You are mistakenly mixing the approval of factories with the approval of the vaccine. While related, they are two different things. Also, you must consider the kind of approval. I haven't brought a vaccine to market but I have been involved in getting factories approved.

Factory approval is about process control, temperatures, chemical content, cleanliness, measurement tracking, batch tracking, etc. It's not about efficacy of the drug, other than efficacy approval establishes the quality parameters that must be met.

1. Factory approval requires a level of documented paperwork and demonstrated compliance with procedures that can be staggering. You must track every item, every machine, every process, every worker, every procedure. These must be documented, logged, etc. Every potential problem, actual problem, modification, etc. must be documented, reviewed, and approved. All of this documentation must be available on demand to an FDA inspector, and the inspector must have instant access to the relevant parts of the factory with no warning, no appointment, and no warrant. The initial approval determines what are the relevant parts of the factory and it's agreed by the FDA. If you relocate any people or machines this can change the access.

This level of inspection access is problematic to many people. I've watched multi-year battles between the FDA and some European companies over this level of access. This kind of access is anathema to a closed controlled country like China.

2. The US vaccines are being made in factories that were already approved for manufacture of other similar drugs using the same equipment. Adding one more drug to the process is trivial in comparison to approving a new factory. That's been one of the limits to increasing production. Once the factories already approved and capable of making the vaccine are at 100% capacity it's very slow to get new factories approved. The FDA has not weakened the manufacturing safety rules.

3. The efficacy rules for the vaccine approval were weakened. If you want to read the endless details they are available. The FDA published the Emergency Use requirements about a year ago. They are the basis for all the current vaccine distribution. They are less stringent than regular requirements. The first vaccine to meet the regular requirements was only approved by FDA about a month ago. The manufacturing rules were not weakened.

I agree that the FDA process is excessively risk averse and excessively bureaucratic. It's prioritization is often terrible. This certainly needs work. The careful improvements needed are not the kind of chanage that you are suggesting.

I've also seen and inspected factories that failed the FDA inspections. I was shocked and appalled. The level of filth and contamination of products was staggering. For example, you should expect a factory floor that you are comfortable eating off. (Of course food won't be allowed into the facility, so you won't actually eat off that floor.) I saw factories with muddy dirty floors, bird droppings, etc. These places wouldn't pass routine kitchen inspection at a restaurant.

Many people don't realize what is needed.

The non-FDA factories that I've seen which would pass FDA cleanliness and process control inspection were semiconductor fabs, precision electronics manufacturing, etc. I helped bring one precision electronics manufacturer up to FDA standards and it was pretty easy. We mostly documented and explained how their existing extremely demanding process control met all the goals set by the FDA. It took about 5% the time and cost of bringing a new production facility up to FDA standards, with very little process change needed.

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I think public health officials cajole rich countries into foregoing booster shots and child vaccination at the peril of global public health. Far better to work on supply. At the end of the day people don't want themselves or their loved ones to get sick or die. Confident, less-stressed rich country residents (who have no reason to complain about people in poor countries) are more apt to support the kinds of global vaccine aid the world needs right now. Reminds me a bit of the climate change sub-debate regarding conservation vs. abundant (green) energy. The latter would be vastly preferable, if it could be pulled off.

In short, rich countries should do more if at all possible, but not at the cost of denying their own citizens medically recommended, optimal vaccine regimens. At least that's my take.

I'm fully vaccinated with Sinovac, for what it's worth.

(Also, Chinese pharma firm Shanghai Fosun is working on a deal with BioNtech, it appears. In the Chinese press, at least, I haven't seen the name "Pfizer" mentioned).


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It seems to me like the underlying utilitarian logic behind denying vaccines to American children so they are available to foreigners is a bit questionable. The moral reasoning might be sound, but we don't follow it in any other context. If every American who vaccinated their kid also gave $100 to a Give Well recommended charity that wouldn't that save more lives than reserving the vaccine supply for foreigners? Wouldn't you gladly spend $100 to vaccinate your kid? In the real world Americans aren't going to actually give an extra $100 to charity, but that's because we don't care much about foreigners!

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First, let me say that I love that you threw shade your panicky neighbors/friends.

I already got my booster shot. I had the Pfizer back in March and April. So I had to come to Argentina to work last week, and I really didn’t feel like ending up in an Argentinian hospital. So I made an operational risk management decision, to get a Moderna booster.

The problem is in Idaho there’s a State Vaccine database, and I already used my insurance on my Pfizer.

The solution was for me to drive across the border to Oregon, and pretend that I was unvaccinated, and that I wanted the Moderna. I just told him that I was self-employed without insurance, and got the shot.

I will say that the Moderna Booster fucked me up for about a day and a half.

I am not advocating everyone do this. But my job involves a lot of international travel working side-by-side with South American technicians. I would say that I am high risk. Add to that that I really don’t want to end up in the south American hospital where I don’t speak the language well. I decided that a little rule breaking was worth it.

As far as the moral argument that I took someone else’s shot. The fact is that these days there’s a lot of vaccine that’s going to waste.

My ex-wife works at a pediatric clinic. And they have given out “boosters” at the end of the day when they have extra vaccine left that will expire.

We half considered vaccinating our 10 and 11 year old, but decided not to. Just on the small chance something happened, we didn’t want to put anyone at risk.

Anyway, even with the vaccine and a booster, I am on day six of my quarantine here in Argentina. I just got my third PCR test. When it comes back negative tomorrow morning, I get to check out of this hotel and go to another hotel to finally start my job.

And while I feel sorry for foreigners, I want my kids to get vaccinated, and I want them to approve vaccines for them.

Yesterday, my 10-year-old got told that she has to sit at home for the next 11 days because she was exposed to someone who had Covid in her class on Friday. My daughter wears a mask, but they aren’t required.

So because of whatever rules, she hast to sit out. My 11-year-old just finished up a 14 day quarantine for the same reason.

At this point, I almost just want every kid in the school to get Covid to just get that shit over with. This in and out of school stuff sucks.

Once vaccines are approved, then we should just treat it like the flu. If your kid is not vaccinated and gets it, send them home, my kids is staying.

I know there’s all sorts of moral and ethical arguments about whether you should help your kids a little bit or foreigners a lot. But, I have no doubt that the Chinese will take care of their own first if they were in the position we were.

On a sidenote, I was speaking with my Trumpy friend who lives in the villages in Florida. Complete anti-VAX dude. He confessed that he got Covid about three weeks ago, but recovered in three days and said it was just like getting the flu. Anyway, he wants me to go to pharmacies here in Argentina and see if I could pick up ivermectin.

Anyway, I feel like this is one of those comment threads/conversations where all of you guys are just a lot smarter than I am. I’m just a blue-collar dude with an average IQ that likes to dictate on his iPhone.

But the good thing is if any of you guys argue with me, I’ve got all day to argue back with you. Bring it on.

As always, I was too lazy to get out my computer, so this whole comment was dictated on my iPhone. So forgive the grammatical errors.

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I'm not sure if your anecdote about the FDA slow-playing boosters and child vaccination is true, but if the Biden Administration is actually trying to prioritize global vaccination then maybe they shouldn't actively humor these paranoid people.

Right now (fully vaccinated) Joe Biden is wearing a mask around his (fully vaccinated) cabinet and the admin has supported school mask mandates. Maybe the low hanging fruit to encourage Americans to prioritize global vaccination would be to act as though (a) the vaccines work and (b) children are at low risk without vaccination. Otherwise people will reasonably believe that the administration is not confidence in the efficacy of the current approach. Trying to backdoor policy through the FDA seems like a plan B.

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Great piece. I certainly agree that the most cautious have become a drag on everyone else. My mom, who has not eaten in a restaurant in 19 months, carries hand sanitizer everywhere and won’t take her grandson to gatherings, comes to mind.

There are two basic ways of dealing with this group: (1) slather the cautious and their young children in vaccines to assuage their fears when these vaccines would do much more good in developing countries or (2) tell them they are being silly and need to chill out.

Too little counter scolding has occurred. The covid cautious imposed coercive distancing on people who were aware of covid risks and willing to take them. They frightened healthy young people with exaggerated claims of lethality, failing to note that covid is a pretty minor risk the young and fit. The cautious prostrated our economy out of fear. Now we are supposed to sacrifice middle aged folks in poor countries so that our kids can play with theirs? Rubbish! Better I say that Charlie only plays with children whose parents are not neurotic than that a 50 year old bread winner in India or Iran be denied an mRNA vaccine.

By all means expand supply. That should be uncontroversial. For the moment, there is a tension between children here and 50 year olds in India, and I side with those at hundreds of times greater risk.

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The evidence for Pfizer boosters, at least for folks over 60, is incontrovertible. Current data shows a 10x reduction in risk of death from booster. Boosters for older Americans should have started at least 2 weeks ago.


CDC and FDA are not fit for purpose. Their inability to perform basic risk mitigation under conditions of uncertainty will likely kill thousands of Americans just on the booster decision alone. That's on top of the deaths due to ongoing mask guidance and rapid testing failures.

Biden's top priority right now should be to do whatever is necessary to stand up a competent public health agency that can oversee our pandemic response. What we have right now is worse than nothing.

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If any of the relevant folks at the fda are actually taking vaccine exports into consideration that’s really bad. I’ve been told so many times these last 18 months that they couldn’t bend on this or that bc their credibility as a regulator of safety and efficacy was paramount. Well … is it?

Seems to me like the boosters and shots for most kids are ready for EUA. But maybe they have some expertise that says otherwise. Either way, the rest of the world really has nothing to do with the calculation.

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This was a bad take on Tweet form and is a bad take in full form.

Like it or not, the Chinese regulatory and political authorities are NOT going to allow production resources to be significant reallocated from domestically-developed vaccines to foreign ones, regardless of global need or efficacy.

They’ve been *frantically* native-washing the Fosun-licensed version of Biontech as it’s become apparent that they need it for use as a post-Sinovac booster shot due to the latter’s poor efficacy. It’s already referred to as 自主研发, “independently developed” all over native media, and the initial wall-to-wall skeptical coverage of mRNA vaccines has dissipated.

Meanwhile, the production capacity simply isn’t there. It’s not clear to me that China could turn out a viral vector vaccine (like Sputnik or AZ) in massive, game-changing numbers, but it’s likely they could make a meaningful contribution to global production at least.

Their mRNA production capabilities are in their infancy by comparison. They’ll have significant trouble scaling production at Fosun even with state resources and strong motivation; there’s just no world in which China is able to hugely contribute to a worldwide rollout of Moderna or Pfizer this year.

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Seems like this one could have used more time in the oven. Based a suspicion that FDA is dragging is feet on pediatric approval for RNA vaccines to free up capacity for adults in other countries, we should divert FDA resources towards review of other, less-good Chinese vaccines? Because the FDA stamp of approval would persuade other countries to start using the Chinese vaccines, even tho there's nothing stopping them from doing so now?

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That's a lot of speculation on the FDA's motives. Children have very different biology than adults and it's never been as simple as saying, "Just give a 5-year-old a half dose." Without actually seeing the study protocols, we have no idea what these outcomes are or what safety flags have been raised.

As for boosters, we've discussed this here on previous posts, but the statistics suggest that they're unnecessary in most cases *right now* (subject to change in the future). There's very little stopping people who want a booster from getting one, but you're probably changing the efficacy from ~80% to maybe 90% (I'm guessing; I haven't actually seen the Pfizer data on this). That's not nothing, but the utilitarian argument of prioritizing first doses makes sense in that case, not to mention the vast majority of COVID cases amongst the fully vaccinated have not led to hospitalization.

Finally, I agree with the sentiment about Sinovac, but I'm not sure I follow the argument about inspections. Do developing countries need the FDA to inspect the facilities in order to accept the doses? I'm the last guy to say "trust China" on nearly any issue, but if the Chinese government wants to use Sinopharm/Sinovac as part of their vaccine diplomacy efforts, let them do the inspections and show the world that the facilities are up to snuff!

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Do you have any evidence WHATSOEVER to justify your "strong suspicion" that the FDA is deliberately slow rolling regulatory approval for political ends, or are you just making things up?

Citing Tyler Cowen's increasingly deranged FDA conspiracy theories does not count as evidence.

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I am curious about whether having the FDA inspect the factories in China would help because I'm genuinely not sure. I have a relative in a country that used a lot of Sinovac vaccines and have acquaintances with friend and family members in countries that depended on the Sinovac/Sinopharm vaccines. There isn't a lot of confidence in those vaccines. It's a combination of knowing that they aren't very effective compared to the mRNA , J&J and AZ vaccines, China having sold substandard PPE and Covid tests to many low income countries, and the way China has seemed to strong arm countries into buying their vaccines. On the other hand, even some protection is better than nothing.

Authorizing the NovaVax vaccine would also help. They should have data for the EU in October. It's about as effective as the mRNA vaccines and was specifically designed for use in low-income countries that don't have a lot of freezers. It's also a protein subunit vaccine, so some of the people who don't trust the mRNA vaccines or J&J might be willing to take it. And it seems to have fewer side effects. They're also working on formulating it along with a flu shot.

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This seems like overly conspiratorial thinking. It seems much more plausible to me that the FDA's stated concerns around safety and efficacy of boosters and child vaccines are the real cause of slowness. Two high level people at the FDA recently published an opinion piece describing exactly why they're uncertain that boosters are needed (https://www.statnews.com/2021/09/13/international-review-argues-against-covid-19-vaccine-boosters/), and their paper only mentions equity concerns in passing at the end. For child vaccines, the risk of death from COVID is objectively low, and there is suggestive evidence that myocarditis side effects of the vaccines tend to inversely correlate with age. That was their stated reason for increasing the followup period and increasing the size of the trials. Maybe it's motivated reasoning, and really they're searching for excuses to delay to encourage global distribution of doses, but this is how the FDA has acted for decades: strictly following bureaucratic formulas around what kinds of evidence is necessary and how rigorously it was collected. I mean of course you can disagree about how reasonable this is under the circumstances (I disagree, for the very little that is worth), but there's no reason to think the FDA is not acting on the level.

But also the equity argument for child vaccines is just objectively much weaker than for adult boosters. The doses Pfizer is testing are 1/3rd of an adult dose for 5-12 years and 1/10th of an adult dose for 0.5-4 years. So if the Pfizer vaccine is approved for children at its current dosage, you could vaccinate 10 young children for the cost of vaccinating one adult (or five for the cost of boosting one adult). Children are less likely to spread the disease than adults, and they are more than 10x less likely to experience severe disease than adults. But still, it's not completely obvious that vaccinating 10 young children slows disease spread less than vaccinating one adult. It is fairly obvious that all else equal, a dose is more useful in an unvaccinated adult than boosting a vaccinated non-elderly/immunocompromised adult.

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How quickly should we reasonably hope to get the world vaccinated? By tomorrow would be great, but may not be possible. MY's post hints at "next spring" (in terms of when supply will be a lot greater), but we can make a better estimate of that.

About a third of the globe is fully vaccinated now. Currently, global vaccinations are averaging ~35M/day. At just that rate of administration, we would hit 75% vaccinated in five months. But, as MY notes, global supply is increasing. That is, four months is a more reasonable estimate for hitting 75%, probably five months for 80-85% and so on.

See: https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/?sref=SvwPxqpB

Even faster would be better, but what are the chances that new interventions would speed the process up all that much, if not actually slow it down?

The real problem is hitting the laggards, and understanding why that is the case. As MY notes, Africa is way behind. That's especially the case for the biggest countries: Nigeria, Egypt, South Africa, not to mention DR Congo. Is it simply a matter of funding (something the advanced world can and should fix)? Or poor healthcare systems that simply can't administer the shots no matter the supply?

I think these are the more critical questions than figuring out how to give supplies a jolt.

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Okay, my big question: When did we all decide that, through this whole pandemic, we were going to use the term “normalcy” instead of “normality”? As someone who prefers the latter term, it’s been wild seeing it just completely discarded.

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