How Pfizer delivered a Covid vaccine in record time
wsj.com
wsj.com
> Rival Moderna, which took funding from a division of the U.S. Department of Health and Human Services, suffered a three-week delay in completing its own mRNA trial after federal officials there asked the company to slow down enrollment to boost the racial and ethnic diversity of study subjects.
All this to say nothing of how the medical establishment generally under serves minorities. There's quite a bit of writing on why it might be so hard for these major pharma corps to find volunteers from these communities.
These things are all so well known, it isn't even worth the effort to track down citations for them, and you still trust them?
https://www.quora.com/We-all-know-the-evil-that-Hitler-did-W...
Edit: Well, since people are obviously not even reading the link, I'm going to quote the bullet points from the first answer in nearly their entirety:
> Nazi regime was the first to introduce animal rights and limited hunting seasons. Hitler had outlawed animal testing (who needs animals when you got thousands of Untermenschen).
> Nazis had the first public anti smoking campaign at a time when smoking was not linked to cancer.
> Hitler had authorized extensive research on cancer and various venereal diseases and abundance of medicine for public.
> Nazi labour laws were best in contemporary world. Reduced work hours, periodic breaks, paid holidays and sponsored trips to Italy as perks.
> Promoted sports culture among youth which led to Germany being a sports power house.
> Hosted the 1936 Berlin Olympics.
> Hitler had announced loans of 1000 Reichsmark (10 month salary in 1939) for married couples at minimal interest and waivers for birth of first child.
> Volkswagen - people's car. Personalized Cars for average germans was laid out in 1937. Volkswagen is an extremely popular brand now.
> German Autobahn(super highways) was introduced in Hitler's era.
> Hitler had forbade German army from using mustard gas or any sort of chemical weapons on enemy forces because of the trauma he suffered in WW1 from mustard gas. As a result, deadly gas warfare of WW 1 was never seen in WW 2.
> Nazis were pioneers in rocket science. America's space programs were guided and led by former Nazi scientists like Werner von Braun and Arthur Rudolph.
They got sponsored trips to a lot of places in Europe: Poland, France, Russia...probably best to avoid that last one though.
Are you saying corporate structure in the law causes these actions?
The things I mentioned previously did not involve any lapse of judgement at all. Saying that is just being an apologist. I'm not saying you're suggesting lapses of judgement are responsible for these things, merely that actually suggesting so would make one an apologist. They are all done with eyes open, focusing on the dollar signs at the end of the road, public interest be damned.
I'm simply stating that they are negative actions by some. If that didn't come across, here it is.
You say "if I were a black man", as if you have any idea of what it means to be a black man in America
[1] https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=RP
why not run the trial in the country where the vaccine is going to be sold?
/s
Most trials were run in countries where a large number of new cases were expected over the trial period. Government measures in almost all first world countries brought the R rate right down, which is disastrous for a trial looking for results.
You can compare that with the demographic table of the US. Looks like they don't quite align, but are presumably within the guidelines. FWIW, all the comments I saw from people more familiar with medical data were pretty positive about the demographic spread.
https://en.wikipedia.org/wiki/Race_and_ethnicity_in_the_Unit...
I’m not saying anything for or against this, but I bet it was in the first phase where the concerns for equity were brought up.
Edit: the difficulty becomes the argument between recruiting equitably vs recruiting quickly, both are going to have downsides. Ideally you would do both at once, the question becomes why is this so hard in the US, and there are lots of reasons.
A lot of studies also recruit people who have a connection to the study (maybe friends/family members, students at the local university, etc...). If there is less diversity in the company and people running the study, I think this would also lead to less diversity in the participants. Again, I have no knowledge of how this one was done.
It's not hard to imagine a patient noping out of an experiment if he's the token black guy in a room full of white doctors poking and prodding at him.
I work for a company that makes medical devices for people with diabetes, (a disease which disproportionately affects people of color), and we go out of our way to ensure that we have a diverse cast of people who interact with the patients in our studies.
I am just guessing a fairly small people asked about Tuskegee would know what it is but maybe it's just me. I am just suggesting maybe asking black people why they don't want a covid vaccine for example and address those issues.
That said, I recently read that most black people (falsely) believe that the Tuskegee subjects were deliberately infected with syphilis, but I can't find the source right now, and it's kind of splitting hairs anyway.
Phase 1 is essentially to test "will this drug cause terrible harm to people who receive it in a reasonably short time frame?" In terms of dosage guidelines, phase 1 studies often don't have variable dosing, or if they do, not an awful lot - because the question around optimal dosing is the target of phase 2.
(Sometimes you can roll 2 and 3 up together, for instance, if the difference in dosing is in duration of therapy rather than an actual difference in drug administered per unit time.)
Phase 1 usually has terribly small samples, because it's only looking for terribly large effects. Seeing homogeneity there, of any stripe, is neither unexpected nor problematic.
(A lot of the vaccine studies rolled up phase 1/2 together because we already have a pretty good understanding of what these delivery mechanisms do to people, and so while you'd be cautious in administering to the initial study participants, it really didn't merit a "test it on five people and hold your breath" approach.)
It's still reasonable that the federal government would be reluctant to fund such a vaccine, though.
There's no excuse for bad testing demographics. If only whites are tested then we'd only find out in the wild if it works on non-whites or has adverse effects on non-whites, which is obviously hideous.
We'd also flat out reject a vaccine that only works on non-whites because we'd never know it.
It's fine to say that a vaccine that only works on some known part of the population is a good thing. It's better than no vaccine. But we have to know who it works on. That's what testing does, and that's what's being discussed.
There never is a "bad testing demographic". The testing demographic can only be "good" or "bad" in relation to the population the vaccine is going to be certified for.
> If only whites are tested then we'd only find out in the wild if it works on non-whites or has adverse effects on non-whites, which is obviously hideous.
That's absolutely correct, if a vaccine is tested on a specific demographic, it should only be certified for that demographic, and only be given to other people after additional tests. In this context, if the FDA notices that there are not enough non-white people in the testing group, the FDA should not certify the vaccine for non-white people. White people can already start being vaccinated, and additional tests need to be performed on non-white groups. The role of the FDA is precisely to notice these stuff, react accordingly, and keep phrama companies in check.
It's already what we are doing for people suffering for immunodeficiency. We develop a vaccine explicitly without including them in the trials - because it's harder to make a vaccine considering them. We certify the vaccine for the non immunodeficient people - as fast as possible. Then we will start looking for a vaccine for immunodeficient people at a later stage. First by testing the already developed vaccine - or by looking in another way if that does no work.
What Pfizer exec decided to do, is put speed above all. And they were absolutely right to do so. They published they trial sampling details and it's up to the FDA to certify the vaccine for the part of the population the FDA think the sample was good enough for. And require additional tests for the others.
The FDA does not certify vaccines as being safe for particular races, for one simple fact -- races are a social construct, not a biological reality. What we call "races" are actually mishmashes of a large variety of different ethnic groups, many of which have little to nothing in common with each other genetically.
Vaccines are certified by age and by gender and that's it. There will never be a "whites-only" vaccine and the very idea is morally repugnant and biologically ridiculous.
I do agree with you, but then what should anyone care about the distribution of ethnic groups in a medical trial if those ethnic groups have absolutely no impact on the result of the trial.
Either it makes sense to differentiate the vaccine according to $variable and testing groups as well as certifications need to reflect that. Or it makes no biological sense to care about $variable, then we should have no requirements about making sure that $variable is correctly sampled in the test groups.
In this case, ethnicity probably has 0 impact on the effectiveness of the vaccine, therefore why does anyone care about the distribution of ethnic groups in the sample ?
https://www.england.nhs.uk/coronavirus/wp-content/uploads/si...
See also the press release from the regulatory agency specifically about anaphylaxis: https://www.gov.uk/government/news/confirmation-of-guidance-...
It's also rather surprising to me (as a relative layman) that this wasn't picked up during safety trials. I get anaphylactic reactions to some food and medicines and carry an EpiPen. There are a few vaccines which have been counterindicated for me due to this so I have always thought it's a relatively well-known potential side effect from at least some vaccines (and other medicines of course). As such I would have expected it to be looked/checked for during safety trials.
Or "anyone with a history of anaphylaxis to a medicine or food should not get"? Do you have a source for anyone with any allergy being denied the vaccine?
They talk about how fast this vaccine was delivered. We could have done it a lot faster. An incredible number of lives and livelihoods could have been saved.
Take 1,000 diverse volunteers from the US military, start an isolated challenge trial (if something very unexpected happens, they're contained). Then expand it after those first thousand show success. Done in half the time that this took. We'll send those soldiers to die in pointless foreign wars, and then we won't do something so obvious as this to actually save American lives. The US would have had as many volunteers as you could handle for a challenge trial, hundreds of thousands of volunteers would have been trivial to get.
The FDA is supposed to issue EUA if the "benefits likely outweigh the risks". That bar was crossed after phase I trials, frankly, definitely after phase II, and is 1000x safer after a phase III trial (even if you don't love everything about it). The FDA is clearly not abiding to this standard, and is instead going with "almost no conceivable downside" standard. That has cost many lives.
There's no need to imply it's the GP's own opinion, and sotto voce that the GP is a racist.
That's a bit sus
[1] https://www.ovg.ox.ac.uk/news/funding-and-manufacturing-boos...
[2] https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
Our genetic makeup is very varied and we know that a lot of medical conditions only manifest in people of certain heritage, or disproportionately among them.
It is far from unthinkable that some ethnic group could react to a novel vaccine badly, or at least in an unexpected way.
As others have pointed out, Pfizer got this right entirely on its own.
It's telling that the top-voted comment happens to be one that bends over backward to somehow turn this into an argument on "political correctness".
FWIW, the Moderna vaccine was the first to apply for approval, and is expected to be approved "within a week" (https://www.businessinsider.com/moderna-vaccine-slaoui-likel...). A one-week difference on a 9-months science project doesn't quite sound significant enough for any conclusions as to the effect of taking government funding, let alone individual events connected with that funding.
1. https://www.faz.net/aktuell/rhein-main/wirtschaft/coronaviru...
[1]: https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-...
Time is a bit pressing here.
The main reason why vaccines are so safe (and why the anti-vax movement is so silly) is that they've been tested on hundreds of millions of people. But until you vaccinate those millions you cannot be absolutely sure about the safety.
The vaccine is called BNT162b2, because it was fundamentally developed at Biontech.
https://en.wikipedia.org/wiki/Tozinameran
>Tozinameran[1] (INN), codenamed BNT162b2 and more commonly known as the Pfizer COVID-19 vaccine, is a COVID-19 vaccine developed by BioNTech and manufactured and distributed by Pfizer
https://www.thelocal.de/20201110/biontech-four-things-to-kno...
>While global headlines tend to lead with Pfizer's involvement, Şahin insisted to Spiegel: "It is our technology."
It bothers me how Americanized the Western media has become. If Biontech was a US company and Pfizer was European, exactly 0 US media would call it the „Pfizer vaccine“. Yet most European media outlets have adopted the US-spin and now call it „Pfizer Vaccine“ (or „Pfizer-Biontech“ at most).
> In a series of interviews over more than seven months, senior Pfizer executives and other managers shed new light on how the vaccine project took shape.
Reading the article, it doesn’t look like the spoke to anyone at Biontech.
> BioNTech simply plugged the genetic code for the spike protein into its software. On Jan. 25, BioNTech Chief Executive Ugur Sahin designed 10 candidates himself.
Ah yes, the Germans simply plugged it into their software. Disregard over a decade of fundamental research done by hundreds of scientists with hundreds of millions of Euros in funding. Now let‘s focus on all the hard work American pharmaceutical Managers did.
>To assemble its mRNA production network, Pfizer used its own money and didn’t take any from the federal government. Executives said they didn’t want to give agencies outside the FDA more leverage over the design of the trials.
Yes, but: https://en.wikipedia.org/wiki/Tozinameran
>In September 2020, the German government granted BioNTech 375 million euros ($445 million) for its COVID-19 vaccine development program at a time when Pfizer funded its portion of development costs without government funding.[20] BioNTech had also received 100 million euros ($119 million) in financing from the European Commission and European Investment Bank in mid-2020.[21] Also: https://www.bloomberg.com/news/articles/2020-11-09/pfizer-va...
And speaking of „Operation Warp Speed“: Coincidentally, „Light Speed“, the name Biontech gave its vaccine development effort, started in mid January. A time when almost nobody had even heard of the virus. Operation Warp Speed wasn‘t announced until April 29, three and a half months later.
> BioNTech simply plugged the genetic code for the spike protein into its software. On Jan. 25, BioNTech Chief Executive Ugur Sahin designed 10 candidates himself.
When I read this, I didn’t take it as dismissive of BioNTech but more (1) a brilliant demonstration of the technology they’ve developed and (2) admirable that the CEO is still in touch with the underlying research.
For example, Russia already has 3 vaccines: two of their own, and one Chinese.
(The fever thing I don't think is actually a big deal, but is certainly not desirable if you want people to take a vaccine!)
The vaccines in question mostly got out ahead of their production capacity anyway too, so the difference is not consequential.
A mild fever, with one participant getting a moderate fever. Very small sample size, so it's not clear how that compares to the Pfizer vaccine. That appears to cause severe enough fever on occasion (~0.1%) that "who pays for the rare precautionary hospitalizations?" could be a very a real issue in countries like the US without public health care. The % of temporary side effects reported is significantly more than most other vaccines.
As you say, the fevers are probably just temporary side effects of the immune response and the supermajority of people recover very quickly (~24hrs or less). But it is an issue that needs monitoring - the trials really aren't that big, so it'll take quite a bit more data to know if those vaccines are safer than covid itself for the not-at-risk population.
Pfizer isn't even the only company distributing it, Fosun does the distribution is China...
And of course, if the govt (leaders) was competent there wouldn't have been 300k lives lost, and arguably economic damage could have been minimized as well. I'd argue that's a goal post that moves independent of delivery time.
> And of course, if the govt (leaders) was competent there wouldn't have been 300k lives lost, and arguably economic damage could have been minimized as well. I'd argue that's a goal post that moves independent of delivery time.
Pure whataboutism. We are stuck with the world we live in now and need to optimize for that.
But, who says it won't save enough lives? It was estimated to wipe out millions, seems like saving millions is enough to me.
And there are more people in my city than in New Zealand. You can't compare the world to a tiny island. Your comparision is unfair and unrealistic. Europe for example couldn't just close it's borders, it's logistically impossible.
If none of the first vaccines were more effective than a placebo, then your $Bs would be wasted until the one 10 years later was developed. Wear a mask, test and contract trace, or find some other solution is a better investment.
We invest in the world before we know the answer to things, so we look for answers as quickly as there's ROI, if that's whataboutism then you have a new definition. Putting together distribution and testing take time no matter how quick the vaccine development is and those are hard parallel problems, whatever the answer to the vaccine effectiveness question is.
There are ways that optimize the time to deliver those as well (mass inoculation, challenge testing), but I don't see you suggesting either of those. Note that we still don't know long term consequences of the vaccines (auto-immune responses were and still are a possibility). I don't expect them to be bad, but then I didn't expect 20% of the US population to deny a viral infection was real and/or the germ theory of disease.
The long incubation period and asymptomatic carriers makes for easy spread of the virus. It's hospitalization rate means a wide spread will literally shut down hospitals in whole regions. At current infection rates we're seeing hospitals being overwhelmed at regional levels.
Even if vaccines had been delivered after a Phase 1 trial of "no one died immediately" in the trial group, we wouldn't have enough vaccinated people to avoid social mitigation. We'd be in a similar situation as we're in right now.
It will take something like 75% of the population to be immune (by vaccine or previous infection) to have effective herd immunity. Even if vaccines had started distributing months ago it would still be a long time before we hit that 75%. Distributing vaccines after the phase 1 trials might ultimately get an immune population to that 75% sooner but it wouldn't stop any of the damage happening until that number is reached.
Even if no one died from COVID the "long hauler" after effects can be crippling. Some 10-20% of COVID patients end up "long haulers". If the virus were to spread to significant portions of the population because no one practiced social spread mitigation because they assumed the vaccine would fix everything you're still in a terrible situation.
Long? The median is between 4 and 6 days. The 14 days often quoted is the 99th percentile. Can we stop perpetuating this myth?
> asymptomatic carriers makes for easy spread of the virus
Actually, most of the spread comes from superspreading events. Most people with the virus don't spread the virus at all, or spread it very little. True asymptomatic people are far less contagious than symptomatic people (up to 10 fold or so less). Severity of the symptoms is also associated with higher chance of spread.
> It will take something like 75% of the population to be immune (by vaccine or previous infection) to have effective herd immunity.
This is often calculated considering an equally susceptible population (which is not the case) with uniform mixing (same), so it's a very pessimistic estimate. The actual figure might be lower (though not as low as 20% as some "skeptics" say).
> Actually, most of the spread comes from superspreading events.
I don't know if we can say this for certain at this point. I was very firmly on the "superspreader" train some time ago but I find it hard to believe given the spread we are seeing in places like Canada where most of what we thought were superspreader circumstances are now illegal. I am sympathetic to the idea but being overconfident about this stuff is also not helpful.
2 to 6 days incubation time is not "long".
> I am sympathetic to the idea but being overconfident
It's not being overconfident: it's what the currently available data says. The largest contact tracing study I am aware of, in India, reported that the largest cause of spread were superspreading events.
If COVID-19 is primarily driven by superspreader events that are largely not happening anymore in the 2nd wave that is causing case increases across nearly every jurisdiction in the world I have doubts.
Were it just me, I'd agree with you, however it is the data that we must look at:
https://science.sciencemag.org/content/early/2020/09/29/scie...
The article in question does not address the fact that I raised, and also you shouldn't make claims the authors are not making:
"Our findings, based on comprehensive surveillance and contact-tracing data from the Indian states of Tamil Nadu and Andhra Pradesh, provide insight into the epidemiology of COVID-19 in resource-limited populations."
Specifically: "Whereas incidence declined steadily at ages older than 30 to 39 years in the two Indian states, incidence increased at ages of ≥65 years in the United States."
So their finding might be applicable if the general trends matched but the study specifically says they don't, in the way that I generally pointed towards.
Also the study in question points to "superspreading individuals" but not "superspreading events" and that difference is significant. A "superspreader" who attends an event that can cause superspreading event, but a superspreader that goes to many places and meets just a few people at those places can super-spread! It's different! The study does NOT support your implied claim that asymptomatic spreaders can't be superspreaders.
Considering we're in the middle of a huge spike in cases that started two weeks after Thanksgiving, suggesting superspreader events are the primary source of infections is ludicrous. Canada had the same problem after their Thanksgiving holiday.
You're also seeming to dismiss asymptomatic carriers because individually they are less infectious than symptomatic carriers. This completely ignores the behavioral component of infection. An asymptomatic carrier will have no reason to seek out testing or participate in contact tracing programs. Someone that becomes symptomatic will know to at least inform recent contacts so they can get tested and attempt to isolate themselves to limit the spread.
Not all vaccines are going to be compatible with one another. If millions of people take your early-release vaccine and it's ineffective they may not be able to get a second one or not get it for a while. This apparently is an issue with the Russian vaccine because of the way it's introduced to the immune system.
This is why vaccines are tested in multiple phases. It's not just to make sure people don't have immediate adverse reactions but to find the edge cases and boundary conditions.
> If millions of people take your early-release vaccine and it's ineffective
Phase 3 studies on Moderna, Pfizer, and AstraZeneca vaccines have shown that they are effective (and nowhere close to an "early release"). Statistics don't lie in that regard.
> This apparently is an issue with the Russian vaccine because of the way it's introduced to the immune system.
I'm not aware of any of such issues. Do you have a primary source I can look up?
The CanSino vaccine also uses Ad5 as it's viral vector. An immunity to Ad5 from say Sputnik V would apparently prevent you from being able to get the CanSino one should Sputnik V prove ineffective for you. You'd also not be able to get a booster of Sputnik V later.
There's lots of adenovirus strains and a few other vaccines are using them for their delivery vectors. Ad5 is an edited adenovirus that has it's replication system retarded/removed. There's other articles I've seen but can't find now lamenting the use of Ad5 specifically. There was also the STEP study that showed increased HIV susceptibility in people that had received Ad5 vaccines.
I am not a medical professional but I do understand immunology is extremely complex. Effective vaccines in vitro aren't necessarily effective in vivo. There's also complex issues around dosing which is part of human trials. Even if a vaccine is "effective" it's not necessarily obvious or known what sort of dosing is appropriate for wide deployment in the general population. A completely "effective" vaccine at the wrong dose can end up being ineffective.
Dosing is done in Phase 1 trials, which also included antibody level testing. This has been already taken into account in the current trials.
I understand the temptation to think that this would be a good way to proceed but developing a complete supply chain for a dud would have been a total disaster for everyone involved and would have taken resources away from viable vaccines.
All of the big vaccine producers had full faith in these candidates and they poured money into their production in advance of phase 3 trials and we are still supply constrained. Making the same bet a month or so earlier (the largest gain possible) would have had a small incremental gain but an enormous downside.
You are assuming that there are no costs associated with one choice vs the other, but we know that is not the case.
It'd be really interesting to know how easy that was to catch: was it guaranteed that they'd notice that kind of issue? Or did they get lucky?
> The use of the H.I.V. protein posed no risk of infecting the volunteers with that virus, the researchers said. But the clamp generated the production of antibodies recognized by H.I.V. tests at higher levels than the scientists had expected.
They thought it was a possibility.
I'll stress: that sounds like a perfectly reasonable approach to try, and they figured out the problem very early on, with very little harm actually done.
Don't worry though. Time would never give this award to Big Pharma, as evidenced by the fact they gave it to Biden/Harris, one of the most milquetoast tickets in recent history, in a year where the first big pandemic in a century is ravaging the world. I'm also surprised they didn't go down the feel-good route of giving it to frontline healthcare workers, but Trump is a bigger deal, apparently.
Which would not be a reason not to have made it (we would want it for the future), but it's still rather early to say how much impact this vaccine will have. There is also the possibility that some other vaccine will be able to roll out doses for 300 million people before this one has successfully made doses for 10 million. I'm not saying that's likely, but it's certainly within the plausible range of possibilities.
No mRNA just the old school modified cold virus delivery mechanism.
Method been done for years .. easier and cheaper to manufacture and distribute.
Call me a cynic but I think the US (and UK) will push through a somewhat experimental version by Pfizer because “money”.
Hope I am wrong. But I would imagine in a year or so we will “discover” that the cheaper vaccine works great (after giving Pfizer plenty of time for $$)
[1]: https://cen.acs.org/pharmaceuticals/vaccines/Adenoviral-vect...
However this article says they bought seven $200M machines to manufacture lipid nanoparticles. This implies to me that $1.4B of $2B Pfizer is supposed to have spent on development was actually just updating their supply chain for mRNA based vaccines.
While I’m happy that they made such a dramatic investment in the interests of bringing a product to market as fast as possible I think it’s also fair to imply it’s R&D that can’t be applied to other products later.
And I suppose they spent a handy sum on marketing to pull off this being known as the "Pfizer vaccine" in domestic media despite this. Note the article headline is "How Pfizer Delivered ..." not "Developed".
Warp Speed funding to AstraZeneca, Moderna, and Johnson & Johnson also included money that was earmarked for manufacturing capability investment.
Conversely it shouldn't be frowned upon that they invested and believed in BioNTech's methods that made it trivial to almost immediately produce a vaccine candidate on an unproven platform.
Moderna likewise had their vaccine candidate within days of having the sequence, vaccines are mostly pretty easy when your first try works!
It'll be very interesting to see just how many people will take the vaccine over the next 6 months or so. I just had two nurses tell me that they will NOT be taking the vaccine, they are too scared of it. Based on what other folks have said, I'm guessing the number is going to be much lower than hoped. I am really hoping I'm wrong. It doesn't worry me at all.
The rate is important. If the rate is miniscule, then it may still be an issue, but not an overly important one.
>If you were to just 'let young people' out and about, hospitals would still be overwhelmed.
Are we sure about that? Any numbers you can share?
That said, young + healthy generally mitigates the risk of Covid 19.
It worries me that so many seem so hesitant towards vaccine and I'll gladly stand first in line, but we're rightly prioritizing the elderly and their caretakers.
We were told a lot of things by the media, nearly all of it oriented towards pessimistic outlooks, worst-case scenarios and often just complete misrepresentation of the science. If you asked the people working on these vaccines back in May, they would have told you 18 months was some made up nonsense.
This actually came from experts. Maybe not the same ones working on the specific vaccines but ones who have decades of experience within the vaccine space. Just because you read it in the media does not mean the media came up with it. They don't actually make things up. And 18 months was not worst-case it was average case with the best case in the media being Autumn. Just because the best case came out, doesn't remove the point that we were repeatedly told by experts (WHO) that 18 months was a good case scenario. While other experts said that was super optimistic.
It was the average case for a once-in-a-generation vaccine development process with unlimited resources, occurring in 2020, with ample research done on similar virus mere years prior?
If not, then it sounds like a useless "average" that was picked to fill air time and not to represent the best data we had at the time. And who had the best data at the time? The vaccine teams that had already developed the vaccines that are now being injected into the arms of Americans today. But they don't trot out on TV, so they had to grab some filler scientists to pretend they knew what they were talking about.
People who are allergic to vaccines are not in trials for obvious reasons...
Beyond that though, to hell with people who still somehow think "only those at risk need to be vaccinated".
I somehow came across an acquaintance who was telling me "I can't wait for people to take the vaccine so everything can reopen, but I would never get it myself". Such absolute trashy selfishness.
Given how fast COVID-19 appears to be spreading even in places with strict lockdown, I won't be surprised if it turns out that vaccines don't actually make much difference with it either.
That is their right, but then they should be given a leave of absence or fired.
How is getting a properly tested vaccine with a known 1 to 10% probability of side effects such as headaches or fever scarier than the prospect of contracting COVID-19 with roughly a 10% probability of developing severe to life-threatening symptoms?
Yes, there might be as of yet unknown vaccine side effects but the same is true for chronic symptoms that might be caused by COVID-19.
Citation needed. For 45-65 year olds IFR seems to be in the 0.3% rate, for under 45s it's way lower.
Hospitalisations about 2-4 times the number of deaths, so that seems to be in the 1% range for 'severe' symptons if you catch it and are towards the older age of nurses
That is, you're comparing apples and oranges.
IFR is almost always significantly lower than CFR for infectious diseases. That's particularly the case with Covid.
A "Case Fatality" is a pretty meaningless number. You can't avoid the consequences of covid19 by not being tested.
Both the humanitarian and economic toll of COVID is off the charts. 20% contraction in the economy, is like 4 Trillion in GDP loss for the US alone, maybe 20 Trillion for the world.
And that's just the money, not the human loss.
Given that, I don't get why nations didn't give them basically blank cheques, enabled the socialization/commandeering of factories and equipment, 5-10% of the Armed Forces for whatever needs etc..
Literally every drug company can 'report their assets' to the COVID task force and they will get deployed as needed. The companies will be happy to do that because they'll earn 3-10x return on those assets otherwise anyhow.
That seems a little dramatic but it's basically nothing compared to the damage COVID is causing.
Also: they didn't go into the actual manufacturing details to much, sadly.
Edit: also interesting would be the sunk cost / opportunity cost calculation on ramping up production of untested vaccines.
If opportunity cost didn't factor in i.e. if ramping up one vaccine didn't come at the cost of another, my bet is that it would have been worth any price.
If the US had spent $2B on ramping up every vaccine candidate before they were approved, and only 1 out of 10 came through, costing $20B for the first massive batch and accelerating subsequent batches, instead of merely $2B - would it have been worth it?
$200 a dose instead of $20 dose?
The math would say it's way beyond worth it. There's a case for 'prepping' every single vaccine candidate to the extent it's possible and even starting to manufacture in quantities way ahead of time.
This financial calculus doesn't work in the context of Pfizer - it doesn't make sense for them - however it absolutely does in the bigger picture.
A 'remedy' for this could have been to offer Pfizer massively increased price per dose for earlier delivery, in which case it would have made sense for the to spend $20B instead of $2, or simply some kind of national 'blank cheque' intervention. The former concept is neat but would be hard to nail down, the later is probably more workable.
Given that vaccine manufacture is 1/2 the equation, not just the R&D, I hope the 'after action reports' will put this in context.
“To assemble its mRNA production network, Pfizer used its own money and didn’t take any from the federal government. Executives said they didn’t want to give agencies outside the FDA more leverage over the design of the trials.”
“Rival Moderna, which took funding from a division of the U.S. Department of Health and Human Services, suffered a three-week delay in completing its own mRNA trial after federal officials there asked the company to slow down enrollment to boost the racial and ethnic diversity of study subjects.”
2) That they didn't take the money is a second order issue in the context of $4 Trillion hit to the economy with 300 000 dead in the US alone. Pfizer will do whatever is best for their economic outcome. Not taking money because they believe it may have slowed them down is one thing, but not taking it because they'd not make as much profit is another.
The profit motivation has obviously distorted early response, to the point that good organized leadership would have required some kind of regulated but open regime for manufacture, with some kind of negotiated price.
Why on earth are we only letting Pfizer manufacture it? The answer is 'free markets' - except they are obviously dysfunctional at the moment.
A better answer would be some kind of 'Open IP' agreement whereby an established royalty would be set for the vaccine, and basically anyone can make it.
We already have government established rates for every single natural resource, and we have controlled rates for energy as well - this is not a new idea.
Also - the government could provide 'infinite credit' for approved pre-production of select vaccines by select manufacturers at a set price, thereby encouraging mass-manufacturing of vaccine candidates even if the candidate failed.
i.e. socialize the risk.
Its counter-intuitive but only in a regular market based context. The math shows how that's upside down though, the ROI is much, much higher with intervention.
Now - if the government has is literally incompetent in every operating capacity, that's another storey, but what I have described here is not 'government manufacture', but rather, a different kind of market-based solution, with a different incentive structure.
(Unless you mean countries like New Zealand where the second wave just isn't happening)
There is a lag between cases and death, and death and the publication of cumulative reports on all-cause mortality.
If you happened to have read anything on the topic during the first wave, you'd know as much. Because it was repeated ad nauseam, until it became too ridiculous for even the most dedicated to keep on insisting that there were no excess deaths.
The 'lag' is accounted for in that most 'second wave' places have past the peak over their waves.
Deaths were 'higher' in the second wave in places that had a small first wave, like Austria.
But for places that had a 'real' first wave, the second wave was generally milder in terms of overall deaths, and much milder in terms of CFR.
We can't ignore the real risk of 'waves' but it's also important not to deny the nuanced reality of them. In particular, the 'second wave' had many more younger people, probably accounting for the lower case fatality rate.
What actually happened in stupid countries is that they reacted too late, too lightly, and everyone's been complaining that "oh the cost was too high". It takes a lockdown of ONE month, enforced strictly, to clear out COVID from the population and resume effectively normal activity (you still need to limit international passenger travel but that's proportionally far simpler).
I'm not terribly well connected socially so I don't take it as a universal, but the people I've heard about having it are a single friend of a friend and my doctor's husband (she volunteered the info during a routine appointment).
So the responses are more visible in peoples minds than the pandemic, and they are thinking intuitively about it, not reasoning about the precarious situation that (pretty much continuously) exists with such a fast spreading infection.
It's why Herman Cain's staff kept tweeting even after he died from COVID. And why people in the White House have been making a big show of hosting superspreader events, even as so many of them have to rely on the best medicine other people's money can buy to recover. Ultimately, I don't think there's a way to understand it rationally, because as you say, it's not rational; it's an emotional response.
Do you really think shops were full and everyone was out an about just ignoring their health (and potentially death) just because of some government mandate? Do you think people don't have their own will or brain?
Restaurants, shops, and bars have fewer customers, but they and other business is surviving.
That is just one data point, but it’s something
"Sweden's neighbours offer them emergency help as its hospitals fill up with coronavirus patients"
[1] https://www.businessinsider.com/sweden-offered-urgent-corona...
Our hospitals already suffered from lines long enough for people to die before getting care. Waiting in line is always the result of socialist government monopolies, and this was the case before COVID as well.
https://emanuelkarlsten.se/number-of-deaths-in-sweden-during...
To recover the economy you have to suppress the virus. Period. There's no magic wand to let people party away.
Moncef Slaoui is the guy in charge. He also mentions how they filter out candidates - for example ones needing an exotic ingredient that would make scaling manufacturing too hard. Check out his interview on Steven Levitts new podcast.
It’s pretty incredible the mRNA vaccine candidate was created only a few days after China released the genetic data of the virus.
And turning RNA into "mRNA vaccine" is just putting in in a little ball of fat (I think) which they know how to do because they worked on this technology for years.
???
It could have been done 5 months ago, by 5 different manufacturers.
We could have had 50M doses in Oct, the rest by January.
Why didn't Pfizer start ramping up? Because of the risk involved with an unproven candidate. That's literally in the article.
It's 'financially crazy' for them to invest billions ramping up on an unproven vaccine. But only 'crazy' for them, not for us. This speaks to the dysfunction of markets in crisis situations.
And why are we entrusting the manufacture of this essential IP to only one company? Pfizer? Because they paid for it? 'We' can 'pay for it' as well. And we can pay a lot more.
If the government established royalty rates for a vaccine, thereby ensuring Pfizer gets a cut if the vaccine is a winner, and allows any manufacturer meeting regs to manufacture it, you'd 10x production.
If the government basically 'pre-paid' or provided guaranteed credit for any manufacturer (up to standard) for any 'early candidate' vaccine, then not only would 10 manufacturers be involved - not just one - but they would have started 5 months ago.
It would have been 'insanely' more expensive to do it this way, probably costing 10x as much.
... but it's actually not 'insane' is my point, it's extremely rational for us to put $200B on the table to accelerate this by 5 months. It's a bargain. It's a win-win-win - Pfizer frankly makes just as much profit (royalties have no underlying unit cost), manufacturers make some, Americans are safer and the economy starts earlier.
We handled it 'poorly' because we didn't manage the situation, put in the right regs, or create the right incentives.
??? And what are you talking about 'rushed'. I'm not talking about changing the nature or timeline of the trial. I'm talking about ramping up production before the vaccine is proven to be safe and working, because the opportunity cost of 'COVID shutdowns' are 1000x greater than the lost opportunity cost of wasted spending on manufacturing vaccines that work.
Again: we should have been mass producing the potential 'good candidate' vaccines months ago. It doesn't matter if some of the failed to pass muster, it would have been well worth any potential wasted money on making vaccines that we can't use.
I didn't read the article, but I don't believe this is true. The vaccine is ultimately not Pfizer's but BioNTech's, and the German government gave them $445 million to develop it.
The former is R&D intensive, the later is op-ex expensive.
The former relies on talent, the later is mostly just bodies and money. The former can be done much earlier in the process if the risk equations are aligned, which they are not, which is why Pfizer ramped up in October, and not back in April, when the could have, but wherein it wouldn't make sense for them.