COVID Transmissions for 4-8-2021

The law says the US has to hoard vaccines, apparently

Apr 08, 2021

Greetings from an undisclosed location in my apartment. Welcome to COVID Transmissions.

It has been 507 days since the first documented human case of COVID-19. In 507, Clovis I, King of the Franks, codified the Salic Law, a book of laws that influenced all of European law for a thousand years and change. One thing it did was help contribute to loads of royal succession issues—and wars—by calling for patrilineal inheritance.

Sometimes, laws or agreements are made that later have serious unintended consequences.

Today the newsletter is dominated by a complex political-legal situation, again the result of unintended consequences, involving vaccine liability, which is preventing the US from sharing our vaccine hoard with the world. Also a reader comment thread.

As usual, bolded terms are linked to the running newsletter glossary.

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Now, let’s talk COVID.

Vaccine politics: why the US appears to be hoarding vaccines

I was alerted by reader Liz Fong-Jones (who posted about sending this to me on Twitter, so assume is OK with this being public info) to a piece in Vanity Fair that explains how Trump-era contracts are preventing the US from sharing surplus vaccine doses with the rest of the world: https://www.vanityfair.com/news/2021/04/why-the-us-still-cant-donate-covid-19-vaccines-to-countries-in-need

I cannot confirm anything in this story, it really isn’t something I’m close to. But I can somewhat explain what is going on here, from my experience with vaccination and vaccine policy.

The article makes it seem like an issue specific to this vaccine is at play here: the vaccine manufacturers are concerned about being liable for harmful vaccine side effects, and so they negotiated deals with the US where the US assumes liability for these outcomes. They did not negotiate deals with other countries, so if the US sends these doses abroad, they could be liable. Thus, they negotiated that the US cannot send doses abroad without accepting the liability for bad side effects.

I believe this could be true, but it fails to appropriately contextualize this complicated area of vaccine manufacturing law. Specifically, all vaccine manufacturers in the US are immune to lawsuits regarding the safety of their vaccines. This is a matter of federal law, 42 U.S. Code § 300aa–22:

"No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

Now, look, on its face this seems like a law that just protects vaccine manufacturers from liability for no apparently good reason, but that isn’t really how it works. For one thing, let’s note that this only applies to situations where something bad happened despite the vaccine being manufactured and administered correctly with good instructions for use. No one is getting shielded from shipping a contaminated product here.

This law exists for a very specific reason: to make sure that any vaccines are made at all. Basically, the US government had to acknowledge in the 80s that society needs vaccines, but that if individual companies could be sued over every potential vaccine-related death, with no controls in place to limit their liability, it would never be viable to manufacture any vaccines and serious shortages would occur. There have been a lot of nuisance lawsuits about vaccines, and beyond that, there are real harms caused rarely by certain vaccines, and no real limits on what awards might be won in court from lawsuits over those harms. A company could go bankrupt over one extremely rare allergic reaction, even if its vaccine had prevented millions of deaths.

Instead of letting companies go under in this way, the US government created the Vaccine Injury Compensation Program. This is a no-fault program that provides compensation to people who suffer ill effects from vaccines that require medical services to treat. Essentially, the US government assumes the liability for vaccine-related harms, and pays out money to people who submit valid claims of harms from receiving vaccines. This is funded by a $0.75 tax on every vaccine dose for every disease that vaccine prevents (for example, the influenza vaccine is taxed at $0.75 per dose because it prevents one disease, by the measles-mumps-rubella vaccine is taxed at $2.25 per dose). Then, the government puts this money into a trust fund dedicated specifically to paying out claims of vaccine injury that are assessed to be valid.

And the reality is, the US government does have some responsibility to bear for vaccine safety. The FDA reviews vaccines and decides whether these safety risks are acceptable considering the societal benefits of vaccines. It is not solely the manufacturer’s responsibility; the government decides that a vaccine should be on the market, too. The American Committee on Immunization Practices, something sponsored by the CDC, then decides how those marketed vaccines ought to be used. There is a lot of government involvement in vaccine sales, and the advertising and marketing of vaccines by the companies that actually make them is severely restricted.

I just want to note here that there is a reason I am careful to avoid saying that a vaccine is “safe” strictly speaking. Every vaccine can, rarely, have serious and harmful side effects. These are generally treatable and do not cause long-term injury, but I would never say that any pharmaceutical product is “safe.” Safe is a loaded word. I like to say that things have a favorable risk-benefit ratio or profile.

I wouldn’t want anyone to think that there is zero risk associated with vaccines. That would be a lie. Nothing in life is safe. Everything that we do is a prioritization of risk against benefit. Vaccines are the same way. We review the clinical data to assure ourselves that the risk of harm is smaller than the benefit provided, and there are certain red lines in the sand that are drawn. Vaccines are rarely approved if they appear to cause any kind of fatal adverse reaction, for example. That just isn’t something that the FDA is willing to accept, perhaps except under rather extreme conditions. However, sometimes a bad outcome is accepted because many worse outcomes are prevented. For example, the influenza vaccine can cause an additional 1-2 cases per million of a neurological condition known as Guillan-Barre syndrome. Most people recover from this condition, and it is not exclusively caused by the influenza vaccine. However, the influenza vaccine prevents many thousands of influenza cases and deaths each year, eliminating many potential long-term consequences that are more threatening to more people. As a result the risk is considered acceptable relative to the benefit.

In making this determination, the US government has also decided to accept responsibility for the consequences. To me, this makes sense.

In the case of the COVID-19 vaccine, the same assumption of liability was made—though I believe that there may have been even stricter arrangements around it, given that the agreements were made before the vaccine safety profiles were known.

Against that backdrop of unknown outcomes, contracts were drawn up that said the US could only distribute these vaccines domestically, where the manufacturers knew they could not be held completely responsible for negative outcomes. The vaccines could not be sent abroad because then the manufacturers could be held responsible for things that they had no say in. Remember that these doses were being pre-purchased whether or not the vaccines were approved and whether or not they worked. That was the whole point of Operation Warp Speed—get the vaccines manufactured as soon as possible. If one of the vaccines wasn’t safe enough for Americans, what was to stop the President, at the time Donald Trump, from selling doses of that vaccine to a poor country, and letting the vaccine manufacturer bear the consequences of whatever harm then ensued? These contracts are what.

Now, we know these vaccines are exceptionally safe, relatively speaking. Serious outcomes are extremely rare, and when they do occur, they generally are transient and medically manageable without long-term consequences. We did not know this when these contracts were negotiated. Now we do, but the contracts still exist.

So to send vaccine doses to another country, either the US government has to decide to accept responsibility for those doses’ effects, or it has to renegotiate the contracts. I imagine doing one or the other of these things will happen, on a case-by-case basis, such that vaccines can be sent from the US more effectively to other countries. But, I also imagine that getting to these solutions will be slow because it will have to go through both government and corporate bureaucracy. It would be great if we could put that all aside, but I’m not a policymaker. I can’t say what would really work, and I assume that even if well-intentioned, any suggestion I could make could also have unintended consequences.

In my opinion, I would think the US could just ask any country accepting vaccine doses to be willing to settle injury claims according to US laws rather than their own domestic laws, paying the $0.75 tax per dose and allowing the Vaccine Injury Compensation Program to handle claims related to bad outcomes. Maybe that would work. Maybe there are a thousand reasons it wouldn’t. I don’t know.

But I do hope that the US finds a solution to this complicated legal problem, so it can stop hoarding vaccines and start helping to save the world.

What am I doing to cope with the pandemic? This:

Getting out on a bike

It was just beautiful today. I took a bike ride by the river, as I often do on Wednesday,s and it was perfect. That’s really all I can say about that.

Carl Fink had some comments on the CDC guidance regarding surfaces:

That CDC brief on surface transmission is annoying vague about certain things.
Note about your analysis: that's 1 in 10,000 *per surface touched*. If you touch 100 contaminated surfaces per day, the risk would appear to rise to 1% per day! Very few people eat 100 eggs per day. (I know of one toxicologist who did it at least once, but that guy used to do some weird stuff.)
Also, what's a "surface" for this purpose? Each door handle, each light switch, each chair back? You could reach 100 easily, if you're in an area with high incidence of infection.
OTOH, it actually says "less than" 1 in 10,000, so ... did I mention it's annoying vague?
Then again, maybe it doesn't take handwashing into account? It says things like, " Hand hygiene is a barrier to fomite transmission and has been associated with lower risk of infection." and "The risk of fomite transmission can be reduced by wearing masks consistently and correctly, practicing hand hygiene, cleaning, and taking other measures to maintain healthy facilities." It doesn't (as you wrote) make clear if its risk assessment does, or does not, include hand hygiene, but I have to think not. If it did, then would this not imply that it also takes into account mask wearing (How is that relevant to surface transmission), cleaning, and "other measures"? And isn't "other measures" ... annoying vague?

I agree that the guidance—and my writing about it—is full of vagueness and approximations. This is science, but it is very inexact science, and I’ll admit that. Here are some clarifying notes that I gave back to Carl:

I do think it's relatively vague, yeah, but all of this is an approximation. We're never going to have great models for anything in this situation. Let's keep in mind, of course, that even my egg example is approximation based on expectation values, since really, given how randomness works, you'd need to go through about three times that many eggs to be almost guaranteed to get one contaminated egg. There's always some chance that you don't encounter the event within the expected number of iterations; anyone who has flipped a coin twice and gotten the same result has experienced a failure of expectation values to represent reality.
When I said I think it takes into account hand hygiene, I was basing it on the fact that the studies cited either considered the effects of cleaning agents or were conducted in real-world circumstances where cleaning agents might have been deployed. I'm questioning my assumption now, though. Regardless, it remains we have seen VERY few transmission incidents involving surfaces.
I think that all of these studies take into account human behaviors relatively well, because they are all at their heart based on real-world measurement of how much SARS-CoV-2 ends up deposited on various surfaces. So that endpoint, as measured, is going to be affected by all of the mitigation strategies in place to some degree. For example, mask-wearing will be relevant to surface transmission, because it will reduce the amount of output virus from an infected person. Reducing the output virus will reduce how much of it becomes deposited on surfaces.
It's a complex scenario, but ultimately, the proof of the low impact of fomite transmission comes out of the relatively low numbers of definitive fomite-transmitted cases that we have encountered in the wild. SARS-CoV-2 has been out in many environments, and you would think that by now we would have, at the very least, thousands of reports of cases where someone walked into a room that had been occupied by a COVID-19 patient an hour earlier, never had contact with that patient, and then became ill. We don't have thousands of such reports, which says to me that fomite (surface) transmission must be exceptionally rare.
The risk level of "less than 1 in 10,000" (it was estimated to range from 1 in 10,000 to 1 in 1,000,000 by the cited paper) is based on reconciling the above fact with information already known about how much virus deposits on surfaces. It's not a rigorous scientific fact, but rather a model based on two observations that have been made. We know that fomite transmission is rare, we know how much virus is likely to be deposited on surfaces, and in trying to reconcile those two things, the authors of the main cited paper came to their reported risk model.
Like most models, it's inadequate and vague, I have to agree, but I think it does help us to prioritize risk. All models are wrong, but some are useful—as the old saying in statistics goes.

You might have some questions or comments! Send them in. As several folks have figured out, you can also email me if you have a comment that you don’t want to share with the whole group.

Join the conversation, and what you say will impact what I talk about in the next issue.

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