or reimburse jurisdictions or any other entities for any redistribution beyond the initial designated primary CDC ship-to location, or for any vaccine-specific portable refrigerators and/or qualified containers and pack-outs." Somewhat less good! Also of note is that the minimum order of a vaccine is 100 doses. In New York City, sure, no problem. How many places in Wyoming can get 100 people in in short order? What if they have 110 people?

For storage, "Jurisdictions are not [sic] advised to purchase ultra-cold storage equipment at this time. Ultra-cold vaccine may be shipped from the manufacturer in coolers that are packed with dry ice. These coolers should be repacked with dry ice within 24 hours of receipt of shipment and repacked again within 5 days." Call me crazy but the mental image of a bunch of med students stuffing dry ice around a life saving vaccine does not fill me with confidence.

For all the other stuff, "CDC will share more information about reimbursement claims for administration fees as it becomes available."

.

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On that note, there are two dozen "will share when available" "will be communicated if available" "will likely be made available" kind of comments sprinkled through the document. Which as I've said before is completely fair! No one knows what exactly the vaccine will look like... and yet the CDC says people "should submit their plans to their CDC project officer by October 16, 2020."

How?

We can (and should!) take significant steps towards planning at this point, because a vaccine of some kind is coming and we will need to distribute it. This artificial timeline that nobody has offered any scientific justification for is making things way harder for no reason... and that's the BEST case scenario! The worst case is that states fail to clear the impossibly high bar, the CDC refuses to fund any of them, a vaccine is approved in late November and nobody can receive it.

[Suppa Hobbit Mage]

Despacito

[Latrinsorm]

More developments in vaccine approval:

Secretary of HHS Azar issued a memo (https://www.nytimes.com/2020/09/19/health/azar-hhs-fda.html) addressed to the heads of "operating and staff divisions" (operating divisions include but are not limited to the CDC and FDA) saying in part "The authority to sign and issue any rule is reserved for the Secretary. Any prior delegation of rulemaking authority, including the authority to sign or issue a rule or a proposed rule, is rescinded."

Days later the FDA (https://www.washingtonpost.com/health/2020/09/22/fda-covid-vaccine-approval-standard/) said it was making the requirements for a vaccine to be authorized stricter.

Then the President (https://www.cnn.com/2020/09/23/politics/trump-fda-coronavirus-vaccine/index.html) said the White House had to approve those requirements, and White House chief of staff Mark Meadows later required the FDA to provide "detailed justification".

We've already seen HHS post guidance on the CDC website the CDC did not approve (and wasn't even aware of until it showed up). The HHS later said essentially that the Azar memo was no big deal, it was all cool, quit overreacting nerd, nothing changed about vaccine approval.

Time, as always, will tell!

[Latrinsorm]

Here we go again. (https://twitter.com/realDonaldTrump/status/1313647605134614529?s=20)

At this point it doesn't even make sense as a political maneuver, as less than 20% (https://www.axios.com/axios-ipsos-poll-trump-coronavirus-vaccine-06428246-c633-41ba-9081-1f789a90e976.html) of Americans would take an unapproved vaccine on the President's say-so. It is incredibly hard to get 80%+ approval from Americans on anything, but what probably helps is that even the vaccine manufacturers (https://www.pfizer.com/health/coronavirus/pledge) are openly breaking with the President.

Big Pharma got Big because it knows how to make a buck, and everyone in the country taking an unproven product is an unbelievably long tailed downside risk.

The FDA won't grant approval.
The manufacturers won't even seek approval.
And the President will try to release a vaccine anyway.

And it might even be a good one! That's among the most horrifying parts of this (and it's really, really, really hard to pick a no. 1). If he would just wait a month, two at the most, he could save thousands of lives.

But he won't.

[Latrinsorm]

Pfizer announced phase III within hours (https://thehill.com/policy/healthcare/public-global-health/509292-pfizer-launches-phase-3-trial-of-coronavirus-vaccine), but even before starting them had confidently (https://www.fiercepharma.com/pharma/after-positive-early-data-pfizer-biontech-ceos-sound-off-vaccine-timelines) declared they'd have proof by September(!!!) and approval by October. An important caveat here is their German partner firm BioNTech puts the proof point in December (https://www.wsj.com/articles/german-biotech-sees-its-coronavirus-vaccine-ready-for-approval-by-december-11594373400), and it is well known that no one who speaks German could be an evil man. It's also I think pretty compelling that their phase III to proof to timeline matches the Ox's exactly if it is in fact December.

A quick update on Pfizer, who as previously mentioned on July 27th claimed they would have proof for their vaccine by September (i.e. the month we're in now). At the time this was eyebrow raising considering Oxford/AstraZeneca started a month earlier and put their closing timeline two months later, and the Pfizer CEO today walked their proof date back to the end of October (https://www.foxbusiness.com/healthcare/pfizer-biontech-look-to-expand-late-stage-covid-19-vaccine-trial). This is still a much shorter timeline than anyone else, but it doesn't appear the CEO considers himself bound by his previous comments, i.e. required to release a vaccine in September regardless of the state of clinical trials.

Today the Pfizer CEO released an open letter (https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert _bourla?linkId=102134275) which while not substantially altering the efficacy proof date (still late October) made explicit that the safety proof date is mid November.

With Moderna and AstraZeneca not having moved up their timeline (and indeed perhaps having even moved it back slightly due to brief pauses), this conclusively ensures there will be no proven safe vaccine by Election Day.

[Suppa Hobbit Mage]

medlenno

[Parkbandit]

Diazepam

[RichardCranium]

Hasenpfeffer Incorporated

[Methais]

Latrinzoft

[Latrinsorm]

Latrinzoft

i'm hard as h-word, sometimes i even let a door on hydraulics shut without holding it to prevent the mildly elevated noise

shows what your know!!!!!

[Methais]

i'm hard as h-word, sometimes i even let a door on hydraulics shut without holding it to prevent the mildly elevated noise

shows what your know!!!!!

I said zoft, not soft, as in Zoloft!

PS: Reported for showing what my know.