What is the best argument against approving the AZ vaccine? Every argument I see against this position here is usually a vague notion that regulatory processes are Good or a reference to how the vaccine hasn't actually been submitted for approval. To me, it reads as a kind of knee-jerk "government agency good, pharma company bad" culture war, which is stupid when literally thousands and thousands of lives are at stake.
Is there an actual good argument on the merits opposing an immediate approval of the AZ vaccine?
To steelman the opposition, I think you'd say that given where we are with the J&J vaccine likely coming soon that vaccine hesitancy is a bigger problem than vaccine supply so anything that raises any chance of increasing hesitancy is bad.
The best argument is that Americans won't trust the vaccine if its rushed through the regulatory process and so won't take it even when it becomes availble. We are already having issues with that for the mRNA vaccines which aced the clinical trials.
The idea that the vaccine hesitance people are carefully watching the FDA process and are going to change their minds about AZ when it clears its current trials is farcical.
Wanting to spend a few thousand human lives on propping up bureaucratic procedure is evil.
The issue isn't that vaccine skeptics are monitoring the trials. It's that if a vaccine jumps the normal bureaucratic process and has any high-profile side effect cases or even just doesn't work against some virus variants, that has the potential to immensely damage public confidence in vaccinations and, by extension, our ability to reach herd immunity.
Nobody here is saying "let's not approve the AZ vaccine because I want more people to die"; this is a dishonest strawman. It's just a question of whether you're more concerned with what's going on right now or what's going to happen in the fall. Reasonable people may disagree.
Nobody is advocating that the AZ vaccine jump the process. The argument is that AZ should file an EUA, the FDA should evaluate it through that process, and then approve it based on the available data.
All vaccines will have side effects. AZ won't be unique in that sense. As long as it goes through the EUA process, there's no reason to think that vaccine-hesitant people will be more fearful of the process from it's approval than other vaccines approved through the same process.
The real issue is that the FDA is prioritizing fealty to trial design over taking a more holistic view of the data. They prioritize it so clearly that AZ won't submit an EUA with the current data. Adhering to trial design is worthwhile and important. Trial deviations and creative post-hoc p-fishing can lead to non-efficacious or harmful drugs being approved. But those don't apply here. The benefit-harm ratio is all on the side of benefit.
Some could argue that making exceptions, even to something as immediately inconsequential as the AZ trial deviations, is harmful and could lead to vaccine hesitancy. But, keep in mind that *none* of the vaccines have been approved through the standard process. All have received emergency authorizations through the expedited EUA process. This more significant deviation is not leading to vaccine hesitancy.
given the shortages we're seeing (like, my 60+ year old parents aren't able to be vaccinated), I don't know how anyone can be concerned that there isn't enough demand for the vaccines.
If anti-vax people are scared, they can be skipped in line. Not sure why they have to slow things down for the rest of us.
Yeah I don't really like this argument either but public health officials love acting as amateur psychologists. Around 40-50% of health care workers and teachers aren't taking the vaccine when it's offered to them so this is a really important issue. We don't know the percentages for other populations, but I think it would be similary high across the country with higher uptake rates for more well educated groups. We have seen higher hesistancy rates among poorer and non-white communities.
The key thing for antivaxxers is that its a sprectum. For parents of school age children, there are only a small percentage that are hard core antivaxx and won't ever get their children vaccinated. However, there are significant minority if not majority of people that have some hesistancy. They express this by spreading out some vaccines for their kids over larger periods of time than reccommended by doctors or all getting some but not all of the reccommended vaccines. For the Covid vaccine, it's similar.
I have talked to quite a few people that say they are willingly to eventualyl get the vaccinated but they hesistant to be one of the first groups vaccinated as they don't trust the vaccine yet.They want to wait for more evidence. I see this hesistancy even among highly educated people but it's more common among the non college educated.
I personally think we should approve the AZ vaccine right away and simply ignore these people until we get everyone willingly vaccinated. However, I think many public health officials worry that any perceived issue with the vaccine approval process will cause this group to never become vaccinated, preventing the country from developing herd immunity from vaccinations.
Demand is very strong among 60+ but is likely to slacken off very substantially after we clear that group. A key part of reaching herd immunity to protect the elderly is going to be getting people in their 20s and 30s to get vaccinated.
There is tons of demand from people in their 20s and 30s. And the way to engage more demand from people in their 20s and 30s two months from now when they may have a chance to get the mRNA vaccines is to see their friends get vaccinated today, and then not get coronavirus when they next go to a party where everyone gets it.
Like, think how powerful the news article is when it's like, "20 people did [some obviously dangerous shit together] -- 17 got coronavirus, 3 were vaccinated."
Idk I am currently on campus with a lot of 20 y/o (not that it's exactly representative) and basically everyone wishes they could get vaccinated. Even the people who are basically acting like the pandemic isn't happening (not masking, going to parties, etc.) want to get vaccinated so they don't feel shame or get bugged by classmates about what they're doing.
That's interesting but only goes so far, simply because college campus young people in their 20s are not very representative of the great majority of Americans who don't have degrees (70% of adults) or who are outside of that age group. (85% of adults are older than 29)
That's trivial to solve: don't include AZ as part of the mainline vaccination effort and let people just ask their doctor for it if they want. That will relieve pressure from the mainline effort without anyone having to worry about being given a crappy vaccine.
The only thing standing between me and the AZ vaccine is the FDA. I'd like them to get the fuck out of my way.
I would trust it and take it, but would prefer others, for obvious reasons.
As to other reasons to tread cautiously, this one is wacky and awkward but lately no one has gone broke overestimating our capacity for partisan hysteria, so here goes:
The AZ vaccine, with refrigerator storage, is good for otherwise under-served communities. BUT we don't have solid trial data and (let me mention the exotic animal in the room) the vaccine is based on a chimpanzee adenovirus.
So who in the Biden Administration (or at a right-wing think tank) wants to be the advocate for letting poor communities be the guinea pigs where we test the "monkey drug"?
Calm, sensible people would not be troubled by the chimp factor, but I'm not talking about calm, sensible people. I'm talking about our current news/political system.
Yes, this is a crazy guess and I understand its rarely safe to try to gauge how crazy other people can be. But the chimpanzee thing *MAY* be giving people pause.
LATE ADD: Apparently I'm thinking like Putin:
"Russian disinformation effort: Oxford’s COVID-19 vaccine turns people into monkeys"
I'm an American and I'm happy to take it. Many others feel the same way. Be open about the situation and let people make the choice. If some people don't want it, then that's their loss.
I'd feel differently if there were questions about it's safety, but there aren't. The "doubts" are about it's efficacy. However, we give out millions of low-to-moserate-efficacy vaccines every year and no one complains. In fact, public health officials say that more people should get them. They're called flu shots.
I think the best argument against authorization is that authorizing the AZ vaccine now would mean that the ongoing U.S. phase III trial would not be able to provide complete results, which in turn would mean that many of the uncertainties about AZ’s vaccine will remain unanswered.
Wow, I had forgotten that AZ has a US trial in progress. Yeah, this is a huge issue. In my opinion, is the nail in the coffin to this "authorize AZ now" position. We need to actually collect the data.
It's not as simple as delay = more deaths. Medicine (and policy) are complex fields that require careful weighing of various risks/benefits. Yes, delaying probably means more deaths in the short run, but it might decrease deaths in the long run (if vaccine hesitancy increases or if many people get a low-efficacy vaccine instead of a more proven one). The FDA digs through the raw data performs that complicated risk/benefit analysis. I personally trust their expertise on this.
Also, if the FDA immediately authorizes the AZ vaccine, that will shift doses to Americans and away from other countries. I don't think that is or should be included in the FDA's analysis, but it does further undermine your "unnecessary deaths" characterization of the decision.
That said, I do hope the FDA is not overly conservative when it comes to authorizing the vaccines. I am very sympathetic to Matt's post and your urgency. I simply have some counterarguments and maybe trust the FDA scientists and bureaucracy more than those asking for a faster approval: https://www.slowboring.com/p/astra-zeneca/comments#comment-1276810
I'm glad we get to have a bit of discourse about this.
Trusting the FDA's expertise on this is great, generally, but when I think about how the public health establishment has bottled the whole crisis (new disease, sure, and political issues, sure, but everyone deserves to be fired for the masking adventure), combined with the fact that the "normal plan" that their expertise created would've left us without any vaccines at all approved at this point in time, I'm more than a bit skeptical that they really know what they're doing. And maybe they know what they're doing, but their institutional knowledge/biases prevent them from grappling with what needs to be done when 3000+ Americans are dying every day.
Additionally, trusting that the FDA's is being the appropriate level of cautious implies that our friends in Europe are being wildly crazed and that they're endangering all their citizens, which is a bit absurd on its face.
I'm skeptical of the "shift doses towards Americans" line, mostly because the mythical Baltimore vaccine plant is in fact making doses right now. Separately, the FDA's concern should primarily be with safeguarding American lives. The State Department and the CDC's Global Health Coordination Unit and such can worry about vaccinating the global South, whether that's by buying vaccines form them or cutting big checks to help India build more vaccine factories.
Let me know if I've misunderstood anything you said.
Yes, it's nice to have a reasonable discussion. :)
I don't think FDA took the "normal plan" for the Moderna or Pfizer vaccines, and I presume they also feel urgency about AZ and J&J. The FDA didn't rush the currently authorized vaccines, and I don't think they should hold AZ to a lower standard for demonstrating safety and effectiveness.
Yes, 3000 people are dying a day in the US. Most of those people are elderly, but the majority of people who will take the vaccine are younger and at much lower risk of death from covid. So the calculus is a little complicated. If everyone had the same 10% risk of dying of covid that the elderly have (or if the vaccine were only authorized for the elderly), the FDA would presumably set the bar very low.
I don't think that Europe are reckless, especially given the fact that the FDA approved the Moderna and Pfizer vaccines before or at the same time as their European counterparts.
If there are stockpiles of doses just waiting for Americans' arms, I would be more sympathetic with the request to let people get the AZ vaccine. I don't know if there are those stockpiles. I understand the Baltimore plant is making the vaccine, but those could already be dedicated to Europe.
Ultimately, I don't have a strong opinion about this issue, except for the belief that I don't have enough information and that I personally am OK with trusting the FDA on this.
I don't understand this argument at all. The data will be collected. The participants are participating. If anything it slows down the trial because there is less covid. But so what?
My understanding is that once the AZ vaccine is authorized, ethical protocols dictate that all the participants must be unblinded so that those who are in the placebo group are given the opportunity to take the real vaccine.
This makes sense in a normal situation, but its not a normal situation today. I think that the phase III trial at this point is to assess efficacy, not safety and given that, I would offer both arms immediate vaccine access as soon as you hit a defined end date. I don't recall the trial or vax candidate but there is apparently more wiggle room in trial design (example, giving the placebo arm a "second chance" before the trial ends on a 50-50 basis). There also should be much more flexibility in reviewing data from the many countries out there that have approved the vaccine. This process you outline makes a lot of sense when we are talking about trials that are expected to take years due to low levels of viral transmission and i do think the use of EUA has been a strong accelerant. But i think we deserve more creative thinking from the FDA.
The best arguments are a) a rushed approval for a vaccine which could potentially end up with a few explosive high-profile side effects would be IMMENSELY damaging to public confidence in vaccination and b) the fact that it appears to be largely ineffective against the South African strain renders it of dubious value overall.
I understand the impetus for "approve everything!" but smart policy money is apparently that we will start to run out of lent-up demand by April. I don’t think there’s much value in introducing a potential ineffective vaccine to the pool when we have a number of highly effective ones.
Except it is likely to be effective against the SA variant (which is not a strain) in the most important categories, hospitalization and death. And so I don't really understand the point of stopping use of the vaccine in SA, much less not allowing it to be used here.
Dr. Fauci revised the "late March/early April" timeline for widespread availability to mid-May/early June. But your point - we shouldn't let a short-term shortage push us into a longer term problem - is good.
I think there has been a lot of unfairness to the Russian vaccine efforts given the Sputnik vaccine seems to work. That said, the perception that the Russian government is willing to cut corners for a quicker win has to be part of the reason 60% of the Russian population doesn't want the vaccine... I don't think it's really fair to analyze just the one case. What is the impact on the population's trust of the FDA and scientific establishment over the long term?
"The inoculation would begin in Moscow, with health-care workers and others who had a high risk of exposure, including teachers and social workers. A poll taken in September, however, had shown that up to half of Russian doctors and other medical professionals weren’t yet willing to get the vaccine, owing to the rushed approval process and a lack of concrete data about the safety and efficacy of Sputnik V. The Levada Center, an independent polling and research organization based in Moscow, found that, as of December, nearly sixty per cent of Russians did not wish to be vaccinated. (At the time, polls in the United States indicated that about a quarter of the population did not want to be vaccinated; in France, which has one of the largest anti-vax movements in Europe, the number hovered around fifty per cent.)"
Here are my reasons. It’s a risk/benefit analysis, and I think the overall benefits might actually be smaller than at first glance (see B).
A) There are a lot of details and a pharma company’s job is to put the best possible light on their trial. I suppose the FDA could just trust it’s European equivalent or the WHO.
B) I don’t think there’s a huge stockpile of the AZ vaccine simply waiting for Americans’ arms. Maybe I’m wrong, but presumably the current supply is being directed at European countries where it is already approved. If rushing the approval makes only a very small increase in US vaccination rate, then the benefits of rushing are small.
C) The drawbacks of rushing range from terrible (if the EUA eventually needs to be withdrawn) to bad (generally increasing vaccine hesitancy).
The FDA will never forget Thalidomide, which was approved in Europe and Canada but not by the more-cautious FDA. It caused horrific suffering wherever approved.
The argument against approving ALL of the vaccines is that we have absolutely no data on long term side effects. None. Zero. Zilch. Approval seems far to much to expect, given that total absence of data.
The leaves the question of emergency use authorization. (It's really quite something to hear/read people mock a regulatory process while making clear that they actually know nothing about about actual process they are mocking. If you can't be bothered top look at the details of the process, of course you are not going to be be able to weight out its benefits and risks.)
What is the case against emergency use authorization? Well, that would take an examination of the data analysis to ensure that there are not errors in it leading to wildly distorting bottom line numbers. It would take looking closely as the nature of the sample of participants, so that the analysis is sure to compare to right baselines, again to be sure that the bottom lines numbers are not distorted. The case against, like the case for, depends on the actual data.
Not just the summery statistics. Not just the unsophisticated average.
But the controlled and careful analysis that actually gives us insight to actual effectiveness.
And, if it turns out that after all of that, the vaccine is moderately but not highly effective? Well, perhaps emergency use authorization is appropriate, as it is by definition temporary. And perhaps actual approval -- which is assumed to be for the normal term -- would not be appropriate, as greater supplies of more effective vaccines become available.
It's in the details. Which is another way of saying that it's in the facts. You know, those pesky facts. Facts that I do have access too, and am not arrogant enough to think I can do without when coming to important conclusions.
>>The leaves the question of emergency use authorization. (It's really quite something to hear/read people mock a regulatory process while making clear that they actually know nothing about about actual process they are mocking. If you can't be bothered top look at the details of the process, of course you are not going to be be able to weight out its benefits and risks.)
This sounds a bit like the gun nuts who say "if you don't know the difference between a clip and a magazine, don't talk to me about gun control"
Were I suggesting that we ban clips but not magazines, and I did not know the difference, I would a fool -- and a lazy one at that. Similar if I suggested banning magazines but not clips. However, if I suggesting banning anything that enabled a gun to hold more than 8 (for example) shots without reloading -- even if my language was off -- and someone resisted because I not know the technical language, that person would be an asshole.
But right now we are in a situation in which we have had emergency use authorization BUT NOT APPROVAL for some vaccines. We are in a thread in response to an article in which the author pointed out that the pharma company was not seeking EUA, but was expecting to receiving approval in a few months. This is a distinction that matters generally AND that matters in the context of this particular set of comments.
I am not suggesting that everyone need to be an expert on everything. Rather, I am suggesting that if you claim that a particular process is too cumbersome, it behooves you to examine the process to understand how cumbersome it ACTUALLY is and -- or order to evaluate whether or not the cumbersomeness is excessive -- what that cumbersomeness accomplishes. Before saying this is too costly for what we get out of it, look at the actual cost and look at the actual benefit.
There are hundreds of thousands of lives on the line -- if not millions around the globe. And there are potentially billions of people who have have long term complications or side effects from experimental drugs that they are taking without full investigation or approval. This stuff matters. Getting it right matters. Paying attention to the details matter.
I am not saying to leave to the experts. I am saying to become moderately expert (or at least highly informed) before blowing them off.
The alternative to be what I have come to call "presidential."
I get what you're saying, but at the same time, at some point even those who haven't looked into the nuts and bolts of the process are entitled to say "by their fruits will ye know them"--and the outcomes in the areas of pandemic response controlled by the FDA have been terrible. I'm not just thinking of vaccines, but also even worse, testing.
1) You know the expression about sausage and legislation? You do NOT want to know about the process of making them? Well, in my experience that is true all over the place. No one actually does anything right. There are shortcuts all over place and the more your know about how work is ACTUALLY done, it more disturbed you can be.
My father was a regulatory attorney who did pharma stuff. Pharma paid for my childhood. My wife is an employment attorney who spent much of my 40's in a pharma company. Above, Allen said that a lot of this stuff sounds like "pharama bad, regulations good." My father and my wife were both on the pharma side, and they taught me that, ummm....yeah....regulations good. Regulations necessary. Without regulations...really really bad.
2) But I don't actually know what it takes to create or approve COVID tests. I am a researcher, but not in the physical sciences. I do not know all stuff that goes into drug approval applications. I'm pretty good on quantitative methods, but -- again -- I don't analyze THAT data. I've never worked such an application or seen one. My dad did (the legal stuff, not the numbers), and my wife was at a company while they did these things. But I don't know that stuff, myself.
Admitting the limits of our knowledge is really important. Assuming that anyone out there has the potential to be perfect or that perfect is the expectation is...it feels like dunning-kruger to me. A kind of arrogance that prevents intelligent analysis.
I don't like what happened to the tests. I don't like how slow these authorizations are. But to criticize them because I -- a well informed outsider with very limited knowledge -- would like it to be faster? Man, I'm pretty fucking arrogant, but I'm not THAT arrogant. I don't know enough to know whether my expectations are the least bit reasonable. I know a lot, but not enough to to know what.
3) And on EUA vs. approval? I didn't know anything about that stuff a year ago. But I've paid attention for the last year and learned that. No insider sources. Just the kind of stuff that available to us all. Not the kinds of journals I read for my own work. Just journalism and mass media.
I too am confused by the actions of the FDA. How about this explanation:
Vaccine skepticism for COVID is more widespread than the normal anti-vaxxer movement, especially for PoC. Estimates of this are up to 35% of the population that doesn’t currently want a vaccine. E.g., my friend works at a vaccine center in the Bronx that had hundreds of doses that were going to waste; they went out on the street to recruit locals but nobody wanted it.
When PoC are told they’re getting a different vaccine from the good one that white people get, that won’t inspire confidence.
Keeping everyone on the same product will alleviate these fears.
How will re-running the AZ clinic trial make this population less hesitant to get it? They're hesitant to get vaccines "that white people get" and that have aced their clinic trials! If they don't want the AZ vaccine, so be it, but this white guy wants it now.
The issue isn't with the trials, it's with segmenting shots by population. If they give "the good shot" to the vulnerable, first responders, and predominantly to white people, and "the new shot" goes to everyone else, that's not going to bring confidence.
If you believe that the AstraZeneca shot is good, then give it to everyone. But only giving it to people who aren't eligible for the other shots may get us to 65%-vaccinated faster but will hurt our ability to get to 90%+.
My proposal would be to give the AZ shot to young people who want to get it, while the mRNA shots continue to be rolled out based on age with younger folks allowed to wait for them if they prefer.
Yeah, I actually agree with your proposal. I'm trying to steelman the opposite case, and I don't think I'm succeeding. To try a little harder on my original line of argument:
This would make the Moderna/Pfizer shots be the good & safe ones, while the AZ would be the riskier one that's only good to give to young people. Does that unfairly denigrate the AZ shot which will reduce vaccine trust overall?
The proximate goal is to get vaccines to everyone who wants, but the long-term goal is to get them in 90% of people's arms.
Remember that this is not a one-shot game, and trust that is built up over time is easily spent. We don't know what is coming (variants, other pandemics), and epistemic humility suggests the FDA shouldn't spend its trust-capital too quickly.
[end steelmanning] OTOH, these are second order effects that are probably massively outweighed by the likelihood of saving 50,000 lives.
What are the chances that, by producing a contrast between "the bad shot young people can get if they want" and "the good shot that old people can get now and others have to wait for", they actually end up *increasing* confidence in "the good shot"? (It's really not obvious to me what the net effect would be - having a "good shot" and a "bad shot" could decrease confidence in both, increase confidence in both, or increase confidence in the good one while decreasing confidence in the bad one.)
Nobody is advocating switching entirely to AZ. We could keep it out of the mainline vaccination effort and let people voluntarily sign up to get an AZ vaccine out of line. That would reduce pressure on the mainline effort and vaccinate more people faster.
I don't understand why any good-faith actor would spread that message unless that was actually happening.
What you're saying is people in the Bronx don't want "the good" vaccine, so if AZ was rolled why would vax rates would go up if "the bad" vaccine was now offered there? But I would guess that in upscale, highly-educated (more white than the Bronx) neighborhoods with unmet vaccine demand, more people would get vaccinated with 'the bad' vaccine.
Even if it played out differently, who would be spreading that kind of message and for what purpose as long as both versions of the vaccine are being distributed as widely as possible?
My best guess for you is "no" (as in: I personally would take AZ), but I don't see any data being collected on this questions unless strategies change.
I don't think there's any data on it, but the AZ vaccine is based on a much different approach that Pfizer or Moderna, so I'd bet that they don't interfere with each other. I think there's more concern about one adenovirus-based vaccine interfering with another.
The mechanism of both is that they trigger an immune system response to the spike protein. It's plausible that the mrna vaccines won't trigger as strong of an immune response after being vaccinated with the AZ vaccine, so the overall immunity will be lower.
I generally agree but am concerned about decrease in efficacy of AZ against the South African variant. Similar findings with J & J and Novavax but still protective against severe illness. The mRNA vaccines seem to be better against SA variant but the only data is from lab experiments and not the real world.
Right. And if I understand the science correctly, it seems the mRNA vaccines are easier to "reprogram" against the new variants than the conventional vaccines.
The AstraZeneca vaccine is in this way more like the mRNA vaccines - it's effectively an mRNA vaccine that, instead of using a lipid nanoparticle, uses a chimpanzee virus to deliver the mRNA to your cells. It trades the cold chain difficulties of the mRNA vaccines for the possibility of immunity to the chimpanzee virus as a way to lose efficacy. But it should be updateable in the same sort of way, I would think.
"Unless someone at the FDA can explain to him in a compelling way that they have actual doubt about the safety and efficacy of the vaccine — as opposed to quibbles about the process or a scientific interest in seeing data from a better-designed trial ..."
Aren't the "quibbles about the process" and the issues with the trial design part of the reason for doubts about efficacy?
>Aren't the "quibbles about the process" and the issues with the trial design part of the reason for doubts about efficacy?
I've seen a lot of people claiming that changing the process will make others less confident in the vaccine, but personally I haven't seen a single person say "because of the changes in the approval process, I do not believe that the vaccine is effective."
I don’t think that’s the issue. I think the more likely issue is the fda approves the vaccine, it is used disproportionately in rural/poorer areas because of its lesser refrigeration requirements, and then there is an unexpected result in the new trial leading to probably sensationalist news stories that result in a lot of distrust. I don’t know if that’s exactly how it would go down or not but I do think it’s important to think through what this would look like in the real world.
It's approved in Europe, though. Do you think that's what's going to happen there?
It can't be the case that their approval process was fine and so their AZ vaccine is safe but ours was rushed so our AZ vaccine will be flawed, because it's the same vaccine and the same human physiology so the results will be the same. Thus if it follows that you think European regulators didn't err in approving the AZ for distribution in Europe, then there's no conceivable objection to also distributing it in the US, immediately.
Yes, absolutely. I find the rush to approve this very problematic in that it completely discounts the immense damage that could be done to campaigns to reach herd immunity by an ineffective or outright flawed vaccine which was perceived to have been rushed through the process by FDA. Most informed policy makers seem confident that we’ll see demand start to slacken by like April, so barely over a month/month and a half. J&J will already more than adequately increase throughput; there is no reason to rush a vaccine which may prove ineffective against new variants.
As Matt observed, the only reason the EU *had* to approve this is that they lack other options. We do have other options that will adequately address demand.
"I find the rush to approve this very problematic in that it completely discounts the immense damage that could be done to campaigns to reach herd immunity by an ineffective or outright flawed vaccine"
Why would it be "flawed or ineffective"? That makes no sense. It's approved for use in Europe - do you think they made a mistake in doing so? Nobody actually seems to think they did.
As Matt observed above, and I observed in my own comment, which you appear to have ignored, the reason it's approved in Europe is that they have to approve it; they don't have adequate supplies of anything else. If that were the case for us too of course I'd support approving it here; but we have considerable supplies of Pfizer, Moderna, and J&J, to the point that experts believe supply will begin to overtake demand within a month or so.
But we actually don't have adequate supplies of anything else, which is why you, me, and most everybody else aren't getting vaccinated until the summer and about ten thousand human lives will be lost that didn't need to be, in the interim.
We don't know this. If anything there is a strong possibility (that would need more data to be confirmed) that in SA, not a single person in the vaccine arm who was diagnosed with COVID exhibited a "severe" case, nor has been hospitalized or died.
If you have doubts about it's efficacy, then choose the lower of the two numbers they produced (which was part of the larger trial). It's still a good enough number.
It's too bad that Republicans and libertarians have become so obsessed with their various culture war hang-ups that any useful good government ideas they may have contributed are squarely in the past at this point.
No. I think the Republican party had something to contribute in this area in the past. It's not like Democratic city governments have always covered themselves in glory on effectiveness. And this had something to do with high growth areas in the west being traditionally Republican in the post-war era. But the trend of the Republican party becoming useless started about 30 years ago and was mostly complete about 10 years ago. Trump is kind of the icing on that cake.
It has to do with part of the original post, near the end:
"'Costly regulations are hurting the country' is the classic conservative and libertarian policy critique. But when I scrolled the front pages of Cato, Heritage, and AEI last week, none of them were highlighting content calling for approval of the AstraZeneca vaccine. Congressional Republicans are criticizing the Biden administration for all kinds of stuff, but they’re not calling on the FDA to approve the AstraZeneca vaccine."
What mpowell is saying is that in the past, the Republican Party and its associated think tanks would have been pushing for faster approval of the vaccine because it fits extremely well with their criticism of over-regulation by the federal government. But now, the GOP is more concerned with who can say what on Twitter than with a productive contribution to policy/politics like advocacy for reduced regulation in a situation where there's a pretty good argument for it.
1) I will be a *lot* more confident that the AZ vaccine works after a panel of experts digs through the raw data and confirms the findings summarized in papers. I don’t fully trust a pharma company’s summary of their trial results. There are a lot of details and a pharma company’s job is to put the best possible light on their trial.
2) Yes, zero people died of covid in the vaccine arm. But only 1 person died in the control arm. Very small numbers here and not reliable to draw a solid conclusion about deaths. That said, it’s pretty clear from the trial that the vaccine is likely safe and effective.
3) I don’t think there’s a huge stockpile of the AZ vaccine simply waiting for Americans’ arms. Maybe I’m wrong, but presumably the current supply is being directed at European countries where it is already approved. If rushing the approval makes only a very small increase in US vaccination rate, then the benefits of rushing are small.
4) The drawbacks of rushing range from terrible (if the EUA eventually needs to be withdrawn) to bad (generally increasing vaccine hesitancy).
Wait, I just want to make sure I have the punchline right? Are you saying that in the _entire_ set of AZ vaccine trials across all countries, they only had one person die in the control groups? Or is that specific to the smaller US trial? Do we know the raw numbers for the EU trials?
Yes. In the entire AZ trial with 11,636 participants, they only reported one covid death, and that was in the control arm.
"From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death."
Also: "There were four non-COVID-19 deaths reported across the studies (three in the control arm and one in the ChAdOx1 nCoV-19 arm) that were all considered unrelated to the vaccine, with cause of death assessed as road traffic accident, blunt force trauma, homicide, and fungal pneumonia."
Very large trials are expensive and difficult and slow. This was fairly large, but the incidence of covid was lower during the trial at the locations they chose. Also, most of the participants were younger, and not at risk of dying from covid in the first place. Because the main measure of the trial was any symptomatic covid, not specifically death, the size of the trial was probably sufficient.
Recruiting and enrolling subjects at test sites is the rate-limiting step, and the larger the trial, the longer that takes. You need to ensure reasonable demographic coverage, some geographic diversity, and so on. You can increase the number of sites, but not unboundedly --- i.e. you can't just get someone's personal doctor to inject them.
Re: 1, exactly. Everyone here keeps talking about how it's approved in Europe and the UK, but those places just trust the summary results from the pharma company and don't actually independently verify via the raw data.
Because the trial was sketchy, there are a lot more data integrity problems. The results were published in a peer-reviewed journal, and that is one level of quality control, but peer-reviewers are unable to make these kinds of assessments
@Tokyo Sex Whale -- great name. Musa Bility and Prince Ali say hi.
My frustration with Matt's (and others') push to approve the AZ vaccine is that the CI for their data is pretty broad due to the sample size -- that's why you run the trial! Sinovac's preliminary efficacy numbers ranged from 70-90%... and then they completed their Phase III trial and reported it at 50%. Sputnik V seemed like something Putin was pulling out of thin air, but it turns out to work pretty well! Lots of insiders thought Merck had an inside track to a leading candidate, and then they pulled both of their efforts. The point is, you don't know until you gather all the data.
Maybe AZ's vaccine is in the ballpark of J&J's (probably the best guess at this point). And maybe it's better! But maybe it's in the 50% range of Sinovac, with no benefit for the elderly. Then what? Do you tell people "yeah, the US government bought all these doses of a vaccine that doesn't work as well as the mRNA vaccines and may not offer protection against the fast-growing variants, but take it anyway"? You'll have a lot of people saying, "No thanks, I'll wait until we have enough doses of Moderna and Pfizer, thank you very much."
At the end of December, the US was averaging 250,000 vaccination shots per day. Currently we're at just under 1.9 million shots per day. In a few weeks, especially if J&J is approved, I would hardly be surprised if we're at 3 million per day. Back in December Biden aggressively called for a goal of 1 million per day, then had to scurry around to increase the bar to 1.5 million per day, obviously well below where we're at.
I'm not saying we shouldn't treat this as a great emergency and not consider all possible resources. I'm just saying we're currently well ahead of where anyone thought we'd be with likely more progress to come. It's possible that the situation will be resolved positively under current processes.
I think you're right. Vaccine hesitancy will replace vaccine access as the biggest problem surprisingly quickly. The percentage of the country that is eager enough to wait in lines for a new vaccine might be a lot smaller than policy makers are prepared for. And once they are covered all these scheduling problems will evaporate overnight.
I'm concerned about vaccine hesitancy as well. In Israel, despite its incredible success in rolling out vaccinations (and the national pride about that), they're finding it harder and harder to get people to come in to get their shots. There are reports that they're running at half capacity simply because enough people aren't showing up.
"Channel 12 also reports that the Health Ministry is considering a campaign of just calling the holdouts and annoying them into getting vaccinated, which Peled Raz says would be fine by her. “If it makes them uncomfortable, that’s also okay; it’s a more gentle form of encouragement.”
The current hypothesis on why the lower dose was more effective is that it was likely due to the time period between the two doses. Basically, the longer interval between two doses probably increases the efficacy.
There's another advantage to the AstraZeneca vaccine, and that's that one of their trials tested the subjects weekly and total infections (symptomatic and asymptomatic) dropped by about 2/3. That's something that's particularly important for a younger population that's more likely to be going to work or otherwise be unable to self-isolate
The other main hypothesis I've heard is that, since the AstraZeneca vaccine uses an adenovirus vector, the first dose is giving people some immunity to the vector virus, which then prevents some of the payload of the second dose from being delivered.
I think it is unfortunate that epidemiologists have not been more forthcoming about the disease-spread models and the objective function they are optimizing to formulate their predictions and recommendations. Their silence undermines trust that they actually know what they are talking about.
Related is the issue of why the US (and other countries) do not incorporate the decisions of other competent regulatory bodies in their decision-making. This would not mean automatic acceptance, but in a Bayesian sense, it ought to affect decisions.
I am writing to you as a concerned member of the public to ask you to approve the AstraZeneca Vaccine as soon as possible.
I know AstraZeneca messed up their trials and you want them to do a new one. However, the AstraZeneca vaccine has already been approved by the UK and EU regulators, a new trial will take months, the flawed data is enough to show safety and at least pretty good efficacy, and millions of doses of this vaccine are already being produced at a factory in Baltimore.
Please ask AstraZeneca to submit an application with the same info they gave the UK and EU regulators. Millions of Americans like me are desperate to get a vaccine to end this horrible pandemic before the more infectious variants spread. I won't be eligible for many months; even if the AstraZeneca vaccine is "worse" than the currently-approved ones, it's better than nothing, which is the alternative for me. In these extraordinary circumstances, where every day is a matter of life and death for thousands, I hope you can summon a renewed and forceful sense of urgency to get as many people as possible vaccinated as quickly as you possibly can.
I have no idea if this is the right venue for this kind of comment from the public. But I feel strongly on this issue and I have no idea what else to do. So I hope someone is reading this, and thank you for considering it.
==========================================
Dear Mr. Paulson:
Thank you for your email to the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER). One of seven centers within FDA, CBER is responsible for the regulation of many biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines, allergenic products, and cell, tissue and gene therapy products.
We appreciate your interest in this matter.
As you may be aware, FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021, to discuss the request for Emergency Use Authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.
FDA regulates vaccines to ensure that they are safe and effective. Vaccines, like all biologic products regulated by FDA, undergo a rigorous review of laboratory, clinical and manufacturing information submitted by the product sponsor to help ensure the safety, purity, and potency of these products.
Please know that FDA has been preparing for the review of Emergency Use Authorizations (EUAs) for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted. While we cannot predict how long FDA’s review will take, we will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can continue to make vaccines available to the American public.
FDA considers the totality of evidence when evaluating the safety and effectiveness of new vaccines and will continue to collaborate with our global regulatory counterparts and exchange information on the rapidly evolving scientific landscape of products and clinical trials and, as possible, discussing the interpretation of data supporting regulatory decisions.
We hope this information is helpful. If you have additional questions, please contact CBER’s Consumer Affairs Branch by email at ocod@fda.hhs.gov or by telephone at 1-800-835-4709.
My conclusion from both this article and the comments is that there is one thing worse than letting hidebound bureaucrats determine the process and that's letting internet take providers do it.
And on the libertarian front, I want to highlight Alex Tabborok and Arnold Kling who have both been using their platforms to repeatedly shout about this for awhile now.
Tabborok does not count as "Libertarian" in this argument. He is deep in neoliberal territory counting costs and benefits. The "libertarian" argument is that without regulations we would not have the exact problems we see, so better not regulate at all.
It’s more than ok to blame the bureaucrats, no need for throat clearing (former government bureaucrat myself).
The amount of harm that has been done in the name of “following standard process” in this world is beyond measure. If you’re an FDA employee at any sort of senior level, you should be leaking the reasons for the delay to the press.
What is the best argument against approving the AZ vaccine? Every argument I see against this position here is usually a vague notion that regulatory processes are Good or a reference to how the vaccine hasn't actually been submitted for approval. To me, it reads as a kind of knee-jerk "government agency good, pharma company bad" culture war, which is stupid when literally thousands and thousands of lives are at stake.
Is there an actual good argument on the merits opposing an immediate approval of the AZ vaccine?
To steelman the opposition, I think you'd say that given where we are with the J&J vaccine likely coming soon that vaccine hesitancy is a bigger problem than vaccine supply so anything that raises any chance of increasing hesitancy is bad.
The best argument is that Americans won't trust the vaccine if its rushed through the regulatory process and so won't take it even when it becomes availble. We are already having issues with that for the mRNA vaccines which aced the clinical trials.
The idea that the vaccine hesitance people are carefully watching the FDA process and are going to change their minds about AZ when it clears its current trials is farcical.
Wanting to spend a few thousand human lives on propping up bureaucratic procedure is evil.
The issue isn't that vaccine skeptics are monitoring the trials. It's that if a vaccine jumps the normal bureaucratic process and has any high-profile side effect cases or even just doesn't work against some virus variants, that has the potential to immensely damage public confidence in vaccinations and, by extension, our ability to reach herd immunity.
Nobody here is saying "let's not approve the AZ vaccine because I want more people to die"; this is a dishonest strawman. It's just a question of whether you're more concerned with what's going on right now or what's going to happen in the fall. Reasonable people may disagree.
Nobody is advocating that the AZ vaccine jump the process. The argument is that AZ should file an EUA, the FDA should evaluate it through that process, and then approve it based on the available data.
All vaccines will have side effects. AZ won't be unique in that sense. As long as it goes through the EUA process, there's no reason to think that vaccine-hesitant people will be more fearful of the process from it's approval than other vaccines approved through the same process.
The real issue is that the FDA is prioritizing fealty to trial design over taking a more holistic view of the data. They prioritize it so clearly that AZ won't submit an EUA with the current data. Adhering to trial design is worthwhile and important. Trial deviations and creative post-hoc p-fishing can lead to non-efficacious or harmful drugs being approved. But those don't apply here. The benefit-harm ratio is all on the side of benefit.
Some could argue that making exceptions, even to something as immediately inconsequential as the AZ trial deviations, is harmful and could lead to vaccine hesitancy. But, keep in mind that *none* of the vaccines have been approved through the standard process. All have received emergency authorizations through the expedited EUA process. This more significant deviation is not leading to vaccine hesitancy.
given the shortages we're seeing (like, my 60+ year old parents aren't able to be vaccinated), I don't know how anyone can be concerned that there isn't enough demand for the vaccines.
If anti-vax people are scared, they can be skipped in line. Not sure why they have to slow things down for the rest of us.
Yeah I don't really like this argument either but public health officials love acting as amateur psychologists. Around 40-50% of health care workers and teachers aren't taking the vaccine when it's offered to them so this is a really important issue. We don't know the percentages for other populations, but I think it would be similary high across the country with higher uptake rates for more well educated groups. We have seen higher hesistancy rates among poorer and non-white communities.
The key thing for antivaxxers is that its a sprectum. For parents of school age children, there are only a small percentage that are hard core antivaxx and won't ever get their children vaccinated. However, there are significant minority if not majority of people that have some hesistancy. They express this by spreading out some vaccines for their kids over larger periods of time than reccommended by doctors or all getting some but not all of the reccommended vaccines. For the Covid vaccine, it's similar.
I have talked to quite a few people that say they are willingly to eventualyl get the vaccinated but they hesistant to be one of the first groups vaccinated as they don't trust the vaccine yet.They want to wait for more evidence. I see this hesistancy even among highly educated people but it's more common among the non college educated.
I personally think we should approve the AZ vaccine right away and simply ignore these people until we get everyone willingly vaccinated. However, I think many public health officials worry that any perceived issue with the vaccine approval process will cause this group to never become vaccinated, preventing the country from developing herd immunity from vaccinations.
Demand is very strong among 60+ but is likely to slacken off very substantially after we clear that group. A key part of reaching herd immunity to protect the elderly is going to be getting people in their 20s and 30s to get vaccinated.
There is tons of demand from people in their 20s and 30s. And the way to engage more demand from people in their 20s and 30s two months from now when they may have a chance to get the mRNA vaccines is to see their friends get vaccinated today, and then not get coronavirus when they next go to a party where everyone gets it.
Like, think how powerful the news article is when it's like, "20 people did [some obviously dangerous shit together] -- 17 got coronavirus, 3 were vaccinated."
Idk I am currently on campus with a lot of 20 y/o (not that it's exactly representative) and basically everyone wishes they could get vaccinated. Even the people who are basically acting like the pandemic isn't happening (not masking, going to parties, etc.) want to get vaccinated so they don't feel shame or get bugged by classmates about what they're doing.
That's interesting but only goes so far, simply because college campus young people in their 20s are not very representative of the great majority of Americans who don't have degrees (70% of adults) or who are outside of that age group. (85% of adults are older than 29)
That's trivial to solve: don't include AZ as part of the mainline vaccination effort and let people just ask their doctor for it if they want. That will relieve pressure from the mainline effort without anyone having to worry about being given a crappy vaccine.
The only thing standing between me and the AZ vaccine is the FDA. I'd like them to get the fuck out of my way.
I would trust it. Let me have it.
I would trust it and take it, but would prefer others, for obvious reasons.
As to other reasons to tread cautiously, this one is wacky and awkward but lately no one has gone broke overestimating our capacity for partisan hysteria, so here goes:
The AZ vaccine, with refrigerator storage, is good for otherwise under-served communities. BUT we don't have solid trial data and (let me mention the exotic animal in the room) the vaccine is based on a chimpanzee adenovirus.
So who in the Biden Administration (or at a right-wing think tank) wants to be the advocate for letting poor communities be the guinea pigs where we test the "monkey drug"?
Calm, sensible people would not be troubled by the chimp factor, but I'm not talking about calm, sensible people. I'm talking about our current news/political system.
Yes, this is a crazy guess and I understand its rarely safe to try to gauge how crazy other people can be. But the chimpanzee thing *MAY* be giving people pause.
LATE ADD: Apparently I'm thinking like Putin:
"Russian disinformation effort: Oxford’s COVID-19 vaccine turns people into monkeys"
By Yaron Steinbuch
https://nypost.com/2020/10/16/russia-disinformation-says-uk-covid-vaccine-turns-people-into-monkeys/
I'm an American and I'm happy to take it. Many others feel the same way. Be open about the situation and let people make the choice. If some people don't want it, then that's their loss.
I'd feel differently if there were questions about it's safety, but there aren't. The "doubts" are about it's efficacy. However, we give out millions of low-to-moserate-efficacy vaccines every year and no one complains. In fact, public health officials say that more people should get them. They're called flu shots.
I think the best argument against authorization is that authorizing the AZ vaccine now would mean that the ongoing U.S. phase III trial would not be able to provide complete results, which in turn would mean that many of the uncertainties about AZ’s vaccine will remain unanswered.
Wow, I had forgotten that AZ has a US trial in progress. Yeah, this is a huge issue. In my opinion, is the nail in the coffin to this "authorize AZ now" position. We need to actually collect the data.
How many unnecessary deaths are you willing to accept while we "actually collect the data"?
I'm not trying to be glib/mean or anything, but that's the choice we make by delaying the approval of the vaccine.
It's not as simple as delay = more deaths. Medicine (and policy) are complex fields that require careful weighing of various risks/benefits. Yes, delaying probably means more deaths in the short run, but it might decrease deaths in the long run (if vaccine hesitancy increases or if many people get a low-efficacy vaccine instead of a more proven one). The FDA digs through the raw data performs that complicated risk/benefit analysis. I personally trust their expertise on this.
Also, if the FDA immediately authorizes the AZ vaccine, that will shift doses to Americans and away from other countries. I don't think that is or should be included in the FDA's analysis, but it does further undermine your "unnecessary deaths" characterization of the decision.
That said, I do hope the FDA is not overly conservative when it comes to authorizing the vaccines. I am very sympathetic to Matt's post and your urgency. I simply have some counterarguments and maybe trust the FDA scientists and bureaucracy more than those asking for a faster approval: https://www.slowboring.com/p/astra-zeneca/comments#comment-1276810
I'm glad we get to have a bit of discourse about this.
Trusting the FDA's expertise on this is great, generally, but when I think about how the public health establishment has bottled the whole crisis (new disease, sure, and political issues, sure, but everyone deserves to be fired for the masking adventure), combined with the fact that the "normal plan" that their expertise created would've left us without any vaccines at all approved at this point in time, I'm more than a bit skeptical that they really know what they're doing. And maybe they know what they're doing, but their institutional knowledge/biases prevent them from grappling with what needs to be done when 3000+ Americans are dying every day.
Additionally, trusting that the FDA's is being the appropriate level of cautious implies that our friends in Europe are being wildly crazed and that they're endangering all their citizens, which is a bit absurd on its face.
I'm skeptical of the "shift doses towards Americans" line, mostly because the mythical Baltimore vaccine plant is in fact making doses right now. Separately, the FDA's concern should primarily be with safeguarding American lives. The State Department and the CDC's Global Health Coordination Unit and such can worry about vaccinating the global South, whether that's by buying vaccines form them or cutting big checks to help India build more vaccine factories.
Let me know if I've misunderstood anything you said.
https://sports.yahoo.com/plant-east-baltimore-making-millions-000000239.html (yahoo sports reprinted the Baltimore Sun article, which is paywalled at the original site)
Yes, it's nice to have a reasonable discussion. :)
I don't think FDA took the "normal plan" for the Moderna or Pfizer vaccines, and I presume they also feel urgency about AZ and J&J. The FDA didn't rush the currently authorized vaccines, and I don't think they should hold AZ to a lower standard for demonstrating safety and effectiveness.
Yes, 3000 people are dying a day in the US. Most of those people are elderly, but the majority of people who will take the vaccine are younger and at much lower risk of death from covid. So the calculus is a little complicated. If everyone had the same 10% risk of dying of covid that the elderly have (or if the vaccine were only authorized for the elderly), the FDA would presumably set the bar very low.
I don't think that Europe are reckless, especially given the fact that the FDA approved the Moderna and Pfizer vaccines before or at the same time as their European counterparts.
If there are stockpiles of doses just waiting for Americans' arms, I would be more sympathetic with the request to let people get the AZ vaccine. I don't know if there are those stockpiles. I understand the Baltimore plant is making the vaccine, but those could already be dedicated to Europe.
Ultimately, I don't have a strong opinion about this issue, except for the belief that I don't have enough information and that I personally am OK with trusting the FDA on this.
I don't understand this argument at all. The data will be collected. The participants are participating. If anything it slows down the trial because there is less covid. But so what?
My understanding is that once the AZ vaccine is authorized, ethical protocols dictate that all the participants must be unblinded so that those who are in the placebo group are given the opportunity to take the real vaccine.
This makes sense in a normal situation, but its not a normal situation today. I think that the phase III trial at this point is to assess efficacy, not safety and given that, I would offer both arms immediate vaccine access as soon as you hit a defined end date. I don't recall the trial or vax candidate but there is apparently more wiggle room in trial design (example, giving the placebo arm a "second chance" before the trial ends on a 50-50 basis). There also should be much more flexibility in reviewing data from the many countries out there that have approved the vaccine. This process you outline makes a lot of sense when we are talking about trials that are expected to take years due to low levels of viral transmission and i do think the use of EUA has been a strong accelerant. But i think we deserve more creative thinking from the FDA.
The best arguments are a) a rushed approval for a vaccine which could potentially end up with a few explosive high-profile side effects would be IMMENSELY damaging to public confidence in vaccination and b) the fact that it appears to be largely ineffective against the South African strain renders it of dubious value overall.
I understand the impetus for "approve everything!" but smart policy money is apparently that we will start to run out of lent-up demand by April. I don’t think there’s much value in introducing a potential ineffective vaccine to the pool when we have a number of highly effective ones.
Except it is likely to be effective against the SA variant (which is not a strain) in the most important categories, hospitalization and death. And so I don't really understand the point of stopping use of the vaccine in SA, much less not allowing it to be used here.
Dr. Fauci revised the "late March/early April" timeline for widespread availability to mid-May/early June. But your point - we shouldn't let a short-term shortage push us into a longer term problem - is good.
https://www.cnbc.com/2021/02/16/dr-fauci-slightly-delays-timeline-for-widespread-vaccine-availability-in-the-us-to-may-.html
I think there has been a lot of unfairness to the Russian vaccine efforts given the Sputnik vaccine seems to work. That said, the perception that the Russian government is willing to cut corners for a quicker win has to be part of the reason 60% of the Russian population doesn't want the vaccine... I don't think it's really fair to analyze just the one case. What is the impact on the population's trust of the FDA and scientific establishment over the long term?
https://www.newyorker.com/magazine/2021/02/08/the-sputnik-v-vaccine-and-russias-race-to-immunity
"The inoculation would begin in Moscow, with health-care workers and others who had a high risk of exposure, including teachers and social workers. A poll taken in September, however, had shown that up to half of Russian doctors and other medical professionals weren’t yet willing to get the vaccine, owing to the rushed approval process and a lack of concrete data about the safety and efficacy of Sputnik V. The Levada Center, an independent polling and research organization based in Moscow, found that, as of December, nearly sixty per cent of Russians did not wish to be vaccinated. (At the time, polls in the United States indicated that about a quarter of the population did not want to be vaccinated; in France, which has one of the largest anti-vax movements in Europe, the number hovered around fifty per cent.)"
Here are my reasons. It’s a risk/benefit analysis, and I think the overall benefits might actually be smaller than at first glance (see B).
A) There are a lot of details and a pharma company’s job is to put the best possible light on their trial. I suppose the FDA could just trust it’s European equivalent or the WHO.
B) I don’t think there’s a huge stockpile of the AZ vaccine simply waiting for Americans’ arms. Maybe I’m wrong, but presumably the current supply is being directed at European countries where it is already approved. If rushing the approval makes only a very small increase in US vaccination rate, then the benefits of rushing are small.
C) The drawbacks of rushing range from terrible (if the EUA eventually needs to be withdrawn) to bad (generally increasing vaccine hesitancy).
The FDA will never forget Thalidomide, which was approved in Europe and Canada but not by the more-cautious FDA. It caused horrific suffering wherever approved.
The argument against approving ALL of the vaccines is that we have absolutely no data on long term side effects. None. Zero. Zilch. Approval seems far to much to expect, given that total absence of data.
The leaves the question of emergency use authorization. (It's really quite something to hear/read people mock a regulatory process while making clear that they actually know nothing about about actual process they are mocking. If you can't be bothered top look at the details of the process, of course you are not going to be be able to weight out its benefits and risks.)
What is the case against emergency use authorization? Well, that would take an examination of the data analysis to ensure that there are not errors in it leading to wildly distorting bottom line numbers. It would take looking closely as the nature of the sample of participants, so that the analysis is sure to compare to right baselines, again to be sure that the bottom lines numbers are not distorted. The case against, like the case for, depends on the actual data.
Not just the summery statistics. Not just the unsophisticated average.
But the controlled and careful analysis that actually gives us insight to actual effectiveness.
And, if it turns out that after all of that, the vaccine is moderately but not highly effective? Well, perhaps emergency use authorization is appropriate, as it is by definition temporary. And perhaps actual approval -- which is assumed to be for the normal term -- would not be appropriate, as greater supplies of more effective vaccines become available.
It's in the details. Which is another way of saying that it's in the facts. You know, those pesky facts. Facts that I do have access too, and am not arrogant enough to think I can do without when coming to important conclusions.
Vaccines have one long-term effect: immunity.
My flu vaccine does not last all that long.
And that's an approved vaccine. The medications that do not get approved often have lots of other side effects.
>>The leaves the question of emergency use authorization. (It's really quite something to hear/read people mock a regulatory process while making clear that they actually know nothing about about actual process they are mocking. If you can't be bothered top look at the details of the process, of course you are not going to be be able to weight out its benefits and risks.)
This sounds a bit like the gun nuts who say "if you don't know the difference between a clip and a magazine, don't talk to me about gun control"
Au contraire.
Were I suggesting that we ban clips but not magazines, and I did not know the difference, I would a fool -- and a lazy one at that. Similar if I suggested banning magazines but not clips. However, if I suggesting banning anything that enabled a gun to hold more than 8 (for example) shots without reloading -- even if my language was off -- and someone resisted because I not know the technical language, that person would be an asshole.
But right now we are in a situation in which we have had emergency use authorization BUT NOT APPROVAL for some vaccines. We are in a thread in response to an article in which the author pointed out that the pharma company was not seeking EUA, but was expecting to receiving approval in a few months. This is a distinction that matters generally AND that matters in the context of this particular set of comments.
I am not suggesting that everyone need to be an expert on everything. Rather, I am suggesting that if you claim that a particular process is too cumbersome, it behooves you to examine the process to understand how cumbersome it ACTUALLY is and -- or order to evaluate whether or not the cumbersomeness is excessive -- what that cumbersomeness accomplishes. Before saying this is too costly for what we get out of it, look at the actual cost and look at the actual benefit.
There are hundreds of thousands of lives on the line -- if not millions around the globe. And there are potentially billions of people who have have long term complications or side effects from experimental drugs that they are taking without full investigation or approval. This stuff matters. Getting it right matters. Paying attention to the details matter.
I am not saying to leave to the experts. I am saying to become moderately expert (or at least highly informed) before blowing them off.
The alternative to be what I have come to call "presidential."
I get what you're saying, but at the same time, at some point even those who haven't looked into the nuts and bolts of the process are entitled to say "by their fruits will ye know them"--and the outcomes in the areas of pandemic response controlled by the FDA have been terrible. I'm not just thinking of vaccines, but also even worse, testing.
two perhaps mildly contradictory points:
1) You know the expression about sausage and legislation? You do NOT want to know about the process of making them? Well, in my experience that is true all over the place. No one actually does anything right. There are shortcuts all over place and the more your know about how work is ACTUALLY done, it more disturbed you can be.
My father was a regulatory attorney who did pharma stuff. Pharma paid for my childhood. My wife is an employment attorney who spent much of my 40's in a pharma company. Above, Allen said that a lot of this stuff sounds like "pharama bad, regulations good." My father and my wife were both on the pharma side, and they taught me that, ummm....yeah....regulations good. Regulations necessary. Without regulations...really really bad.
2) But I don't actually know what it takes to create or approve COVID tests. I am a researcher, but not in the physical sciences. I do not know all stuff that goes into drug approval applications. I'm pretty good on quantitative methods, but -- again -- I don't analyze THAT data. I've never worked such an application or seen one. My dad did (the legal stuff, not the numbers), and my wife was at a company while they did these things. But I don't know that stuff, myself.
Admitting the limits of our knowledge is really important. Assuming that anyone out there has the potential to be perfect or that perfect is the expectation is...it feels like dunning-kruger to me. A kind of arrogance that prevents intelligent analysis.
I don't like what happened to the tests. I don't like how slow these authorizations are. But to criticize them because I -- a well informed outsider with very limited knowledge -- would like it to be faster? Man, I'm pretty fucking arrogant, but I'm not THAT arrogant. I don't know enough to know whether my expectations are the least bit reasonable. I know a lot, but not enough to to know what.
3) And on EUA vs. approval? I didn't know anything about that stuff a year ago. But I've paid attention for the last year and learned that. No insider sources. Just the kind of stuff that available to us all. Not the kinds of journals I read for my own work. Just journalism and mass media.
I too am confused by the actions of the FDA. How about this explanation:
Vaccine skepticism for COVID is more widespread than the normal anti-vaxxer movement, especially for PoC. Estimates of this are up to 35% of the population that doesn’t currently want a vaccine. E.g., my friend works at a vaccine center in the Bronx that had hundreds of doses that were going to waste; they went out on the street to recruit locals but nobody wanted it.
When PoC are told they’re getting a different vaccine from the good one that white people get, that won’t inspire confidence.
Keeping everyone on the same product will alleviate these fears.
Thoughts?
How will re-running the AZ clinic trial make this population less hesitant to get it? They're hesitant to get vaccines "that white people get" and that have aced their clinic trials! If they don't want the AZ vaccine, so be it, but this white guy wants it now.
The issue isn't with the trials, it's with segmenting shots by population. If they give "the good shot" to the vulnerable, first responders, and predominantly to white people, and "the new shot" goes to everyone else, that's not going to bring confidence.
If you believe that the AstraZeneca shot is good, then give it to everyone. But only giving it to people who aren't eligible for the other shots may get us to 65%-vaccinated faster but will hurt our ability to get to 90%+.
My proposal would be to give the AZ shot to young people who want to get it, while the mRNA shots continue to be rolled out based on age with younger folks allowed to wait for them if they prefer.
Yeah, I actually agree with your proposal. I'm trying to steelman the opposite case, and I don't think I'm succeeding. To try a little harder on my original line of argument:
This would make the Moderna/Pfizer shots be the good & safe ones, while the AZ would be the riskier one that's only good to give to young people. Does that unfairly denigrate the AZ shot which will reduce vaccine trust overall?
The proximate goal is to get vaccines to everyone who wants, but the long-term goal is to get them in 90% of people's arms.
Remember that this is not a one-shot game, and trust that is built up over time is easily spent. We don't know what is coming (variants, other pandemics), and epistemic humility suggests the FDA shouldn't spend its trust-capital too quickly.
[end steelmanning] OTOH, these are second order effects that are probably massively outweighed by the likelihood of saving 50,000 lives.
What are the chances that, by producing a contrast between "the bad shot young people can get if they want" and "the good shot that old people can get now and others have to wait for", they actually end up *increasing* confidence in "the good shot"? (It's really not obvious to me what the net effect would be - having a "good shot" and a "bad shot" could decrease confidence in both, increase confidence in both, or increase confidence in the good one while decreasing confidence in the bad one.)
Nobody is advocating switching entirely to AZ. We could keep it out of the mainline vaccination effort and let people voluntarily sign up to get an AZ vaccine out of line. That would reduce pressure on the mainline effort and vaccinate more people faster.
"...predominantly to white people..."
What?
...you could also give educated and young people the AZ vaccine and save the more efficacious Pfizer/Moderna vaccines for more vulnerable populations
I don't understand why any good-faith actor would spread that message unless that was actually happening.
What you're saying is people in the Bronx don't want "the good" vaccine, so if AZ was rolled why would vax rates would go up if "the bad" vaccine was now offered there? But I would guess that in upscale, highly-educated (more white than the Bronx) neighborhoods with unmet vaccine demand, more people would get vaccinated with 'the bad' vaccine.
Even if it played out differently, who would be spreading that kind of message and for what purpose as long as both versions of the vaccine are being distributed as widely as possible?
“I don't understand why any good-faith actor would spread that message unless that was actually happening.”
Two words: Fox News.
If they can create a scandal over a tan suit, they can sure as hell create a scandal around “good shots” and “bad shots”.
Do we know if the effectiveness of Pfizer and Moderna are impeded by a prior administration of AstraZeneca?
This is the key question and it’s been frustratingly under discussed.
My best guess for you is "no" (as in: I personally would take AZ), but I don't see any data being collected on this questions unless strategies change.
I don't think there's any data on it, but the AZ vaccine is based on a much different approach that Pfizer or Moderna, so I'd bet that they don't interfere with each other. I think there's more concern about one adenovirus-based vaccine interfering with another.
Just remember, AZ is not a human adenovirus. J&J vs Sputnik V would be more of a problem.
The mechanism of both is that they trigger an immune system response to the spike protein. It's plausible that the mrna vaccines won't trigger as strong of an immune response after being vaccinated with the AZ vaccine, so the overall immunity will be lower.
"“their failures to do the basics of drug research cannot be dismissed based on the whims of masturbating libertarians.”"
Man, why do people have to use such gross and revolting language?
I would *never* call someone a "libertarian" like that.
I'm going to start an emo band called "masturbating libertarians". Everyone in the band will play lead guitar. :-)
I generally agree but am concerned about decrease in efficacy of AZ against the South African variant. Similar findings with J & J and Novavax but still protective against severe illness. The mRNA vaccines seem to be better against SA variant but the only data is from lab experiments and not the real world.
Right. And if I understand the science correctly, it seems the mRNA vaccines are easier to "reprogram" against the new variants than the conventional vaccines.
The AstraZeneca vaccine is in this way more like the mRNA vaccines - it's effectively an mRNA vaccine that, instead of using a lipid nanoparticle, uses a chimpanzee virus to deliver the mRNA to your cells. It trades the cold chain difficulties of the mRNA vaccines for the possibility of immunity to the chimpanzee virus as a way to lose efficacy. But it should be updateable in the same sort of way, I would think.
It's a DNA vaccine, for what it's worth. I *think* that's why it requires an adenovirus vector, to get to the cell nucleus.
"Unless someone at the FDA can explain to him in a compelling way that they have actual doubt about the safety and efficacy of the vaccine — as opposed to quibbles about the process or a scientific interest in seeing data from a better-designed trial ..."
Aren't the "quibbles about the process" and the issues with the trial design part of the reason for doubts about efficacy?
>Aren't the "quibbles about the process" and the issues with the trial design part of the reason for doubts about efficacy?
I've seen a lot of people claiming that changing the process will make others less confident in the vaccine, but personally I haven't seen a single person say "because of the changes in the approval process, I do not believe that the vaccine is effective."
I don’t think that’s the issue. I think the more likely issue is the fda approves the vaccine, it is used disproportionately in rural/poorer areas because of its lesser refrigeration requirements, and then there is an unexpected result in the new trial leading to probably sensationalist news stories that result in a lot of distrust. I don’t know if that’s exactly how it would go down or not but I do think it’s important to think through what this would look like in the real world.
It's approved in Europe, though. Do you think that's what's going to happen there?
It can't be the case that their approval process was fine and so their AZ vaccine is safe but ours was rushed so our AZ vaccine will be flawed, because it's the same vaccine and the same human physiology so the results will be the same. Thus if it follows that you think European regulators didn't err in approving the AZ for distribution in Europe, then there's no conceivable objection to also distributing it in the US, immediately.
Yes, absolutely. I find the rush to approve this very problematic in that it completely discounts the immense damage that could be done to campaigns to reach herd immunity by an ineffective or outright flawed vaccine which was perceived to have been rushed through the process by FDA. Most informed policy makers seem confident that we’ll see demand start to slacken by like April, so barely over a month/month and a half. J&J will already more than adequately increase throughput; there is no reason to rush a vaccine which may prove ineffective against new variants.
As Matt observed, the only reason the EU *had* to approve this is that they lack other options. We do have other options that will adequately address demand.
"I find the rush to approve this very problematic in that it completely discounts the immense damage that could be done to campaigns to reach herd immunity by an ineffective or outright flawed vaccine"
Why would it be "flawed or ineffective"? That makes no sense. It's approved for use in Europe - do you think they made a mistake in doing so? Nobody actually seems to think they did.
As Matt observed above, and I observed in my own comment, which you appear to have ignored, the reason it's approved in Europe is that they have to approve it; they don't have adequate supplies of anything else. If that were the case for us too of course I'd support approving it here; but we have considerable supplies of Pfizer, Moderna, and J&J, to the point that experts believe supply will begin to overtake demand within a month or so.
But we actually don't have adequate supplies of anything else, which is why you, me, and most everybody else aren't getting vaccinated until the summer and about ten thousand human lives will be lost that didn't need to be, in the interim.
As for "ineffective", we already know that it's not useful against the SA variant to the point that SA is literally giving away its doses.
Great but we don't live in South Africa and that's not the predominant variant in the US.
We don't know this. If anything there is a strong possibility (that would need more data to be confirmed) that in SA, not a single person in the vaccine arm who was diagnosed with COVID exhibited a "severe" case, nor has been hospitalized or died.
If you have doubts about it's efficacy, then choose the lower of the two numbers they produced (which was part of the larger trial). It's still a good enough number.
It's too bad that Republicans and libertarians have become so obsessed with their various culture war hang-ups that any useful good government ideas they may have contributed are squarely in the past at this point.
No. I think the Republican party had something to contribute in this area in the past. It's not like Democratic city governments have always covered themselves in glory on effectiveness. And this had something to do with high growth areas in the west being traditionally Republican in the post-war era. But the trend of the Republican party becoming useless started about 30 years ago and was mostly complete about 10 years ago. Trump is kind of the icing on that cake.
It has to do with part of the original post, near the end:
"'Costly regulations are hurting the country' is the classic conservative and libertarian policy critique. But when I scrolled the front pages of Cato, Heritage, and AEI last week, none of them were highlighting content calling for approval of the AstraZeneca vaccine. Congressional Republicans are criticizing the Biden administration for all kinds of stuff, but they’re not calling on the FDA to approve the AstraZeneca vaccine."
What mpowell is saying is that in the past, the Republican Party and its associated think tanks would have been pushing for faster approval of the vaccine because it fits extremely well with their criticism of over-regulation by the federal government. But now, the GOP is more concerned with who can say what on Twitter than with a productive contribution to policy/politics like advocacy for reduced regulation in a situation where there's a pretty good argument for it.
Exactly.
1) I will be a *lot* more confident that the AZ vaccine works after a panel of experts digs through the raw data and confirms the findings summarized in papers. I don’t fully trust a pharma company’s summary of their trial results. There are a lot of details and a pharma company’s job is to put the best possible light on their trial.
2) Yes, zero people died of covid in the vaccine arm. But only 1 person died in the control arm. Very small numbers here and not reliable to draw a solid conclusion about deaths. That said, it’s pretty clear from the trial that the vaccine is likely safe and effective.
3) I don’t think there’s a huge stockpile of the AZ vaccine simply waiting for Americans’ arms. Maybe I’m wrong, but presumably the current supply is being directed at European countries where it is already approved. If rushing the approval makes only a very small increase in US vaccination rate, then the benefits of rushing are small.
4) The drawbacks of rushing range from terrible (if the EUA eventually needs to be withdrawn) to bad (generally increasing vaccine hesitancy).
Wait, I just want to make sure I have the punchline right? Are you saying that in the _entire_ set of AZ vaccine trials across all countries, they only had one person die in the control groups? Or is that specific to the smaller US trial? Do we know the raw numbers for the EU trials?
Yes. In the entire AZ trial with 11,636 participants, they only reported one covid death, and that was in the control arm.
"From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death."
Also: "There were four non-COVID-19 deaths reported across the studies (three in the control arm and one in the ChAdOx1 nCoV-19 arm) that were all considered unrelated to the vaccine, with cause of death assessed as road traffic accident, blunt force trauma, homicide, and fungal pneumonia."
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext
Man....I'm not a stats guy but that seems...really really weak? :-(. Why was the trial so small?
Very large trials are expensive and difficult and slow. This was fairly large, but the incidence of covid was lower during the trial at the locations they chose. Also, most of the participants were younger, and not at risk of dying from covid in the first place. Because the main measure of the trial was any symptomatic covid, not specifically death, the size of the trial was probably sufficient.
Why are very large trials slow? One would expect them to be faster, since higher N means less time until a significant result is recorded.
Recruiting and enrolling subjects at test sites is the rate-limiting step, and the larger the trial, the longer that takes. You need to ensure reasonable demographic coverage, some geographic diversity, and so on. You can increase the number of sites, but not unboundedly --- i.e. you can't just get someone's personal doctor to inject them.
I'm sure that you're right that they could be fast, given sufficient resources. :)
Re: 1, exactly. Everyone here keeps talking about how it's approved in Europe and the UK, but those places just trust the summary results from the pharma company and don't actually independently verify via the raw data.
Serious questions, because you've been vocal about this for awhile: 1) what dosing regime should we use? And 2) should we approve Russia's Sputnik V vaccine? That trial was far more sketchy than AZ's, subject to a wide range of vocal disapproval across the globe, and yet is now showing 92% efficacy. https://www.npr.org/sections/coronavirus-live-updates/2021/02/02/963166648/russias-sputnik-vaccine-is-reported-to-be-92-effective-against-covid-19
Because the trial was sketchy, there are a lot more data integrity problems. The results were published in a peer-reviewed journal, and that is one level of quality control, but peer-reviewers are unable to make these kinds of assessments
@Tokyo Sex Whale -- great name. Musa Bility and Prince Ali say hi.
My frustration with Matt's (and others') push to approve the AZ vaccine is that the CI for their data is pretty broad due to the sample size -- that's why you run the trial! Sinovac's preliminary efficacy numbers ranged from 70-90%... and then they completed their Phase III trial and reported it at 50%. Sputnik V seemed like something Putin was pulling out of thin air, but it turns out to work pretty well! Lots of insiders thought Merck had an inside track to a leading candidate, and then they pulled both of their efforts. The point is, you don't know until you gather all the data.
Maybe AZ's vaccine is in the ballpark of J&J's (probably the best guess at this point). And maybe it's better! But maybe it's in the 50% range of Sinovac, with no benefit for the elderly. Then what? Do you tell people "yeah, the US government bought all these doses of a vaccine that doesn't work as well as the mRNA vaccines and may not offer protection against the fast-growing variants, but take it anyway"? You'll have a lot of people saying, "No thanks, I'll wait until we have enough doses of Moderna and Pfizer, thank you very much."
At the end of December, the US was averaging 250,000 vaccination shots per day. Currently we're at just under 1.9 million shots per day. In a few weeks, especially if J&J is approved, I would hardly be surprised if we're at 3 million per day. Back in December Biden aggressively called for a goal of 1 million per day, then had to scurry around to increase the bar to 1.5 million per day, obviously well below where we're at.
I'm not saying we shouldn't treat this as a great emergency and not consider all possible resources. I'm just saying we're currently well ahead of where anyone thought we'd be with likely more progress to come. It's possible that the situation will be resolved positively under current processes.
I think you're right. Vaccine hesitancy will replace vaccine access as the biggest problem surprisingly quickly. The percentage of the country that is eager enough to wait in lines for a new vaccine might be a lot smaller than policy makers are prepared for. And once they are covered all these scheduling problems will evaporate overnight.
I'm concerned about vaccine hesitancy as well. In Israel, despite its incredible success in rolling out vaccinations (and the national pride about that), they're finding it harder and harder to get people to come in to get their shots. There are reports that they're running at half capacity simply because enough people aren't showing up.
https://www.timesofisrael.com/israels-vaccination-stagnation-why-weve-caught-it-how-to-cure-it/
Just saw this as well:
"Channel 12 also reports that the Health Ministry is considering a campaign of just calling the holdouts and annoying them into getting vaccinated, which Peled Raz says would be fine by her. “If it makes them uncomfortable, that’s also okay; it’s a more gentle form of encouragement.”
https://www.timesofisrael.com/the-pass-is-always-greener-what-the-press-is-saying-about-needling-the-shot-shy/
The current hypothesis on why the lower dose was more effective is that it was likely due to the time period between the two doses. Basically, the longer interval between two doses probably increases the efficacy.
https://www.bmj.com/content/372/bmj.n326
There's another advantage to the AstraZeneca vaccine, and that's that one of their trials tested the subjects weekly and total infections (symptomatic and asymptomatic) dropped by about 2/3. That's something that's particularly important for a younger population that's more likely to be going to work or otherwise be unable to self-isolate
The other main hypothesis I've heard is that, since the AstraZeneca vaccine uses an adenovirus vector, the first dose is giving people some immunity to the vector virus, which then prevents some of the payload of the second dose from being delivered.
I think it is unfortunate that epidemiologists have not been more forthcoming about the disease-spread models and the objective function they are optimizing to formulate their predictions and recommendations. Their silence undermines trust that they actually know what they are talking about.
Related is the issue of why the US (and other countries) do not incorporate the decisions of other competent regulatory bodies in their decision-making. This would not mean automatic acceptance, but in a Bayesian sense, it ought to affect decisions.
I sent an email to the FDA on this subject a few weeks ago. Probably not useful...but I don't know what is. Did get a reply, but it didn't say much.
=============================================
to: ocod@fda.hhs.gov
Subject: Please approve the AstraZeneca Vaccine
I am writing to you as a concerned member of the public to ask you to approve the AstraZeneca Vaccine as soon as possible.
I know AstraZeneca messed up their trials and you want them to do a new one. However, the AstraZeneca vaccine has already been approved by the UK and EU regulators, a new trial will take months, the flawed data is enough to show safety and at least pretty good efficacy, and millions of doses of this vaccine are already being produced at a factory in Baltimore.
Please ask AstraZeneca to submit an application with the same info they gave the UK and EU regulators. Millions of Americans like me are desperate to get a vaccine to end this horrible pandemic before the more infectious variants spread. I won't be eligible for many months; even if the AstraZeneca vaccine is "worse" than the currently-approved ones, it's better than nothing, which is the alternative for me. In these extraordinary circumstances, where every day is a matter of life and death for thousands, I hope you can summon a renewed and forceful sense of urgency to get as many people as possible vaccinated as quickly as you possibly can.
I have no idea if this is the right venue for this kind of comment from the public. But I feel strongly on this issue and I have no idea what else to do. So I hope someone is reading this, and thank you for considering it.
==========================================
Dear Mr. Paulson:
Thank you for your email to the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER). One of seven centers within FDA, CBER is responsible for the regulation of many biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines, allergenic products, and cell, tissue and gene therapy products.
We appreciate your interest in this matter.
As you may be aware, FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021, to discuss the request for Emergency Use Authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.
FDA regulates vaccines to ensure that they are safe and effective. Vaccines, like all biologic products regulated by FDA, undergo a rigorous review of laboratory, clinical and manufacturing information submitted by the product sponsor to help ensure the safety, purity, and potency of these products.
Please know that FDA has been preparing for the review of Emergency Use Authorizations (EUAs) for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted. While we cannot predict how long FDA’s review will take, we will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can continue to make vaccines available to the American public.
FDA considers the totality of evidence when evaluating the safety and effectiveness of new vaccines and will continue to collaborate with our global regulatory counterparts and exchange information on the rapidly evolving scientific landscape of products and clinical trials and, as possible, discussing the interpretation of data supporting regulatory decisions.
If you would like to receive email updates, from CBER you may subscribe to our mailing list on our website at: https://www.fda.gov/vaccines.../resources-you-biologics....
We hope this information is helpful. If you have additional questions, please contact CBER’s Consumer Affairs Branch by email at ocod@fda.hhs.gov or by telephone at 1-800-835-4709.
The FDA reply is just too much.
My conclusion from both this article and the comments is that there is one thing worse than letting hidebound bureaucrats determine the process and that's letting internet take providers do it.
Bravo on this article.
And on the libertarian front, I want to highlight Alex Tabborok and Arnold Kling who have both been using their platforms to repeatedly shout about this for awhile now.
Tabborok does not count as "Libertarian" in this argument. He is deep in neoliberal territory counting costs and benefits. The "libertarian" argument is that without regulations we would not have the exact problems we see, so better not regulate at all.
It’s more than ok to blame the bureaucrats, no need for throat clearing (former government bureaucrat myself).
The amount of harm that has been done in the name of “following standard process” in this world is beyond measure. If you’re an FDA employee at any sort of senior level, you should be leaking the reasons for the delay to the press.