COVID Transmissions for 3-30-2021

Mar 30, 2021

Greetings from an undisclosed location in my new apartment. Good morning and welcome to COVID Transmissions.

It has been 498 days since the first documented human case of COVID-19. In 498, Kavadh I returned from exile to the Sassanid Empire, with an army of 30,000. He used this army to punish those who ousted him, including his own brother.

I think if we can take something away from this, it’s that if you turn your back on a threat it’s may come back to bite you. The same could happen with COVID-19.

Today we have a short headlines section and a lot of response to reader comments, because some really interesting ones have come in.

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

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Now, let’s talk COVID.

US situation: CDC director Walensky warns of “impending doom” while President Biden urges that mask mandates be restored

I can’t believe I’m writing this, but it looks like the US may be set for a fourth surge in cases, despite a timeline for full adult availability of vaccines.

Yesterday the CDC director, Dr. Rochelle Walensky, told Americans that she has a sense of “impending doom” and that a fourth surge is looking more likely.

Meanwhile, the President urged governors around the country who have ended mask mandates that these need to be restored so that we can try to slow or stop the spread.

The New York Times covers both stories here: https://www.nytimes.com/2021/03/29/us/politics/biden-virus-vaccine.html

I’m sorry that this isn’t some interesting science story. The principles here are not new, and I’ve talked about the risks that we run, here in the “fourth quarter” of this pandemic and the score favoring human success. This is ours to lose. We need to do everything we can not to lose it, and the US needs to get with that program. At the federal level it now appears we have leaders who want to fight the pandemic. I’m hoping we can have that at the state and local level, too.

I would really like to be able to cover interesting science instead of doom and gloom that could be solved if people would be responsible and try to keep each other safe.

Results from the WHO investigation of SARS-CoV-2 origins

A WHO team has been investigating virus origins. Consider this a placeholder, because the actual report comes out today. However, early journalism on this based on draft versions suggests that the most likely origin scenario is a natural spillover event of the virus from bats or other animals into humans, and not something more unusual or exotic. Not a big surprise to me, but once I have access to the final report, I’ll look at it in detail and report back here.

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

Passover

Passover takes over one’s life, as I’ve said before. This year, we held a seder at which almost everyone was vaccinated. In accordance with CDC guidelines, one unvaccinated individual can associate with a household of all vaccinated individuals—in this equation, I was the unvaccinated person. Even so, to reduce the risk level, we held our seder outside on our new apartment’s balcony.

We went for a catered food option, which I have to say was really worth the added expense. It saved me enough time that it more than paid for itself. While many of you will be aware that I love to cook, when it comes to Passover in a new apartment during a pandemic, I have to admit that outsourcing that task was a good call.

Duration of protection

Reader Deborah Blass asked for a clarification—a much-needed one, I might add—about the implications of the story I covered last issue regarding how well-protected people with past COVID-19 infection are:

Should we read this to conclude that people who got sick from COVID-19 do not need to be vaccinated? I believe this has not been the official guidance.

Here’s my reply:

No, I definitely would not say that previous COVID-19 illness is protective enough to skip vaccination. Immune responses to natural infection are too variable, and response to vaccination are very consistent.
It is still an open question as to whether or not the two-dose vaccines need to have both doses given in previously-infected patients, but having both doses doesn't seem to cause any harm--I've covered this before in issues you may have read.
As always, I recommend following the recommendations of the FDA and CDC with regard to vaccination as well as consulting your doctor, but in my opinion everyone who is medically and legally qualified to do so should receive one of the authorized vaccines according to the labeled instructions for use without deviation.

While in the news item that I covered, I was talking in broad strokes about large populations, a vaccination is a personal medical intervention. Perhaps at the population level, a combination of infection-induced and vaccine-induced immunity could help us slow the spread of COVID-19—I don’t know for sure—but at the individual level, there are too many variables in a person’s immune response to a virus for me to say each and every person who has been infected is adequately as well-protected against future COVID-19 as they would be if they got the vaccine.

While symptomatic reinfections may be relatively rare, they still happen. I personally know someone who has had this happen, so it must not be all that rare. Your best bet for protection is vaccination. I need to be clear about that.

DIY vaccines

Reader Orborde left the following series of comments:

I think you're kind of missing the point on RaDVaC.
RaDVaC was put together by people with the appropriate expertise applying reasonable design criteria, and it uses a delivery mechanism that is (as far as I know) incredibly difficult to render unsafe. So I'd ballpark a 10% chance that it does work, and a 1% or less chance that using it could hurt you.
A 10%-chance effective (but almost certainly safe) vaccine is pretty crummy, but you can't evaluate that in a vacuum - you have to compare it to what the regulated pharma pipeline has produced, which is, for me, a 34-year-old healthy male in the United States, no vaccine whatsoever so far. And there's not a lot of reason to believe that the existing system would move any faster for a variant that evaded existing vaccines. Given that situation, I think "take your chances with RaDVaC (assuming they updated it to address emerging strains)" is far from a stupid move.
You correctly point out that RaDVaC isn't produced according to modern pharmaceutical standards, but I think this is not an especially compelling objection. The impossible-to-homebrew part (peptide synthesis) is handled by firms with the specialized equipment to do it, and there's no strong reason to think that they'd fail to do their job. And I think you overstate the extent to which careful production controls are strictly necessary, even for products that are complex mixes of large organic molecules: as far as I know, smallpox vaccination ~100 years ago involved individual pharmacists just kinda getting vaccinia preparations from a catalog and mixing them up in the kitchen, so to speak. I doubt that this would pass modern regulatory scrutiny, and yet it worked well enough.
At a high level, I think the level of care our civilization has taken around COVID-19 vaccines is striking the wrong cost-benefit tradeoff in the face of a disease that's killing thousands of people every day.

To be clear: here's the decision I think is appropriate for me: if RaDVaC cost <$20, I would take it and then continue to take lots of precautions. I'm not very confident in RaDVaC's effectiveness, but it's better than nothing.
I haven't taken RaDVaC because I think it would take at least $1,000 of time and money.

I realized that I didn't have as clear a picture of early smallpox vaccine production as I thought. I found this pretty informative: https://www.sciencedirect.com/science/article/pii/S0264410X2030668X

I pieced this together from multiple comments, but I wanted to start off by being thankful for that link at the end. That was a pretty interesting article about the history of smallpox vaccine manufacturing and regulation thereof. Thanks for sharing that!

That said, I strongly disagree with the sentiments expressed here. Of course ultimately anything involving this is a personal decision, but decisions have consequences, and not always just on the decider. Here is my—very long—reply:

I think you're wrong, to be very clear. I think you are missing quite a few key points of understanding on the difference between products created for human use versus products created for research use, which is really vitally important to understand the issues with RaDVaC and other DIY operations compared with regulated manufacturers with real oversight. I'll discuss that in detail, but I want to begin with this:
"I am not very confident in RaDVaC's effectiveness, but it's better than nothing."
Prove it. What makes it better than nothing? What is the safety profile of RaDVaC that supports this claim? How many people will have fatal allergic reactions if this preparation is administered to them? How many people will have debilitating neurological reactions? What is the dollar value of the healthcare resources that will be diverted, per dose administered, to dealing with less severe adverse reactions to this product?
Answering these questions is why we do clinical trials. We do not have the answers to these questions for these DIY vaccines, and untested medications create unreasonable systemic burdens, so you cannot explain this away by saying it is a "personal choice." It is not a personal choice if you end up filling a hospital bed.
Physicians and other healthcare professionals have a crystal-clear perspective on the need to maintain standards, because every intervention that is not safe has the potential to turn them from a healer into an assassin. There is a reason that an evidence-based approach to medicine has evolved over the years, and it is because we wish to be certain beyond reasonable doubt that the risk-benefit profile of a given medication is favorable in the prevention or treatment of the indicated condition.
When "citizen-scientists" circumvent the scientific process through projects like this, they not only harm the cause of evidence based medicine, though. They also harm the cause of science. We've developed science in order to answer questions in a way that gives us reliable answers. We have left in the past the days of trying to do things off a guess and hoping for the best. RaDVac represents a return to the latter out of desperation, and it is a definitive step backwards.
You bring up a claim that vaccinia preparations were made generally by individual pharmacists 100 years ago--though I'm aware the article you shared indicates that this isn't actually true. Even so, let's travel back to an even more recent world where smallpox vaccination was routine. Vaccinia causes serious adverse reactions. It can spread from the site of vaccination throughout the body, and to other people, potentially causing fatal infections. See here for a summary: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1069029
However, we are aware that it works and that the risk of death from smallpox is substantially higher than the risk of death from the vaccine. This is, again, something that we learned through careful study, development, and improvement of the vaccine and the vaccination process. By the 1960s, there were still fatal events involving the smallpox vaccine, although they had become exceedingly rare. Before the 20th century, however, we did not have the medical surveillance quality to really monitor these events. The standardization of manufacturing has also coincided with improvements in our ability to detect safety events in the field use of medical products--a field known as pharmacovigilance.
I'm saying this to point out that we don't really know how many people bad smallpox vaccines killed before there were standards in place for their manufacture. It's not an example we can actually have a fully informed conversation about. We can't support the claim that it "worked well enough." It took almost 200 years to eradicate smallpox, and for most of that time, we don't have any information on whether or not common vaccine preparations did more harm than good, because we didn't have robust clinical trials or the technology to run them. In the end we beat smallpox, but I don't feel confident saying we beat it with an optimal strategy and no unnecessary deaths.
However, there are some things I do feel confident making statements about. We do know that vaccine manufacture can go quite wrong. The Cutter Incident, a famous disaster involving polio vaccine manufacturing, resulted in 5 fatalities and even more cases of disease. That was an error made by improper inactivation of polio virus at Cutter Labs, and was a key moment in the history of GxP development. A lot of the standards that are observed today originated with things like the Cutter Incident, because the fact is, when mistakes are made, people can die. Another more recent example has to do with the contamination of the rotavirus vaccine Rotarix with porcine circoviruses. Sure, these are ultimately considered harmless, but there are many non-harmless pathogens that can find their way into bioreactors. If a massive pharmaceutical company with legions of quality control specialists missed virus contamination, do you think a rogue operator with no process control would somehow do better? If you wish to make a bet on this, remember what you're gambling with--it's not just the lives of the people receiving the vaccine, it's also the reputation of vaccination as a concept.
When people die or have other adverse outcomes, there are serious and impactful harms on the overall cause of vaccination. Antivaccination campaigners are, I assure you, delighted to see people play fast and loose with safety in the medical community. It provides them with ammunition to claim that the industry cares only about profits and that "natural" treatments are safer.
Public confidence in vaccines matters a lot. For vaccines to be really effective, they need to be adopted at a scale where they have population-level impacts. We're seeing this now in Israel with COVID-19 vaccines, as the overall rates of disease and even test positivity are plummeting as more and more of the country is vaccinated. This is made possible by a public that trusts the science behind vaccination--because that science is available. I can't condone any kind of maverick project that could potentially put an unsafe treatment into a human being, kill them, and thus undermine another 100 or 1,000 people's confidence in vaccination. The only thing that I can condone is evidence-based approaches that show us that a product works.
Now, you can object that COVID-19 is killing thousands of people every day, and we have to do something. And you're right, but the thing you're suggestion isn't it. What we had to do was isolate, wear masks, and develop national test-and-trace strategies. Most countries did this, and the ones that did not have suffered worse for their recklessness. Trying to solve that recklessness with more reckless and risky approaches doesn't make sense to me.
I'm glad we didn't trade the problem of COVID-19 for the problem of open-air medical experimentation on desperate people with interventions that were about as likely to do harm than good. Yes, it meant we had to wait longer for a safe and effective vaccine, but the fact that some countries let the pandemic run amok during that waiting time is not the fault of the vaccination development program. That part was run responsibly and was a huge success. In the US at least, it's everything else that failed.

Look, the reality is that it takes studies, effort, and quality control to produce vaccines and medicines that balance safety with efficacy. Given in the wrong amounts or at the wrong time, any substance can be a poison, so a system of very stern and serious medical ethics has been developed. This system was not developed because it sounded like a good idea. It was developed because we tried other approaches and people died unnecessarily. Many rules of bioethics are written in blood. We live in a world that has benefited from those past mistakes, both in terms of the things we have learned about human health and also in terms of learning not to make those mistakes again. DIY vaccines are a 18th century solution, with 18th century consequences. We live in the 21st century. Life isn’t as cheap as it used to be. We make every effort to preserve it, by testing medical interventions ethically and with care. I strongly believe in this approach, and there is little that will convince me otherwise.

When I say “vaccines are safe and effective,” it is not because I have a religious conviction in this fact. It is because the studies were done and the work was reviewed and published. Approaches that don’t do the work and don’t take medical ethics into consideration are not going to win my favor. Yes, I’m firm about this, and yes, there will be those who disagree, but that’s how I feel.

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.

Also, let me know any other thoughts you might have about the newsletter. I’d like to make sure you’re getting what you want out of this.

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